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Transdermal Formulation For Muscle Protein Synthesis.

Abstract: TITLE: TRANSDERMAL FORMULATION FOR MUSCLE PROTEIN SYNTHESIS. ABSTRACT: The transdermal formulation for muscle protein synthesis. More particularly the present invention relates to a cream formulation comprising Creatine phosphate, Potassium chloride, essential amino acids, and essential trace elements as an active ingredients. The present transdermal formulation to deliver therapeutic levels of a drug which causes or assist in muscle protein synthesis. The present invention further in addition to active ingredient in formulation contains ingredient form the category of vasodilator and antioxidant agent to a form a composition. The present invention more particularly applicable for better protein synthesis in the targeted muscle mass before, during and/or after strenuous work out or exercises like resistance training, marathon running, swimming, high intensity interval training. The formulation further assists in preventing sarcopenia/muscle loss in adults when applied daily on all body muscles.

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Patent Information

Application #
Filing Date
27 June 2020
Publication Number
03/2022
Publication Type
INA
Invention Field
FOOD
Status
Email
patent@infinventip.com
Parent Application

Applicants

THRIVE SELFCARE LLP
B-15 & 16, Basement Smrajya II, Mujmahud, Vadodara, Gujarat, India - 390007

Inventors

1. MR. RAJESH C PARIKH
B-604, Bhadralok Apartment, Near Tube company, old Padra Road, Vadodara, Gujarat, India 390007

Specification

DESC:FIELD OF THE INVENTION:
The present invention relates to a topical formulation containing Amino acids and minerals with creatine phosphate composition for transdermal application. More particularly the present invention relates to a synergistic composition for transdermal application is a cream formulation. The present cream formulation is use for increasing muscle mass after strenuous work out or exercise during rest time where the user desires muscle pump and better protein synthesis in the targeted muscle mass before, during and/or after strenuous work out or exercises like resistance training, marathon running, swimming, high intensity interval training. The formulation further assists in preventing sarcopenia/muscle loss in adults when applied daily on all body muscles.
BACKGROUND OF THE INVENTION:
Skeletal muscle protein synthesis (MPS) usually stimulated by Feeding and resistance exercise. Food supplements for enhancing an athlete's muscle size and strength have become popular substitutes for steroids and other drugs in various sports and body building regimes. However, as athletes continually strive for improved performance, there is a continuing need for supplements for improving lean muscle mass and strength.

One factor which enables any person or specifically to an athlete to participate effectively is a high degree of development of the aerobic capacity and/or strength of skeletal muscle. Strength is a function of training and of muscle mass which requires a net synthesis of proteins in the muscle. Strenuous exercise is an effective stimulus for protein synthesis. Exercise is the repeated use or activity of a muscle group or organ. Exercise is bodily exertion for the sake of developing and maintaining physical fitness. Anaerobic exercise occurs when the activity results in the body incurring an oxygen debt. In contrast, aerobic exercise is physical conditioning involving exercise that does not cause an oxygen debt, such as distance running, jogging, walking, swimming, circuit training or cross country skiing strenuously performed so as to cause a marked, but steady increase in respiration and heart rate over an extended period of time.
Athletes engage in strenuous training to accomplish the goals of their sport. In the period after strenuous exercise, muscle tissue enters a stage of rapid nitrogen absorption in the form of amino acids and small peptides in order to rebuild the muscle fibers, grow and add new muscle fibers. Athletes sometimes enter into a catabolic state during this period. For example, this can happen during sleep after the release of the body's growth hormone (GH) has abated, and drastically cuts the body's ability to synthesize new protein.
Human growth hormone is secreted in a pulsatile fashion following a circadian rhythm. GH has many varied roles throughout life, including increasing rate of protein synthesis and increased turnover of muscle, bone and collagen to the regulation of metabolic function including increased fat metabolism. It is known that about 90% of the body's daily supply of growth hormone is released during the first four hours that a person sleeps. Thus, during sleep, if proteins and nutrients are made readily available to muscles, the body can successfully perform the muscle-repairing, muscle-rebuilding processes that ultimately result in increased muscle size and strength.
Some protein supplements in the form of solid foods and drinks abound. Therefore, one might naturally attempt to wake up during the night to consume one of the many protein supplements during this four (4) hour peak of growth hormone production. However, this method may not work and may be counterproductive to gaining lean muscle mass because many of these supplements have been designed and developed for rapid absorption.
Specialized “pre-workout” and “post-workout” protein supplements are very effective in enhancing muscle growth when used just before and just after strength training, but these may not be optimum when it comes to mitigating sleep-induced muscle catabolism because the proteins are digested and assimilated so rapidly. In addition, the proteins in typical protein supplements are rapidly used up after only the first hour or so of sleep, leaving little protein to be used during the most productive period of slow-wave sleep, when about 90% of the body's growth hormone is released. Waking up in the middle of the night to consume another serving of a typical protein supplement is ultimately counterproductive, since the practice results in disruption of sleep patterns and increased cortisone from the stress accompanied with sleep loss. These stress factors greatly reduce the probability that the protein serving will contribute to protein synthesis and will also disrupt whatever constructive synthesis may be taking place at the moment of waking. The only viable solution to the problem is invention envisioned herein, whereby proteins and carbohydrates are provided in a manner that doesn't disrupt slow wave sleep, GH release or insulin-like growth factor-1 (IGF-I) metabolism, but works in concert to encourage growth of muscle and promote a feeling of relaxation during periods of rest.
Therefore, in order to maximize muscle growth, necessary proteins and nutrients need to be provided to the body to utilize during this growth hormone spike and subsequent increase in endogenous IGF-I levels that occurs secondary to the growth hormone a spike and lasts for several hours. Providing proteins and nutrients throughout the night time period is important in order to make full use of the anabolic and ant catabolic properties of both GH and IGF-I. In this way, muscle and strength loss due to sleep induced catabolism may be reduced. That is, the body needs to be provided with the proper building blocks during the rest stage in order to maximize muscle growth.
There is also a need for a nutritional supplement that increases muscle strength during periods when training efforts have stopped (i.e. during sleep or exercise during periods of rest between physical workouts) and the body in a state of repair and growth. It is during this period of repair and growth that there is a desire to prolong the rate of protein digestion over an extended period because it is important that the muscle cells have available sufficient levels of nitrogen in the form of amino acids.
Even though there are various prior art available on muscle mass building composition but those are the general state of the art and particularly not relevant to the present invention.
The present invention is directed as compositions for topical application of said composition in cream formulation for increasing muscle mass, muscle size and strength after exercise and/or between physical workouts. Apart from various dosages form of available for the said composition in individual or with some other form, topical application at the right portion is more acceptable. Also oral form of consumption is associated with gastric irritation and taste masking problems associated with it. The present invention claims cream formulation which alone or in combination with each other are available in market either as oils to be applied as it is on the skin of affected part, or as ointments and balm. All these formulations are very oily and give greasy feeling. It is not very easy to wash off. Ointment and balm are thick, not very easily spreadable.
Considering the preexisting prior arts related to present invention, the present invention enhances deals with composition formulated in cream dosage form for transdermal drug delivery. Transdermal delivery can be defined as the application of a drug to the skin for treat systemic disease or disorders or any target deficiencies. The main aim of this delivery is achieving systemically active levels of the drug or active constituents at the site of deficiency. The main important requisite for this delivery is percutaneous absorption with appreciable systemic drug accumulation.
Further protein Synthesis and pumping at targeted Muscle, the transdermal cream composition is approached in order to avoid GI (Gastro-Intestinal) absorption and first pass metabolism. In addition the present cream formulation achieves various objective for above mentioned objective easy skin penetration with comprising ingredients, increases blood flow with nitric oxide flux to increase muscle pump and along with anabolic agents promotes protein synthesis to increase muscle mass.
The present invention of synergistic composition is a cream formulation. Cream is a semisolid emulsion formulation for application to the skin or mucous membranes. Water in oil (w/o) emulsion type creams are less greasy and good spread ability as comparison to ointments whereas oil in water (o/w) emulsion creams readily rub into the skin is termed as vanishing cream and is readily removed by water. Application on skin or body surface is also soothing as compared to other topical dosage forms.
The present formulation in Cream formulations and is easy to wash and not greasy. Also Cream base contain large amounts of water so that can increase the release of the drug. In present cream formulation the surface tension of the skin will be lowered by the emulsifiers so that absorption. Further present cream formulation is easy to use, provides good drug dispersion on the skin surface.
SUMMARY OF THE INVENTION:
The principal objective of the present invention to provide a synergistic composition comprising extracts or fractions derived from salvia tomentosa; creatine phosphate, essential amino acids, trace minerals, potassium chloride; and at least one ingredient from Anti-inflammatory, antioxidants, vasodilator, antispasmodic, analgesic agents and formulation thereof, for increasing muscle strength or muscle mass.
Another objective of the present invention is to disclose a synergistic herbal composition of the present invention is for transdermal application and is particularly a cream formulation.
Another object of the present invention is to disclose herbal composition wherein Anti-inflammatory agent is oils extract from plant source, including cypress oil or ginger oil or mixture thereof.
Yet another object of the present invention is to disclose herbal composition wherein Antioxidant agent is extract from plant source including Aloe Vera or tocopherol or mixture thereof.
Another object of the present invention is to disclose herbal composition wherein Antispasmodic - Analgesic Agent oils extract from plant source including Olive oil, Orange oil or mixture thereof.
Another object of the present invention is to disclose herbal composition wherein vasodilator oils extract from plant source including lemongrass oil or eucalyptus oil or mixture thereof.
Another aspect of the present invention discloses aforesaid formulation for herbal composition containing Humectant, Emulsifier – Lubricant, Penetration Enhancer, Fragrance and Distilled Water.
Another object of the present invention is to disclose composition of cream formulation for herbal composition wherein Humectant is glycerin or sorbitol or mixture thereof.
Another object of the present invention is to disclose composition of cream formulation for herbal composition wherein Emulsifier – Lubricant is stearic acid or bees wax or carnauba wax or mixture thereof.
Another object of the present invention is to disclose composition of cream formulation for herbal composition wherein penetration enhancer is Jojoba oil or ethanol or mixture thereof.
Another object of the present invention is to disclose composition of cream formulation for herbal composition wherein emulsifying stabilizer is stearic acid or emulsifying wax or mixture thereof.
In another aspect of the present invention it contains present formulation vitamins molecule can be selected from various forms of tocopherol, shows activity of vitamin E.
According to the aspect of the present invention, there is provided a synergistic composition for increasing muscle mass during the period of resting time after exercise.
In another aspect of the present invention provides composition for suppressing exercise induced excessive inflammation.
Yet another aspect of present invention is, it provides composition for increasing muscle mass and suppressing exercise induced anxiety and exercise induced nausea.

DETAIL DESCRIPTION OF THE INVENTION:
The present invention in detailed provides a synergistic herbal composition use therapeutically for increasing and building lean muscle mass.
In still another embodiment of the present invention is an herbal composition, wherein the said composition is in form of cream.
The invention will now be described in detail in connection with certain preferred and optional embodiments, so that various aspects thereof may be more fully understood and appreciated. However, any skilled person will appreciate the extent to which such embodiments could be extrapolated in practice.
The present invention of cream formulation discloses one ingredient from the category of Anti-inflammatory, antioxidants, vasodilator, antispasmodic, analgesic agents and formulation of cream for increasing muscle strength or muscle mass thereof.
The present cream formulation contains active ingredients, excipients to form cream base along with some acceptable additives and fragrance to add refreshing effect in present cream formulation.
In yet another embodiment, herbal composition wherein the plant extracts are obtained from plant parts selected from leaf, seeds, floral parts rhizome and aerial parts.
Creams are semi-solid emulsions of oil and water. They are divided into two types: oil-in-water (O/W) creams which are composed of small droplets of oil dispersed in a continuous water phase, and water-in-oil (W/O) creams which are composed of small droplets of water dispersed in a continuous oily phase. Oil-in-water creams are more comfortable and cosmetically acceptable as they are less greasy and more easily washed off using water. Water-in-oil creams are more difficult to handle but many drugs which are incorporated into creams are hydrophobic and will be released more readily from a water-in-oil cream than an oil-in-water cream. Water-in-oil creams are also more moisturising as they provide an oily barrier which reduces water loss from the stratum corneum, the outermost layer of the skin.
Transdermal delivery systems (TDS) are self-contained, discrete dosage forms that, when applied to intact skin, are designed to deliver the drug(s) through the skin to the systemic circulation. Systems typically comprise an outer covering (barrier), a drug reservoir that may have a drug release–controlling membrane, a contact adhesive applied to some or all parts of the system and the system/skin interface, and a protective liner that is removed before the patient applies the system. The dose of these systems is defined in terms of the release rate of the drug(s) from the system and surface area of the patch and is expressed as mass per unit time for a given surface area. With these drug products, the skin typically is the rate-controlling membrane for the drug input into the body. The total duration of drug release from the system and system surface area may also be stated. TDS work by diffusion: The drug diffuses from the drug reservoir, directly or through the rate-controlling membrane and/or contact adhesive if present, and then through the skin into the general circulation. Typically, modified-release systems are designed to provide drug delivery at a constant rate so that a true steady-state blood concentration is achieved and maintained until the system is removed. Following removal of the system, blood concentration declines at a rate consistent with the pharmacokinetics of the drug.
Creams are multiphase preparations consisting of a lipophilic phase (oil phase) and an aqueous phase.
Lipophilic creams: Lipophilic creams have as the continuous phase (larger component) the lipophilic phase. They usually contain water-in-oil emulsifying agents such as lanolin, sorbitan esters and monoglycerides.
Hydrophilic creams: Hydrophilic creams have as the continuous phase (larger component) the aqueous phase. They contain oil-in-water emulsifying agents such as sodium or trolamine soaps, sulfated fatty alcohols, polysorbates and polyoxyl fatty acid and fatty alcohol esters combined, if necessary, with water-in-oil emulsifying agents.
Creams are semisolid dosage forms containing one or more drug substances dissolved or dispersed in a suitable base. This term has traditionally been applied to semisolids that possess a relatively fluid consistency formulated as either water-in-oil or oil in water emulsions. However, more recently the term has been restricted to products consisting of oil-in-water emulsions or aqueous microcrystalline dispersions of long-chain fatty acids or alcohols that are water washable and more cosmetically and aesthetically acceptable.
The choice of cream base depends on the drug, base compatibility, absorption: skin properties, blood flow and type of wound. The main consideration is the consistency of the expected dosage, the properties of the substance used and the basic requirements include: non-irritant, easy to clean, not left on the skin, stable not dependent on pH, homogenous with various drugs.
The cream base consists of a base type W / O and O / W emulsion:
- W / O type emulsion base. Example: lanolin, cold cream. The properties of the W / O type emulsion base are emollient, occlusive, contain water, some absorb added water, and oily.
- O / W type emulsion base. Example: hydrophilic ointment. The properties of the O / W type emulsion base are easily washed with water, not greasy, can be diluted with water, not occlusive.
During use, a continuous phase will evaporate, and increase the concentration of water soluble substances in the attached layer. To prevent the deposition of drugs, and to increase absorption through the skin, added substances that are mixed with water but do not evaporate, namely humectant. A better formulation is a cream that can deposit fat and other moisturizing compounds to help hydrate the skin.
The emulsion base consists of three components, namely the oil phase, water phase and emulsifier.
The oil phase:
Oils make up, anywhere between 11 and 24% of the bulk of a cream. The heavier purely medicinal creams contain a higher proportion of oil but water is still their major ingredient. Oil-soluble herbal ingredients like resins dissolve and become incorporated into this phase which gives creams a richer and heavier feel. Many oils are susceptible to oxidation or rancidification over a period of time. This process is hindered by the addition of antioxidants like vitamin E, to all our creams and lotions. The oil phase is usually formed from petrolatum or liquid petrolatum with one or more high molecular weight alcohols such as cetyl or stearyl alcohol. Stearil alcohol and petrolatum form the oil phase which has the purpose of softening and making the skin comfortable. Stearyl alcohol also acts as an emulsifying adjuvant.
In the present invention ingredients Lemongrass oil, Orange Oil, Cypress Oil, Ginger Oil, Eucalyptus Oil, Tocopherol, Stearic acid, Emulsifying Wax, Carnauba Wax, Jojoba Oil comprises the oil phase for the cream formulation and amounts 5-50% w/w of the formulation.
The aqueous (water) phase:
Water constitutes the major ingredient (61-77%) of most creams. The lighter and more cosmetic-type creams contain more water and less oil. This phase contains the water-soluble herbal ingredients of a cream. In our creams, the water phase is never tap or deionised water as is the case with most creams, except in our base cream. We always incorporate beneficial high quality active ingredients into the water phase in the form of distilled aromatic waters, strong infusions and decoctions and cold percolates of organic herbs.
The water phase contains preservatives, emulsifiers or parts of emulsifiers and humectants. Humectants are usually in the form of glycerine, propylene glycol or polyethylene glycol. The water phase can also contain water-soluble components from the emulsion system, along with other additives such as stabilizers, antioxidants, buffers etc.
In the present invention ingredients comprises Leucine, Isoleucine, Valine, Lysine, Threonine, Methionine, Phenylalanine, Tryptophan, Disodium hydrogen phosphate, MgO, CaO, KCl, Creatine Phosphate, Aloe-vera, Ethanol, Sorbitol, Glycerine, Na-Methyl Paraben, Phenoxy-ethanol the aqueous phase for the cream formulation.
Leucine, Isoleucine, Valine, Lysine, Threonine, Methionine, Phenylalanine, Tryptophan, Disodium hydrogen phosphate, MgO, CaO, KCl, Creatine Phosphate, Aloe-vera, Ethanol, Sorbitol, Glycerine, Na-Methyl Paraben, Phenoxy-ethanol and amounts 5-50% w/w of the formulation.
Emulsifier:
The ideal emulsifiers must stable, inert, free of toxic and irritant ingredients, odourless, tasteless and colourless, produces a stable emulsion of the desired type. The emulsifying agent consists of anionic emulsifiers, cationic and non-ionic emulsifiers. The main consideration in choosing an emulsifiers is the comparison of hydrophilic and lipophilic groups. Hydrophilic Lipophilic Balance (HLB) is a measure of the balance of the state of lipophilic and hydrophilic which is a characteristic of the surfactant group emulsifiers.
The most important step in producing an emulsion is the selection of a suitable emulsifier. The most commonly used emulsifiers are anionic and nonionic systems, or combinations of the two. The primary selection is based on the emulsion type (oil/water or water/oil) and the emulsifier must be compatible with the oil phase, water phase and the actives used in the formulation. The primary emulsifier is the main determinant factor of the emulsion type, while the secondary emulsifier serves to strengthen the interphase thereby improving its stability. The use of sodium soaps is often rejected, as they are too alkaline. When neutralized they produce a hard soap with limited solubility. Potassium Stearate is one of the most widely used emulsifiers as they are cheap and readily available. But it is irritating to the skin the skin and has a tendency to gel with time. A number of other factors like mildness on skin, color, odor, emollient effect and solubility in both the phases would also be considered while selecting the emulsifier system. The emulsifiers to be incorporated in the herbal compositions are selected from stearic acid, sodium stearate, potassium stearate, PEG 400 stearate, Glyceryl monostearate, Arlacel 165, bees wax, carnauba wax, emulsifying wax or mixture thereof.
Stearic acid:
Stearic Acid may be used to form the base of other ingredients that are intended to be incorporated into formulations as lubricants, emollients, and emulsifiers. In emulsions, Stearic Acid is an effective stabilizer, thickener, and softener that contributes a cooling sensation on the skin. It is also known to contribute a pearly finish to lubricants.
Bees wax or carnauba wax:
Used to thicken formulations, with emollient and protective qualities, waxes can provide stability to cream and topical applications and boost their viscosity and consistency.
Beeswax is naturally produced in the bee hive or honeycomb. Beeswaxes are BP/USP certified and come in white or yellow colour. Carnauba wax is obtained from the leaves of the Carnauba palm of Brazil. It is used in many polishes and personal care products as it imparts excellent shine and hardness.
Emulsifying wax:
Emulsifying Wax is the chemical uses to bind oil and water together to form a smooth lotion, cream and emulsion.
Emulsifying wax is a cosmetic emulsifying ingredient. The ingredient name is often followed by the initials NF, indicating that it conforms to the specifications of the National Formulary.
Emulsifying wax is created when a wax material (either a vegetable wax of some kind or a petroleum-based wax) is treated with a detergent (typically sodium dodecyl sulfate or polysorbates) to cause it to make oil and water bind together into a smooth emulsion. It is a white waxy solid with a low fatty alcohol odor.
The ingredients for emulsifying wax NF are cetearyl alcohol and a polyoxyethylene derivative of a fatty acid ester of sorbitan (a polysorbate)
In a cream product, if the emulsifying wax used meets the standards for the National Formulary, it may be listed in the ingredient declaration by the term "emulsifying wax NF". Otherwise, the emulsifier is considered a blended ingredient and the individual components must be listed individually in the ingredient declaration, placed appropriately in descending order of predominance in the whole. In present cream formulation also it acts as an emulsifier and stabilizer.
Humectant:
Humectants (or moisturizers) are important cream ingredients allowing to prevent loss of moisture thereby retaining the skin's natural moisture. Some compounds also have the ability to actively attract moisture. Humectants are key ingredients in most skin care products but are also often used in hair care products to volumize the hair by attracting moisture which expands the hair shaft. There is a large variety of very different compounds providing moisturizing effects including proteins, acids, polysaccharides, and various small molecules.
In present invention humectant is selected from sorbitol or urea or aloe vera or urea or glycols or essential oils like eucalyptus oil, jojoba oil, peppermint oil, fennel oil, almond oil or mixture thereof.
Sorbitol:
Natural polyhydric alcohol derived from a sugar solution (dextrose) from wheat (gluten-free), consists of the alcohols D-glucitol & D-mannitol. White, crystalline powder, slightly sweet odor. Soluble in water or alcohols. Effective moisturizing properties (avoids moisture loss). It acts as a stabilizes gels and provides good clarity, has skin softening and conditioning effects. In present formulation it support as a moisturizer and preservative.
Sorbitol is also used as a humectant moisturizer in as creams formulation. A humectant is a hygroscopic substance that often has a molecular structure with several hydrophilic groups. This structure allows humectants to attract and retain the moisture in the air nearby via absorption, drawing the water vapor into or beneath the surface.
Glycerin:
In present cream formulation glycerin acts as a neutralizing agent and as a moisturizer. Glycerin is a humectant, a type of moisturizing agent that pulls water into the outer layer of your skin from deeper levels of your skin and the air. In skin care products, glycerin is commonly used with occlusive, another type of moisturizing agent, to trap the moisture that it draws into the skin.
Permeation Enhancer:
The human skin serves as an impediment, a thermo regulator and prevents excessive loss of water from the internal organs. Various ways of transferring the drugs have been developed by modifying the barrier properties of the skin. Enhancement in skin penetration by hydration of the stratum corneum, or by use of chemical enhancers acting on the lipids and keratinized structures in the stratum corneum, partitioning and solubility effects is a promising tool in potential clinical applications. Penetration enhancement is a new emerging technology which has the potential to increase the number of drugs taken trans-dermally. Also the drugs with short biological half-life could be easily administered. Among many advantages over other routes the three crucial ones are avoiding metabolism in liver, minimal negative effects and increased bioavailability. Also, the stratum corneum prevents the loss of physiologically essential substances and as a result provides penetration resistance by acting as a protective barrier. This is the rate limiting step in the absorption of the drug percutaneously.
Permeation enhancers are those substances which promote the absorption of drug through the skin temporarily by transiently enhancing the skin permeability. They are employed to transfer the delivery of drugs which are ionizable and impermeable; to maintain drug levels in blood, to provide higher dose of less potentially active drugs, to deliver high molecular weight hormones and peptides and to lessen the lag time of transdermal drug delivery system.
For the present invention the permeation enhancers are selected from Ethanol, dimethyl sulfoxide, dimethyl isosorbide, Isopropyl myristate and propylene glycol, eucalyptus oil, jojoba oil, peppermint oil, fennel oil, almond oil or mixture thereof.
Preservatives:
Preservatives are used to retard microbial (bacterial and fungal) contamination of cosmetics. The high water content of many cosmetics makes them suitable places for microbial growth. Combinations of preservatives are frequently used. The preservatives would include a combination of any 2-5 preservatives from the list - methyl paraben, propyl paraben, butyl paraben, Quaternium-8, -14 or -15, imidazolidinyl urea, diazolidinyl urea, phenoxy ethanol, citric acid and ethanol.
For the present invention preservative for cream formulation is selected from methyl paraben, propyl paraben, butyl paraben, phenoxy ethanol, citric acid, Sorbic Acid/Potassium sorbate, Levulinic Acid, Anisic Acid and ethanol.
Ethanol:
Ethanol in cream formulation or topical applications acts as a skin penetration enhancer and facilitate the transdermal absorption of active ingredients also. In the present cream formulation it also acts as a solvent vehicle. In cream formulation it acts as a preservative for increasing the shelf life of all the ingredients in the composition.
Jojoba oil:
In the present formulation it acts as moisturizer and skin penetration for getting better result as a transdermal formulation. In most of the transdermal application like cream, lotion, ointments it acts a preservative also.
Fragrance:
The fragrance(s) that may be included in the composition are not relevant to the inventive concepts disclosed herein, and those skilled in the art are familiar with the wide range of fragrances available. Therefore, any suitable fragrance or combination of fragrance natural and/or artificial, is within the contemplated scope of the present disclosure.
Essential amino acids:
Amino acids, often referred to as the building blocks of proteins, are compounds that play many critical roles in your body. They're needed for vital processes like the building of proteins and synthesis of hormones and neurotransmitters. Some may also be taken in supplement form for a natural way to boost athletic performance or improve mood. They’re categorized as essential, conditionally essential or nonessential depending on several factors.
Essential Amino Acids:
Amino acids are organic compounds composed of nitrogen, carbon, hydrogen and oxygen, along with a variable side chain group. Human body needs 20 different amino acids to grow and function properly. Though all 20 of these are important for health, only nine amino acids are classified as essential. These are histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan and valine. Unlike nonessential amino acids, essential amino acids can’t be made by human body and must be obtained through diet. The best sources of essential amino acids are soya bean, fruits, milk products, cereals, animal proteins like meat, eggs and poultry. When we eat protein, it’s broken down into amino acids, which are then used to help body with various processes such as building muscle and regulating immune function.

Conditionally Essential Amino Acids:
There are several nonessential amino acids that are classified as conditionally essential. These are considered to be essential only under specific circumstances such as illness or stress. For example, although arginine is considered nonessential, body can’t meet demands when fighting certain diseases like cancer. That’s why arginine must be supplemented through diet in order to meet body’s needs in certain situations.
The nine essential amino acids perform a number of important and varied functions in human body in addition to strengthening muscle and assist in muscle protein synthesis:
Phenylalanine: Phenylalanine is a precursor for the neurotransmitters tyrosine, dopamine, epinephrine and norepinephrine. It plays an integral role in the structure and function of proteins and enzymes and the production of other amino acids.
Valine: Valine is one of three branched-chain amino acids, meaning it has a chain branching off to one side of its molecular structure. Valine helps stimulate muscle growth and regeneration and is involved in energy production.
Threonine: Threonine is a principal part of structural proteins such as collagen and elastin, which are important components of the skin and connective tissue. It also plays a role in fat metabolism and immune function.
Tryptophan: Though often associated with causing drowsiness, tryptophan has many other functions. It’s needed to maintain proper nitrogen balance and is a precursor to serotonin, a neurotransmitter that regulates your appetite, sleep and mood.
Methionine: Methionine plays an important role in metabolism and detoxification. It’s also necessary for tissue growth and the absorption of zinc and selenium, minerals that are vital to your health.
Leucine: Like valine, leucine is a branched-chain amino acid that is critical for protein synthesis and muscle repair. It also helps regulate blood sugar levels, stimulates wound healing and produces growth hormones.
Isoleucine: The last of the three branched-chain amino acids, isoleucine is involved in muscle metabolism and is heavily concentrated in muscle tissue. It’s also important for immune function, hemoglobin production and energy regulation.
Lysine: Lysine plays major roles in protein synthesis, hormone and enzyme production and the absorption of calcium. It’s also important for energy production, immune function and the production of collagen and elastin.
Histidine: Histidine is used to produce histamine, a neurotransmitter that is vital to immune response, digestion, sexual function and sleep-wake cycles. It’s critical for maintaining the myelin sheath, a protective barrier that surrounds your nerve cells.
There are 20 different amino acids that make up the thousands of different proteins in human body. Nine of the 20 are considered essential amino acids, meaning they cannot be made by your body and must be obtained through diet. Of the nine essential amino acids, three are the branched-chain amino acids (BCAAs): leucine, isoleucine and valine.
Effect of BCAA along with essential amino acids on muscle:
? Increase Muscle Growth
One of the most popular uses of BCAAs is to increase muscle growth. The BCAA leucine activates a certain pathway in the body that stimulates muscle protein synthesis, which is the process of making muscle. Whey protein contains all the essential amino acids needed to build muscle. Therefore, while BCAAs can increase muscle protein synthesis, they can’t do so maximally without the other essential amino acids.
? Decrease Muscle Soreness
BCAAs can help decrease muscle soreness after a workout. This soreness is called delayed onset muscle soreness (DOMS), which develops 12 to 24 hours after exercise and can last up to 72 hours. BCAAs have been shown to decrease muscle damage, which may help reduce the length and severity of DOMS. Several studies show that BCAAs decrease protein breakdown during exercise and decrease levels of creatine kinase, which is an indicator of muscle damage. In one study, people who supplemented with BCAAs before a squat exercise experienced reduced DOMS and muscle fatigue compared to the placebo group. Therefore, supplementing with BCAAs, especially before exercise, may speed up recovery time.
? Reduce Exercise Fatigue
Everyone experiences fatigue and exhaustion from exercise at some point. How quickly one tire depends on several factors, including exercise intensity and duration, environmental conditions and your nutrition and fitness level.
Our muscles use BCAAs during exercise, causing levels in your blood to decrease. When blood levels of BCAAs decline, levels of the essential amino acid tryptophan in your brain increase. In brain, tryptophan is converted to serotonin, a brain chemical that is thought to contribute to the development of fatigue during exercise.
? Prevent Muscle Wasting
BCAAs can help prevent muscle wasting or breakdown. Muscle proteins are constantly broken down and rebuilt (synthesized). The balance between muscle protein breakdown and synthesis determines the amount of protein in muscle. Muscle wasting or breakdown occurs when protein breakdown exceeds muscle protein synthesis. Muscle wasting is a sign of malnutrition and occurs with chronic infections, cancer, periods of fasting and as a natural part of the aging process.
Physiology of amino acid involvement in muscle protein synthesis and muscle strengthening:
In humans, BCAAs account for 35% of the essential amino acids found in muscle proteins. They account for 40% of the total amino acids required by our body.
Therefore, it’s important that the BCAAs and other essential amino acids are replaced during times of muscle wasting to halt it or to slow its progression.
The use of BCAA for inhibiting muscle protein breakdown is suggested. This may improve health outcomes and quality of living in certain populations, such as the elderly and those with wasting diseases like cancer.
Branch chain amino acids (BCAAs) have unique properties with diverse physiological and metabolic roles. They have functions other than simple nutrition. Different diseases including metabolic disease lead to protein loss, especially muscle protein. Supplementation of BCAAs promotes protein synthesis and reduces break down, as well as improving disease conditions. They are important regulators of mTOR signaling pathway and regulate protein synthesis as well as protein turnover. BCAAs facilitate glucose uptake by liver and skeletal muscle and also enhance glycogen synthesis. Oxidation of BCAAs seems to be beneficial for metabolic health as their catabolism increases fatty acid oxidation and reduces risk of obesity. BCAAs are also important in immunity, brain function, and other physiological aspects of well-being. All three BCAAs are absolutely required for lymphocyte growth and proliferation. They are also important for proper immune cell function. BCAAs may influence brain protein synthesis, and production of energy and may influence synthesis of different neurotransmitters.
Initiation of mRNA translation is one of the key steps in protein synthesis. Amino acids may stimulate protein synthesis by enhancing this important step of protein synthesis. Deacylated tRNA reduces or inhibits protein synthesis by affecting the initiation step. BCAAs may lead to formation of aminoacyl-tRNA derivatives that enhance initiation of protein synthesis by minimizing that inhibitory effect. Another possible way that BCAAs may influence protein synthesis is the formation of active metabolic intermediate by the oxidation of BCAAs. BCAAs have unique role in protein synthesis as well as in turnover.
A significant increase of muscle protein synthesis and significant decrease in protein degradation were observed in perfused supplemented group compared to control. It was also observed that when the BCAAs were removed from complete mixture of amino acids, the rest of the amino acids showed no effects on protein turnover. So, BCAAs not only enhance protein synthesis, but also influence protein turnover.
BCAAs make up a large proportion of the total amino acid content in skeletal muscle and are readily broken down (catabolized) to produce energy during exercise. Taking BCAAs before and after training ensures that the blood has an abundance of essential amino necessary to fuel workout and support recovery, which increases fatigue resistance, protects the body from catabolism and decreases recovery time. The BCAA leucine also boosts the release of the anabolic hormone insulin. One’s insulin levels to be rapidly elevated after workouts because this hormone carries nutrients such as glucose and amino acids into muscle cells, promoting greater protein synthesis and muscular gains.
Potassium Chloride (KCl):
It is the third most abundant mineral in the human body and is a powerful element in improving health. It contains the components for maintaining a high level of well-being and an improved lifestyle.
Apart from acting as an electrolyte, this mineral is required for keeping the heart, brain, kidney, muscle tissue, and other important organ systems of the human body in a good condition. Potassium chloride is the main variety of this mineral, and it works in association with sodium to perform a number of critical tasks within the body.
Chloride ion released form potassium chloride helps to balance the normal electrolyte balance in the body, maintain buffer system of the body and maintain pH balance of the body.
The health benefits of potassium include relief from stroke, high blood pressure, heart and kidney disorders, and anxiety and stress. It helps enhance muscle strength, metabolism, water balance, electrolytic functions, and the nervous system.
? Beneficial health benefits of potassium:
It is often considered an essential nutrient that cures blood pressure, reduces anxiety and stress, and improves many more health disorders.
Stimulates Neural Activity:
It plays an important role in keeping brain function at a normal level. High levels of potassium allow more oxygen to reach the brain, thereby stimulating neural activity and increasing cognitive function.
It is of great importance in preventing the occurrence of stroke in the human brain. It is no secret that people at high risk for this tragic condition are often found to be deficient in this essential nutrient. Since it acts as a vasodilator, the blood vessels relax throughout the body when a proper amount of this mineral is consumed. This means that blood flows more freely and is less likely to clot and break off to cause strokes.
Stabilizes Blood Sugar:
A decrease in the potassium level causes a drop in blood sugar. A decrease in blood sugar can cause sweating, headache, weakness, trembling, and nervousness. Intake of potassium chloride and sodium provides immediate relief from such situations. This is also why diabetics are encouraged to keep their potassium levels normal, to reduce the chances of unpredictable spikes and plunges in their glucose and insulin levels by stabilizing the blood sugar levels throughout the body.
Reduces Muscle Disorders:
A sufficient concentration of this mineral is required for the regular contraction and relaxation of muscles. Most of the potassium ions in the human body are located in the muscle cells. It maintains optimal muscle and nerve function and helps keep reflexes fast because it stimulates the neural connectivity of muscles and the brain.
Prevents Cramps:
Muscle cramps are a common result of low levels of potassium in the blood, a condition called hypokalemia.
Enhances Bone Health:
The benefits of potassium even extend to improving the health of your bones. There are certain qualities of this mineral that neutralize various acids in the body, which helps in retaining and preserving calcium, making it accessible to use for bone strength and durability.
Regulates neural function:
Potassium channels play a key role in maintaining the electrical conductivity of the brain and dramatically affecting the brain function. It is also involved in higher brain function like memory and learning. In addition to this, ailments like epilepsy are related to the dysfunction of potassium channels that can occur through its deficiency. There are potassium currents that play a major role in mammalian neurons. These channels are interconnected with a vast array of neural function and can help moderate and regulate electrical currents throughout the body.
Stabilizes Blood Pressure:
Potassium is helpful in reversing the role of sodium in unbalancing normal blood pressure. Thus, it acts as a vital component that maintains the normality of blood pressure in the human body. This further reduces the risk of heart diseases and hypertension. Regulation of blood pressure is one of the most important functions of this powerful mineral. As mentioned earlier, it has vasodilation properties that work to relieve the tension of blood vessels, which is one of the main causes of high blood pressure.
Strengthens Muscles:
One of the useful benefits of potassium is its role in ensuring the proper growth of muscle tissues and the utilization of energy released during metabolism, which adds significantly to muscular strength.
Stimulating cell growth and providing the metabolic energy to do so is a vital function of potassium and muscular health would be compromised without it. Also, without the contraction and relaxation that potassium allows muscles to perform, exercise and additional muscle training would be impossible.
? Deficiency of Potassium:
Potassium is an essential nutrient that the body requires for a wide range of functions, including keeping the heart beating. Severe potassium deficiency is called hypokalemia, and it occurs when a person’s potassium levels fall below 3.6 millimoles per liter (mmol/L).
Doctors consider a person to have severe hypokalemia a potentially life-threatening condition when their potassium levels are less than 2.5 mmol/L.
Muscle weakness:
Potassium deficiency can affect other muscles in the body, including those in the arms and legs, which can lead to general muscle weakness and cramping.
A person loses small amounts of potassium through sweat, which is why heavy sweating from intense physical activity or being in a hot climate can often lead to muscle weakness or cramping.
Unexplained fatigue:
Potassium is an essential nutrient that is present in all of the body’s cells and tissues. When potassium levels fall, this can significantly affect a wide range of bodily functions, which can lead to low energy levels and both physical and mental fatigue.
Muscle paralysis:
People with severe hypokalemia can experience muscle paralysis. When the levels of potassium in the body are very low, the muscles are unable to contract properly and may stop working altogether.
? Mechanism of effect of potassium on muscle:
The concentrations of extracellular and intracellular potassium (K+) in skeletal muscle influence muscle cell function and are also important determinants of cardiovascular and respiratory function. Several studies over the years have shown that exercise results in a release of K+ ions from contracting muscles which produces a decrease in intracellular K+ concentrations and an increase in plasma K+ concentrations. Following exercise there is a recovery of intracellular K+ concentrations in previously contracting muscle and plasma K+ concentrations rapidly return to resting values. The cardiovascular and respiratory responses to K+ released by contracting muscle produce some changes which aid exercise performance. Increases in the interstitial K+ concentrations of contracting muscles stimulate CIII and CIV afferents to directly stimulate heart rate and the rate of ventilation. Localised K+ release causes a vasodilatation of the vascular bed within contracting muscle. This, together with the increase in cardiac output (through increased heart rate), results in an increase in blood flow to isometrically contracted muscle upon cessation of contraction and to dynamically contracting muscle. This exercise hyperaemia aids in the delivery of metabolic substrates to, and in the removal of metabolic endproducts from, contracting and recovering muscle tissues. In contrast to the beneficial respiratory and cardiovascular effects of elevations in interstitial and plasma K+ concentrations, the responses of contracting muscle to decreases in intracellular K+ concentrations and increases in intracellular Na+ concentrations and extracellular K+ concentrations contribute to a reduction in the strength of muscular contraction. Muscle K+ loss has thus been cited as a major factor associated with or contributing to muscle fatigue. The sarcolemma, because of changes in intracellular and extracellular K+ concentrations and Na+ concentrations on the membrane potential and cell excitability, contributes to a fatigue 'safety mechanism'. The purpose of this safety mechanism would be to prevent the muscle cell from the self-destruction which is evident upon overload (metabolic insufficiency) of the tissues. The net loss of K+ and associated net gain of Na+ by contracting muscles may contribute to the pain and degenerative changes seen with prolonged exercise. During exercise, mechanisms are brought into play which serve to regulate cellular and whole body K+ homeostasis. Increased rates of uptake of K+ by contracting muscles and inactive tissues through activation of the Na(+)-K+ pump serve to restore active muscle intracellular K+ concentrations towards precontraction levels and to prevent plasma K+ concentrations from rising to toxic levels. These effects are at least partially mediated by exercise-induced increases in plasma catecholamines, particularly adrenaline.
Further, Interstitial potassium concentration, [K+], is modulated during muscle activity due to a number of different mechanisms: diffusion and active transport of K+ in combination with water fluxes. The relative significance of the various mechanisms for muscle function is quantified. The effect of interstitial [K+] locally on the single muscle fiber is discussed along with its effect on the cardiovascular and respiratory systems and its role in motor control. It is concluded that K+ may play a significant role in the prevention as well as the development of fatigue.
Creatine Phosphate:
Phosphocreatine, also known as creatine phosphate (CP) or PCr (Pcr), is a phosphorylated creatine molecule that serves as a rapidly mobilizable reserve of high-energy phosphates in skeletal muscle, myocard and the brain to recycle adenosine triphosphate, the energy currency of the cell.
In the kidneys, the enzyme AGAT catalyzes the conversion of two amino acids — arginine and glycine — into guanidinoacetate (also called glycocyamine or GAA), which is then transported in the blood to the liver. A methyl group is added to GAA from the amino acid methionine by the enzyme GAMT, forming non-phosphorylated creatine. This is then released into the blood by the liver where it travels mainly to the muscle cells (95% of the body's creatine is in muscles), and to a lesser extent the brain, heart, and pancreas. Once inside the cells it is transformed into phosphocreatine by the enzyme complex creatine kinase, which makes it able to donate its phosphate group to convert adenosine diphosphate (ADP) into adenosine triphosphate (ATP). This process is an important component of all vertebrates' bioenergetic systems. For instance, while the human body only produces 250g of ATP daily, it recycles its entire body weight in ATP each day through creatine phosphate.
Creatine phosphate can be broken down into creatinine, which is then excreted in the urine. A 70-kg man contains around 120g of creatine, with 40% being the unphosphorylated form and 60% as creatine phosphate. Of that amount, 1–2% is broken down and excreted each day as creatinine.
Creatine in increasing muscle strength and energy:
Adenosine triphosphate (ATP) is the most basic form of energy in your body's cells. It plays a fundamental role in metabolism and muscle function. Unfortunately, one can only store enough ATP for 8–10 seconds of high-intensity exercise. After this, one body must produce new ATP to match the demands of the activity. Performing exercise at maximum intensity requires more ATP per second than body can produce. Creatine increase body's stores of phosphocreatine, which is used to produce new ATP during high-intensity exercise. In addition to creatine's role in ATP energy production, it also improve the function of muscle cells in other ways. One way is an increase in the water content of muscle cells, which is known as cell volumization or swelling. It may also increase IGF-1, a key hormone for muscle growth.
These changes trigger several processes that lead to the formation of new proteins, subsequently creating new muscle mass. Creatine may also help to reduce muscle breakdown and retain muscle during exercise. This may result in a greater amount of muscle in the long-term. Another long-term benefit of creatine is the ability to perform more exercises or repetitions and lift heavier weights per training session.
Trace minerals:
Micro nutrients are basically vitamins and minerals and fiber. Specifically trace minerals are those which required in the diet each day in smaller amounts, specifically 100 milligrams or less but their long term deficiency may lead to severe problems in human body. Trace minerals are very essential for building muscles and eventually strengthening them.
They can be found in a huge variety of foods, but the highest concentrations are found in fruits and vegetables, meats, grains and pulses to name just a few. A lack of variety in the diet can lead to deficiencies in certain nutrients.
Micro nutrients help to maximize muscle growth, support recovery and help to maintain health and immune function.
The body uses the vitamins and minerals to facilitate physiological functions such as energy production, muscle contraction and tissue growth \ repair– essential parts of the muscle building process.
It is understood, therefore, that this invention is not limited to the particular embodiments or examples disclosed, but is intended to cover modifications within the objectives and scope of the present invention as defined in the specification. The presented examples illustrate the invention, but they should not be considered to limit the scope of the invention in any way.
The following example describe the invention and are in no way limiting the scope of the invention.

Transdermal formulation comprising herbal composition for muscle protein synthesis:

Sr.
No.:
INGREDIENTS
CONCENTRATION

1. Leucine 0.5-20%
2. Isoleucine 0.5-20%
3. Valine 0.5-20%
4. Lysine 0.5-20%
5. Threonine 0.5-20%
6. Methionine 0.5-20%
7. Phenylalanine 0.5-20%
8. Tryptophan 0.5-20%
9. Disodium hydrogen phosphate 0.2-5%
10. MgO 0.2-5%
11. CaO 0.2-5%
12. KCl 0.2-10%
13. Creatine Phosphate 0.2-10%
14. Lemongrass oil 0.1 to 20%
15. Orange Oil 3 to 15 %
16. Cypress Oil 0.5 to 15%
17. Ginger Oil 0.1 to 8%
18. Eucalyptus Oil 1 to 25%
19. Tocopherol 0.1 to 5%
20. Stearic acid 2 to 20%
21. Emulsifying Wax 2 to 18%
22. Carnauba Wax 2 to 12%
23. Jojoba Oil 2 to 18%
24. Aloe-vera L/E 2.5 to 10%
25. Ethanol 5 to 15%
26. Sorbitol 2 to 8%
27. Glycerine 5 to 15%
28. Na-Methyl Paraben 0.1 to .15%
29. Phenoxy-ethanol 0.1 to 0.3%
30. Distilled Water q.s

METHOD OF PREPARATION:
1. In one container, dissolve essential amino acid, Aloe Vera Extract/Gel in same with Ethanol and half quantity of water.
2. In another container, dissolve MgO, CaO, Dihydrogen phosphate, KCL and Creatine phosphate in one container with distilled water and mix with the above step.
3. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
4. Mix Step 1 and Step 3 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
5. Mix all other essential oils, carrier oil and preservative in above step 3.
6. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
7. Mix Step 5 in Step 6.
8. Continue to mix until it become proper blend and consistent Cream.

EXAMPLE: 1

Transdermal formulation comprising herbal composition for muscle protein synthesis:

Sr. No.
INGREDIENTS
CONCENTRATION

1. Leucine 2%
2. Isoleucine 4%
3. Valine 2%
4. Lysine 0.70%
5. Threonine 0.40%
6. Methionine 0.15%
7. Phenylalanine 0.80%
8. Tryptophan 0.25%
9. Disodium hydrogen phosphate 4%
10. MgO 0.50%
11. CaO 0.50%
12. KCl 0.50%
13. Creatine Phosphate 2%
14. Lemongrass oil 4%
15. Orange Oil 2%
16. Cypress Oil 2%
17. Ginger Oil 1%
18. Eucalyptus Oil 12%
19. Tocopherol 0.40%
20. Stearic acid 16%
21. Emulsifying Wax 5%
22. Carnauba Wax 4%
23. Jojoba Oil 8%
24. Aloe-vera L/E 2.50%
25. Ethanol 3%
26. Sorbitol 3%
27. Glycerine 6%
28. Na-Methyl Paraben Quantity S.
29. Phenoxy-ethanol Quantity S.
30. Distilled Water Quantity S.
METHOD OF PREPARATION:
1. In one container, dissolve essential amino acid, Aloe Vera Extract/Gel in same with Ethanol and half quantity of water.
2. In another container, dissolve MgO, CaO, Dihydrogen phosphate, KCL and Creatine phosphate in one container with distilled water and mix with the above step.
3. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
4. Mix Step 1 and Step 3 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
5. Mix all other essential oils, carrier oil and preservative in above step 3.
6. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
7. Mix Step 5 in Step 6.
8. Continue to mix until it become proper blend and consistent Cream.

EXAMPLE: 2
Transdermal formulation comprising herbal composition for muscle protein synthesis:

Sr. No.
INGREDIENTS
CONCENTRATION

1. Leucine 0.20%
2. Isoleucine 0.40%
3. Valine 0.22%
4. Lysine 0.70%
5. Threonine 0.40%
6. Methionine 0.25%
7. Phenylalanine 0.40%
8. Tryptophan 0.12%
9. Disodium hydrogen phosphate 2%
10. MgO 0.25%
11. CaO 0.50%
12. KCl 0.20%
13. Creatine Phosphate 4%
14. Lemongrass oil 4%
15. Orange Oil 2%
16. Cypress Oil 2%
17. Ginger Oil 1%
18. Eucalyptus Oil 12%
19. Tocopherol 0.40%
20. Stearic acid 16%
21. Emulsifying Wax 5%
22. Carnauba Wax 4%
23. Jojoba Oil 8%
24. Aloe-vera L/E 2.50%
25. Ethanol 3%
26. Sorbitol 3%
27. Glycerine 6%
28. Na-Methyl Paraben Quantity S.
29. Phenoxy-ethanol Quantity S.
30. Distilled Water Quantity S.

METHOD OF PREPARATION:
1. In one container, dissolve essential amino acid, Aloe Vera Extract/Gel in same with Ethanol and half quantity of water.
2. In another container, dissolve MgO, CaO, Dihydrogen phosphate, KCL and Creatine phosphate in one container with distilled water and mix with the above step.
3. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
4. Mix Step 1 and Step 3 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
5. Mix all other essential oils, carrier oil and preservative in above step 3.
6. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
7. Mix Step 5 in Step 6.
8. Continue to mix until it become proper blend and consistent Cream.

EXAMPLE: 3
Transdermal formulation comprising herbal composition for muscle protein synthesis:
Sr. No.
INGREDIENTS
CONCENTRATION

1. Leucine 4%
2. Isoleucine 8%
3. Valine 4%
4. Lysine 1.50%
5. Threonine 0.90%
6. Methionine 0.35%
7. Phenylalanine 0.50%
8. Tryptophan 0.40%
9. Disodium hydrogen phosphate 6%
10. MgO 3%
11. CaO 2%
12. KCl 4%
13. Creatine Phosphate 6%
14. Lemongrass oil 4%
15. Orange Oil 2%
16. Cypress Oil 2%
17. Ginger Oil 1%
18. Eucalyptus Oil 12%
19. Tocopherol 0.40%
20. Stearic acid 16%
21. Emulsifying Wax 5%
22. Carnauba Wax 4%
23. Jojoba Oil 8%
24. Aloe-vera L/E 2.50%
25. Ethanol 3%
26. Sorbitol 3%
27. Glycerine 6%
28. Na-Methyl Paraben Quantity S.
29. Phenoxy-ethanol Quantity S.
30. Distilled Water Quantity S.

METHOD OF PREPARATION:
1. In one container, dissolve essential amino acid, Aloe Vera Extract/Gel same with Ethanol and half quantity of water.
2. In another container, dissolve MgO, CaO, Dihydrogen phosphate, KCL and Creatine phosphate in one container with distilled water and mix with the above step.
3. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
4. Mix Step 1 and Step 3 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
5. Mix all other essential oils, carrier oil and preservative in above step 3.
6. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
7. Mix Step 5 in Step 6.
8. Continue to mix until it become proper blend and consistent Cream.

Cream base formulations are easy to spread and remove. Cream base drug delivery system with proper excipients and manufacturing process is elegant drug delivery system. Cream base drug delivery system is pleasing both in appearance and feel post application also. Creams are not greasy and easy to rinse. They are very good for the most of the topical purposes and are considered particularly suited for application on skin portion and inflamed sites also. The present invention is formulated in cream base and hence most preferred drug delivery system for aforesaid herbal composition.
Any methods of delivery and/or administration of present application is considered within the scope of this invention, including for example and not by way of limitation, tablet, capsule, powder, granule, microgranule, pellet, soft gel, controlled release form, liquid, Solution, elixir, syrup, Suspension, emulsion, magma, gel, cream ointment, lotion, transdermal. Sub lingual, ophthalmic, nasal, optic, aerosol, inhalation, spray, parenteral, Suppository and the like. In Suitable cases, composition may be administered by intravenous or intra-arterial infusion. Compositions of the present invention may also be administered in Nutraceuticals or functional foods. In addition the effective amount of present application may be combined with amino acids, botanicals, functional foods, herbals, nucleotides, Nutraceuticals, pharmaceuticals, proteins, and/or vitamins in an effort to enhance the targeted activity.
STABILITY STUDY OF CREAM FORMULATION:
Storage stability study has been conducted for present cream formulation comprising aforesaid composition. The results are generated for exemplified combinations are provided merely as illustrations of the invention and are not intended to be construed as a limitation thereof.

Table 1: Storage stability Study of the cream formulation:


*Y-yes, NC-Not Changed.

Table 2:
C1 Creatine Phosphate(2%)+KCL(1.5%)+MgO(0.4%)+ Selected EAAs (Leucine(1.4%), Isoleucine(0.55%),Valine(1.25),Lysine(1.00%),Threonine(0.80%),Phenylalanine(0.90%),Tryptophan(0.27))+Cao(0.4)
C2 Creatine Phosphate (1%)+KCL(0.8%)+MgO(0.2%)+ Selected EAAs (Leucine(0.7%),
Isoleucine(0.28%),Valine(0.630%),Lysine(0.5%),Threonine(0.40%),Phenylalanine(0.450)%,Tryptophan(0.15))+Cao(0.2)
C3 Creatine Phosphate(3%)+KCL(2.25%)+MgO(0.6%)+ Selected EAAs(Leucine(2.1%),
Isoleucine(1.60%),Valine(1.8),Lysine(1.5%),Threonine(1.20%,Phenylalanine(1.40%),Tryptophan(0.41))+Cao(0.6)
C4 Creatine Phosphate(4%)+KCL(3.5%)+MgO(0.8%)+ Selected EAAs (Leucine(2.8%), Isoleucine(2.20%),Valine(2.5),Lysine(2.1%),Threonine(1.60%,Phenylalanine(1.93%),Tryptophan(0.55))+Cao(0.8)
C5 Creatine Phosphate(5%)+KCL(4.2%)+MgO(1%)+ Selected EAAs (Leucine(3.5%), Isoleucine(2.80%),Valine(3%),Lysine(2.70%),Threonine(2%),Phenylalanine(2.40%),Tryptophan(1.2))+Cao(1%)
EFFICACY STUDY OF CREAM FORMULATION:
Table 3:
Formulation Code Composition
CONTROL No application of cream or cream with no active ingredients

F1 Cream formulation without Essential amino acids (Creatine Phosphate(4%)+KCL(3.5%)+MgO(0.8%)+Cao(0.8)+) with listed cream Base
F2 Cream formulation with only Essential amino acids (Leucine(2.8%),Isoleucine(2.20%),Valine(2.5),Lysine(2.1%),Threonine(1.60%,Phenylalanine(1.93%),Tryptophan(0.55))+Cao(0.8)+) with listed cream Base
F3 Marketed cream Formulation contains BCAAs only
F4 Patented Formulation contains Creatine
Phosphate(4%)+KCL(3.5%)+MgO(0.8%)+ Selected EAAs (Leucine(2.8%),Isoleucine(2.20%),Valine(2.5),Lysine(2.1%),Threonine(1.60%,Phenylalanine(1.93%),Tryptophan(0.55))+Cao(0.8)+with listed cream base)

EXAMPLE: 4
STUDY PURPOSE: This study is based on the Total Lean mass of selected subjects on the application of Designed formulation with marketed Preparation on applying up to 4 weeks and 8 weeks.
CONDITION: All Subjects Weight and Age noted and they are following the regular diet up to the period of study. Body caliper used to measure the Body fat with the percentage at the site of particulars at Biceps, Triceps and Chest. Form the total weight of Body and from the percentage Body fat, here we get the Lean muscle mass of subject with our Patented Formulation.
Result:
Avg. Actual increase in Lean Body Mass after 4 Weeks Avg. Actual Increase in Lean Body Mass after 8 Weeks Cumulative Percentage 1 Cumulative Percentage2
ONLY EXERCISE 0.425 0.942 0 0
FORMULA:1 0.423 0.917 99.5294118 97.3460722
FORMULA:2 0.669 1.85 157.411765 196.390658
FORMULA:3 0.534 1.54 125.647059 163.481953
FORMULA:4 0.902 2.14 212.235294 227.176221

CONCLUSION:
From the above stated Result, we can conclude that after applying F4 we can increase in Lean Body mass up to 212% from the routine exercise after 4 weeks and 227% from the routine exercise which is 168% and 134% more compare to marketed Formulation (F3) respectively after 4th and 8th weeks and 138% and 115% more compare to Essential Amino acid formulation respectively after 4th and 8th weeks.

EXAMPLE: 5
STUDY PURPOSE: This study is based on the estimation of Total serum protein selected subjects on the application of Designed formulation with marketed Preparation on applying up to 4 weeks an 8 weeks with compare to control (without applied Cream subjects)
CONDITION: All Subjects Weight and Age noted and they are following the regular Diet up to the period of study. Biuret method used to estimate the concentration of total serum protein by using UV Spectroscopic method at 546nm. Here we prepared the standard solution by using 100g/L solution and prepared standard mean with concentration to compare the physiological solution of our blood samples taken from applying our patented formula and marketed preparations. Form the total weight of Body and from the percentage Body fat, here we get the Lean muscle mass of subject with our Patented Formulation.
Result:
Avg Normal Protein Level of Subjects (n=20) Avg Normal Protein Level of Subjects after applying Cream(n=20) for 4 weeks Avg Normal Protein Level of Subjects after applying Cream(n=20) for 8 weeks cumulative 1 cumilitive2
ONLY EXERCISE 66.25 67 67.5 0 0
FORMULA:1 66 66.75 69 99.62686567 102.222222
FORMULA:2 69.5 74.75 79.75 111.9850187 115.57971
FORMULA:3 64.5 71.25 78 106.3432836 115.555556
FORMULA:4 65 75.25 85.5 112.3134328 126.666667

CONCLUSION:
From the above stated Result, we can conclude that after applying F4 we found in % of total serum protein level is 112% and 126% from without applying cream after 4 weeks and 8 weeks respectively, it also conclude that F4 also increase Serum Protein level of subjects from F3 (Marketed Product) up to 6% and 10% after 4 weeks and 8 weeks respectively and from F2 (only EAAs) it helps to increase up to 5% and 10% after 4weeks and 8 weeks respectively. From this we conclude that Our Formulation F4 is boosting the Muscle mass and Protein synthesis after strenuous workout to furnish body.
From this above two examples, we conclude that Our Formulation F4 is boosting the Muscle mass and Protein synthesis after strenuous workout to furnish body.

EXAMPLE: 6
Subject Number: 4
Days of application: 1-7 and 15
Applied Quantity: 0.5 to 1 g of each Cream
Method of Application on Subject:
The bio-efficacy study of the present cream formulation is done with comparison to marketed cream formulation; and placebo or control with no active ingredients or none of the formulation applied on subject.
The study was done based on applying formulation on biceps, triceps and chest region of 4 different age and weight group of human subjects has been done. The effect is monitored as a visual observation and comments of the subject after applying the formulation during exercise. More particularly on lifting the variable weights by the human subjects and its effect on the number of sets of variable weights lifted by the subject has been collected.
Normal sets (without any cream application)
On starting time of exercise with 2 number of set with both hand with marketed cream.
Applied on right hand at targeted site before doing weight lifting
With patented cream: applied on left hand at targeted site before doing weight lifting.

Table 4:
D Sub Formulation

Area Wgt in AvgNo. Wgt in AvgNo. Wgt in AvgNo. Wgt in AvgNo.
A No. of Kg lifted of sets Kg lifted of sets Kg lifted of sets Kg lifted of sets
Y / appli-
Code cation
Control (Without Cream) Biceps 2.5 2 5 2 7.5 1 10 0
S1 F3 Triceps 2.5 1 5 1 7.5 0 10 0
F4 chest 2.5 0 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 3 5 2 7.5 1 10 0
S2 F3 Triceps 2.5 2 5 1 7.5 0 10 0
1 F4 chest 2.5 0 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 2 5 3 7.5 2 10 0
S3 F3 Triceps 2.5 1 5 2 7.5 1 10 0
F4 chest 2.5 0 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 3 5 2 7.5 2 10 0
S4 F3 Triceps 2.5 2 5 1 7.5 1 10 0
F4 chest 2.5 0 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 3 5 3 7.5 1 10 1
S1 F3 Triceps 2.5 2 5 2 7.5 0 10 0
F4 chest 2.5 0 5 1 7.5 0 10 0
Control (Without Cream) Biceps 2.5 3 5 3 7.5 2 10 1
S2 F3 Triceps 2.5 2 5 2 7.5 1 10 0
2 F4 chest 2.5 1 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 4 5 4 7.5 1 10 1
S3 F3 Triceps 2.5 2 5 3 7.5 0 10 0
F4 chest 2.5 1 5 0 7.5 0 10 0
Control (Without Cream) Biceps 2.5 3 5 3 7.5 2 10 1
S4 F3 Triceps 2.5 2 5 2 7.5 1 10 0
F4 chest 2.5 1 5 1 7.5 0 10 0
Control (Without Cream) Biceps 2.5 4 5 4 7.5 3 10 2
S1 F3 Triceps 2.5 3 5 2 7.5 2 10 1
F4 chest 2.5 1 5 1 7.5 1 10 0
Control (Without Cream) Biceps 2.5 4 5 4 7.5 3 10 3
S2 F3 Triceps 2.5 3 5 2 7.5 2 10 2
F4 chest 2.5 1 5 1 7.5 1 10 1
3 Control (Without Cream) Biceps 2.5 5 5 4 7.5 3 10 2
S3 F3 Triceps 2.5 4 5 3 7.5 2 10 1
F4 chest 2.5 3 5 2 7.5 1 10 0
Control (Without Cream) Biceps 2.5 4 5 3 7.5 4 10 4
S4 F3 Triceps 2.5 3 5 2 7.5 2 10 2
F4 chest 2.5 2 5 1 7.5 1 10 1
Control (Without Cream) Biceps 2.5 5 5 5 7.5 4 10 4
S1 F3 Triceps 2.5 4 5 4 7.5 3 10 3
F4 chest 2.5 3 5 2 7.5 2 10 2
Control (Without Cream) Biceps 2.5 4 5 4 7.5 4 10 3
S2 F3 Triceps 2.5 3 5 2 7.5 2 10 2
4 F4 chest 2.5 2 5 1 7.5 1 10 1
Control (Without Cream) Biceps 2.5 5 5 5 7.5 4 10 3
S3 F3 Triceps 2.5 3 5 3 7.5 2 10 2
F4 chest 2.5 2 5 2 7.5 1 10 1
Control (Without Cream) Biceps 2.5 5 5 4 7.5 4 10 4
S4 F3 Triceps 2.5 4 5 3 7.5 3 10 3
F4 chest 2.5 3 5 2 7.5 2 10 2
Control (Without Cream) Biceps 2.5 7 5 6 7.5 5 10 5
S1 F3 Triceps 2.5 6 5 5 7.5 4 10 4
F4 chest 2.5 5 5 4 7.5 3 10 2
Control (Without Cream) Biceps 2.5 6 5 6 7.5 5 10 5
S2 F3 Triceps 2.5 5 5 4 7.5 3 10 3
5 F4 chest 2.5 4 5 3 7.5 2 10 2
Control (Without Cream) Biceps 2.5 7 5 6 7.5 5 10 5
S3 F3 Triceps 2.5 5 5 5 7.5 4 10 4
F4 chest 2.5 3 5 3 7.5 3 10 3
Control (Without Cream) Biceps 2.5 6 5 5 7.5 5 10 5
S4 F3 Triceps 2.5 5 5 4 7.5 4 10 4
F4 chest 2.5 3 5 3 7.5 2 10 2
Control (Without Cream) Biceps 2.5 9 5 9 7.5 8 10 7
S1 F3 Triceps 2.5 8 5 7 7.5 7 10 6
F4 chest 2.5 7 5 6 7.5 6 10 5
Control (Without Cream) Biceps 2.5 9 5 8 7.5 7 10 7
S2 F3 Triceps 2.5 8 5 7 7.5 6 10 6
6 F4 chest 2.5 6 5 6 7.5 5 10 4
Control (Without Cream) Biceps 2.5 9 5 9 7.5 8 10 6
S3 F3 Triceps 2.5 7 5 8 7.5 7 10 5
F4 chest 2.5 5 5 6 7.5 5 10 4
Control (Without Cream) Biceps 2.5 9 5 9 7.5 8 10 7
S4 F3 Triceps 2.5 7 5 7 7.5 6 10 5
F4 chest 2.5 6 5 5 7.5 5 10 3
Control (Without Cream) Biceps 2.5 12 5 12 7.5 11 10 10
S1 F3 Triceps 2.5 11 5 10 7.5 10 10 8
F4 chest 2.5 10 5 9 7.5 8 10 7
Control (Without Cream) Biceps 2.5 12 5 12 7.5 11 10 10
S2 F3 Triceps 2.5 11 5 11 7.5 10 10 9
7 F4 chest 2.5 9 5 8 7.5 8 10 8
Control (Without Cream) Biceps 2.5 12 5 12 7.5 10 10 10
S3 F3 Triceps 2.5 9 5 9 7.5 9 10 9
F4 chest 2.5 8 5 8 7.5 8 10 6
Control (Without Cream) Biceps 2.5 12 5 12 7.5 11 10 10
S4 F2 Triceps 2.5 11 5 10 7.5 8 10 9
F3 chest 2.5 9 5 9 7.5 7 10 7
Control (Without Cream) Biceps 2.5 16 5 16 7.5 15 10 15
S1 F3 Triceps 2.5 15 5 14 7.5 14 10 14
F4 chest 2.5 13 5 13 7.5 12 10 11
Control (Without Cream) Biceps 2.5 16 5 16 7.5 15 10 15
S2 F3 Triceps 2.5 15 5 13 7.5 13 10 13
15 F4 chest 2.5 14 5 12 7.5 11 10 11
Control (Without Cream) Biceps 2.5 15 5 15 7.5 15 10 15
S3 F3 Triceps 2.5 14 5 14 7.5 14 10 13
F4 chest 2.5 12 5 13 7.5 11 10 11
Control (Without Cream) Biceps 2.5 14 5 14 7.5 14 10 14
S4 F3 Triceps 2.5 13 5 13 7.5 13 10 13
F4 chest 2.5 12 5 12 7.5 11 10 10

OBSERVATIONS:
Effect when applied on the region of Biceps
IN 2.5 Kg: By Applying of F4cream at site of Biceps, compare to Control (Without Cream),F2 (only EAAs) it will increase up to 70% (0.70x) in muscle strength and 15%-20% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 5 Kg: By Applying of F4cream at site of Biceps, compare to Control (Without Cream), will increase up to 85% (0.85x) in muscle strength and 10%-15% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 7.5 Kg: By Applying of F4cream at site of Biceps, compare to Control (Without Cream), will increase up to 80% (0.80x) in muscle strength and 7-12% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 10 Kg: By Applying of F4cream at site of Biceps, compare to Control (Without Cream), will increase up to 94% (0.94x) in muscle strength and 35%-40% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.

Effect when applied on the region of Triceps:
IN 2.5 Kg: By Applying of F4cream at site of Triceps, compare to Control (Without Cream), will increase up to 94% (0.94x) in muscle strength and 35%-40% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 5 Kg: By Applying of F4cream at site of Triceps, compare to Control (Without Cream), will increase up to 65% (0.65x) in muscle strength and 15%-20% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 7.5 Kg: By Applying of F4cream at site of Triceps, compare to Control (Without Cream), will increase up to 80% (0.80x) in muscle strength and 25%-30% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 10 Kg: By Applying of F4cream at site of Triceps, compare to Control (Without Cream), will increase up to 91% (0.91x) in muscle strength and 30%-35% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.

Effect when applied on the region of Chest:
IN 2.5 Kg: By Applying of F4cream at site of Chest, compare to Control (Without Cream), will increase up to 75% (0.75x) in muscle strength and 25%-30% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 5 Kg: By Applying of F4cream at site of Chest, compare to Control (Without Cream), it will increase up to 82% (0.82x) in muscle strength and 15%-20% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 7.5 Kg: By Applying of F4cream at site of Chest, compare to Control (Without Cream), will increase up to 55% (0.55x) in muscle strength and 15%-25% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.
IN 10 Kg: By Applying of F4cream at site of Chest, compare to Control (Without Cream), will increase up to 87% (0.87x) in muscle strength and 25%30% increasing compare to F3 (Marketed Cream/preparation of other ingredients) for same.

RESULTS:

After application of marketed cream subject feels tightness in muscle only so can’t conduct other count and have doms also.
After application of present cream formula there is observation in increasing in pumping and sets count with the no pain and feels relaxation in muscle and no complaint regarding doms (delayed on set of muscle pain).

CONCLUSION:

As compare to marketed preparation and without any cream on applying biceps, triceps and chest, present cream formulation have a role to increase blood flow, increasing set count with vasodilation and relief from pain during and after exercise (doms).
Cream base formulations are easy to spread and remove. Cream base drug delivery system with proper excipients and manufacturing process is elegant drug delivery system. Cream base drug delivery system is pleasing both in appearance and feel post application also. Creams are not greasy and easy to rinse. They are very good for the most of the topical purposes and are considered particularly suited for application on skin portion and inflamed sites also. The present invention is formulated in cream base and hence most preferred drug delivery system for aforesaid herbal composition.
While the present invention is described above in connection with preferred or illustrative embodiments are not intended to be exhaustive or limiting of the invention, rather, the invention is intended to cover all alternatives, modifications and equivalents included within its scope, as defined by the appended claim.

,CLAIMS:CLAIMS:
We Claim:

1. A transdermal cream formulation for muscle protein synthesis comprising:
i. Creatine Phosphate present in an amount of 0.2-10%;
ii. an essential amino acid or mixture thereof present in an amount of 0.5-20%;
iii. Potassium chloride present in an amount of 0.2-10%;
iv. an essential elements or mixture thereof present in an amount of 0.2-5%;
v. an anti-inflammatory agent or mixture thereof;
vi. a vasodilator or mixture thereof;
vii. an antioxidant or mixture thereof;
viii. an antispasmodic agent or mixture thereof;
ix. inactive excipient or mixture thereof;
Wherein 5-50% of the formulation comprises an oil phase and
61-77% of the formulation comprises aqueous phase.

2. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein essential amino acids are selected from Leucine, Isoleucine, Valine, Lysine, Threonine, Methionine , Phenylalanine , Tryptophan or mixture thereof.

3. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein essential elements are selected from disodium hydrogen phosphate, magnesium oxide, calcium oxide or mixture thereof.

4. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein an anti-inflammatory agent is selected from cypress oil present in an amount of 0.5-15% or ginger oil present in an amount of 0.1- 8% or mixture thereof.

5. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein vasodilator is an oil extract from plant source selected from lemongrass oil present in an amount of 0.1-20% or eucalyptus oil present in an amount of 1-25% or mixture thereof.

6. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein antioxidant agent is extract from plant source selected from Aloe Vera present in an amount of 2.5-10% or tocopherol present in an amount of 0.1-5% or mixture thereof.

7. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein antispasmodic agent is Orange oil present in an amount of 3-15%.

8. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein the formulation in addition includes one or more inactive excipients selected from the category of emulsifier, permeation enhancer, preservative, humectant, fragrance.

9. The transdermal cream formulation for muscle protein synthesis as claimed in claim 10, wherein Emulsifier is selected from stearic acid, potassium stearate, PEG 400 stearate, Glyceryl monostearate, Arlacel 165, sodium stearate, bees wax, carnauba wax, emulsifying wax or mixture thereof.

10. The transdermal cream formulation for muscle protein synthesis as claimed in claim 10, wherein permeation enhancer is selected from Ethanol, ginger extract/oil, dimethyl sulfoxide, dimethyl isosorbide, Isopropyl myristate and propylene glycol, eucalyptus oil, jojoba oil, peppermint oil, fennel oil, almond oil or mixture thereof.

11. The transdermal cream formulation for muscle protein synthesis as claimed in claim 10, wherein humectant is selected from Sorbitol or aloe Vera gel or glycerin or xylitol, maltitol, propylene glycol, butylene glycol or mixture thereof.

12. The transdermal cream formulation for muscle protein synthesis as claimed in claim 10, wherein preservative is selected from Methylparben, Propyl paraben, Butyl paraben, ethanol, phenoxy ethanol, Benzoic Acid/Sodium Benzoate, citric acid, Sorbic Acid/Potassium sorbate, Levulinic Acid, Anisic Acid or mixture thereof.

13. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1, wherein the aqueous (water) phase includes Leucine, Isoleucine, Valine, Lysine, Threonine, Methionine, Phenylalanine, Tryptophan, Disodium hydrogen phosphate, MgO, CaO, KCl, Creatine Phosphate, Aloe-vera, Ethanol, Sorbitol, Glycerine, Na-Methyl Paraben, Phenoxy-ethanol.

14. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1- claim 13, wherein the oil phase includes Lemongrass oil, Orange Oil, Cypress Oil, Ginger Oil, Eucalyptus Oil, Tocopherol, Stearic acid, Emulsifying Wax, Carnauba Wax, Jojoba Oil.

15. The transdermal cream formulation for muscle protein synthesis as claimed in claim 1- claim 13, wherein said composition shows synergistic activity and said cream formulation is stable.

Documents

Application Documents

# Name Date
1 202021027372-STATEMENT OF UNDERTAKING (FORM 3) [27-06-2020(online)].pdf 2020-06-27
2 202021027372-PROVISIONAL SPECIFICATION [27-06-2020(online)].pdf 2020-06-27
3 202021027372-POWER OF AUTHORITY [27-06-2020(online)].pdf 2020-06-27
4 202021027372-FORM FOR SMALL ENTITY(FORM-28) [27-06-2020(online)].pdf 2020-06-27
5 202021027372-FORM FOR SMALL ENTITY [27-06-2020(online)].pdf 2020-06-27
6 202021027372-FORM 1 [27-06-2020(online)].pdf 2020-06-27
7 202021027372-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [27-06-2020(online)].pdf 2020-06-27
8 202021027372-EVIDENCE FOR REGISTRATION UNDER SSI [27-06-2020(online)].pdf 2020-06-27
9 202021027372-DECLARATION OF INVENTORSHIP (FORM 5) [27-06-2020(online)].pdf 2020-06-27
10 202021027372-ENDORSEMENT BY INVENTORS [26-06-2021(online)].pdf 2021-06-26
11 202021027372-CORRESPONDENCE-OTHERS [26-06-2021(online)].pdf 2021-06-26
12 202021027372-COMPLETE SPECIFICATION [26-06-2021(online)].pdf 2021-06-26
13 202021027372- ORIGINAL UR 6(1A) FORM 1 & FORM 26-010321.pdf 2021-10-19
14 202021027372-MSME CERTIFICATE [06-04-2022(online)].pdf 2022-04-06
15 202021027372-FORM28 [06-04-2022(online)].pdf 2022-04-06
16 202021027372-FORM 18A [06-04-2022(online)].pdf 2022-04-06
17 202021027372-FER.pdf 2022-06-15
18 202021027372-OTHERS [15-12-2022(online)].pdf 2022-12-15
19 202021027372-FER_SER_REPLY [15-12-2022(online)].pdf 2022-12-15
20 202021027372-CLAIMS [15-12-2022(online)].pdf 2022-12-15
21 202021027372-FORM-8 [24-02-2023(online)].pdf 2023-02-24
22 202021027372-NBA INTIMATION TO APPLICANT COMPLY WITH REQUIREMENT-31-03-2023.pdf 2023-03-31

Search Strategy

1 searchstrategyE_14-06-2022.pdf