DESC:FIELD OF THE INVENTION:
The present invention relates to a topical formulation containing herbal composition for transdermal application. More particularly the present invention relates to a synergistic herbal 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 assist 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 a 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 dosage 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 herbal composition comprising extracts or fractions derived from withania somnifera, salvia tomentosa 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 herbal composition with synergistic effect comprising extracts or fractions derived from withania somnifera, salvia tomentosa, and at least 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.

Withania somnifera:
Ashwagandha is a member of the family of herbs referred to as “adaptogens”. The term “adaptogen” is applied to a herb with phytonutrients that regulate metabolism when a body is perturbed by physical or mental stress, and help the body adapt by (a) normalizing system functions, (b) developing resistance to future such stress, and (c) elevating the body’s functioning to a higher level of performance.
Studies in healthy normal adults demonstrated that ashwagandha improves muscular strength/coordination, and cardiorespiratory endurance. Ashwagandha’ s roots are classified as a “rasayana” (rejuvenator), and have been used toward promoting health and longevity, slowing the aging process, revitalizing the body and generally creating a sense of well-being. Ashwagandha has a wide range of pharmacological effects: it has anxiolytic, hypotensive, sedative, central nervous system, immunomodulatory, analgesic, anti-inflammatory, anti-tumor, anabolic, cardiopulmonary and antioxidant effects.
It contains steroidal lactones (withanolides, withaferins), saponins and alkaloids like isopelletierine and a ferine. The adaptogenic properties of ashwagandha raise the possibility of it being an effective ergogenic aid because the strain from exercise can be viewed as a form of stress, with enhanced human physical performance as the corresponding stress response upon ashwagandha supplementation.
Ashwagandha Extract which is natural source of steroidal hormone and an aphrodisiac, live- tonic, anti-inflammatory agent, and more recently to treat asthma, ulcers, insomnia, and senile dementia. Ashwagandha extract and or one or more derivatives thereof applied through the transdermal cream travels/enters in the blood stream and helps to produce testosterone at the muscle tissue. It is drawn into the muscle cell's receiving dock, called an androgen receptor. Once delivered to the muscle cell, the testosterone can interact with the cell's DNA and stimulate the protein synthesis process that promotes cell growth which helps in increasing muscle mass.
Ashwagandha (Withaferin) mimics estrogen and stimulates activation of estrogen receptors in the muscle which stimulates more satellite cell activation which aids in more muscle growth and more collagen synthesis. When Ashwagandha (Withaferin) gets into your muscle, they will pull all the sugar and nutrients into the muscle, it can increase glucose disposal and nutrients absorption. Ashwagandha can also drive amino acids into the muscle and encourage the protein synthesis for muscle recovery.
Withania somnifera also involve in muscle building also. It increases muscle mass during resting phase. Proper dose intake of extract increases muscle mass in efficient way. Withania somnifera increases muscle mass by two following ways (i) Increase in testosterone, which leads to muscle growth and (ii) decrease in the levels of cortisol, which as a catabolic agent detracts from muscle mass. Hence in this way it acts as an anabolic agent for the process of muscle mass building.

Luteoline
Luteolin is a flavone, a type of flavonoid, with a yellow crystalline appearance. Luteolin is most often found in leaves, but it is also seen in rinds, barks, clover blossom, and ragweed pollen. It has also been isolated from the aromatic flowering plant, Salvia tomentosa in the mint family, Lamiaceae.
Dietary sources include celery, broccoli, green pepper, parsley, thyme, dandelion, perilla, chamomile tea, carrots, olive oil, peppermint, rosemary, navel oranges, and oregano. It can also be found in the seeds of the palm Aiphanes aculeata.
Luteoline have numerous beneficial medicinal properties such as anti-cancer, anti-oxidant, anti-inflammatory, and anti-allergic actions, anti-lipidermic action and increasing eNOS (endothelial Nitric Oxide Synthase) gene expression. Luteoline elicited relaxation of potassium contracted aortic rings which results in vasorelaxation effect attenuated by the eNOS inhibitor, N-nitro-L-arginine methyl ester, suggesting that this Luteoline action is at least partially mediated by activating eNOS activity and increased eNOS phosphorylation and NO production. Luteoline can directly act on vascular ECs (Endothelial Cells), leading to rapid eNOS activation and NO production, thereby causing relaxation of vascular tension which increases the blood flow at the muscle site and rate of Muscle pumping.
In present formulation Luteoline enhances exercise sprint performance, likely by improving brain oxygenation and allowing a higher muscle extraction of oxygen. It improves the muscle mass by improving vasodilation by acting as a nitric oxide donor to blood vessels. It is most efficient flavonoid for the muscle mass building and anti-stress agent.
Anti-inflammatory agents:
In some embodiments of the present invention at least one anti-inflammatory agent or mixture thereof in oil extract form are selected from cypress oil, ginger oil, Thyme oil, clove oil, rose oil, eucalyptus oil, fennel, bergamot, lavender oil, eucalyptus, rosemary oil, yarrow oil, Chamomile oil.
Ginger oil:
Ginger oil offers relief from aching muscle mass and also eases spasms in the muscle mass. Ginger supports muscles in this way with its heating activity together with its analgesic buildings. These buildings aid it to calm painful joints, muscles as well as signs of arthritis. With exceptional warming, soothing as well as antispasmodic residential properties marjoram oil helps to alleviate joint pain and muscle mass convulsions. It also improves the blood circulation in the body.
Further Ginger rhizomes (Zingiber officinale) Extract and/or their derivatives thereof contains proteolytic enzymes which act similar to the action of papain and helps in this transdermal composition in order to facilitate the skin penetration of other substances.
Cypress oil:
Cypress calms and relaxes muscles spasms and works to soothe inflammation. Cypress oil increase blood circulation. It also work as anti-inflammatory agent.
Anti-oxidant
In some embodiments of the present invention at least one anti-oxidant agent or mixture thereof in oil extract form are selected from aloe vera, Lemongrass oil, eucalyptus oil, clove oil, myrrh oil, thyme oil, oregano oil, eucalyptus oil, orange oil, mountain savory, Fennel oil extract, marjoram oil, Melisa oil, black pepper, cypress oil, vitamin source like tocopherol
Aloevera:
Aloe Vera inhibits this pathway and reduces the formation of prostaglandins (inflammatory agents). It also possesses peptidase bradykinase that breaks down bradykinin, an inflammatory and pain-causing substance that plays a key role in the development of DOMS i.e. Delayed Onset Muscle Soreness.
Tocopherol:
The antioxidants according to the invention may be used either alone or in association with other antioxidants such as vitamin C, vitamin E (tocopherols and tocotrienols), carotenoids (carotenes, lycopene, lutein and zeaxanthine) and other sources of flavonoids with antioxidant activity, compounds that upregulate cell antioxidant defense (e.g. ursodeoxycholic acid for increased glutathione S-transferase, ursolic acid for increased catalase, ginseng and ginsenosides for increase superoxide dismutase).
Vitamin E play an important role in trying to stay healthy, prevent certain diseases, and can be helpful in preventing muscle loss. This last consequence can be very important for weightlifters trying to maintain muscle mass while dieting away fat.
Antispasmodic-analgesic agent:
In some embodiments of the present invention at least one Antispasmodic-analgesic agent or mixture thereof in oil extract form are selected from olive oil, orange oil, lemongrass oil , eucalyptus oil, coriander oil, clove oil, fennel oil extract, cypress oil, sandalwood oil, eucalyptus oil, peppermint oil, helichrysum oil, marjoram oil
Olive oil:
Olive Oil helps build muscle by reducing the rate of inflammation. This is key to helping build muscle mass. It also acts as a vasodilator vehicle. It is also a powerful antioxidant and anti-inflammatory agent. In present invention olive oil function as an antispasmodic agent.
Orange oil:
The main chemical constituents of Orange Oil are: Limonene, Monoterpene Hydrocarbons (ß- Myrcene and a-Pinene), Alcohols (Citronellol, Geraniol, and Linalool), and Aldehydes (Neral). In present invention it acts as an antioxidant, anti-inflammatory agent and as an analgesic agent in muscular pain.
Vasodilating agent:
In some embodiments of the present invention at least one vasodilating agent or mixture thereof in oil extract form are selected from lemongrass oil, eucalyptus oil, Wintergreen essential oil, Cinnamon Essential Oil, Patchouli Essential Oil, coriander oil, peppermint oil, cypress oil, lentisque oil extract, Helichrysum oil extract, Juniper berry, Niaouli oil extract, olive oil, orange oil, lemongrass oil , eucalyptus oil, coriander oil, clove oil, fennel oil extract, cypress oil, sandalwood oil, eucalyptus oil, peppermint oil, helichrysum oil, marjoram oil
Lemongrass oil:
Lemongrass Essential Oil’s analgesic and anti-inflammatory properties have been found to relieve muscle and joint pains caused by overexertion of muscles through exercise. It also act as a vasodilator effect by acting as NO (nitric oxide) donor.
Eucalyptus oil:
It rejuvenate and gives cooling effect to as sore muscles. It also acts as a vasodilator and NO donor. It also relieves muscle pains and act as an anti-inflammatory agent.
In present formulation Eucalyptus oil which helps in delivering oxygen to muscle tissue when applied locally. After Ashwagandha has dilated the blood vessels, normally the blood pressure in the vessel drops. But eucalyptus oil allows you to have dilated blood vessels by maintaining the local blood pressure (without dropping) and delivers the oxygen across the muscle tissue.
Any methods of delivery and/or administration of present composition is considered to be 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, Sublingual, ophthalmic, nasal, otic, aerosol, inhalation, spray, parenteral, Suppository and the like. In Suitable cases, Luteoline/Ashwagandha (Withanolides or Withaferin) may be administered by intravenous or intra-arterial infusion. Compositions of the present invention may also be administered in nutraceutical or functional foods. In addition the effective amount of present composition 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.
CREAM FORMULATION:
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 stearic acid, jojoba oil, coco butter, olive oil comprises the oil phase for the cream 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 Glycerine, aloe vera extract or gel, demineralised water, sorbitol, and perfume comprises the aqueous phase for the cream 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.
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 process for preparing the present novel synergistic composition and formulation thereof can be modified accordingly by any person skilled in the art based on the knowledge of the manufacturing the formulation. However all such variation and modification is still covered by the scope of present invention.
While the foregoing written description of the invention enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should therefore not be limited by the above described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention. The invention shall now be described with reference to the following specific examples. It should be noted that the example(s) appended below illustrate rather than limit the invention, and that those skilled in the art will be able to design many alternative embodiments without departing from the scope of the present invention.
The extract of containing withaferin or withanolide; extract containing Luteolin; and other extracts used for the present formulation are commercially available and procure from vendor.
These and other aspects of the invention may become more apparent from the examples set forth herein below. These examples are provided merely as illustrations of the invention and are not intended to be construed as a limitation thereof.

EXAMPLE: 1

Formulation of cream comprising herbal composition for building muscle mass

Sr. No.
INGREDIENTS
CONCENTRATION

1 • Withania somnifera (Ashwagandha) Extract/Oil
(Withaferin/Withanolides- 2.5% to 98%) - 2-70%
2 • Salvia tomentosa extract (Luteoline 1 to 98%) - 1-60%
3 • Orange Oil - 3-15%
4 • Cypress Oil - 0.5-15%
5 • Ginger Oil - 0.1-08%
6 • Aloevera - 2.5-10%
7 • Sorbitol - 2-8%
8 • Ethanol - 5-15%
9 • Glycerin - 5-15%
10 • Lemongrass oil - 0.1-20%
11 • Eucalyptus Oil - 1-25%
12 • Tocopherol - 0.1-0.5%
13 • Steric acid - 2-20%
14 • Bees/Carnauba Wax - 2-12%
15 • Jojoba Oil - 2-18%
16 • Olive oil - 2-12%
17 • Emulsifying Wax - 2-18%
18 • D.Water - Quantity S.
19 • Fragrance - Quantity S.

According to present invention the most preferred process of manufacturing cream formulation comprises of the following steps:
METHOD OF PREPARATION:
1. In one container, Dissolve Ashwagandha Extract, Aloe Vera Extract/Gel and Luteoline in same with Ethanol and half quantity of water.
2. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
3. Mix Step 1 and Step 2 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
4. Mix all other essential oils, carrier oil and preservative in above step 3.
5. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
6. Mix Step 4 in Step 5.
7. Continue to mix until it become proper blend and consistent Cream.

EXAMPLE: 2

Formulation of cream comprising herbal composition for building muscle mass

Sr. No.
INGREDIENTS
CONCENTRATION

1 • Withania somnifera (Ashwagandha) Extract/Oil
(Withaferin/Woithanolides- 2.5% to 98%) - 18%
2 • Salvia tomentosa extract (Luteoline 1 to 98%) - 10%
3 • Lemongrass oil - 3%
4 • Orange Oil - 3%
5 • Cypress Oil - 1.5%
6 • Ginger Oil - 0.5%
7 • Eucalyptus Oil - 10%
8 • Tocopherol - 0.450%
9 • Stearic acid - 18%
10 • Emulsifying Wax - 7%
11 • Carnauba Wax - 7%
12 • Jojoba Oil - 9%
13 • Aloe-vera L/E - 2%
14 • Ethanol - 2.5%
15 • Sorbitol - 3%
16 • Glycerin - 6%
17 • Na-Methyl Paraben - Quantity S.
18 • Phenoxy-ethanol - Quantity S.
19 • Distilled Water - Quantity S.
According to present invention the most preferred process of manufacturing cream formulation comprises of the following steps:
METHOD OF PREPARATION:
1. In one container, Dissolve Ashwagandha Extract, Aloe Vera Extract/Gel and Luteoline in same with Ethanol and half quantity of water.
2. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
3. Mix Step 1 and Step 2 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
4. Mix all other essential oils, carrier oil and preservative in above step 3.
5. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
6. Mix Step 4 in Step 5.
7. Continue to mix until it become proper blend and consistent Cream

EXAMPLE: 3

Formulation of cream comprising herbal composition for building muscle mass

Sr. No.
INGREDIENTS
CONCENTRATION

1 • Withania somnifera (Ashwagandha) Extract/Oil
(Withaferin/Woithanolides- 2.5% to 98%) - 12%
2 • Salvia tomentosa extract (Luteoline 1 to 98%) - 15%
3 • Lemongrass oil - 4%
4 • Orange Oil - 2%
5 • Cypress Oil - 2%
6 • Ginger Oil - 1%
7 • Eucalyptus Oil - 12%
8 • Tocopherol - 0.40%
9 • Stearic acid - 16%
10 • Emulsifying Wax - 5%
11 • Carnauba Wax - 4%
12 • Jojoba Oil - 8%
13 • Aloe-vera L/E - 2.5%
14 • Ethanol - 3%
15 • Sorbitol - 3%
16 • Glycerin - 6%
17 • Na-Methyl Paraben - Quantity S.
18 • Phenoxy-ethanol - Quantity S.
19 • Distilled Water - Quantity S.
According to present invention the most preferred process of manufacturing cream formulation comprises of the following steps:
METHOD OF PREPARATION:
1. In one container, Dissolve Ashwagandha Extract, Aloe Vera Extract/Gel and Luteoline in same with Ethanol and half quantity of water.
2. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
3. Mix Step 1 and Step 2 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
4. Mix all other essential oils, carrier oil and preservative in above step 3.
5. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
6. Mix Step 4 in Step 5.
7. Continue to mix until it become proper blend and consistent Cream.

EXAMPLE: 4

Formulation of cream comprising herbal composition for building muscle mass

Sr. No.
INGREDIENTS
CONCENTRATION

1 • Withania somnifera (Ashwagandha) Extract/Oil
(Withaferin/Woithanolides-2.5% to 98%) - 2%
2 • Salvia tomentosa extract (Luteoline 1 to 98%) - 10%
3 • Lemongrass oil - 3.2%
4 • Orange Oil - 6%
5 • Cypress Oil - 3%
6 • Ginger Oil - 0.2%
7 • Eucalyptus Oil - 19%
8 • Tocopherol - 0.20%
9 • Stearic acid - 16%
10 • Emulsifying Wax - 7.8%
11 • Carnauba Wax - 6.8%
12 • Jojoba Oil - 8%
13 • Aloe-vera L/E - 5%
14 • Ethanol - 3%
15 • Sorbitol - 3%
16 • Glycerin - 6%
17 • Na-Methyl Paraben - Quantity S.
18 • Phenoxy-ethanol - Quantity S.
19 • Distilled Water - Quantity S.

According to present invention the most preferred process of manufacturing cream formulation comprises of the following steps:
METHOD OF PREPARATION:
1. In one container, Dissolve Ashwagandha Extract, Aloe Vera Extract/Gel and Luteoline in same with Ethanol and half quantity of water.
2. In another Container, Dissolve selected Emulsifier with continuous temperature and stir until no lumps observed.
3. Mix Step 1 and Step 2 with addition of stearic acid and Tocopherol (Vitamin-E) until it becomes liquid with smooth texture.
4. Mix all other essential oils, carrier oil and preservative in above step 3.
5. Dissolve and make proper liquid phase in emulsifier tank by mixing water phase and remaining quantity of water.
6. Mix Step 4 in Step 5.
7. Continue to mix until it become proper blend and consistent Cream.

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:

No.
of days Temp Formulation code Assessment Parameters
pH range Homogenicity Appearance Spreadability After feel effect Ease of removal
5 At 54±2 0C C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
10 At 54±2 0C C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
15 At 54±2 0C C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
1 month RT C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
6 month RT C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
12 month RT C1 5.6-6.0 Good NC Good emollient Y
C2 5.6-6.0 Good NC Good emollient Y
C3 5.6-6.0 Good NC Good emollient Y
C4 5.6-6.0 Good NC Good emollient Y
*Y-yes, NC-Not Changed,
Formulation code Composition of the active ingredients
C1 (Withaferin/withanolide) in 18% + Luteolin 10%
C2 (Withaferin/withanolide) in 12% + Luteolin 15%
C3 (Withaferin/withanolide) in 2% + Luteolin 10%
C4 (Withaferin/withanolide) in 20 % + Luteolin 28%

EFFICACY STUDY OF CREAM FORMULATION:
Experimental Design:
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.
Formulation Code Composition
F1 (Cream_Present application) (Withaferin/withanolide) in 2.5-98% + Luteolin 1-98% + other ingredients of formula disclosed in present patent application.

F2 (marketed preparation) Various ingredient for the same application

F3 (controlled/ Placebo) No application of cream or cream with no active ingredients

Clinical study of present cream formulation assessed individually by human subjects (volunteers) when applied on triceps region of the body with comparison to control and marketed preparation
Table 2(a):
Data for Triceps Work-outs
Subject 1 Subject 2
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 2.5kg 5.0kg 7.5kg 10kg
Control Group F3 15 12 9 4 16 11 8 2
With Market Cream F2 24 20 13 5 23 17 12 3
With Present Formulation F1 27 23 16 7 27 20 15 5

Table 2(b):
Data for Triceps Work-outs
Subject 3 Subject 4
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 2.5kg 5.0kg 7.5kg 10kg
Control Group F3 15 12 8 3 15 12 8 3
With Market Cream F2 25 19 14 4 24 20 13 5
With Present Formulation F1 27 22 15 7 26 23 16 7

Table 2(c):
Summary for Muscle Growth of Triceps Average from 4 Subjects
With Present Formulation in terms of percentage
Work-Outs Sets 2.5kg % 5.0kg % 7.5kg % 10kg %
Control Group 15.25 100 11.75 100 8.25 100 3 100
With Market Cream 24 157 19 162 13 158 4.25 142
With Patented Formulation 26.75 175 22 187 15.5 188 6.5 217

OBSERVATIONS:
Effect when applied on the region of Triceps
IN 2.5 Kg By Applying of F1cream at site of Triceps, compare to Control F3 (Without Cream),it will increase up to 75% in muscle strength and 70%-76% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 5 Kg By Applying of F1 cream at site of Triceps,, compare to Control F3 (Without Cream),it will increase up to 87% in muscle strength and 70%-72% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 7.5 Kg By Applying of F1 cream at site of Triceps,, compare to Control F3 (Without Cream),it will increase up to 97% in muscle strength and 55%-59% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 10 Kg By Applying of F1 cream at site of Triceps,, compare to Control F3 (Without Cream),it will increase up to 117% in muscle strength and 30%-35% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.

Clinical study of present cream formulation assessed individually by human subjects (volunteers) when applied on biceps region of the body with comparison to control and marketed preparation

Table 3(a):
Data for Biceps Work-outs
Subject 1 Subject 2
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 12.5kg 2.5kg 5.0kg 7.5kg 10kg 12.5kg
Control Group F3 19 11 8 4 6 13 14 9 4 4
With Market Cream F2 19 16 12 7 8 17 17 12 7 6
With Present Formulation F1 22 20 15 9 11 19 20 14 10 9

Table 3(b):
Data for Biceps Work-outs
Subject 3 Subject 4
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 12.5kg 2.5kg 5.0kg 7.5kg 10kg 12.5kg
Control Group F3 16 16 9 5 2 17 14 10 5 6
With Market Cream F2 19 20 12 8 3 21 16 14 9 9
With Present Formulation F1 22 23 15 11 4 26 19 17 12 12

Table 3(c):
Summary for Muscle Growth of Biceps Average from 4 Subjects
With Present Formulation in terms of percentage
Work-Outs Sets 2.5kg % 5.0kg % 7.5kg % 10kg % 12.5kg %
Control Group 16.25 100 13.75 100 9 100 4.5 100 4.5 100
With Market Cream 19 117 17.25 125 12.5 139 7.75 172 6.5 144
With Patented Formulation 22.25 137 20.5 149 15.25 169 10.5 233 9 200

Effect when applied on the region of Biceps
IN 2.5 Kg By Applying of F1cream at site of Biceps, compare to Control F3 (Without Cream),it will increase up to 37% in muscle strength and 35%-40% increasing compare to F2 (Marketed Cream/preparation of other ingredients) for same.
IN 5 Kg By Applying of F1 cream at site of Biceps, compare to Control F3 (Without Cream),it will increase up to 49% in muscle strength and 49%-61% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 7.5 Kg By Applying of F1 cream at site of Biceps, compare to Control F3 (Without Cream),it will increase up to 69% in muscle strength and 50%-56% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 10 Kg By Applying of F1 cream at site of Biceps, compare to Control F3 (Without Cream),it will increase up to 133% in muscle strength and 50%-54% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 12.5 Kg By Applying of F1 cream at site of Biceps, compare to Control F3 (Without Cream),it will increase up to 100% in muscle strength and 40%-44% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
Clinical study of present cream formulation assessed individually by human subjects (volunteers) when applied on chest region of the body with comparison to control and marketed preparation
Table 4(a):
Data for Chest Work-outs
Subject 1 Subject 2
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 12.5kg 2.5kg 5.0kg 7.5kg 10kg 12.5kg
Control Group F3 15 12 8 3 2 18 15 10 4 3
With Market Cream F2 21 17 12 5 3 25 22 13 6 4
With Present Formulation F1 24 21 15 7 4 30 25 17 7 5

Table 4(b):
Data for Chest Work-outs
Average Work-Outs Sets of Week Average Work-Outs Sets of Week
Work-Outs Sets 2.5kg 5.0kg 7.5kg 10kg 12.5kg 2.5kg 5.0kg 7.5kg 10kg 12.5kg
Control Group F3 18 15 8 3 2 13 12 8 3 2
With Market Cream F2 21 21 12 5 4 16 17 12 6 5
With Present Formulation F1 30 26 15 8 8 22 23 15 8 8

Table 4(c):
Summary for Muscle Growth of Chest Average from 4 Subjects
With Present Formulation in terms of percentage
Work-Outs Sets 2.5kg % 5.0kg % 7.5kg % 10kg % 12.5kg %
Control Group 16 100 13.5 100 8.5 100 3.25 100 2.25 100
With Market Cream 20.75 130 19.25 143 12.25 144 5.5 169 4 178
With Patented Formulation 26.5 166 23.75 176 15.5 182 7.5 231 6.25 278

OBSERVATIONS:
Effect when applied on the region of Chest
IN 2.5 Kg By Applying of F1cream at site of Chest, compare to Control F3 (Without Cream),it will increase up to 90% in muscle strength and 30%-33% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 5 Kg By Applying of F1 cream at site of Chest,, compare to Control F3 (Without Cream),it will increase up to 91% in muscle strength and 40%-47% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 7.5 Kg By Applying of F1 cream at site of Chest, compare to Control F3 (Without Cream),it will increase up to 89% in muscle strength and 70%-77% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 10 Kg By Applying of F1 cream at site of Chest,, compare to Control F3 (Without Cream),it will increase up to 131% in muscle strength and 50%-59% increasing compare to F2 (Marketed Cream/ preparation of other ingredients) for same.
IN 12.5 Kg By Applying of F1 cream at site of Chest, compare to Control F3 (Without Cream),it will increase up to 98% in muscle strength and 70%-79% increasing compare to F2 (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 increasing muscle mass comprising:
- Withaferin and/or Withanolide present in amount of 2-70% by weight;
- Luteolin present in amount of 2-70% by weight;
- oil phase present in the range of 5-50% by weight;
- Aqueous phase present in the range of 61-77% by weight.

2. The cream formulation for increasing muscle mass as claimed in claim 1, wherein said formulation further comprises ingredient as an additives from category of anti-inflammatory, vasodilator, antioxidant and antispasmodic agent.

3. The cream formulation for increasing muscle mass as claimed in claim 1, wherein anti-inflammatory agent is cypress oil with concentration of 0.5-15% or ginger oil with concentration of 0.1-0.8% or mixture thereof.

4. The cream formulation for increasing muscle mass as claimed in claim 1, wherein vasodilator oils extract from plant source including lemongrass oil with concentration of 0.1-20% or eucalyptus oil with concentration of 1-25% or mixture thereof.

5. The cream formulation for increasing muscle mass as claimed in claim 1, wherein antioxidant agent is extract from plant source including Aloe Vera with concentration of 2.5-10% or tocopherol with concentration of 0.1-0.5% or mixture thereof.

6. The cream formulation for increasing muscle mass as claimed in claim 1, wherein antispasmodic agent is Olive oil with concentration of 2-12% or Orange oil with concentration of 3-8% or mixture thereof.

7. The cream formulation for increasing muscle mass as claimed in claim 1, wherein the aqueous (water) phase includes glycerin, sorbitol, demineralized water, perfume.

8. The cream formulation for increasing muscle mass as claimed in claim 1, wherein the oil phase includes stearic acid, jojoba oil, and olive oil.

9. The cream formulation for increasing muscle mass as claimed in claim 1, wherein the formulation in addition includes emulsifier, permeation enhancer, preservative, humectant, fragrance.

10. The cream formulation for increasing muscle mass as claimed in claim 9, 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.

11. The cream formulation for increasing muscle mass as claimed in claim 9, 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.

12. The cream formulation for increasing muscle mass as claimed in claim 9, wherein Humectant is selected from Sorbitol or aloe Vera gel or glycerin or xylitol, maltitol, propylene glycol, butylene glycol or mixture thereof.

13. The cream formulation for increasing muscle mass as claimed in claim 9, 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.

14. The cream formulation for increasing muscle mass as claimed in claim 1 and 2, wherein said composition shows synergistic activity.

15. The cream formulation for increasing muscle mass as claimed in claim 1, wherein Withaferin and Withanolide is obtained from withania somnifera.

16. The cream formulation for increasing muscle mass as claimed in claim 1, wherein Luteolin is obtained from salvia tomentosa ( Balsamic Saga) or Apium graveolens ( Celery) or Capsicum annum ( green pepper) or Thymus vulgaris (Thyme) or Matricaca Chamomilla, Chrysanthemum morifolium or Loricena japonica.

Dated this 04th day of January 2020.