Abstract: The present invention provides an orally administrable capsule comprising one or more nutraceuticals, pharmaceuticals, or combinations thereof, and optionally one or more excipients, with each active ingredient present as a distinct layer. The capsule features a single continuous compartment or multiple isolated or connected compartments. Layers of different ingredients are separated by excipient films to ensure compatibility. The capsule contains various forms of active ingredients, including solids, semisolids, gels, liquids, and suspensions, and supports a wide range of health conditions such as hair, nail, skin, cardiovascular, cognitive, joint, metabolic, hormonal health and other health conditions. The capsules are customizable in terms of ingredient selection and dosage, and are manufactured using 3-D printing technology, allowing precise layering and encapsulation. This method enhances the bioavailability and stability of the active ingredients, providing a scalable, hygienic, and cost-effective solution for personalized health supplementation. The capsule shell can also be customized and 3-D printed.
DESC:FIELD OF THE INVENTION
The present invention relates to the field of oral delivery systems, particularly customizable delivery systems for nutraceuticals and pharmaceuticals and methods thereof.
BACKGROUND OF THE INVENTION
Nutraceuticals is a broad term used to describe products derived from food sources with health benefits in addition to the nutritional value found in foods. Nutraceuticals is a nutrient-rich food, a medicinally active food, or a specific component of a particular food, such as, garlic, Omega 3, minerals, vitamins, hydrolysed proteins, and the like.
There are various nutraceutical products available in the market and in various delivery and dosage forms. A common delivery form of nutraceuticals is in the form of tablets and capsules which are orally administrable and cost effective. However, a certain subset of the population, such as children or older people may not be able to swallow a capsule easily. To cater to such a population, chewable tablets (“gummies”) are also available. Both tablets and gummies are comprised of multiple excipients to improve their taste profile in order to make them palatable. Further, there is also an inherent size constraint of tablets and gummies. In the case of capsules, a person generally has to take multiple different capsules, each containing one or more different compatible nutraceuticals, which reduces user compliance.
Pharmaceutical drugs are also known in the art in various forms, particularly for oral delivery, such as tablets, capsules, chewable, liquids, etc. However, a common limitation in all available pharmaceutical preparations is that they are not customized and are available only in limited dosage amounts. Therefore, a person has limited choices in dosage.
Another limitation is that there is a lack of user/individual customization of nutraceuticals and/or pharmaceuticals as per an individual’s need. Nutraceuticals available in the market are standardized and a consumer is limited to what is available and cannot customize nutraceutical choices based on his/her individual need.
Therefore, there is a need to provide a delivery system, that is customizable and can incorporate multiple compatible/ non-compatible nutraceuticals and/or pharmaceuticals in a single delivery system so as to improve user compliance and also provide maximal dosage in a compact delivery system.
OBJECTIVE OF THE INVENTION
The main objective of the present invention is to provide precision and customization which means each dosage unit can be tailored precisely to the patient's needs, such as dosage strength, release profile, and even personalized medicine requirements.
Yet another objective of the present invention is to provide improved drug delivery by controlling the release profile of drugs, or nutraceutical to enhance bioavailability, reduce side effects, and improve patient compliance, 3D printing can enable mass customization of product.
Yet another objective of the present invention is to provide benefits to patients with specific needs, such as those requiring pediatric doses or geriatric-friendly formulations, who can benefit from customized dosage forms.
Yet another objective of the present invention is to provide fast prototyping and iteration which means pharmaceutical companies can rapidly prototype and iterate different formulations and designs, that helps in speeding up the development process.
Yet another objective of the present invention is to provide reduce waste, means precise manufacturing can reduce material waste compared to traditional manufacturing methods.
Yet another objective of the present invention is that 3D printing allows for the creation of complex geometries that traditional manufacturing methods cannot achieve, this includes intricate drug release patterns or structures that enhance drug absorption.
Further objectives, advantages, and features of the present invention will become apparent from the detailed description provided herein below, in which various embodiments of the disclosed invention are illustrated by way of example.
SUMMARY OF THE INVENTION
The present invention describes an orally administrable capsule include a nutraceutical, a pharmaceutical, or combinations thereof, with optional excipients. Each active ingredient is layered on the capsule, that ranges from 0.5 to 1.5cc in total volume, with individual ingredient volumes of 0.01cc. The capsule have either a single compartment or multiple isolated or connected compartments. The invention allows for the separation of compatible and non-compatible ingredients with excipient layers, including single or multiple films. The capsule includes up to 20 different nutraceuticals and pharmaceuticals, in various forms such as solid, semisolids, gels, suspension, liquid, or oil and combination thereof. The excipient layer is either fully or partially covered with the ingredients to control contact between different substances. Nutraceuticals include a wide variety of vitamins, minerals, herbal extracts, and other supplements. Pharmaceuticals include any known substances, including over-the-counter or restricted drugs. The capsule is tailored for various health conditions, include but is not limited to hair, nail, skin, cardiovascular, cognitive, joint, metabolic, women's health, sexual health, digestive, and aging-related issues. Each formulation is designed with scientifically justifiable doses for the specific condition it aims to address. The bioavailability of the ingredients is controlled through the choice of excipients, encapsulation techniques, and layering profiles. The invention emphasizes minimal use of excipients to maximize active ingredients and reduce dosage amounts. The capsule has a shelf life of up to 12 months under specific conditions. The capsules are manufactured using 3-D printing methods, which allow for customizable dosages and combinations of ingredients. This invention provides a scalable, customizable, and efficient method for producing nutraceutical and pharmaceutical capsules tailored to specific health needs
The main advantage of the present invention is that it provides precision and customization which means each dosage unit can be tailored precisely to the patient's needs, such as dosage strength, release profile, and even personalized medicine requirements.
Yet another advantage of the present invention is that it improves drug delivery by controlling the release profile of drugs, or nutraceutical to enhance bioavailability, reduce side effects, and improve patient compliance, 3D printing can enable mass customization of product.
Yet another advantage of the present invention is that it benefits patients with specific needs, such as those requiring pediatric doses or geriatric-friendly formulations, who can benefit from customized dosage forms.
Yet another advantage of the present invention is to provide fast prototyping and iteration which means pharmaceutical companies can rapidly prototype and iterate different formulations and designs, speeding up the development process.
Yet another advantage of the present invention is that it helps in reducing waste meaning precise manufacturing can reduce material waste compared to traditional manufacturing methods.
Yet another advantage of the present invention is that 3D printing allows for the creation of complex geometries that traditional manufacturing methods cannot achieve, this includes intricate drug release patterns or structures that enhance drug absorption.
Further objectives, advantages, and features of the present invention will become apparent from the detailed description provided herein below, in which various embodiments of the disclosed invention are illustrated by way of example.
DETAILED DESCRIPTION OF THE INVENTION
Definition
The term “a” or “an”, as used herein, is defined as one. The term “plurality”, as used herein, is defined as two or more than one. The term “another”, as used herein, is defined as at least a second or more. The terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open language).
The term “comprising” is not intended to limit the present invention with such terminology rather is used in a wider sense. Any invention using the term comprising could be separated into one or more claims using “consisting” or “consisting of”. The term “comprising” may be used interchangeably with the terms “having” or “containing”.
Reference in this document to “one embodiment”, “certain embodiments”, “an embodiment”, “another embodiment”, and “yet another embodiment” or similar terms, throughout the document means that a specific feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, the appearances of such phrases in various places, this specification throughout are not necessarily all referring to the same embodiment. Furthermore, the specific features, structures, or characteristics are combined in any suitable manner in one or more embodiments without limitation.
The term “or” as used herein is to be interpreted as inclusive or meaning any one or more combinations. Therefore, “A, B or C” means any of the following: “A; B; C; A and B; A and C; B and C; A, B and C”. An exception to this definition will occur only when a combination of elements, functions, steps, or acts are in mutually exclusive, inherently.
As used herein, the term "one or more" generally refers to, but is not limited to, the singular as well as the plural form of the term.
The present invention provides an orally administrable capsule that includes (a) at least one or more nutraceuticals, pharmaceuticals, or combinations thereof; and (b) optionally one or more excipients. Each nutraceutical and pharmaceutical in the capsule is present in the form of a layer. In an embodiment, the layer of nutraceutical and pharmaceutical includes a single film. In another embodiment, the layer of nutraceutical and pharmaceutical includes a plurality of films. The total volume of nutraceuticals and pharmaceuticals in the capsule is in the range of 0.5-1.5cc. The volume of any single nutraceutical and pharmaceutical is 0.01cc. In an embodiment of the present invention, the capsule includes a single continuous compartment. In another embodiment, the capsule includes a plurality of compartments. In an embodiment, the plurality of compartments is isolated from each other such that no nutraceutical and pharmaceutical in a compartment is physically in contact with an adjoining compartment. In another embodiment, a subset of the plurality of the compartments are connected to each other such that a part of a nutraceutical and pharmaceutical in a compartment is physically in contact with the contents of an adjoining compartment. In an embodiment, adjacent layers of two different compatible nutraceuticals and pharmaceuticals are separated by a layer of an excipient. In another embodiment, adjacent layers of two different non-compatible nutraceuticals and pharmaceuticals are separated by a layer of an excipient. In an embodiment, the nutraceutical and pharmaceutical layers are separated by a single excipient. In another embodiment, the nutraceuticals and pharmaceutical layers are separated by a plurality of excipients. In an embodiment, the layer of excipient includes a single film. The total volume of the one or more nutraceuticals and pharmaceuticals or their combination that varies from 0.5-1cc. In an embodiment, the capsule of the present invention comprises up to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 19, or 20 different nutraceuticals and pharmaceuticals or combination of both. In an embodiment, the nutraceutical and pharmaceutical is a solid. In an embodiment, the nutraceutical and pharmaceutical is a suspension. In an embodiment, the nutraceutical and pharmaceutical is a liquid. In an embodiment, the nutraceutical and pharmaceutical is an oil. In an embodiment, the nutraceutical and pharmaceutical is encapsulated in solid granular form, pills, tablets, semisolids, gels or combination thereof. In an embodiment, the excipient layer covers the entire surface of a first nutraceutical and pharmaceutical in order to isolate the first nutraceutical and pharmaceutical from contacting a second nutraceutical. In another embodiment, the excipient layer partially covers the surface of a first nutraceutical and pharmaceutical such that a part of the first nutraceutical and pharmaceutical is in contact with a second nutraceutical and pharmaceutical.
In an embodiment, the nutraceutical includes but is not limited to of Anacyclus Pyrethrum Root, Andrographis Paniculata Extract, Asparagus Racemosus Rhizome/Tuber, Bacopa Monnieri Extract, Beta-Carotene, Biotin, Black Pepper Extract, Boswellia Serrata, Caffeine, Chlorophytum Borivilianum Root, Chromium Picolinate, CoQ10, Curcumin Rhizome Extract, Garcinia Cambogia, Garlic Bulb Extract, Ginger Extract, Ginkgo Biloba, Glycyrrhiza Glabra Root Extract, Green Coffee Bean Extract, L-Arginine, L-Arginine HCl, L-Glutathione, L-Theanine, L-Tyrosine, Lycopene, Lycopene Extract, Magnesium, Melatonin, Mucuna Pruriens Seed, Panax Ginseng, Piper Nigrum Seed, Selenium, Sida Cordifolia Root, Tribulus Terrestris Fruit, Urtica Dioica Leaf, Vitamin A, Vitamin B12, Vitamin B6, Vitamin C, Vitamin D3, Vitamin E, Withania Sominifera Root, Zinc, Ammonium Molybdate (Molybdenum (VI)), Apple Cider Vinegar, Beta Glucan, Biotin (B7), Chromium (III) Chloride, Chromium (III) Sulfate, Copper Oxide (Copper (II) Oxide, Cupric Oxide and Black Copper Oxide), Cupric Carbonate, Cupric Gluconate, Cupric Sulfate, Evening Primrose Oil, Ferric Ammonium Citrate, Ferric Diphosphate, Ferrous Citrate, Ferrous Fumarate, Ferrous Gluconate, Ferrous Lactate, Ferrous Orthophosphate, Ferrous Sulfate, Folic Acid, Inositol, Lactoferrin, Maca Powder, Magnesium Carbonate, Magnesium Chloride, Magnesium Gluconate, Magnesium Oxide, Magnesium Phosphate Dibasic, Magnesium Phosphate Tribasic, Magnesium Sulfate, Manganese Carbonate, Manganese Chloride, Manganese Citrate, Manganese Gluconate, Manganese Sulfate, Milk Thistle Extract, Niacin B3, Potassium Iodate, Potassium Iodide, Pyridoxine B6, Resveratrol, Riboflavin B2, Selenomethionine, Sodium Hydrogen Selenite, Sodium Iodate, Sodium Iodide, Sodium Molybdate (Molybdenum (VI)), Sodium Selenate, Sodium Selenite, Tart Cherry Extract, Thiamine B1, Vitamin B12 (Cyanocobalamin), Vitamin D, Vitamin K, White Kidney Bean Extract, Zinc Acetate, Zinc Carbonate, Zinc Chloride, Zinc Citrate, Zinc Gluconate, Zinc Lactate, Zinc Oxide, Zinc Sulfate, and combinations thereof.
In an embodiment, the pharmaceutical includes any pharmaceutical substance known in the art. In an embodiment, the pharmaceutical is an OTC substance. In another embodiment, the pharmaceutical is a restricted substance. In an embodiment, a formulation for managing low to moderate hair health conditions includes but not limited to Biotin (Vitamin B7), Vitamin C, Vitamin E, and Iron. This blend is ideal for individuals experiencing mild to moderate hair thinning and breakage. Biotin supports hair growth and strength, Vitamin C aids in collagen production and protects hair follicles from oxidative stress, Vitamin E improves scalp circulation, and Iron ensures proper oxygen supply to hair roots, promoting healthy hair growth, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe hair health conditions includes but not limited to Biotin (Vitamin B7), Vitamin C, Vitamin E, Collagen Peptides, Omega-3 Fatty Acids, Zinc, Silica, Keratin, Saw Palmetto Extract, and Vitamin D3. This formulation is tailored for individuals with severe hair loss and damage. Biotin, Vitamin C, and Vitamin E enhance hair strength and protect follicles from damage. Collagen Peptides and Omega-3 Fatty Acids improve hair hydration and elasticity. Zinc aids hair repair, Silica supports hair structure, Keratin enhances hair resilience, Saw Palmetto Extract helps reduce hair thinning, and Vitamin D3 supports overall hair health, all in an appropriate scientifically justifiable dose.
In an embodiment, a formulation for managing low to moderate nail health conditions includes but not limited to Biotin (Vitamin B7), Vitamin C, Vitamin E, and Zinc. This blend is ideal for individuals experiencing mild to moderate nail brittleness and breakage. Biotin supports nail growth and strength, Vitamin C aids in collagen synthesis for healthy nail beds, Vitamin E protects nails from oxidative damage, and Zinc supports nail regeneration, all in an appropriate scientifically justifiable dose. In an embodiment, the health supplement is aimed at providing advanced support for severe nail health conditions includes Biotin (Vitamin B7), Vitamin C, Vitamin E, Collagen Peptides, Zinc, Silica, Calcium, Keratin, Iron, and Vitamin D3. This formulation is tailored for individuals with severe nail brittleness and damage. Biotin, Vitamin C, and Vitamin E enhance nail strength and protect from damage. Collagen Peptides and Silica improve nail hydration and structure. Zinc supports nail repair, Calcium strengthens nail hardness, Keratin enhances nail resilience, Iron ensures proper oxygen supply for nail health, and Vitamin D3 promotes overall nail health, all in an appropriate scientifically justifiable dose.
In another embodiment, a health supplement aimed at providing advanced support for severe skin health conditions includes but is not limited to Vitamin C, Vitamin E, Collagen Peptides, Hyaluronic Acid, Omega-3 Fatty Acids, Zinc, Silica, Resveratrol, CoQ10, and Vitamin D3. This formulation is tailored for individuals with severe skin concerns such as deep wrinkles, significant dryness, and loss of elasticity. Vitamin C and E provide antioxidant protection and support collagen synthesis, Collagen Peptides and Hyaluronic Acid enhance skin hydration and firmness, Omega-3 Fatty Acids reduce inflammation, Zinc aids in skin repair, Silica supports connective tissue health, Resveratrol offers potent antioxidant benefits, CoQ10 improves cellular energy production, and Vitamin D3 promotes overall skin health, all in an appropriate scientifically justifiable dose. In another embodiment, a formulation for managing low to moderate skin health conditions includes but is not limited to Vitamin C, Vitamin E, Collagen Peptides, and Hyaluronic Acid. This blend is ideal for individuals experiencing mild to moderate dryness, fine lines, and dull skin. Vitamin C aids in collagen production and protects skin from oxidative damage, Vitamin E improves skin hydration and reduces inflammation, Collagen Peptides enhance skin elasticity and firmness, and Hyaluronic Acid boosts skin moisture levels, all in an appropriate scientifically justifiable dose.
In an embodiment, a dietary supplement for preventing common health issues and promoting overall wellness includes but is not limited to Beta-Carotene, Vitamin C, Zinc, and Black Pepper Extract. This combination is suitable for general health maintenance and immune support. Beta-carotene and Vitamin C act as antioxidants, Zinc enhances immune function, and Black Pepper Extract increases the bioavailability of these nutrients, all in an appropriate scientifically justifiable dose.
In an embodiment, a formulation for managing moderate cardiovascular conditions includes but is not limited to Garlic Bulb Extract, Curcumin Rhizome Extract, Lycopene, Selenium, and CoQ10. This blend is ideal for individuals with mild to moderate cardiovascular concerns such as elevated cholesterol and blood pressure. Garlic Bulb Extract and Curcumin reduce inflammation, Lycopene provides antioxidant protection, Selenium supports heart health, and CoQ10 improves cellular energy production, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe cardiovascular conditions includes but is not limited to Garlic Bulb Extract, Curcumin Rhizome Extract, Lycopene, Selenium, CoQ10, Panax Ginseng, Omega-3 Fatty Acids, Vitamin D3, Magnesium, and Resveratrol. This formulation is tailored for individuals with severe cardiovascular concerns, such as chronic heart disease. Garlic Bulb Extract and Curcumin offer anti-inflammatory benefits, Lycopene and Resveratrol provide antioxidant protection, Selenium and CoQ10 support heart health, Panax Ginseng boosts energy, Omega-3 Fatty Acids reduce inflammation, and Vitamin D3 and Magnesium support overall cardiovascular function, all in an appropriate scientifically justifiable dose.
In an embodiment, a dietary supplement for enhancing cognitive function and reducing mild to moderate stress includes but is not limited to Bacopa Monnieri Extract, L-Theanine, Ginkgo Biloba, Magnesium, and Vitamin B12. This combination is particularly useful for improving mental clarity and reducing stress levels. Bacopa Monnieri Extract and Ginkgo Biloba enhance cognitive function, L-Theanine and Magnesium promote relaxation, and Vitamin B12 supports brain health, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at managing advanced cognitive decline and severe stress includes but is not limited to Bacopa Monnieri Extract, L-Theanine, Ginkgo Biloba, Magnesium, Vitamin B12, Curcumin Rhizome Extract, Omega-3 Fatty Acids, Resveratrol, CoQ10, and Selenium. This formulation is ideal for individuals experiencing significant cognitive decline and high levels of stress. Bacopa Monnieri Extract and Ginkgo Biloba enhance cognitive function, L-Theanine and Magnesium promote relaxation, Vitamin B12 supports brain health, Curcumin and Omega-3 Fatty Acids provide anti-inflammatory effects, Resveratrol offers antioxidant protection, CoQ10 supports cellular energy, and Selenium enhances overall brain function, all in an appropriate scientifically justifiable dose. In an embodiment, a dietary supplement for supporting joint health and reducing mild inflammation includes but is not limited to Boswellia Serrata, Ginger Extract, Vitamin E, and Magnesium. This combination is beneficial for individuals with mild joint pain and inflammation. Boswellia Serrata and Ginger Extract provide anti-inflammatory effects, Vitamin E protects joint tissues, and Magnesium supports muscle relaxation, all in an appropriate scientifically justifiable dose.
In an embodiment, a formulation designed for moderate joint health management includes but is not limited to Boswellia Serrata, Ginger Extract, Vitamin E, Magnesium, Vitamin D3, and Selenium. This blend is ideal for individuals experiencing moderate joint pain and inflammation. Boswellia Serrata and Ginger Extract offer anti-inflammatory benefits, Vitamin E and Selenium provide antioxidant protection, Magnesium supports muscle relaxation, and Vitamin D3 aids in bone health, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe joint conditions and chronic inflammation includes but is not limited to Boswellia Serrata, Ginger Extract, Vitamin E, Magnesium, Vitamin D3, Curcumin Rhizome Extract, Omega-3 Fatty Acids, Resveratrol, Selenium, and Zinc. This formulation is ideal for individuals with advanced arthritis or chronic inflammatory conditions. Boswellia Serrata and Ginger Extract reduce inflammation, Vitamin E protects joint tissues, Magnesium and Vitamin D3 support bone and muscle health, Curcumin and Omega-3 Fatty Acids provide potent anti-inflammatory effects, Selenium and Zinc support immune function, and Resveratrol offers antioxidant protection, all in an appropriate scientifically justifiable dose.
In an embodiment, a dietary supplement for enhancing metabolic function and aiding in mild weight management includes but is not limited to Garcinia Cambogia, Green Coffee Bean Extract, Chromium Picolinate, and Apple Cider Vinegar. This combination is ideal for individuals with mild weight management issues. Garcinia Cambogia and Green Coffee Bean Extract aid in fat metabolism, Chromium Picolinate regulates blood sugar levels, and Apple Cider Vinegar supports digestion and satiety, all in an appropriate scientifically justifiable dose. In an embodiment, a formulation for managing moderate metabolic and weight management issues includes but is not limited to Garcinia Cambogia, Green Coffee Bean Extract, Chromium Picolinate, Apple Cider Vinegar, CoQ10, and L-Arginine. This blend is suitable for individuals with moderate weight management challenges. Garcinia Cambogia and Green Coffee Bean Extract aid in fat metabolism, Chromium Picolinate regulates blood sugar levels, Apple Cider Vinegar supports digestion, CoQ10 enhances cellular energy, and L-Arginine supports circulation and muscle growth, all in an appropriate scientifically justifiable dose.
In an embodiment, a health supplement aimed at providing advanced support for severe metabolic issues and chronic weight management includes but is not limited to Garcinia Cambogia, Green Coffee Bean Extract, Chromium Picolinate, Apple Cider Vinegar, CoQ10, L-Arginine, Panax Ginseng, Omega-3 Fatty Acids, Resveratrol, and Vitamin D3. This formulation is ideal for individuals with severe weight management and metabolic concerns. Garcinia Cambogia and Green Coffee Bean Extract aid in fat metabolism, Chromium Picolinate regulates blood sugar levels, Apple Cider Vinegar supports digestion, CoQ10 enhances cellular energy, L-Arginine supports circulation and muscle growth, Panax Ginseng boosts energy, Omega-3 Fatty Acids reduce inflammation, Resveratrol offers antioxidant protection, and Vitamin D3 supports overall metabolic health, all in an appropriate scientifically justifiable dose. In an embodiment, a dietary supplement for supporting women's health and hormonal balance includes but is not limited to Evening Primrose Oil, Vitamin B6, Magnesium, and Chromium Picolinate. This combination is particularly beneficial for women experiencing mild hormonal fluctuations. Evening Primrose Oil helps balance hormones, Vitamin B6 supports mood regulation, Magnesium aids in muscle relaxation, and Chromium Picolinate regulates blood sugar levels, all in an appropriate scientifically justifiable dose. In an embodiment, a formulation for managing moderate symptoms of premenstrual syndrome (PMS) includes but is not limited to Evening Primrose Oil, Vitamin B6, Magnesium, Chromium Picolinate, and Chasteberry Extract. This blend is suitable for women experiencing moderate PMS symptoms such as mood swings, bloating, and cramps. Evening Primrose Oil and Chasteberry Extract help balance hormones, Vitamin B6 supports mood regulation, Magnesium reduces muscle cramps, and Chromium Picolinate regulates blood sugar levels, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe symptoms of polycystic ovary syndrome (PCOS) includes but is not limited to Inositol, Chromium Picolinate, Omega-3 Fatty Acids, Vitamin D3, Magnesium, N-Acetylcysteine, Green Tea Extract, Selenium, Resveratrol, and Berberine. This formulation is ideal for women with severe PCOS symptoms, such as irregular periods, insulin resistance, and hormonal imbalances. Inositol and Berberine improve insulin sensitivity, Chromium Picolinate regulates blood sugar, Omega-3 Fatty Acids and Resveratrol reduce inflammation, Vitamin D3 and Magnesium support hormonal balance, N-Acetylcysteine aids in detoxification, Green Tea Extract provides antioxidant benefits, and Selenium supports thyroid function, all in an appropriate scientifically justifiable dose.
In an embodiment, a dietary supplement for enhancing sexual health and vitality includes but is not limited to Panax Ginseng, Maca Powder, Tribulus Terrestris Fruit, and L-Arginine. This combination is particularly useful for improving libido and sexual performance. Panax Ginseng and Maca Powder boost energy and libido, Tribulus Terrestris Fruit supports hormonal balance, and L-Arginine enhances blood flow, all in an appropriate scientifically justifiable dose.
In an embodiment, a formulation for improving sperm count and motility includes but is not limited to L-Arginine, CoQ10, Zinc, Selenium, and Maca Powder. This blend is ideal for men experiencing moderate issues with sperm health. L-Arginine supports blood flow and nitric oxide production, CoQ10 provides cellular energy, Zinc and Selenium enhance sperm quality and motility, and Maca Powder boosts libido and overall reproductive health, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe issues with sperm count and motility includes but is not limited to L-Arginine, CoQ10, Zinc, Selenium, Maca Powder, Omega-3 Fatty Acids, Vitamin E, Folic Acid, Carnitine, and Ashwagandha. This formulation is particularly beneficial for men with significant reproductive health concerns. L-Arginine and CoQ10 support cellular energy and blood flow, Zinc and Selenium enhance sperm quality and motility, Maca Powder and Ashwagandha boost libido, Omega-3 Fatty Acids reduce inflammation, Vitamin E provides antioxidant protection, Folic Acid supports cellular health, and Carnitine enhances sperm motility, all in an appropriate scientifically justifiable dose.
In an embodiment, a formulation for managing moderate digestive health issues includes but is not limited to Probiotics, Folic Acid, Inositol, Zinc, and Aloe Vera Extract. This blend is suitable for individuals experiencing moderate digestive discomfort, such as bloating and irregular bowel movements. Probiotics support gut health, Folic Acid aids in nutrient absorption, Inositol supports liver function, Zinc promotes digestive enzyme production, and Aloe Vera Extract soothes the digestive tract, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for chronic digestive conditions includes Probiotics, Folic Acid, Inositol, Zinc, Aloe Vera Extract, Curcumin Rhizome Extract, Ginger Extract, Magnesium, Vitamin D3, and L-Glutamine. This formulation is ideal for individuals with chronic digestive conditions such as irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD). Probiotics restore gut flora, Folic Acid aids in nutrient absorption, Inositol supports liver function, Zinc and Aloe Vera Extract promote digestive health, Curcumin and Ginger Extract reduce inflammation, Magnesium supports muscle function, Vitamin D3 aids in immune regulation, and L-Glutamine promotes gut lining repair, all in an appropriate scientifically justifiable dose.
In an embodiment, a dietary supplement for supporting healthy aging and reducing oxidative stress includes but is not limited to Resveratrol, Vitamin E, Selenium, and CoQ10. This combination is suitable for individuals looking to support healthy aging and protect against oxidative stress. Resveratrol and CoQ10 provide antioxidant protection, Vitamin E supports skin health, and Selenium enhances immune function, all in an appropriate scientifically justifiable dose. In an embodiment, a formulation for managing moderate signs of aging and promoting longevity includes Resveratrol, Vitamin E, Selenium, CoQ10, Omega-3 Fatty Acids, and Green Tea Extract. This blend is suitable for individuals experiencing moderate signs of aging, such as reduced energy and skin elasticity. Resveratrol, CoQ10, and Green Tea Extract provide antioxidant protection, Vitamin E supports skin health, Selenium enhances immune function, and Omega-3 Fatty Acids reduce inflammation, all in an appropriate scientifically justifiable dose. In an embodiment, a health supplement aimed at providing advanced support for severe aging concerns and promoting longevity includes Resveratrol, Vitamin E, Selenium, CoQ10, Omega-3 Fatty Acids, Green Tea Extract, Curcumin Rhizome Extract, Vitamin C, Magnesium, and Zinc. This formulation is ideal for individuals with severe aging concerns, such as chronic inflammation and oxidative stress. Resveratrol, CoQ10, Green Tea Extract, Curcumin, and Vitamin C provide potent antioxidant protection, Vitamin E supports skin health, Selenium enhances immune function, Omega-3 Fatty Acids reduce inflammation, Magnesium supports muscle and bone health, and Zinc aids in cellular repair, all in an appropriate scientifically justifiable dose.
In an embodiment, the bioavailability of nutraceuticals and pharmaceuticals in the capsule of the present invention can be varied based on one or more characteristics such as, excipient choice/ selection, encapsulation techniques of nutraceuticals, pharmaceuticals or excipients, and layering/ arrangement profile of nutraceuticals, pharmaceuticals and/or excipients.
In an embodiment, the capsule has minimal amounts of excipients in order to maximize the number of nutraceuticals and pharmaceuticals and reduce dosage amounts. In an embodiment, the shelf life of the capsule is up to 12 months at 40°C at 75% humidity. In an embodiment, the excipient is a filler, and includes but is not limited to pullulan, xanthan gum and the like. In an embodiment, the total dosage amount per capsule is in the range of 0.5-1.5cc. The individual nutraceutical and pharmaceutical dosage amount can be at least 0.01cc.
In an embodiment, the method for manufacturing the orally administrable capsule includes:
feeding varying dosages of nutraceuticals, pharmaceuticals, including excipients, into the 3-D printing system software;
moving the 3-D printer via at least one nozzle in a predetermined or customizable format to deposit at least one film of nutraceuticals, pharmaceuticals, and/or excipients to form a plurality of layers in a desired shape and form;
curing the deposited composition by: Heating, UV treatment, Cooling/freezing, a combination of heating followed by UV treatment, UV treatment followed by heating;
customizing at the level of nutraceutical and pharmaceutical selection and dosage;
using nutraceutical, pharmaceutically active ingredients in the construction of the shells or containers in real-time using a blend of excipients and additives.
Although the present disclosure has been described specifically to structural and/or functional features and/or methods, the scope of the present disclosure is not to be construed as limited to the literal disclosure of the present specification. Obvious modifications are deemed to be well within the scope of the present invention. ,CLAIMS:1. An orally administrable capsule, the orally administrable capsule comprising:
an at least one nutraceuticals, pharmaceuticals, or combinations thereof; and
optionally an at least one excipient;
wherein each nutraceutical and pharmaceutical in the capsule is present in the form of a layer;
wherein the shelf life of the capsule is up to 12 months at 40°C and 75% humidity;
wherein the size of the capsule is as per dosage requirement and is customized;
wherein the nutraceutical and pharmaceutical layers are separated by a single excipient, or a plurality of excipients; and
wherein the excipient layer comprises a single film and a plurality of films.
2. The orally administrable capsule as claimed in claim 1, wherein the layer of nutraceutical and pharmaceutical comprises a single film and plurality of films.
3. The orally administrable capsule as claimed in claim 1, wherein the capsule consists of a single continuous compartment and comprises a plurality of compartments.
4. The orally administrable capsule as claimed in claim 1, wherein the plurality of compartments is isolated from each other such that no nutraceutical and pharmaceutical in a compartment is physically contact an adjoining compartment.
5. The orally administrable capsule as claimed in claim 1, wherein subset of the plurality of compartments are connected to each other such that the part of a nutraceutical and pharmaceutical in one compartment is physically in contact with contents of an adjoining compartment.
6. The orally administrable capsule as claimed in claim 1, wherein adjacent layers of two different nutraceuticals and pharmaceuticals are separated by one excipient.
7. The orally administrable capsule as claimed in claim 1, wherein the total volume of nutraceutical and pharmaceutical content is in the range of 0.5-1.5cc, and the volume of any single nutraceutical and pharmaceutical is 0.01cc.
8. The orally administrable capsule as claimed in claim 1, wherein the capsule is selected from up to 20 different nutraceuticals and pharmaceuticals and combination of both, in solid, semisolid, gels, suspension, liquid, oil, encapsulated solid granular form and combination thereof.
9. The orally administrable capsule as claimed in claim 1, wherein the excipient layer covers the entire surface, partially covers the surface of a first nutraceutical and pharmaceutical.
10. The orally administrable capsule as claimed in claim 1, wherein the nutraceutical is selected from a specified group of nutraceuticals Anacyclus Pyrethrum Root, Andrographis Paniculata Extract, Asparagus Racemosus Rhizome/Tuber, Bacopa Monnieri Extract, Beta-Carotene, Biotin, Black Pepper Extract, Boswellia Serrata, Caffeine, Chlorophytum Borivilianum Root, Chromium Picolinate, CoQ10, Curcumin Rhizome Extract, Garcinia Cambogia, Garlic Bulb Extract, Ginger Extract, Ginkgo Biloba, Glycyrrhiza Glabra Root Extract, Green Coffee Bean Extract, L-Arginine, L-Arginine HCl, L-Glutathione, L-Theanine, L-Tyrosine, Lycopene Extract, Magnesium, Melatonin, Mucuna Pruriens Seed, Panax Ginseng, Piper Nigrum Seed, Selenium, Sida Cordifolia Root, Tribulus Terrestris Fruit, Urtica Dioica Leaf, Vitamin A, Vitamin B12, Vitamin B6, Vitamin C, Vitamin D3, Vitamin E, Withania Sominifera Root, Zinc, Ammonium Molybdate (Molybdenum (VI)), Apple Cider Vinegar, Beta Glucan, Biotin (B7), Chromium (III) Chloride, Chromium (III) Sulfate, Copper Oxide (Copper (II) Oxide, Cupric Oxide and Black Copper Oxide), Cupric Carbonate, Cupric Gluconate, Cupric Sulfate, Evening Primrose Oil, Ferric Ammonium Citrate, Ferric Diphosphate, Ferrous Citrate, Ferrous Fumarate, Ferrous Gluconate, Ferrous Lactate, Ferrous Orthophosphate, Ferrous Sulfate, Folic Acid, Inositol, Lactoferrin, Maca Powder, Magnesium Carbonate, Magnesium Chloride, Magnesium Gluconate, Magnesium Oxide, Magnesium Phosphate Dibasic, Magnesium Phosphate Tribasic, Magnesium Sulfate, Manganese Carbonate, Manganese Chloride, Manganese Citrate, Manganese Gluconate, Manganese Sulfate, Milk Thistle Extract, Niacin B3, Potassium Iodate, Potassium Iodide, Pyridoxine B6, Resveratrol, Riboflavin B2, Selenomethionine, Sodium Hydrogen Selenite, Sodium Iodate, Sodium Iodide, Sodium Molybdate (Molybdenum (VI)), Sodium Selenate, Sodium Selenite, Tart Cherry Extract, Thiamine B1, Vitamin B12 (Cyanocobalamin), Vitamin D, Vitamin K, White Kidney Bean Extract, Zinc Acetate, Zinc Carbonate, Zinc Chloride, Zinc Citrate, Zinc Gluconate, Zinc Lactate, Zinc Oxide, Zinc Sulfate, and combinations thereof.
11. The orally administrable capsule as claimed in claim 1, wherein the pharmaceutical is selected from any pharmaceutical substance known in the art, including OTC and restricted substances.
12. The orally administrable capsule as claimed in claim 1, wherein the excipient works as filler and is selected from pullulan, xanthan gum and the like.
13. The orally administrable capsule as claimed in claim 1, wherein the formulation for managing low to severe health conditions related to hair, nails, skin, cardiovascular health, cognitive function, joint health, metabolic function, women's health, hormonal balance, polycystic ovary syndrome (PCOS), sexual health, digestive health, healthy aging, and longevity is selected from scientifically justifiable doses of Biotin, Vitamin C, Vitamin E, Iron, Collagen Peptides, Omega-3 Fatty Acids, Zinc, Silica, Keratin, Saw Palmetto Extract, Vitamin D3, Calcium, Hyaluronic Acid, Resveratrol, CoQ10, Beta-Carotene, Black Pepper Extract, Garlic Bulb Extract, Curcumin Rhizome Extract, Lycopene, Selenium, Panax Ginseng, Magnesium, Bacopa Monnieri Extract, L-Theanine, Ginkgo Biloba, Vitamin B12, Boswellia Serrata, Ginger Extract, Garcinia Cambogia, Green Coffee Bean Extract, Chromium Picolinate, Apple Cider Vinegar, L-Arginine, Evening Primrose Oil, Vitamin B6, Chasteberry Extract, Inositol, N-Acetylcysteine, Green Tea Extract, Berberine, Maca Powder, Tribulus Terrestris Fruit, Folic Acid, Carnitine, Ashwagandha, Probiotics, Aloe Vera Extract, and L-Glutamine.
14. The orally administrable capsule as claimed in claim 1, wherein the bioavailability of nutraceuticals and pharmaceuticals is varied based on characteristics such as excipient selection, encapsulation techniques, and layering profiles.
15. The orally administrable capsule as claimed in claim 1, wherein the capsule has minimal amounts of excipients to maximize the amounts of nutraceuticals and pharmaceuticals.
16. The orally administrable capsule as claimed in claim 1, wherein the customization is done at the level of nutraceutical and pharmaceutical selection, dosage, or both.
17. The method of manufacturing the orally administrable capsule as claimed in claim 1, comprising:
feeding varying dosages of nutraceuticals, pharmaceuticals, comprising excipients, into the 3-D printing system software;
moving the 3-D printer via at least one nozzle in a predetermined or customizable format to deposit at least one film of nutraceuticals, pharmaceuticals, and/or excipients to form a plurality of layers in a desired shape and form;
curing the deposited composition by: Heating, UV treatment, Cooling/freezing, a combination of heating followed by UV treatment, UV treatment followed by heating;
customizing at the level of nutraceutical and pharmaceutical selection and dosage;
using nutraceutical, pharmaceutically active ingredients in the construction of the shells or containers in real-time using a blend of excipients and additives.
| # | Name | Date |
|---|---|---|
| 1 | 202311089428-STATEMENT OF UNDERTAKING (FORM 3) [28-12-2023(online)].pdf | 2023-12-28 |
| 2 | 202311089428-PROVISIONAL SPECIFICATION [28-12-2023(online)].pdf | 2023-12-28 |
| 3 | 202311089428-FORM 1 [28-12-2023(online)].pdf | 2023-12-28 |
| 4 | 202311089428-Proof of Right [23-02-2024(online)].pdf | 2024-02-23 |
| 5 | 202311089428-FORM-26 [23-02-2024(online)].pdf | 2024-02-23 |
| 6 | 202311089428-Others-020524.pdf | 2024-05-14 |
| 7 | 202311089428-GPA-020524.pdf | 2024-05-14 |
| 8 | 202311089428-Correspondence-020524.pdf | 2024-05-14 |
| 9 | 202311089428-RELEVANT DOCUMENTS [28-08-2024(online)].pdf | 2024-08-28 |
| 10 | 202311089428-RELEVANT DOCUMENTS [28-08-2024(online)]-1.pdf | 2024-08-28 |
| 11 | 202311089428-Proof of Right [28-08-2024(online)].pdf | 2024-08-28 |
| 12 | 202311089428-POA [28-08-2024(online)].pdf | 2024-08-28 |
| 13 | 202311089428-FORM-5 [28-08-2024(online)].pdf | 2024-08-28 |
| 14 | 202311089428-FORM-26 [28-08-2024(online)].pdf | 2024-08-28 |
| 15 | 202311089428-FORM 3 [28-08-2024(online)].pdf | 2024-08-28 |
| 16 | 202311089428-FORM 13 [28-08-2024(online)].pdf | 2024-08-28 |
| 17 | 202311089428-FORM 13 [28-08-2024(online)]-2.pdf | 2024-08-28 |
| 18 | 202311089428-FORM 13 [28-08-2024(online)]-1.pdf | 2024-08-28 |
| 19 | 202311089428-COMPLETE SPECIFICATION [28-08-2024(online)].pdf | 2024-08-28 |
| 20 | 202311089428-Response to office action [09-10-2024(online)].pdf | 2024-10-09 |
| 21 | 202311089428-Response to office action [09-10-2024(online)]-1.pdf | 2024-10-09 |