A synergistic bioactive composition for muscle health

Abstract

The present invention relates to a synergistic composition comprising Astaxanthin, Calcium Hydroxy Methyl Butyrate (CaHMB) and Leucine with pharmaceutically acceptable additives and excipients for the promotion of muscle health. The present invention also provides a process for the preparation of the said synergistic composition. The invention provides an effective and synergistic composition to counteract sarcopenia, enhancing muscle strength, mobility, and quality of life in affected individuals.

Description

[0001] A SYNERGISTIC BIOACTIVE COMPOSITION FOR MUSCLE HEALTH

[0002] RELATED APPLICATION:

[0003] The present application claims benefit of the Indian Provisional Application No. IN202521014274 filed on, Feb 19th, 2025 the entire contents of which are hereby incorporated by reference.

[0004] FIELD OF THE INVENTION:

[0005] The present invention relates to a synergistic composition comprising Astaxanthin, Calcium Hydroxy Methyl Butyrate (CaHMB) and Leucine with pharmaceutically acceptable additives and excipients for the promotion of muscle health. The present invention also provides a process for the preparation of the said synergistic composition. The invention provides an effective and synergistic composition to counteract sarcopenia, enhancing muscle strength, mobility, and quality of life in affected individuals.

[0006] BACKGROUND OF THE INVENTION:

[0007] Sarcopenia is an age-related, progressive disorder characterized by the gradual loss of skeletal muscle mass, strength, and function. It is a major concern among the elderly population, as it leads to muscle weakness, which in turn increases the risk of falls, fractures, and loss of mobility, ultimately compromising quality of life. Sarcopenia is also associated with poor overall survival rates, longer hospitalization periods, postoperative complications, metabolic disorders, cognitive decline, and increased mortality risk.

[0008] The primary causes of sarcopenia include aging, physical inactivity, and inadequate nutrition. While aging is an unavoidable factor, scientific research suggests that specific nutritional interventions can help mitigate muscle deterioration and improve muscle function in sarcopenic individuals. Nutrients such as Leucine, P-hydroxy-P-methylbutyrate (HMB), and Astaxanthin have shown potential in promoting muscle protein synthesis, reducing muscle degradation, and enhancing overall muscle health. However, there remains a lack of optimized and targeted formulations that leverage these compounds synergistically for the treatment of sarcopenia.Several prior art references disclose various compositions and methods aimed at improving muscle health and treating muscle loss-related conditions, including sarcopenia. However, these references fail to disclose or suggest a composition comprising Calcium -P-hydroxy-P-methylbutyrate (CaHMB), Leucine, and Astaxanthin in combination for this purpose.

[0009] Several studies and scientific articles discuss the individual effects of Leucine, HMB, and Astaxanthin on muscle health. However, none of these references disclose or suggest their combined use in a single composition for sarcopenia treatment.

[0010] D J Wilkinson et al., in their article titled “Effects of Leucine and Its Metabolite -Hydroxy-P-Methylbutyrate (HMB) on Human Skeletal Muscle Protein Metabolism;” J Physiol, 2013 Jun 1;591(11):2911-23, highlight the role of Leucine and HMB in stimulating muscle protein synthesis. However, it does not discuss the Ca-HMB form of HMB or its use in combination with Astaxanthin.

[0011] Francisco M. Martinez-Arnau et al in their article titled “Effects of Leucine Administration in Sarcopenia: A Randomized and Placebo-Controlled Clinical Trial;” Nutrients. 2020, Mar 27;12(4):932., report Leucine supplementation can be beneficial in sarcopenia treatment. However, the study does not disclose a composition incorporating Ca-HMB and Astaxanthin as part of its study.

[0012] Sok Kuan Wong et al., in their article “Effects of Astaxanthin on the Protection of Muscle Health (Review)” Experimental and Therapeutic Medicine, October-2020, Volume 20, Issue 4, Pages: 2941-2952, discuss the potential of Astaxanthin in muscle health and its possible role in sarcopenia management. However, it does not disclose or suggest the use of Ca-HMB in combination with Astaxanthin to treat muscle loss.

[0013] The prior art fails to address the following key aspects:

[0014] (1) Although individual components have been studied, the synergistic combination of CaHMB, leucine, and astaxanthin in a single formulation for sarcopenia treatment has not been explored.(2) A comprehensive formulation specifically designed for sarcopenia management is lacking. Existing patents and studies focus on general muscle health or muscle strength enhancement but do not explicitly target sarcopenia as a clinical condition with a well-defined composition.

[0015] Accordingly, it can be said that the prior art fails to provide a synergistic bioactive composition comprising Leucine, Astaxanthin, Calcium-P-hydroxy-P-methylbutyrate (CaHMB) together with pharmaceutical excipient for muscle health and specifically treating the symptoms of sarcopenia.

[0016] Hence there is a need for synergistic bioactive composition or formulation which is cost-effective, readily available, and easy to administering daily life to maintain good muscle health and aid in managing diseases like sarcopenia.

[0017] OBJECTIVE OF THE INVENTION:

[0018] The principal objective of the present invention is to provide a synergistic bioactive composition for muscle health.

[0019] Another main objective of the present invention is to provide a synergistic bioactive composition comprising Leucine, Astaxanthin, and Calcium Hydroxyl Methyl Butyrate (CaHMB) to treat symptoms of sarcopenia and maintain good muscle health.

[0020] Yet another objective of the present invention is to prepare a synergistic bioactive composition comprising Leucine, Calcium hydroxyl methyl butyrate (CaHMB), Astaxanthin and pharmaceutically acceptable excipients selected from a diluent, a binder, a surfactant, a lubricant, a glidant, an additive, a solvent or mixtures thereof.

[0021] Another objective of the present invention is to provide the synergistic bioactive composition with improved bodily absorption, improved recovery of muscles and to maintain a good muscle health in the presence of sarcopenia symptoms.Yet another objective of the present invention is to provide the synergistic bioactive composition comprising Leucine, Astaxanthin, Calcium Hydroxyl Methyl Butyrate (CaHMB) along with additives and excipients that enhance absorption in the body and promote rapid muscle recovery.

[0022] One more objective of the present invention is to provide a synergistic bioactive composition or formulation which is cost-effective, readily available, and easily administered in daily life to maintain good muscle health and also show enhanced efficacy to treat the symptoms of the disease sarcopenia.

[0023] Yet another objective of the present invention is to provide a cost-effective synergistic bioactive composition comprising leucine, astaxanthin, and calcium hydroxyl methylbutyrate (CaHMB), along with pharmaceutically acceptable excipients, that offers enhanced efficacy in maintaining muscle health and in treating symptoms of diseases such as sarcopenia.

[0024] SUMMARY OF THE INVENTION:

[0025] The present invention provides a synergistic composition comprising a synergistic combination of Calcium-P-hydroxy-P-methylbutyrate (CaHMB), Leucine, and Astaxanthin. The synergistic composition may contain suitable pharmaceutical excipients, and the synergistic composition is suitable for preparing dosage forms which can be administered to the person in need thereof for muscle health. Further, the present invention provides a process for the preparation of the said synergistic composition. The invention provides a synergistic composition which is advantageous over prior art disclosures.

[0026] This unique combination addresses the limitations of prior formulations by leveraging the synergistic effects of CaHMB, Leucine, and Astaxanthin, offering superior efficacy in the prevention and management of sarcopenia. The composition may be formulated as a dietary supplement, pharmaceutical composition, or functional food, providing a convenient option for administration to aging individuals and those at risk of muscle deterioration.The invention thus provides an effective and synergistic composition for counteracting sarcopenia, thereby enhancing muscle strength, mobility, and quality of life in affected individuals.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS:

[0028] FIGURE-1: Study Results Comparative Graph for Evaluation of the synergistic effect of Astaxanthin, Calcium hydroxy methyl butyrate (CaHMB) and Leucine in animal model for Grip Strength.

[0029] FIGURE-2: Study Results Comparative Graph for Evaluation of the synergistic effect of Astaxanthin, Calcium hydroxy methyl butyrate (CaHMB) and Leucine in animal model for Motor Activity.

[0030] FIGURE-3: Study Results Comparative Graph for Evaluation of the synergistic effect of Astaxanthin, Calcium hydroxy methyl butyrate (CaHMB) and Leucine in animal model for Rotated.

[0031] FIGURE-4: Study Results Comparative Graph for Evaluation of the synergistic effect of Astaxanthin, Calcium hydroxy methyl butyrate (CaHMB) and Leucine in animal model for Serum IL-6 levels.

[0032] FIGURE-5: Study Results Comparative Graph for Evaluation of the synergistic effect of Astaxanthin, Calcium hydroxy methyl butyrate (CaHMB) and Leucine in animal model for Serum SIRT1 levels.

[0033] DETAILED DESCRIPTION OF THE INVENTION:

[0034] The detailed description and examples provided herein are illustrative and not limiting. Modifications and variations within the scope of the invention will be apparent to a person skilled in the art.The following detailed description presents various embodiments of the present invention. These embodiments are described with sufficient detail to enable those skilled in the art to implement and practice the invention. However, other embodiments and modifications may be employed without departing from the scope of the invention.

[0035] References to "an," "one," or "various" embodiments in this disclosure do not necessarily refer to the same embodiment, and such references contemplate multiple embodiments. Accordingly, the following detailed description should not be interpreted in a limiting sense, as the scope of the invention is defined solely by the appended claims, along with the full scope of legal equivalents to which such claims are entitled.

[0036] Furthermore, unless otherwise defined, all technical and scientific terms used herein shall be interpreted as understood by a person ordinarily skilled in the art.

[0037] The present invention addresses the field of Pharmaceutics, medicine and pharmacology, specifically focusing on a synergistic bioactive composition with improved recovery of muscles and to maintain a good muscle health in the condition of sarcopenia in mammals.

[0038] The present invention provides a synergistic bioactive composition comprising of Leucine, Astaxanthin and Calcium Hydroxy Methyl Butyrate (CaHMB) with pharmaceutically acceptable excipients for muscle health.

[0039] In one of the embodiments, the present invention provides a synergistic bioactive composition comprising of Leucine, Astaxanthin and Calcium Hydroxy Methyl Butyrate (CaHMB) with pharmaceutically acceptable excipients for the treatment of sarcopenia.

[0040] According to present invention, the synergistic composition contains Leucin, Astaxanthin and Calcium Hydroxy Methyl Butyrate (CaHMB) in a ratio of CaHMB: Leucine Astaxanthin ratio is 1:240:2, 1:200:1.75, 1:150:1.5, 1:125:1.25, 1:100: 1, 1:75:0.9, 1:50:0.8, 1:25:0.5, 1:20:0.1, 1:10:0.05, 1:5:0.02, 1:4.3860:0.0175, 1: 0.0042:0.0001.According to present invention the amount of Leucine is 25mg to 6000mg, 50mg to 5000mg, 75mg to 4000mg or 100 mg to 3000 mg; amount of Astaxanthin is 1 mg to 50 mg, Img to 40mg, Img to 30 mg or Img to 20 mg; and amount of Calcium Hydroxy Methyl Butyrate (CaHMB) is 25 mg to 6000mg, 100 mg to 6000 mg, 200 mg to 5000 mg, 300 mg to 4000mg, 400mg to 3500 mg or 500 mg to 3000 mg in the composition.

[0041] According to present invention the amount of Leucine is 2% to 85%, amount of Astaxanthin is 0.1 % to 25 % and amount of Calcium Hydroxy Methyl Butyrate (CaHMB) is l0%to 95% in the composition.

[0042] According to the present invention the amount mentioned herein is based on dosage required, accordingly, as per need the total dosage can be divided into multiple units for administration.

[0043] The present invention provides a synergistic bioactive composition consisting of Leucine, Astaxanthin and Calcium Hydroxy Methyl Butyrate (CaHMB) with pharmaceutically acceptable excipients for muscle health.

[0044] The present invention provides a synergistic bioactive composition consisting of Leucine, Astaxanthin and Calcium Hydroxy Methyl Butyrate (CaHMB) with pharmaceutically acceptable excipients for the treatment of sarcopenia.

[0045] In another embodiment the present invention provides a synergistic bioactive composition comprising of Leucine, Astaxanthin, Calcium hydroxymethyl butyrate (CaHMB) along with pharmaceutically acceptable salts to improve and maintain good muscle health.

[0046] In another embodiment the present invention provides a synergistic nutraceutical composition wherein Leucine, Astaxanthin and Calcium hydroxyl methyl butyrate (CaHMB) are in a ratio suitable for the desired therapeutic effect.According to present invention, the synergistic bioactive composition as provided in present invention wherein the pharmaceutically acceptable excipients are selected from a diluent, a binder, a surfactant, a lubricant, a glidant, or a like or a mixture thereof.

[0047] Diluents are selected one or more from Microcrystalline cellulose, Calcium carbonate, Dicalcium phosphate, Lactose monohydrate, Sorbitol, Mannitol, Starch, Maltodextrin, Pregelatinized starch, Croscarmellose sodium, Guar gum, Xanthan gum, Sodium alginate, Polyvinylpyrrolidone (PVP), Sodium carboxymethyl cellulose (CMC), Ammonium alginate, Calcium lactate, Calcium phosphate dibasic anhydrous, Calcium phosphate dibasic dihydrate, Calcium phosphate tribasic, Calcium silicate, Calcium sulfate, Cellulose powdered, Cellulose silicified microcrystalline, Cellulose acetate, Com starch and Pregelatinized starch, Dextrates, Dextrin, Dextrose, Erythritol, Ethylcellulose, Fructose, Fumaric acid, Glyceryl palmito stearate, Isomalt, Kaolin, Lactitol, Lactose anhydrous, Lactose monohydrate and Com starch, Lactose monohydrate and Povidone, Lactose monohydrate and Lactose spray-dried, Lactose monohydrate and Microcrystalline cellulose, Magnesium carbonate, Magnesium oxide, Maltitol, Maltose, Polydextrose, Polymethacrylates, Simethicone, Sodium chloride, Starch sterilizable maize, Sucrose, Sugar compressible, Sugar confectioner’s, Sugar spheres, Sulfobutylether b- cyclodextrin, Sunflower oil, Talc, Tragacanth, Trehalose, Xylitol and mixtures thereof.

[0048] Binders are selected one or more from Starch, Pregelatinized starch, Polyvinylpyrrolidone (PVP), Methylcellulose, Hypromellose, Hydroxypropyl cellulose (HPC), Sodium alginate, Xanthan gum, Acacia. Agar, Alginic acid, Calcium carbonate, Calcium phosphate tribasic, Calcium lactate, Carbomer, Carboxymethylcellulose sodium, Carrageenan, Cellulose acetate phthalate, Ceratonia, Microcrystalline cellulose, Chitosan, Copovidone, Cottonseed oil, Dextrates, Dextrin, Dextrose, Ethylcellulose, Gelatin, Liquid glucose, Glyceryl behenate, Guar gum, Hydroxyethyl cellulose, Hydroxyethylmethyl cellulose, Hydroxypropyl starch, Lactose anhydrous, Spray-dried lactose, Low- substituted hydroxypropyl cellulose, Inulin, Monohydrate lactose, Magnesium aluminum silicate, Maltodextrin, Maltose, Methylcellulose, Pectin, Poloxamer, Polycarbophil, Polydextrose, Polyethylene oxide, Polymethacrylates, Povidone, Sucrose, Sunflower oil, Hydrogenatedvegetable oil, Vitamin E, Polyethylene glycol succinate, Zein, Tragacanth, Polyethylene glycol, Polyvinylpyrrolidone, Stearic acid, Tricaprylin and mixtures thereof.

[0049] Surfactants are selected one or more from Sodium lauryl sulfate, Polysorbate 80, Polysorbate 20, Sorbitan monolaurate, Sorbitan monooleate, Sorbitan monopalmitate, Sorbitan monostearate, Cetyltrimethylammonium bromide (CTAB), Poloxamer, Polyethylene glycol, Sodium dodecylbenzene sulfonate, Glycerol monostearate, Tween 80. Benzalkonium chloride, Benzethonium chloride, Cetylpyridinium chloride, Docusate sodium, Glycine, Glycofurol, Hypromellose, Phospholipids, Polyoxyethylene alkyl ethers, Polyoxyethylene castor oil derivatives, Polyoxyethylene sorbitan fatty acid esters, Polyoxyethylene stearates, Sodium lauryl sulfate, Sorbitan esters (sorbitan fatty acid esters), Tricaprylin and mixtures thereof.

[0050] Lubricants and / or glidants are selected one or more from Magnesium stearate, Calcium stearate, Zinc stearate, Stearic acid, Sodium stearyl fumarate, Talc, Polyethylene glycol, Colloidal Silicon dioxide, Colloidal silica, Hydrogenated vegetable oil, Sodium benzoate, Polyvinyl acetate, Glyceryl behenate, Canola oil, Castor oil, Glyceryl monostearate, Glyceryl palmitostearate, Lauric acid, Leucine, Light mineral oil, Mineral oil, Magnesium lauryl sulfate, Myristic acid, Octyldodecanol, Palmitic acid, Poloxamer, Polyvinyl alcohol, Potassium benzoate, Sodium hyaluronate, Sodium lauryl sulfate, Spray-dried lactose, Starch sterilizable maize, Tricaprylin, Sodium chloride, Tribasic calcium phosphate, Powdered cellulose, Magnesium oxide, Magnesium trisilicate, Magnesium silicate, Silicon dioxide, and mixtures thereof.

[0051] Another embodiment of the present invention provides synergistic nutraceutical composition wherein the pharmaceutically acceptable additives and excipients are present in the amount of 1% w / w to 99% of the total composition.

[0052] Another embodiment of the present invention provides the synergistic bioactive composition which helps to reduce the symptoms of sarcopenia.Another embodiment of the present invention provides evaluation of the synergistic efficacy of Leucine, Calcium hydroxyl methyl butyrate (CaHMB) and Astaxanthin in the treatment of symptoms of sarcopenia.

[0053] According to present invention, the synergistic composition of the present invention may further contain additional excipients like acids, bases, buffers, oxidizers, disintegrants, preservative, antioxidants and like or mixture thereof.

[0054] Yet another embodiment of the present invention is to provide a pharmaceutical composition available in various forms such as powder, granules, pellets, tablets, minitablets, sachets, and solutions enhancing versatility and patient compliance.

[0055] According to the present invention, the synergistic composition can be prepared using various conventional and advanced pharmaceutical techniques known in the art, such as direct compression, wet or dry granulation, spray drying, or extrusion-spheronization. The composition can be formulated into solid dosage forms, including tablets, capsules, sachets, powders, granules, and orally disintegrating tablets (ODTs), depending on the intended use and patient compliance requirements.

[0056] Additionally, the composition can be incorporated into liquid dosage forms, such as solutions, suspensions, emulsions, or syrups, to enhance bioavailability and ease of administration, particularly for individuals with difficulty swallowing solid forms. Furthermore, the formulation can be adapted into semi-solid forms, including gels, creams, or pastes, if required for alternative routes of administration.

[0057] For controlled or targeted delivery, the composition may also be processed into sustained-release, delayed-release, or enteric -coated formulations to optimize absorption and therapeutic efficacy. Other specialized delivery systems, such as orodispersible films, effervescent tablets, chewable formulations, and transdermal patches, can also be developed based on patient-specific needs.Thus, the invention provides a versatile and adaptable formulation that can be customized into various pharmaceutical dosage forms for optimal administration and therapeutic effectiveness.

[0058] A pharmaceutical composition for improvement in muscle health comprising Astaxanthin, Calcium Hydroxy Methyl Butyrate, Leucine and one or more acceptable pharmaceutical excipients.

[0059] The pharmaceutical composition as per the present invention, wherein the composition further comprise one or more diluents, disintegrants, binders, surfactants, lubricants, polymers, preservatives, anti -microbial agent and glidants.

[0060] The pharmaceutical composition as per the present invention, wherein one or more suitable diluents are selected from but not limited to microcrystaline cellulose, sucrose, lactose, lactose monohydrate, maltodextrin, calcium carbonate, mannitol, sorbitol or mixtures thereof.

[0061] The pharmaceutical composition as per the present invention, wherein one or more suitable binders are selected from but not limited to Hypromellose / Hydroxypropyl methylcellulose, Maize starch, Modified starch, Acacia gum, Xanthan gum, Polivinyl pyrrolidone or mixtures thereof.

[0062] The pharmaceutical composition as per the present invention, wherein one or more suitable disintegrants are selected from but not limited to crospovidone, Croscarmellose sodium, Sodium carboxymethyl cellulose or mixtures thereof.

[0063] The pharmaceutical composition as per the present invention, wherein one or more suitable surfactants are selected from but not limited to disodium EDTA, polysorbate 80 or mixtures thereof.

[0064] The pharmaceutical composition as per the present invention, wherein one or more suitable lubricant and glidants are selected from magnesium stearate, zinc stearate, talc, colloidal silicon dioxide or mixtures thereof.The pharmaceutical composition as per the present invention, wherein one or more suitable polymers are selected from but not limited to medium chain triglycerides, polyethylene glycol, bees wax, cellulose acetate phthalate, ethyl cellulose or mixtures thereof.

[0065] The pharmaceutical composition as per the present invention, wherein one or more suitable Preservatives are selected from but not limited to sodium phosphate, sodium benzoate, propyl paraben, methyl paraben, citric acid, butylated hydroxyanisole, butylated hydroxytoluene or mixtures thereof.

[0066] The pharmaceutical composition as per the present invention, wherein the composition is in the form of but not limited to tablet, capsule, suspension, and sachet.

[0067] The present invention addresses the unmet need by providing a novel composition comprising Calcium-P-hydroxy-P-methylbutyrate (CaHMB), Leucine, and Astaxanthin for the prevention and treatment of sarcopenia.

[0068] Thus, the present invention provides a unique, synergistic composition that is not disclosed or suggested by the prior art, fulfilling a critical need in the management of sarcopenia.

[0069] EXAMPLES:

[0070] EXAMPLE-1: COMPOSITION

[0071] Following is general composition formula as per the present invention.

[0072]

[0073] EXAMPLE-2: COMPOSITION

[0074]

[0075]

[0076] EXAMPLE-3 TABLET COMPOSITION

[0077]

[0078] Process for preparation:

[0079] Step-1) All raw materials were dispensed, verified against the formulation sheet, and weighed individually using a calibrated balance.

[0080] Step-2) The weighed materials were sifted through a suitable mesh (typically #40) to eliminate foreign matter and ensure uniform particle size.

[0081] Step-3) The sifted materials from no. 1 to no. 5 were transferred to a suitable blender and dry mixed for achieving uniformity.

[0082] Step-4) A binder solution was prepared by dissolving Polyvinyl pyrrolidone in purified water under continuous stirring until a clear solution was obtained.

[0083] Step-5) The dry mix was transferred to a rapid mixer granulator, and the binder solution was added gradually. Granulation was carried out until a uniform wet mass was obtained.

[0084] Step-6) The wet granules were dried using a fluid bed dryer at a controlled temperature (60-65°C) until the loss on drying was below 2.5% w / w. The dried granules were then sifted through a #20 mesh.

[0085] Step-7) Oversized granules were milled and re-sifted through a #20 mesh. Lubricants such as magnesium stearate, talc, zinc stearate, and colloidal silicon dioxide were added and blended with the dried granules for uniform lubrication.Step-8) The lubricated blend was compressed into tablets using rotary compression equipment. The tablets were then coated in a perforated coating pan using a suitable fdm coating suspension under controlled conditions.

[0086] Step-9) The coated tablets were visually inspected on an inspection belt, and defective units were manually removed.

[0087] Step-10) The final tablets were packed in HDPE containers with desiccants or other suitable packs, labelled, and stored under recommended conditions.

[0088] EXAMPLE-4 TABLET COMPOSITION

[0089]

[0090] Process for preparation:

[0091] Step-1) All raw materials were dispensed, verified against the formulation sheet, and weighed individually using a calibrated balance.Step-2) The weighed materials were sifted through a suitable #40 mesh to eliminate foreign matter and ensure uniform particle size.

[0092] Step-3) The sifted materials from no. 1 to no. 19 were transferred to a suitable blender and dry mixed for achieving uniformity.

[0093] Step-4) A binder solution was prepared by dissolving Polyvinyl pyrrolidone in purified water under continuous stirring until a clear solution was obtained.

[0094] Step-5) The dry mix was transferred to a rapid mixer granulator, and the binder solution was added gradually. Granulation was carried out until a uniform wet mass was obtained.

[0095] Step-6) The wet granules were dried using a fluid bed dryer at a controlled temperature (60-65°C) until the loss on drying was below 2.5% w / w. The dried granules were then sifted through a #20 mesh.

[0096] Step-7) Oversized granules were milled and re-sifted through a #20 mesh. Lubricants such as magnesium stearate, talc, and colloidal silicon dioxide were added and blended with the dried granules for uniform lubrication.

[0097] Step-8) The lubricated blend was compressed into tablets using rotary compression equipment. The tablets were then coated in a perforated coating pan using a suitable film coating suspension under controlled conditions.

[0098] Step-9) The coated tablets were visually inspected on an inspection belt, and defective units were manually removed.

[0099] Step-10) The final tablets were packed in HDPE containers with desiccants or other suitable packs, labelled, and stored under recommended conditions.EXAMPLE S SACHET COMPOSITION

[0100]

[0101] Process for preparation:

[0102] Step-1) All raw materials were dispensed, verified against the master formulation record, and accurately weighed using a calibrated balance.

[0103] Step-2) The weighed materials were sifted through an appropriate #40 mesh to remove extraneous matter and to achieve uniform particle size distribution.

[0104] Step-3) The sifted ingredients were transferred to a suitable blender and dry mixed for a predetermined time about 10 to 15 minutes to ensure homogeneity of the blend.

[0105] Step-4) The homogeneous powder blend was filled into pre-formed laminate or aluminum foil sachets using an automatic sachet filling machine under controlled conditions.

[0106] Step-5) Each sachet was hermetically sealed by heat sealing to ensure product integrity and protection from moisture and contamination.

[0107] Step-6) The filled and sealed sachets were visually inspected on an inspection conveyor.

[0108] Any defective, leaky, or misfilled sachets were manually rejected.

[0109] Step-7) The inspected sachets were counted, collated, and packed into secondary packaging such as cartons or boxes, followed by labelling as per approved artwork.

[0110] Step-8) The final packaged units were transferred to the designated storage area and stored under recommended temperature and humidity conditionsEXAMPLE-6 SACHET COMPOSITION

[0111]

[0112] Process for preparation:

[0113] It was prepared as per example-5.

[0114] EXAMPLE-8 SUSPENSION COMPOSITION

[0115]

[0116] Process for preparation:

[0117] Step-1) All raw materials were dispensed and accurately weighed using a calibrated balance.

[0118] Step-2) The weighed materials were sifted through an appropriate mesh to eliminate foreign particles and ensure uniformity.

[0119] Step-3) A syrup base was prepared by dissolving sucrose in purified water under continuous stirring until a clear solution was obtained.

[0120] Step-4) The prepared syrup base was transferred into a stainless steel mixing vessel equipped with an appropriate agitator.

[0121] Step-5) The remaining ingredients were added one by one into the syrup base in accordance with the specified sequence and under controlled mixing conditions.

[0122] Step-6) The mixture was stirred continuously for 60 minutes to ensure uniform dispersion and dissolution of all components.

[0123] Step-7) After complete mixing, the final syrup was transferred to a filling line where it was filled into bottles and hermetically sealed.

[0124] Step-8) The filled and sealed bottles were labelled with approved artwork and packed into secondary cartons, then stored under recommended storage conditions.

[0125] Animal study brief:

[0126] Objective: To Evaluate the Synergistic Effect of a combination of Calcium hydroxyl Methylbutyrate on Muscle Health in Sarcopenic Wistar Rats.

[0127] Materials and Methods:

[0128] Animals:

[0129] • Female Wistar rats, acclimatized for 5 days.

[0130] Induction of osteoarthritis:

[0131] All animals were divided into the groups mentioned below, each containing 6 animals. Sarcopenia was induced by intraperitoneal administration of dexamethasone (800 mcg / kg) for 5 consecutive days to all the groups except normal group. Treatment were given to all the groups for 28 days except normal group and control (disease) group as described below:Treatment groups:

[0132]

[0133] OD: Once in a Day

[0134] b.wt: Body weight

[0135] Ca HMB: Calcium hydroxy methylbutyrate.

[0136] Outcome measures:

[0137] • Grip strength

[0138] • Motor activity

[0139] • Rotarod test

[0140] • Serum IL-6 levels

[0141] • Serum SIRT-1 levels

[0142] Statistical Analysis:

[0143] All measurements were statistically analyzed using one-way ANOVA followed by Dunnett's multiple comparison test.

[0144] The results of the study are presented in the examples below.

[0145] EXAMPLE-9: STUDY RESULTS FOR EVALUATION OF THE SYNERGISTIC EFFECT OF ASTAXANTHIN, CALCIUM HYDROXY METHYL BUTYRATE (CaHMB) AND LEUCINE IN ANIMAL MODEL FOR GRIP STRENGTH (GM FORCE) / KG BODY WEIGHT

[0146]

[0147] Grip strength is one of the earliest indicators of declining muscle function and is often reduced before significant muscle mass loss becomes apparent. Low grip strength correlates with decreased physical performance. The combination of Leucine, Astaxanthin, 5 and CaHMB (S. No. 9) demonstrated a greater improvement in grip strength compared to Leucine alone (S. No. 3), Astaxanthin alone (S. No. 4), and CaHMB alone (S. No. 5), suggesting a synergistic effect of the combination (S. No. 9). All treatment groups showed an improvement in grip strength compared to the control group (S. No. 2). The study results are provided in the above table and figure 1.

[0148] 10

[0149] EXAMPLE-10: STUDY RESULTS FOR EVALUATION OF THE SYNERGISTIC EFFECT OF ASTAXANTHIN, CALCIUM HYDROXY METHYL BUTYRATE (CaHMB) AND LEUCINE IN ANIMAL MODEL FOR MOTOR ACTIVITY

[0150]

[0151]

[0152] Motor activity, encompassing movements and overall mobility, plays a vital role in both the prevention and management of sarcopenia. Sarcopenia involves not only the loss of muscle mass but also a decline in muscle strength and physical function — factors that are 5 all directly influenced by motor activity. A reduction in motor activity is among the earliest indicators of sarcopenia and reflects the functional impact of muscle loss. The combination of Leucine, Astaxanthin, and CaHMB (S. No. 9) showed a greater enhancement in motor activity compared to Leucine alone (S. No. 3), Astaxanthin alone (S. No. 4), and CaHMB alone (S. No. 5), indicating a synergistic effect of this combination. Additionally, all 10 treatment groups demonstrated improved motor activity relative to the control group (S.

[0153] No. 2). The study results are provided in the above table and figure 2.

[0154] EXAMPLE-11: STUDY RESULTS FOR EVALUATION OF THE SYNERGISTIC EFFECT OF ASTAXANTHIN, CALCIUM HYDROXY METHYL BUTYRATE 15 (CaHMB) AND LEUCINE IN ANIMAL MODEL FOR ROTAROD (TIME IN SECONDS)

[0155]

[0156]

[0157] The rotarod test is a commonly employed experimental technique used to assess motor coordination, balance, and endurance in animal models, making it particularly relevant for studying sarcopenia — the age-related decline in muscle mass and function. The length of 5 time an animal remains on the rotating rod serves as a measure of muscle endurance and fatigue resistance. Reductions in these metrics are indicative of sarcopenia, while improvements suggest therapeutic efficacy. The combination of Leucine, Astaxanthin, and CaHMB (S. No. 9) resulted in a significant increase in the duration animals stayed on the rotarod compared to Leucine alone (S. No. 3), Astaxanthin alone (S. No. 4), and CaHMB 10 alone (S. No. 5), demonstrating a synergistic effect of this combination. Furthermore, all treatment groups exhibited improved performance on the rotarod test relative to the control group (S. No. 2). The study results are provided in the above table and figure 3.

[0158] EXAMPLE-12: STUDY RESULTS FOR EVALUATION OF THE SYNERGISTIC 15 EFFECT OF ASTAXANTHIN, CALCIUM HYDROXY METHYL BUTYRATE (CaHMB) AND LEUCINE IN ANIMAL MODEL FOR SERUM IL-6 (PG / ML)

[0159]

[0160]

[0161] Interleukin-6 (IL-6) is a pro-inflammatory cytokine that plays a multifaceted and crucial role in the onset and progression of sarcopenia, which is characterized by the age-related decline in muscle mass and function. Chronic inflammation is a major contributor to muscle 5 catabolism and the impairment of muscle regeneration in sarcopenia. Elevated IL-6 levels promote the breakdown of muscle proteins while inhibiting their synthesis, leading to muscle atrophy by activating pathways that enhance muscle degradation. The combination of Leucine, Astaxanthin, and CaHMB (S. No. 9) significantly reduced serum IL-6 levels compared to Leucine alone (S. No. 3), Astaxanthin alone (S. No. 4), and CaHMB alone (S. 10 No. 5), indicating a synergistic effect of the combination. Additionally, all treatment groups showed a decrease in serum IL-6 levels relative to the control group (S. No. 2). The study results are provided in the above table and figure 4.

[0162] EXAMPLE-13: STUDY RESULTS FOR EVALUATION OF THE SYNERGISTIC 15 EFFECT OF ASTAXANTHIN, CALCIUM HYDROXY METHYL BUTYRATE (CaHMB) AND LEUCINE IN ANIMAL MODEL FOR SERUM SIRT1 (PG / ML)

[0163]

[0164]

[0165]

[0166] SIRT1 (Sirtuin 1) is a vital regulatory protein involved in cellular aging, metabolism, and muscle health, making it particularly important in the context of sarcopenia — the age- associated loss of muscle mass and function. SIRT1 promotes the activation and proliferation of muscle stem cells (satellite cells), facilitating muscle repair and regeneration. A decline in SIRT1 activity with age reduces the muscle’s regenerative capacity, thereby contributing to muscle deterioration. The combination of Leucine, Astaxanthin, and CaHMB (S. No. 9) produced a significant increase in SIRT1 levels compared to Leucine alone (S. No. 3), Astaxanthin alone (S. No. 4), and CaHMB alone (S. No. 5), demonstrating a synergistic effect. Furthermore, all treatment groups exhibited elevated SIRT1 levels relative to the control group (S. No. 2). The study results are provided in the above table and figure 5.

[0167] The invention described herein comprises in various objects and their description as mentioned above, with respect to characteristics and processes adopted. While these aspects are emphasized in the invention, any variations of the invention described above are not to be regarded as departure from the spirit and scope of the invention as described.

Claims

aim:

1. A pharmaceutical composition for improvement in muscle health comprising Astaxanthin, Calcium Hydroxy Methyl Butyrate, Leucine, and one or more acceptable pharmaceutical excipient.

2. The pharmaceutical composition as claimed in claim 1 , wherein the ratio of Calcium Hydroxy Methyl Butyrate to Leucine to Astaxanthin is ranges from 1:0.0042:0.0001 to 1:240:2.

3. The pharmaceutical composition as claimed in claim 1, wherein:a) Astaxanthin is present in an amount ranging from 0.1 % to 25 % w / w, b) Calcium Hydroxy Methyl Butyrate is present in an amount ranging from 10% to 95% w / w, andc) Leucine is present in an amount ranging from 2% to 85% w / wbased on the total weight of the composition.

4. The pharmaceutical composition as claimed in claim 1, wherein the composition comprises:a) Astaxanthin in an amount ranging from 1 mg to 50 mg,b) Calcium Hydroxy Methyl Butyrate in an amount ranging from 25 mg to 6000 mg, andc) Leucine in an amount ranging from 25 mg to 6000 mg.

5. A kit comprising Astaxanthin, Calcium Hydroxy Methyl Butyrate, Leucine, and one or more acceptable pharmaceutical excipients, wherein:a) Astaxanthin is present in an amount ranging from 1 mg to 50 mg,b) Calcium Hydroxy Methyl Butyrate is present in an amount ranging from 25 mg to 6000 mg, andc) Leucine is present in an amount ranging from 25 mg to 6000 mg. wherein Astaxanthin, Calcium Hydroxy Methyl Butyrate, and Leucine are either provided in a single composition or as separate compositions within the kit; and wherein the kit is intended for enhancing muscle health.

6. The pharmaceutical composition as claimed in claim 1, wherein the one or more pharmaceutically acceptable excipient is selected from diluents, disintegrants, binders, lubricants, preservatives, glidants, or mixtures thereof.

7. The pharmaceutical composition as claimed in claim 6, wherein the diluent is selected from microcrystalline cellulose, sucrose, lactose, lactose monohydrate, maltodextrin, calcium carbonate, mannitol, sorbitol, or mixtures thereof.

8. The pharmaceutical composition as claimed in claim 1, wherein the composition is fdled in a sachet or is formulated as a tablet, capsule, suspension, or any other suitable dosage form.

9. The pharmaceutical composition as claimed in claim 1, wherein the composition is intended for the treatment of sarcopenia.

10. A pharmaceutical composition for improvement in muscle health, comprising: a) Astaxanthin is present in an amount ranging from 1 mg to 50 mg,b) Calcium Hydroxy Methyl Butyrate is present in an amount ranging from 25 mg to 6000 mg, andc) Leucine is present in an amount ranging from 25 mg to 6000 mg. wherein the composition is supplied in a sachet.

Images