Formulation of native collagen product from fish skin tissues for oral administration
The gelatin capsule with native collagen and ascorbic acid addresses packaging challenges and enhances digestibility by providing immediate release and enzymatic support for collagen synthesis.
Patent Information
- Authority / Receiving Office
- RU · RU
- Patent Type
- Patents
- Current Assignee / Owner
- FEDERALNOE GOSUDARSTVENNOE BYUDZHETNOE OBRAZOVATELNOE UCHREZHDENIE VYSSHEGO OBRAZOVANIYA SEVERNYJ GOSUDARSTVENNYJ MEDITSINSKIJ UNIV MINISTSTVA ZDRAVOOKHRANENIYA ROSSIJSKOJ FEDERATSII
- Filing Date
- 2025-07-25
- Publication Date
- 2026-06-30
AI Technical Summary
Existing methods for oral administration of native collagen products require additional measures for dosing and packaging, and insufficient ascorbic acid levels negatively affect collagen synthesis and conformation, necessitating a new dosage form that includes ascorbic acid and an anti-caking agent for improved digestibility and immediate release.
A gelatin capsule with an immediate release formulation containing native collagen, ascorbic acid, and calcium stearate as an anti-caking agent, designed for oral administration without an enteric coating.
The proposed dosage form ensures immediate release and enhanced digestibility of collagen with ascorbic acid, addressing the packaging challenges and enzymatic activity issues of existing methods.
Abstract
Description
[0001] The invention relates to the field of pharmaceuticals and relates to a dosage form for oral administration for immediate release of a therapeutically effective amount of a native collagen product with the addition of ascorbic acid.
[0002] The production, study of the structure and properties of native collagen obtained from the skins of sea and river fish are the subject of research throughout the world [1].
[0003] At least 45% of the human body's protein structures are comprised of various types of collagen, which are part of skeletal and connective tissues [2]. Oral administration of collagen peptides to wounds has clearly demonstrated accelerated healing in several experiments compared to control groups. Collagen deposition is also promoted by the increasing level of hydroxyproline under these conditions [3].
[0004] A method for producing a native collagen product (RU 2844054) [4] obtained from fish skin tissue is known. This product is obtained in powder form, the use of which as a medicinal form of collagen requires additional measures for dosing and packaging. Furthermore, oral administration of native collagen should be supplemented with an antioxidant, such as ascorbic acid. All collagens have three left-handed helices coiled into a right-handed superhelix [5]. Collagen synthesis and conformation is a multi-stage process in which a significant role is assigned to hydroxylation and glycosylation reactions. An insufficient amount of ascorbic acid not only reduces the activity of catalyzing enzymes during hydroxylation, but also negatively affects the cleavage of N- and C-terminal peptides during glycosylation [2].The above facts confirm the need to enrich collagen-based dietary supplements with a significant amount of ascorbic acid. To improve the digestibility of the amino acid pool when consuming a collagen product, we propose adding ascorbic acid, while using calcium stearate as an anti-caking agent. This dosage form releases the collagen product in the stomach after oral administration.
[0005] The objective of the invention is to expand the range of means for oral administration of a therapeutically effective amount of a native collagen product.
[0006] To solve the problem, a dosage form is proposed, which is a gelatin capsule with immediate release without an enteric coating and a central part containing a native collagen product obtained from fish skins, and additionally containing ascorbic acid and an anti-caking component with the following content of components, wt. %: native collagen product 83.08, ascorbic acid 14.96, calcium stearate 1.96.
[0007] The main difference of the proposed form is that it is intended for oral administration, as well as immediate release of a therapeutically effective amount of native collagen product with the addition of ascorbic acid.
[0008] Brief technology for obtaining the dosage form: to obtain 20 gelatin capsules, take 10 g of native collagen product, 1.8 g of ascorbic acid, 0.236 g of calcium stearate, mix until smooth and pack using a capsule machine.
[0009] The form proposed as a source of collagen is not known from the prior art according to available information sources, and can be practically implemented in serial production using conventional technology, that is, it meets the criteria of patentability.
[0010] SOURCES OF INFORMATION
[0011] 1. Li C., Singla A., Li Y. Biomedical application of collagen / / International Pharmaceutical Journal. 2001. Vol. 221. No. 1-2. P. 1-22.
[0012] 2. Dydykina I.S., Kovalenko P.S., Kovalenko A.A., Aboleshina A.V. The importance of undenatured collagen for normalizing the function of joint cartilage tissue. Medical Council. 2022. Vol. 16. No. 14. P. 145-153.
[0013] 3. Gunter N.A., Kopeikina D.A., Ledneva A.A., Pereverzev V.Yu., Bagiryan T.G. Prospects for the use of marine collagen in medicine and cosmetology. Science Flagship. 2024. No. 6 (17). P. 125-129.
[0014] 4. Kashutin S. L., Shutskiy N. A., Katorina M. V., Toropov A. V., Mizgirev D. V., Gorbatova L. N., Opravin A. S., Felenko N. S. Method for isolating a native collagen product from fish skin tissues / / Russian Patent No. 2844054. 2025. Bull. No. 21.
[0015] 5. Borzykh O.B., Schneider N.A., Karpova E.I., Petrova M.M., Demina O.M., Nasyrova R.F. Collagen synthesis in the skin, its functional and structural features. Medical Bulletin of the North Caucasus. 2021. Vol. 16. No. 4. P. 443-450.