Development of a biodegradable polymer film formulation for protein-based drug delivery



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Abstract

The advancement of biotechnological methods for developing therapeutic molecules necessitates the selection of a drug formulation that is appropriate for the intended route of administration and ensures the desired therapeutic effect. Currently, drug films registered in the Russian Federation contain only small molecules (nitroglycerin, drotaverine, sildenafil, and taurine). Promising high-molecular compounds for incorporation into films include proteolytic enzymes, antimicrobial peptides, hormones, and others. The aim of this study was to test the incorporation of a model protein compound—bovine serum albumin—into a film-based drug formulation. The films were produced using polymer solution casting technique: the matrix components were dissolved in deionized water with heating (90-95 °C) and stirring (300-500 rpm) on a laboratory hotplate stirrer. The model protein was then dissolved in this gel at room temperature. The mixture was cast onto polymer weighing boats in 2.0 g portions, transferred to a fume hood, and left overnight for solvent evaporation. As a result of this research, a composition for the polymer film matrix was developed, containing 2 % w/w polyvinyl alcohol, 0.5 % w/w sodium carboxymethyl cellulose, and 0.5 % w/w glycerol. The model protein was loaded into the casting solution at a concentration of 40 mg/ml. It was determined that the film can contain up to 30 mg of protein (326 mg/g of film) without significant changes in quality parameters, with complete release occurring in a solvent medium within 15 minutes. The resulting films were homogeneous, semi-transparent, odorless, and square-shaped, with a length and width of 32 ± 1 mm. The average film mass was 0.092 ± 0.0036 g, with 95.36 ± 0.06% solvent evaporation. The producing technics does not changes the protein's molecular weight, confirming the feasibility of incorporating therapeutically active proteins for local action into such films.

About the authors

Georgij S. Stepanov

State Scientific Research Testing Institute of Military Medicine of the Ministry of Defense of the Russian Federation

Email: gniiivm_5@mil.ru
ORCID iD: 0000-0001-7959-8559

Junior Researcher

Russian Federation, Санкт-Петербург

Evgenij G. Kruchinin

State Scientific Research Testing Institute of Military Medicine of the Ministry of Defense of the Russian Federation

Email: Kruchinin81John@yandex.ru
ORCID iD: 0000-0003-1417-0636

Cand. Sci. Med., Head of the Research Testing Department

Russian Federation, Санкт-Петербург

Nikolai G. Vengerovich

State Scientific Research Testing Institute of Military Medicine of the Ministry of Defense of the Russian Federation; Saint Petersburg State Chemical Pharmaceutical University of the Ministry of Health of the Russian Federation

Author for correspondence.
Email: nickolai.vengerovich@pharminnotech.com
ORCID iD: 0000-0003-3219-341X
SPIN-code: 6690-9649
Scopus Author ID: 55639823300
ResearcherId: U-3467-2019
https://journals.eco-vector.com/PharmForm/about/editorialTeamBio/37267

Doctor of Medicine (MD),  Head of the Research Department, Professor of the Industrial Ecology Department

Russian Federation, Санкт-Петербург

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