Development of a film for the treatment of open soft tissue injuries

Introduction. Applicational dosage forms, particularly films, are a practical and convenient form of treatment for wounds on the skin and mucous membranes, keloids, and scars. It should be noted that film-based medications are currently limited on the Russian pharmaceutical market. Therefore, research into the composition and technology of these film-based medications is essential. The study utilized a comprehensive approach, including the pharmaceutical development of films for application to wound surfaces of the skin and mucous membranes, as well as an examination of the factors determining the success of the final product. The results will allow, among other things, the formulation of recommendations for the structure and content of the temporary pharmacopoeial monograph “Applicational dosage forms intended for application to wound surfaces”.

Objective. Development of an optimal composition and justification of the technology of a wound-healing application dosage form – a film containing snail mucin and zinc oxide nanoparticles as active ingredients.

Material and methods. During the development of the dosage form, the study subjects were drug substances and excipients that meet the requirements of regulatory documentation. To achieve the study objective, a series of tests were applied (“Description”, “Film dimensions”, “Mass homogeneity”, “Solution pH”, “Disintegration”, “Mass loss on drying or Water”) corresponding to OFS.1.4.1.0035 “Films”. The choice of carrier matrix for the pharmacologically active substances was substantiated by studying their organoleptic and pharmaceutical-technological characteristics. Tensile testing of the films was conducted in accordance with GOST 14236-81 “Polymer films. Tensile testing method”. The reliability of the study results was assessed using mathematical and statistical methods.

Results. An analysis of the range of medicinal products registered in the State Register of Medicinal Products (GRLS) in the form of films was conducted. It was established that five medicinal products produced in the form of films are sold in the Russian Federation - two variants of “Trinitrolong”, “Devatorin” or “Notaspazm”, “Individa ODP”, “Taurine”. A composition of a multicomponent film with snail mucin and nanosized zinc oxide was developed. Tests were carried out in accordance with OFS.1.4.1.0035 “Films” and GOST 14236-81 “Polymer films. Tensile test method”. Optimal polymer carriers of snail mucin and nanosized zinc oxide for the manufacture of films were determined: composition No.3, containing Na-carboxymethyl cellulose; Compositions No.4 and No.10, containing Na-carboxymethylcellulose and polyvinyl alcohol in a ratio of 2:1; composition No.2, containing methylcellulose and polyvinyl alcohol in a ratio of 2:1. An optimal technological scheme for producing films that meet the requirements of regulatory documentation is presented, using the example of films with snail mucin and zinc oxide nanoparticles based on sodium carboxymethylcellulose with polyvinyl alcohol.

Conclusion. The results of the conducted research made it possible to develop the composition and technology of an application dosage form in the form of a film with snail mucin and zinc oxide nanoparticles.