Development of the composition and justification of the technology of biodegradable films with etoricoxib

Introduction. One of the current directions of pharmaceutical development is the creation of new drugs with anti-inflammatory and analgesic activity. Among the promising dosage forms are biodegradable films, which have a number of advantages over traditionally used forms. The use of biodegradable films containing nonsteroidal anti-inflammatory drugs as active ingredients prevents a number of side effects characteristic of oral dosage forms containing these drugs that enter directly into the gastrointestinal tract.

Objective: development of the optimal composition and substantiation of the technology of biodegradable films containing etoricoxib as an active ingredient, which has anti-inflammatory and analgesic activity.

Material and methods. The following pharmaceutical substances and excipients approved in the territory of the Russian Federation were used in the development of the composition of biodegradable films: etoricoxib (manufacturer Alembic Pharmaceuticals Ltd, India, serial number 2102010991), gelatin (PA.2.1.0099.18), sodium carmellose (PA.2.1.0377), dextrose (PA.2.1.0092.18), cocoa powder (SIS 108-214), citric acid (PA.2.1.0024.15), peppermint oil (PA.2.4.0001.18), glycerol (PA.2.2.0006.15), miramistin (PA 42-3498-98), sodium chloride (PA.2.2.0014), purified water (PA.2.2.0020).

The rationale for the choice of a carrier matrix was carried out by studying film-forming polymers with the addition of pharmacologically active and auxiliary substances permitted in the territory of the Russian Federation. The quality indicators of polymer bases were evaluated by organoleptic and pharmaceutical-technological characteristics.

To determine the dosing uniformity index, a VM-153M laboratory electronic scale (manufacturer LLC OKB Vesta, Saint-Petersburg, Russia) was used. The quality of the polymer bases was evaluated by organoleptic parameters and pharmaceutical and technological characteristics. Statistical analysis methods were used to substantiate the reliability of the results.

Results. As a result of the theoretical and experimental studies carried out, the choice of the active substance – a nonsteroidal anti–inflammatory agent of selective action etoricoxib was made and its optimal dosage of 60 mg was justified, providing significant relief of pain and improvement of the condition of patients suffering from osteoarthritis. The optimal composition of a biodegradable film containing 2.14% etoricoxib, 7.14% gelatin, 10.00% glycerol, 2.14% miramistin, 4.29% dextrose, 2.86% cocoa powder and 71.42% purified water has been developed. An optimal technology for the production of biodegradable films has been developed and justified, which is based on the method of casting films in the form of a suspension due to the availability of the technological process.

Conclusion. As a result of the conducted research, the optimal composition and technology of biodegradable films with etoricoxib based on gelatin have been theoretically and experimentally substantiated and developed. It has been established that the developed composition has satisfactory organoleptic properties and pharmaceutical and technological characteristics.