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One of the promising areas of the pharmaceutical industry is the development of local drug delivery systems consisting of a biocompatible matrix and a drug. Such local delivery systems include medicinal films. Ensuring pharmacological action, accuracy of dosing, strong fixation to damaged tissues of the mucous membrane, prolongation of action are the undoubted advantages of medicinal films in comparison with traditional means of treating wound processes. The development of the technology of the drug film containing in its composition the drug cycvalone, which has a wide range of biological activity-antioxidant, anti-inflammatory, antibacterial and others - is an urgent task of pharmacy. As a result of the conducted research, the technology of a drug film with cycvalone in the form of an inclusion complex with β-cyclodextrin based on a matrix of a biodegradable polymer of sodium alginate was developed. It should be noted the availability, safety and pharmacological effectiveness of medicinal substances used in the technology of the dosage form. The inclusion of cyclodextrin in the composition of the film is due to the solubilization of the active substance molecule and an increase in the bioavailability of cycvalone during application therapy. Introduction of cycvalone in the form of complex inclusion also has a positive effect on the uniformity of distribution of the drug in the matrix and, consequently, determines the accuracy of drug dosing. After the release of the active substance, cyclodextrin is able to show detoxifying properties in the wound. The use of a modern biodegradable material as a film-forming agent provides a prolonged action of active substances, high bioavailability and enhanced therapeutic properties of the composition. The values of quality indicators of medicinal films confirming the rational selection of the composition and the optimal technology of the dosage form were experimentally established.
One of the promising areas of the pharmaceutical industry is the development of local drug delivery systems consisting of a biocompatible matrix and a drug. Such local delivery systems include medicinal films. Ensuring pharmacological action, accuracy of dosing, strong fixation to damaged tissues of the mucous membrane, prolongation of action are the undoubted advantages of medicinal films in comparison with traditional means of treating wound processes. The development of the technology of the drug film containing in its composition the drug cycvalone, which has a wide range of biological activity-antioxidant, anti-inflammatory, antibacterial and others - is an urgent task of pharmacy. As a result of the conducted research, the technology of a drug film with cycvalone in the form of an inclusion complex with β-cyclodextrin based on a matrix of a biodegradable polymer of sodium alginate was developed. It should be noted the availability, safety and pharmacological effectiveness of medicinal substances used in the technology of the dosage form. The inclusion of cyclodextrin in the composition of the film is due to the solubilization of the active substance molecule and an increase in the bioavailability of cycvalone during application therapy. Introduction of cycvalone in the form of complex inclusion also has a positive effect on the uniformity of distribution of the drug in the matrix and, consequently, determines the accuracy of drug dosing. After the release of the active substance, cyclodextrin is able to show detoxifying properties in the wound. The use of a modern biodegradable material as a film-forming agent provides a prolonged action of active substances, high bioavailability and enhanced therapeutic properties of the composition. The values of quality indicators of medicinal films confirming the rational selection of the composition and the optimal technology of the dosage form were experimentally established.
Abstract. The spread of ophthalmic infectious diseases around the world and uniformity of the market of dosage forms for their therapy generate an incentive for scientists to develop innovative drug forms, to create improved therapy for such diseases as uevitis, conjunctivitis, keratitis and blepharitis. There are two types of eye dosage forms on the market of the Russian Federation - drops and ointments, which have a short shelf life after the first application, a high risk of microbial infection and infection of a "healthy" eye. Based on these facts, the study aims to develop a solid extended dosed biodegradable ocular insert for use in ophthalmotherapy. This article is devoted to the peculiarities of influence of film forming agents of different nature, plasticizer and solubilizing agent (poloxamer) and their ratio on the biopharmaceutical properties of the polymeric base of ocular insert. Polymers of both natural and semi-synthetic nature (hydroxyethylcellulose, sodium alginate, xanthan and gellan gum) were used to create the polymeric basis. Placebo inserts were formed at room temperature in open space for three days. The test of the samples was carried out according to the parameters of description, elasticity, dissolution time, humidity, which include in the State Pharmacopeia XIV, and mucohedhesion, that is an important parameter for locally administering on mucosa, although it is not regulated in official documents. The series of experiments showed the optimum concentrations and ratios of the auxiliary substances used, namely 0.5% to 2.5% for film type manufacturers, 2% for plasticizers and 0.5% for poloxamers, respectively. The formulations that showed the best performance when evaluating the parameters were - sodium alginate 2.5%, glycerin 2%, poloxamer 0.5%, water purified up to 40.0; xanthan gum 0.4%, glycerin 2%, poloxamer 0.5%, water purified up to 40.0.have a wide variation in different age categories, which requires further study. on additional samples of children in the region.
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.
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