The concept of quality guarantee for medicines in the Pharmaceutical Quality System, and quality management, and taking into account the requirements for a systemic approach to quality risk management stages include the following: learning problems and disease etiology, market research, pharmaceutical development, preclinical, clinical trials, manufacturing, control of quality, packing, storage, sale and provision of information for the doctor and patients.

All of the stages apart in the overall schemes are important in a general chart, but the initial stage which formed the quality of medicines is pharmaceutical elaboration. This stage involves a series of comprehensive studies that eventually appear in this document as regulatory technical technological instruction. This document confirms that the chosen type of medicinal form, the proposed structure, the technological schemes of production; packaging and proposed storage conditions meet the legal requirements for medications. The aim of the present work was to study development of quality control methods for stomatological medicinal films with decametoxine in the form of polymer films that can be applied on the mucous membrane in the treatment of diseases of oral mucous and periodontum.

Standardization of stomatological medicinal films for applications as a means of treatment of the diseases of the oral mucous and periodontum is complicated due to the fact that the regulatory technical documentation for this medicinal form is now practically absent.

In order to produce new medicinal forms as medical stomatological films technological scheme of production has been developed.

General technological process of manufacturing stomatological medicinal films involves 9 stages.

The probability of risk of production of low-quality products for stomatological medical films with decametoxine through improving the system of quality control methods, which are reflected in the 16 points of specification was evaluated.

As a result of scientific research and in partnership with a limited liability company “Pharmaceutical factory” (from Ivano-Frankivsk) quality control methods for stomatological medicinal films with decametoxine based on stepwise control provided for extemporal production to meet the requirements of GMP, normative-technical documentation and state Pharmacopeia of Ukraine have been developed.

Conclusions. The general technological “flow diagram” – sheme, which consists of 9 main stages and a specification that provides 16 stages of quality control were elaborated for production of medicinal stomatological films.

Scientific novelty of the research confirmed a patent for utility model in Ukraine: № 23785 (Bulletin of 11.06.2007 № 8 years).

The development of technology of stomatological films for local treatment of the periodontium is actual, both for modern pharmaceutical technology, and for stomatological practice. Local treatment in periodontology is complicated due to the dissolution of the traditional soft-consistency dressings by saliva, which constantly washes out the medications.

Stomatological polymeric films, a form of periodontal dressings, are new effective, alternative methods in comparison with the traditional forms of treatment for oral mucous membrane.

The research allows standardizing the development of stomatological medicinal films with decametoxin, in accordance with the requirements of GMP and State Pharmacopoeia of Ukraine.

Keywords: decamethoxin, methods of quality control, specification, stomatological medicinal films

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