EXPERIMENTAL RESEARCH ON THE DEVELOPMENT OF THE COMPOSITION AND TECHNOLOGY OF SOLID GELATIN CAPSULES AND METHODS OF THEIR ANALYSIS

Abstract

Introduction. According to the World Health Organization (WHO), diseases of the digestive tract are one of the most common groups of diseases and account for about 10 % of all diseases. In Europe, more than 30,000 new cases of colitis per million population are registered every year. According to the official data of the Ministry of Health of Ukraine, more than 70 % of the population of Ukraine suffers from diseases of the digestive organs, and colitis is one of the most common inflammatory bowel disease in the country.

The aim of the study – to conduct experimental research on the development of an original medicinal product in the form of hard gelatin capsules with dry polyextract.

Research Methods. Bibliosemantic, pharmacotherapeutic, physico-chemical, biopharmaceutical and statistical (Statistica (StatSoft, USA)) research methods were used. Crystallographic studies of the dry polyextract were carried out using microscopic analysis on a Konus-Academy laboratory microscope (with a 40-fold eyepiece magnification) with a built-in video camera Scope Tek. Bulk volume and bulk density were determined on a shaker model 545-AK-3, and flowability was determined using a funnel with a VP-12A vibrating device. Biologically active substances analysis was carried out using a Schimadzu UV-2600 spectrophotometer, Japan.

Results and Discussion. The initial technological parameters of the dry polyextract were studied and it was determined that it has an overestimated fluidity index, which will negatively affect the encapsulation process during the technological process. Considering the need to reduce the moisture absorption of the polyextract and increase the effect of the fluidity of the capsule mass, the following auxiliary substances were chosen during the experimental studies: microcrystalline cellulose 145 mg, ‘aerosyl’ 3 mg and talc 2 mg. A technique for determining the amount of polyphenolic compounds in terms of gallic acid by absorption spectrophotometry has been developed. The electronic absorption spectrum of a 0.005 % aqueous solution of dry polyextract in the range from 220 to 400 nm is characterized by the presence of a shoulder in the range from 260 to 269 nm. Under the conditions of the experiment, the capsules, after 30 minutes, showed a degree of dissolution of ≥ 85 % of the sum of polyphenolic compounds in terms of gallic acid.

Conclusions. Based on the conducted pharmacotechnological, crystallographic, physicochemical and biopharmaceutical studies, the optimal composition was experimentally substantiated and developed, and some technological parameters of the production of capsules with dry phytoextract were determined, as well as the method of determining the amount of polyphenolic compounds in terms of gallic acid.