СРАВНИТЕЛЬНАЯ ОЦЕНКА ВЛАГОСОРБЦИОННЫХ СВОЙСТВ ЖЕЛАТИНОВЫХ И ГИПРОМЕЛЛОЗНЫХ ТВЕРДЫХ КАПСУЛ

Abstract

Aim. Comparative evaluation of the shells of solid capsules made of gelatin and hypromelose of hygroscopicity and disintegration indicators. Materials and Methods. Solid gelatin and hypromellose capsules produced by Capsugel (Belgium), as well as pharmaceutical compositions with bifidobacterium lyophilisate were used as objects of research. Hygroscopicity was determined according to FEES methods. Hygroscopicity is determined by the weight method according to the GF RF XV according to the OFS.1.1.0042 "Determination of hygroscopicity". The water-absorbing properties of capsule shells were evaluated by the rate of moisture gain of empty and filled solid capsules. Tests on the disintegration index were conducted according to the GF of the Russian Federation XV, OFS.1.4.2.0013 "Disintegration of solid dosage forms", OFS.1.7.1.0003.15 "Bifido-containing probiotics". Results. Comprehensive pharmaceutical-technological studies of empty hard capsules and model samples with encapsulated composition with bifidobacterium lyophilisate in hard capsules produced by Capsugel® (Belgium) were carried out. As a result of comparative analysis of characteristics of empty hard capsules Coni-Snap and Vcaps Plus, it was revealed that Vcaps Plus capsules have faster disintegration, higher rate of moisture gain, low hygroscopicity of the capsulated composition with preservation of the shape and structure of the capsule shell. Conclusion. Comparative studies of the water-absorption properties of gelatin and hypromellose capsules have shown the rationality of using hypromellose capsules for encapsulating hygroscopic AFS, in particular lyophilizates.