FIELD: chemical- pharmaceutical industry. SUBSTANCE: invention relates to the development of a pharmaceutical composition showing a spasmolytic activity. The proposed composition comprises drotaverine hydrochloride, lactose, potato starch, crospovidone (collidone CL), talc, calcium stearate. Invention proposes a method of preparing the pharmaceutical composition that involves wetting a mixture of drotaverine hydrochloride, potato starch and lactose with 3% starch paste, granulation and drying followed by repeated passing through a granulator device; obtained dry granulate is mixed with crospovidone, calcium stearate and talc and granulated. Method provides uniform mixing components, optimal bioavailability of an active substance and provides utilization of production waste. The proposed composition corresponds to requirements of The State Pharmacopoeia XI, it shows stability in prolonged storage and shows the improved organoleptic properties. The combination of all accessory substances provides high index of dissolving where optimal pattern of release of drotaverine hydrochloride is attained. EFFECT: improved quality and properties of composition, improved method of preparing. 3 cl, 2 ex
Authors
Dates
2002-06-10—Published
2001-08-13—Filed