FORMULATION AND DEVELOPMENT OF FLAVOXATE HYDROCHLORIDE EXTENDED RELEASE CAPSULES

Flavoxate Hydrochloride is an antispasmodic, mainly used for treating painful urination, urgency of urination and incontinence. The primary objective of the study was to formulate extended release capsules of Flavoxate hydrochloride to reduce dosing frequency and decreasing the associated side effects. The extended release capsules were formulated using extrusion spheronisation process with ethyl cellulose, HPMC polymers. First, pellets (C1 to C6) containing varying amounts of Ethyl cellulose or Microcrystalline cellulose, Dicalcium phosphate and Eudragit NE30D55 were prepared using extrusion spheronisation (C6 was selected). Then the selected pellets were coated with different drug loading solution (DL 1 to DL7) with varying concentrations of Methocel (DL7 was selected).Finally extended release coating was applied to optimized drug loaded pellets and ten batches (E1 to E10) were prepared.. The dissolution profile comparison of the prepared batches E1 to E10and market preparation (Urispass) was done by difference factor (f1) and similarity factor (f₂) determination. The formulation E9 (EC: HPMC 1:1 ratio) with a difference factor f1 (5.9) and similarity factor (f₂) of 64.6   was selected as the optimized formulae for scale-up batches.  The dissolution data were fitted into zero-order, first-order, Higuchi and Korsmeyer-Peppas models to identify the pharmacokinetics and mechanism of drug release.