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The aims of this study were to develop a predictive immediate release tablet formulation system for soluble drugs. Ranitidine hydrochloride, silicifiedmicrocrystallinecellulose (SMCC), polyplasdone XL and hydroxyprophylmethylcellulose (HPMC) E6 were evaluated for powder properties. The effects of binder (HPMC E6) and disintegrant (Polyplasdone XL) were investigated. A 3 2 factorial design was applied to optimize the drug release profile. The amount of binder and disintegrant were selected as independent variables. The times required for 50% (t50) and 80% (t80) drug dissolution and similarity factor (f 2 ) were chosen as dependent variables. The results of factorial design indicated that a high amount of binder and low amount of disintegrate favored the preparation of drug release. The difference (f 1 ) and similarity (f 2 ) factors were used to measure the relative error and the closeness (similarity) between the factorial design batches and brand name drugs. No significant difference was observed between the brand drug and ranitidine batches F1, F2, F5, F6 and F9. Ranitidine batch F2 yielded the highest value of f 2 (71%) and the lowest of f 1 (10%). This research indicates that the proper amount of binder and disintegrant can produce drug dissolution profiles comparable to their brands.

FACTORIAL DESIGN USED IN OPTIMIZATION IMMEDIATE RELEASE SOLID DOSAGE RANITIDINE HYDROCHLORIC