Abstract
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 32 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 (f2) 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 (f1) and similarity (f2) 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 f2(71%)and the lowest of f1(10%). This research indicates that the proper amount of binder and disintegrant can produce drug dissolution profiles comparable to their brands.
Highlights
The majority of the pharmaceutical companies use the expression “state of the art” referent a drug design
A 32 factorial design was constructed to study the effect of binder and disintegrant levels. t50 and t80 were selected as dependent variables
Tablet matrix was developed based on ratio 40% of active product ingredient (API) Ranitidine
Summary
The majority of the pharmaceutical companies use the expression “state of the art” referent a drug design. The design of a drug is a science. Experimental design is a planned structure interference in the natural order of events. Its strength lies in the fact that much of the substantial gain in knowledge in all sciences has come from actively or deliberately manipulating or interfering with the stream of events. A physical model must be constructed and in the basis of either empirical data or experimental values. Various mathematical formulas are investigated with the objective of obtaining a most suitable formula which will form the basis of linking the variables of the process. The formulas include dissolution profiles of all batches, which can be fitted to zero order, first order [1,2], Higuchi , Hixson Crowell, Korsemeyer and Peppas , and Weibull models to ascertain the kinetic modeling of drug release
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