International Journal of Pharmaceutics & Drug Research

Parag Das1*, Debajyoti Das2

ABSTRACT

Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. The stability of Esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. As the API is acid Habile, so the main strategy was to develop a formulation giving protection to API as well as safe and effective release so as to impart its action in an effective manner. So first of all conventional formulations were designed having drug and buffer part compressed together (Tablet in Tablet), along with alkalizing agent. The purpose of the research work as the esomeprazole is acid Habile, so the main strategy was to develop a formulation giving protection to API as well as safe and effective release so as to impart its action in an effective manner. So first of all conventional formulations were designed having drug and buffer part compressed together (Tablet in Tablet), along with alkalizing agent. The formulation is designed as a way to have release as well as, to give protection to drug part against acid environment of stomach, for that tablet in tablet strategy was followed in such a way that buffer part of final tablet provide protection to drug part by mechanism of raising pH as well as by maintaining that pH range for a period of sufficient time so that total drug from inner tablet is released and absorb from that pH. The prepared batches of tablets were evaluated for hardness, friability, drug content, wetting time, dispersion time, disintegration time and dissolution studies. Based on tested for in-vitro drug release pattern (in 0.1N HCL) and short term stability studies. Among the promising formulations, the formulation F6 emerged as the overall best formulation based on drug release characteristic.

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