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Vol. 7, Issue 10 (2018)

Formulation design, development and optimization of Apixaban INN tablet a new era on immediate release drug delivery system

Author(s):
Monoj Kumar Shaha, Md. Asmat Ullah, Md. Mehdi Hasan and Md. Khairul Mamun
Abstract:
The oral drug delivery system which includes the solid dosages form such as conventional dosages form and immediate release dosages form. Tablet is most popular among the all dosages forms today and recently found mostly accepted tablet dosages forms. Because of its convenience easy to administration, convenience of self-administration, compactness and easy for the manufacturing. In number of cases immediate onset of action is required than conventional therapy. The basic approach used in development immediate release solid dosages form by using superdisintegrant like sodium starch glycolate (Primogel, Explotab), Polyvinylpyrrolidone (PVP) etc. which provides in instantaneous disintegration of tablet after administration. By using various techniques in can be formulate like wet granulation, direct compression etc. Hence its having A new dosage form allows a manufacturer to extend market exclusivity, while offering its patient population a more convenient dosage form or dosing regimen. Prepared batches were evaluated for all pre-compression parameters and post-compression parameters. This method was found to be linear in a concentration range of 5-30 μg/ml of the drug (r 2= 0.999). The low value of % RSD in the precision study indicates reproducibility of the method. The low value of LOD and LOQ suggests the sensitivity of the method. The results of forced degradation studies indicated that the drug was less stable in thermal and photolytic condition and degraded in acidic, basic, oxidative conditions. On the basis of formulation evaluation, batch was found to be promising formulation suitable for the immediate release of apixaban. Results obtained by validation studies suggested that the developed stability indicating assay method is simple, accurate, specific, sensitive and precise. Thus, this method can be used for routine analysis of apixaban formulation and to check the stability testing. Pharmaceutical products designed for oral delivery and currently available on the prescription and over-the-counter markets are mostly the immediate release type, which are designed for immediate release of drug for rapid absorption.
Pages: 298-306  |  245 Views  18 Downloads
How to cite this article:
Monoj Kumar Shaha, Md. Asmat Ullah, Md. Mehdi Hasan, Md. Khairul Mamun. Formulation design, development and optimization of Apixaban INN tablet a new era on immediate release drug delivery system. Pharma Innovation 2018;7(10):298-306.
The Pharma Innovation Journal