Abstract

STATISTICAL OPTIMIZATION OF FORMULATION OF MICROGRANULES OF ACETYLSALICYLIC ACID USING AQUEOUS SYSTEM

Vijay Kumar Sharma*, Neeraj Kumar Fuloria, Sokkalingan Arumugam Dhanaraj ,Shivkanya Fuloria, Gunjan Vyas

ABSTRACT

The objective of the present study was to evaluate three factors for the development of ASA drug loaded pellets. The selected independent factors, Atomization (A), Product temperature (B), and Binder concentration (C), were optimized with a three factor, two level Central Composite Design small (CCDS). The selected dependent factors were the % Efficiency (Y1), % agglomeration (Y2) and cumulative % drug release of label claim (Y3). Optimization was performed for A, B and C using the following target ranges; 80% ≤ Y1 ≥ 100%; 0% ≤ Y2 ≥ 10%; 85% ≤ Y3 ≥ 100%. Results of optimization procedure indicate that the optimized level of atomization (A), product temperature (B) and binder concentration (C) were 0.50 bar to 2.35 bar, 35⁰C to 38⁰C and 3.50% w/w respectively. Various solutions were suggested which give desirability =1. Binder concentration is the common significant term, while atomizations as well as product temperature are factors have main and interaction effect on the ASA pellets. These drug loaded pellets are to be used for the development of the enteric coated pellets to release the ASA after some delay or after pellets passes GI tract. In this study the drug loading was done in the aqueous dispersion. Generally, ASA degrades to salicylic acid in the aqueous system, but in this study it is done in the aqueous system.

Keywords: AcetylSalicylic Acid, Central Composite Design, Pellets, Optimization, Statistical