Formulation, optimization, and evaluation of aspirin oral disintegrating tablets, prepared from direct compression method
by Abhishek Agrawal
Developed under the guidance of:
Dr. Mali Gupta
Pharmaceutical Sciences (Industrial Pharmacy)
The objective of this study is to formulate and optimize directly compressible oral disintegrating tablets (ODT) of aspirin (81 mg /tablet) using different synthetic superdisintegrants (Crospovidone, Sodium starch glycolate, and Croscarmellose sodium) and binders (Microcrystalline cellulose and Povidon K30) to achieve a disintegration time of less than 30 seconds. The Active Pharmaceutical Ingredient (API)-excipient compatibility is studied using Differential Scanning Calorimetry (DSC). Various tablet formulations containing different combinations of superdisintegrants and binders will be prepared and compressed using 16 station Manesty Betapress and evaluated for: disintegration time, tablet hardness, and thickness. The formulation showing fastest disintegration time is selected for further optimization using mixture design by varying the concentration of superdisintegrant and binder in the formulation. Tablets obtained from the optimized formulation will be evaluated for weight variation, thickness, hardness, in vitro disintegration time, and drug content. Accelerated stability studies will be carried on the optimized formulation by storing the tablets at 40 ± 2 0C and 75 ± 5 % relative humidity for one and two weeks respectively.
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