Design and Optimization of Lyophilization Cycle for Anti ulcer Drug

Abstract

The present work was planned to study a lyophilized dosage form of anti-ulcer drug with different processing parameters. The drug is having stability problem in liquid dosage form. Hence, the aim and objective of present work is to troubleshoot the challenges related to drug by developing formulation using lyophilization process to improve its stability. First trial was taken in smart lyophilizer which minimize the trial and error method. Blow out of the product from the vial was observed due to high vacuum. Hence, other 4 trials were taken in simple lyophilizer by varying vacuum to overcome blow out problem. After solving the powder ejection challenge, different batches were taken based on changing temperature and vacuum to observe its effect on the final product characteristics. Evaluation of each batches where done. And concluded that vacuum from 400mTorr to 600mTorr is considered to be optimum and no variation will be seen in the final product. But, final product characteristics was changed when all the temperature was increased to +5˚C. In last two batches, reconstitution time, no powder ejection, water content and assay was optimum according to the specification. Hence, it was considered as a optimized batch