
The present study aims to design and optimize the Azilsartan Mini tablets formulation using the Quality by design (QbD) approach. A randomized two factorial experimental design was used to characterize the effect of the critical factors by varying the quantity of Hypromellose, Povidone PVP K and ethyl cellulose and assessed for their impacts on the critical quality attributes (responses), including friability, dissolution time, and content uniformity. The drug-excipients interaction of the formulation was investigated using FTIR and DSC, respectively. The accelerated stability study at 40 °C/75% relative humidity and real time stability study at 25 °C/60% relative humidity was performed. FTIR revealed an absence of any significant chemical interaction in solid state. The formulations exhibited acceptable friability (0.2 to 0.9%). The dissolution study of all eleven formulations ranged from 79 to 97%. The overall study showed that the optimum level of independent factors was found to be 4mg of hypomellose, 6 mg of ethyl cellulose and 4 mg povidone PVP K in each tablet. Accelerated stability studies showed the compendial acceptable hardness and friability. The application of QbD approach can help in the detailed understanding of the effect of CMAs and CPPs on the CQAs on Azilsartan final product.
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 0 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Average | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Average | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Average |
