Home|Journals|Articles by Year|Audio Abstracts
 

Original Article

J App Pharm Sci. 2021; 11(4): 96-105


Formulation of somatostatin analog tablets using quality by design approach

Zoya Shprakh.




Abstract
Cited by 5 Articles

The primary purpose of the present study was to apply the quality by design approach to the formulation of the somatostatin analog (SSA) cyphetrylin dosage form. Experimental investigations of cyphetrylin activity in vivo showed that its oral administration is optimal. For better patient compliance and product quality, an interdisciplinary team identified the quality target product profile and determined the critical quality attributes (CQAs) related to product safety and efficacy. On the basis of our own in vitro/in vivo nonclinical data and experience of SSA medicinal use, we estimated the criticality of each CQA by a specially created scale. Because of the minimal quantity of the active substance in the tablet, the assay and uniformity of content are defined as the most CQAs. Estimation of the manufacturing process by methods of the risk analysis and mitigation matrix and failure mode effect analysis allowed us to determine the effects of process unit operations on final product in-process CQAs and to characterize the granulation and compression as the most critical steps. It has been shown that the moisture content of granulate is the most significant in-process CQA, which affects the disintegration and resistance to crushing of tablets and their microbial limits.

Key words: Key words: somatostatin analogue, quality by design, quality target product profile, critical quality attributes, risk assessment, tablet






Full-text options


Share this Article


Online Article Submission
• ejmanager.com




ejPort - eJManager.com
Refer & Earn
JournalList
About BiblioMed
License Information
Terms & Conditions
Privacy Policy
Contact Us

The articles in Bibliomed are open access articles licensed under Creative Commons Attribution 4.0 International License (CC BY), which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.