Abstract

REVIEW ON PROCESS VALIDATION OF OPTIMIZED FORMULATION OF DELAMANID IN TABLET DOSAGE FORM

Malti Nishad, Prem Prasad and Sanjay Kumar Kushwaha*

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Abstract

This review paper provides a thorough examination of the process validation steps involved in optimizing the formulation of Delamanid, a potent anti- tuberculosis medication, holds promise in combatting drug- resistant strains of tuberculosis. Delamanid, a crucial antituberculosis agent, necessitates precise formulation and validation to ensure its efficacy and safety in tablet dosage form. This review focuses on the process validation of optimized formulations of delamanid tablets, encompassing critical aspects such as method development, quality control, and regulatory compliance. It discusses the importance of process validation in pharmaceutical manufacturing, highlighting its role in guaranteeing consistent product quality and adherence to Good Manufacturing Practices (GMP). Key stages of validation, including design qualification, installation qualification, operational qualification, and performance qualification, are examined in detail. The review also explores various analytical methods used to evaluate the physical and chemical properties of delamanid tablets, ensuring optimal bioavailability and stability. Challenges encountered during the formulation process, such as solubility issues and maintaining potency, are addressed alongside innovative solutions implemented to overcome these obstacles. Furthermore, the review underscores the significance of continuous monitoring and validation to adapt to potential variations in the manufacturing process. Overall, this comprehensive review provides valuable insights into the systematic approach required for the successful validation and optimization of delamanid tablet formulations, aiming to enhance therapeutic outcomes and ensure patient safety.

Keywords: Delamanid, Anti- Tb drug, Process validation, Optimization, MDR-Tb.