Investigation on influence of Wurster coating process parameters for the development of delayed release minitablets of Naproxen

Abstract

The present work aims at studying process parameters affecting coating of minitablets (3 mm in diameter) through Wurster coating process. Minitablets of Naproxen with high drug loading were manufactured using 3 mm multi-tip punches. The release profile of core pellets (published) and minitablets was compared with that of marketed formulation. The core formulation of minitablets was found to show similarity in dissolution profile with marketed formulation and hence was further carried forward for functional coating over it. Wurster processing was implemented to pursue functional coating over core formulation. Different process parameters were screened and control strategy was applied for factors significantly affecting the process. Modified Plackett Burman Design was applied for studying important factors. Based on the significant factors and minimum level of coating required for functionalization, optimized process was executed. Final coated batch was evaluated for coating thickness, surface morphology, and drug release study.

Keywords:

• Naproxen
• Wurster processing
• M-tabs
• MiniQuest F

Acknowledgments

The authors are thankful to Mr. Ketan Savjani (Emcure Pharmaceuticals, Ahmedabad) and Mr. Mahesh Bhadagale (Callidus Research Laboratories, Pune) for execution of compression of M-tabs at their facility; to Mr. Jnanadev Bhat (ACG Associated Capsules, Mumbai) for providing with gift sample of capsule; Mr. Amit Chivate (Ashland Pharmaceuticals) and Mr. Tyagin Nanavati (Alembic Pharmaceuticals, Vadodara) for providing gift sample of Naproxen.

Disclosure statement

The authors report no conflict of interest. The authors alone are responsible for the content and writing of paper.

Additional information

Funding

The authors are thankful to Department of Science and Technology (DST-INSPIRE) for providing fellowship (IF131007) as financial assistance and to Institute of Pharmacy, Nirma University for providing platform to carry out research work, which is a part of Doctor of Philosophy (Ph.D) research work of Neha Shah, to be submitted to Nirma University, Ahmedabad, India.