March 19, 2024

 

Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal and ACG Capsules, Mumbai jointly organized a webinar on Insights into ACG’s Oral Dosage Technology on 19 March 2024, through MS Teams. The webinar featured presentations by Dr Jnanadeva Bhat, Head - Formulation R&D, and Ms Dorene Almeida, Lead – Application Lab in R&D, ACG Capsules, Mumbai. They provided valuable insights into ACG's oral dosage technologies, focusing on the journey of capsule manufacturing process.

Dr Jnanadeva Bhat initiated the discussion by introducing ACG as a leader in the pharmaceutical manufacturing sector, specifically highlighting its achievements in capsule production and the evolution of its value-added services. He then delved into the history and development of hard capsules, offering a detailed explanation of the steps involved in manufacturing empty hard capsules, from solution preparation to capping. Dr Bhat also discussed the development process flow in the capsule manufacturing process from sales order to dispatch. He also briefed about the in-process quality-control tests and regulatory requirements across different countries such as the US, China, Korea, etc. Also, he gave insights into the importance of CEP number, EDQM Certification (Europe), letter of access (Canada), ARTG number, and TSE/BSE certification requirement and also about the importance of the difference in nomenclature for colorant in Europe. Additionally, he provided insights into common manufacturing defects of capsules (minor, major, critical). He proceeded with the advancements in hard capsule shells, including innovations like gelatin capsules with plasticizer, HPMC Capsules, HPMC without gelling agent, and delayed-release capsules. He elaborated on HPMC Capsules, highlighting their emergence as a vegetarian-friendly substitute for gelatin capsules. He also provided a comparison between HPMC and gelatin capsules.

Following Dr Bhat's presentation, Ms Dorene Almeida discussed the latest applications and technologies in capsules. She touched upon solid-solid combinations, liquid fill technology, capsules for dry powder inhalation, and tablet enrobing technology. Ms Almeida explained how different combinations, such as pellets and tablets or powder and pellets, are utilized in both research and development and manufacturing settings. She also highlighted the advantages of liquid-filled hard capsules over soft gels and tablets, emphasizing factors such as solubility, absorption rate, and excipient compatibility. Furthermore, Ms Almeida provided insights into the liquid filling technology and discussed capsule applications for inhalation, particularly DPIs, and the various types of DPI devices available. Finally, she elaborated on capsule types for tablet enrobing and provided a list of approved products in each category.

Postgraduate students of Pharmaceutical Regulatory Affairs and Management, Pharmaceutics and Industrial Pharmacy attended along with faculty members of Department of Pharmaceutical Regulatory Affairs and Management.

Dr D Sreedhar, Additional Professor and Head, Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal welcomed the speakers and participants. The Webinar was moderated by Dr Bhavana B Bhat, Assistant Professor - Senior Scale, Department of Pharmaceutical Regulatory Affairs and Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal and Ms Manali Dalvi, Senior Executive – R&D Formulation, ACG Capsules Pvt. Ltd. Mumbai.