India Workshop 2007

Aashruti Kak - Mumbai

The India Workshop 2007 on 'Primary packaging and drug delivery trends for injectables' was held in October. The workshop was sponsored by Nuova Ompi from the Stevanato Group, Ypsomed, and West Pharmaceuticals. The speakers present at the workshop were Corrado Giovinazzo, Associate Director, Regulatory Affairs and Conformance, Wyeth; Gaetano Baccinelli, Sales Manager, Optrel (Engineering division of Stevanato group); Koh Sok Tiang Director, Technical Services and Business Development for Asia Pacific, West Pharmaceutical Services; Simon Micheal, Business Development Manager, Ypsomed; Hans Thomas, Sales and Marketing Director, Bausch+Stroebel Group; Ulrich Steuerer, Director, Customer Relations, Schreiner MediPharm; Lee H Leichter, President, P/L Biomedical, and Matthias Birkhoff, Director Business Development, Pfeiffer. The workshop was moderated by Dr Fabiano Nicoletti, Vice-President, International Commission of Glass.

The speakers addressed different topics on the lines of the pharma perspective on primary packaging and drug delivery, new development and trends, patient compliance, prevention of medication errors through value added secondary packaging, drug delivery, processing of injectables and the machinery involved, and the regulatory perspectives with regards to drug delivery and injectables. "Clinical evidence indicates that intravenous treatments with lower levels of particulate contamination are associated with a reduction in the incidence of adverse drug reactions. Therefore it is essential that stringent quality systems in place at plant operation are supported by process equipment, non-process equipment and primary components fully in compliance with product formulation," said Giovinazzo, while addressing the issue of adverse drug reactions due to high particulate contamination.

Speaking on the regulatory aspects of drug delivery systems, Leichter said, "The market trend has been to integrate delivery system earlier in the drug development process. They are no longer an afterthought, but are now integrated into the drug product as a method for addressing unique customer needs and/or extending the lifecycle for established drugs." He further said, "These systems include pre-filled syringes, disposable and reusable pens, and pre-filled nasal and oral delivery systems, among others. These 'combination products' pose challenges to the manufacturers and the regulatory agencies as to how to regulate the product. This includes determining what information is required during development, manufacturing and post marketing support."