Abstract

The first Panel Discussion that Pharma Horizion presents in 2018 is dedicated to the Oral Solid Dosage (Osd) Manufacturing Process. As we are used to do, we offered the opportunity to seat around this virtual table to the main industry players, called to express their opinion on some food for thought proposed by our editorial team.

The following companies have joined the initiative – Alcami, DrReddys, Grace and Lonza – that have been involved asking them about the main challenges that manufactures of Osd forms have to face, such as quality, safety and productivity. The panelists also questioned about technical advancements, production management, operational excellence aspects and tech transfer ones. And, last but not least, about packaging operations.

Here are their opinions. Enjoy the reading.

In the next issue of the journal we are preparing a Panel Discussion on Parenteral Drug Manufacturing. Stay tuned!

Catherine Hanley 

Sr. Director of Marketing and Corporate Communications

Alcami

"It is critical to design experiments that investigate the interaction of multi-variables on the drug product"

IT’A MATTER OF QUALITY, SAFETY AND PRODUCTIVITY

With regard to formulations, early-stage oral solid dosage (OSD) development challenges include solubility issues and difficult-to-formulate products, poorly controlled pharmacokinetics, polymorphism and stability, and limited amounts of the active pharmaceutical ingredient (API). During late-stage development, product manufacturability challenges can occur with processing and packaging as higher scale manufacturing can significantly impact the physico-chemical characteristics of a product.

Therefore, it is critical to design experiments that investigate the interaction of multi-variables on the drug product. Today’s business demands push the limits on the d ... ...