Evaluating the Technology for Hot-Melt Extrusion and Highly Potent APIs

Have you seen the first issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report yet? As editor of the eNewsletter, I look forward to your feedback.

Our feature story focused on the critical issue of solubilization strategies for poorly soluble drugs, which is a growing challenge as a greater number of new drug candidates fall into this category. We examined the use of solid dispersions through hot-melt extrusion (HME) as one strategy. Let us know how you are leveraging HME in your developmental or commercial work or share your opinion on the advantages or limitations of the technology. Some points for your input:

• ·         Do you see HME as having real potential to increase the availability of poorly soluble drugs or are its limitations (the need for thermally stable APIs, for example) too difficult to overcome?
• ·         How important is the fact that no solvents are used in this type of solid dispersion process?
• ·         Do you agree that the development of excipients that are specifically designed for use with HME will have a big impact?
• ·         What do you think can be done to improve the mixing efficiency when using HME?

We also turned to experts in the manufacture of highly potent APIs (HPAPI) to learn about recent advances in handling these types of compounds. The availability of HPAPI capacity is of growing importance because of demand for new drug substances, particularly oncology therapies, which are highly potent and that require specialized containment for their manufacture.  Some points for your input:

• ·         What are you looking for when you need to find a custom manufacturer for your highly potent compounds?
• ·         What banding system does your company use for categorizing HPAPIs?
• ·         Is it important to find one supplier that can provide material from development through commercialization?
• ·         In your experience, what are the biggest challenges when manufacturing HPAPIs?

Having been involved in the chemical and allied industries in roles that included basic R&D, technical support, business development, regulatory management, and now as a science/business editor, it has become abundantly clear that the sharing of knowledge and expertise across all aspects of a business is critical for the development of successful advances in both practical technological and business solutions.

Please share your experiences that are important to further progress in the pharmaceutical industry.

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report