Evolving Pharmaceutical Industry Fundamentals Create Technical Challenges

The pharmaceutical industry is evolving from one focused on the development of blockbuster drugs to one dominated by niche, small-volume therapies, a trend that is affecting all drug product forms, from solid dosage to parenterals. At the same time, the number of large-molecule biologics is increasing at the expense of small-molecule APIs.

Attendant to these changes is the ongoing need to improve drug product forms to ensure patient compliance and convenience, which is seen in increased demand for prefilled syringes, a topic that we cover in the March 13 issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report.  Prefilled syringes offer several advantages to pharmaceutical companies and CMOs/CDMOs, as well as healthcare professionals and patients. Lower cost, increased convenience, reduced risk of contamination, greater safety, all are factors driving the growing interest in this method of drug delivery.

Of course, there are also more manufacturing steps involved. The viscosity of the formulated drug can cause issues, and glass breakage is a real concern if the syringe design is not matched properly with the properties of the drug product. Interactions between the API and the wall of the syringe can come into play as well.

• ·         What is your experience with prefilled syringes? Do they provide added convenience for the user?
• ·         Can they increase productivity at healthcare facilities?
• ·         How important is the issue of viscosity, and can it be overcome with traditional syringe designs, or are new technologies needed?
• ·         What other advances might be anticipated in the future in the area of prefilled syringes?

Speaking of the future, we are looking forward to the publication of the third issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report. With INTERPHEX coming up next month (April 23-25), we have gathered input from leading producers of equipment for solid-dosage manufacturing on continuous tableting and mixing and blending.

Other topics to be covered in the third issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report include the following:

• ·         Advances in chemical catalyst technology for chiral synthesis
• ·         Issues surrounding the filtration of parenterals
• ·         The introduction by SAFC of new Pharma Grade raw materials
• ·         A discussion of the advantages of rapid microbiological testing

Are any of these topics hot button issues for you? Please weigh in with your thoughts. Why are they important? What technical advances are most noteworthy? What problems or limitations remain?

Make sure, if you haven’t already, to sign up to receive The Pharmaceutical Sciences, Manufacturing & Marketplace Report so that you can read what experts in the field have to say about these topics. Then come back and let us know whether you agree or disagree with the points they make, or if a key concept was overlooked. 

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report