Newsletter | November 1, 2023

Best of October: Top 5 Insights In Drug Formulation & Delivery

Drug Delivery Leader



#1 Global Market Trends For Drug–Device Combination Products

Drug–device combination products, also known simply as combination products, have a wide range of applications, including drug-eluting stents, prefilled syringes with medications, inhalers with drugs, transdermal patches with therapeutic agents, and more. 

#2  Strategies For Accelerating The Development Of Modified Release Oral Forms

An impressive variety of MR formulation technologies are available eliciting a wide range of control on drug release and delivery. Explore why careful selection of appropriate excipients and delivery technologies is key to the design of modified release (MR) formulations fulfilling specific performance requirements.

#3 Your Best Chance At Regulatory Compliance For Combination Products: Integrated Development

The near-term future of combination products continues to be the growth of prefillable syringe systems (PFS) and their use in autoinjectors (AI), especially due to the trend toward self-administration. The coming together of the drug with its packaging and its delivery system brings with it some of the greatest challenges for manufacturers from a technical and regulatory standpoint.

#4  Inspection Of Injectable Products For Visible Particulates

This white paper will examine the risks posed by particulates, the potential sources and types of particulates, and approaches to detect and measure visible particulates in injectables, as well as review the draft FDA guidance on inspection of injectable products for visible particulates and discuss how to apply the recommendations.

#5  Combination Product QMS Requirements For Pharma Companies Entering The EU Market

Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.