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.
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.
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.
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.
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.