Formulation Forum

Controlling the bacteria Burkholderia Cepacia Complex (BCC) in non-sterile pharmaceutical products has received increased attention in recent years.  BCC has now been classified as an “objectionable organism” by the industry and will need to be controlled...

The FDA Inactive Ingredient Database (IID) is heavily used by formulators when developing drug products.  This resource has been available since 19871 and has since informed the inactive ingredient (excipient) selections and concentrations made by formulation...

CMC is critical to a successful topical drug product program.  Important aspects of CMC that are unique to topical products are discussed in this presentation.

One of the most common issues faced during topical formulation development is difficulty in dissolving the active pharmaceutical ingredient (API) in water or other water-soluble solvent systems. When this happens, several approaches may be taken when trying to...

Proper scale up of a 1 kg batch to a 1,000+ kg batch takes engineering effort to execute properly.  Why is this so difficult?  The short answer is because of the math.  The physical forces on a semi-solid product while manufacturing a 1 kg laboratory batch vs. that of...

Pros and Cons of topical products containing a suspended API Prescription drug products contain an active pharmaceutical ingredient (API)1. While traditional topical drug product development focuses on dissolving the API, challenges can arise from dissolved systems....