Topical Product Formulation – Getting the Terminology Right

One little mentioned aspect of topical product development that can be a challenge to client-CRO relations is that of terminology. There are a wide variety of terms used to describe product types; cream, ointment, lotion etc which many people use interchangeably yet, to the formulator each has a very specific meaning. As you can imagine this leads to some confusion and frustration so, in an...

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Velesco’s Non-Clinical Formulation Philosophy – Part 1

As I’ve gained more time in the CRO world versus big pharma, I have come to see that there are two fairly distinct schools of thought for determining pre-clinical formulations for very early stage compounds.  One uses the compound structure and an iterative process to determine an appropriate vehicle for early stage formulations.  The other uses a high throughput screening methodology...

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CMC in Preclinical Development – is Polymorph Screening Appropriate?

I was fortunate to be invited to participate in a recent MPI Research sponsored event at the WBBA facility in Seattle, Washington. Titled “Chemical Manufacturing Controls: What’s Driving the Entire Drug Development Process?” it addressed those scientific and regulatory aspects of drug characterization needed at the pre-clinical stage of development. The meeting was excellently...

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Cyclodextrins as Early Stage Toxicology Formulation Solubilizers: These Things are Really Cool.

Cyclodextrins are powerful tools in the early stage formulator’s toolbox, especially with the poorly soluble compounds that we are frequently formulating.  Many of our clients are unfamiliar with these compounds, their limitations, and how they can be used for formulation.  One large advantage is that Cyclodextrins are typically water soluble, and therefore your formulation can be appropriate...

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