Formulating an Oral Suspension (part 2)

In part 1 of this article I described the need to ensure the delivery of a uniform dose of a suspension, how this can be achieved and the challenges that can be encountered.  In part 2 I’d like to discuss preserving against microbial growth, taste & “mouthfeel” and manufacturability.  Suppressing microbial growth Aqueous solutions containing viscosity modifying polymers and other...

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Formulating an Oral Suspension (part 1)

  Frequently we at Velesco are approached with a request to formulate a suspension of a new compound for use in a clinical study.  Often this request contains the helpful information “we mixed some drug with some 2% methylcellulose solution and dosed it to the rats without issues so this shouldn’t be a big job, right?” Well maybe yes but probably no is the answer to that. Formulating...

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Clinical Supplies Group Conference – Study Drug Returns and Reconciliation

A couple of weeks ago I attended and exhibited at the Global Clinical Supplies Group conference which was held at the wonderful Hyatt Regency Tamaya Resort & Spa in Santa Ana Pueblo NM . It was a great meeting with about 250 attendees who specialize in the co-ordination of clinical study supplies and thirty something exhibitors.  The meeting was very well organized by George Wills and...

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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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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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