WHITE PAPER: HPAPI Drug Solid Oral Dosage (SOD) Manufacturing – Ensuring Content Uniformity

What techniques should manufacturers employ when working with low-dose drug products?

By: Thomas Daggs, MBA, Vice President, Product Development & Quality Control, and Angelo Consalvo, Director of Manufacturing, Enteris BioPharma

Anyone who takes an oral tablet medication – whether prescribed or over-the-counter – does so under the presumption that each tablet in the bottle is, for all intents and purposes, identical and will provide the desired pharmacological effect without any noticeable difference among doses.  Each tablet looks the same, therefore each is the same.  Anything less would, for most people, be impossible to fathom.

For drug developers, achieving this “pharmaceutical guarantee” is no small task.  It requires the precise distribution of the active pharmaceutical ingredient (API) within the drug product batch in a manner that meets industry standards of “content uniformity…”