Drug Release & Permeation

Characterizing Drug Product Performance

Drug release and permeation studies characterize how active pharmaceutical ingredients are released from dosage forms and, for topical and transdermal products, how they penetrate biological membranes. These studies inform formulation optimization, support regulatory submissions, and enable comparisons between test and reference products for bioequivalence or comparability assessments.

Biotts provides dissolution, release, and permeation testing capabilities supporting development programs from early formulation screening through regulatory filing. Our services address three distinct test types: dissolution testing for oral solids using pharmacopeial apparatus (USP <711>, Ph. Eur. 2.9.3), in vitro release testing (IVRT) for semi-solid dosage forms, and in vitro permeation testing (IVPT) for transdermal systems – each with methodology aligned to relevant regulatory guidance where applicable.

Release and permeation data address multiple development questions: Is the release profile appropriate for the intended therapeutic effect? How does the formulation compare to the reference product? What is the sensitivity of release to formulation or process changes? Studies are designed to answer specific questions with appropriate controls, using fit-for-purpose approaches for development work or validated methods where regulatory submission is intended.