Primera is highly experienced with development, validation, or transfer of discriminating product dissolution methods in accordance with ICH, FDA and USP guidance for drug discovery and generic companies. We fully understand the critical need to measure the drugs bioavailability and therapeutic effectiveness in terms of the release rate and immediate release, extended release, or controlled release dosage form (solid oral dose, topical, suspension, etc.). When designing a dissolution method, we take into consideration the Biopharmaceutics Classification System which can be used as a basis for setting in vitro dissolution specification as well as predicting a successful in vivo-in vitro correlation.
We refer to the Product-Specific Guidance, the USP Dissolution Methods, for each monograph as well as those methods recommended in the FDA dissolution database (Division of Bioequivalence, Office of Generic Drugs). In order to support these methods, Primera has all 7 USP apparatus. These apparatuses are listed below. They are qualified and calibrated to ensure compliance with cGMP following PVT in accordance with USP <711>. USP points out that this is critical in order to assess suitable performance of apparatus used in dissolution testing ensuring reliability of dissolution results that reflects the quality of the drug product and not the condition of the test equipment.
Every dissolution apparatus is equipped with an autosampler to enable long and complex profiles.
Primera has experience with a wide variety of controlled release formulations. Contact us to learn how we can support you with your IVIVC/IVRT/IVPT studies.