Dissolution

Dissolution testing provides crucial in-vitro drug release information that is routinely used for quality-control (QC) and quality-assurance (QA) purposes in the pharmaceutical industry. The quality-by-design (QbD) approach places strong emphasis on the role of dissolution testing in optimization of a formulation’s drug release rate and evaluation of critical process parameters (CPPs) in the manufacturing process that may affect performance of the dosage form. Data from dissolution studies form an essential component in regulatory submissions and all stages of the approval process. Post approval, the dissolution test provides continual assurance of batch-to-batch consistency in product performance as well as the ability to reject sub-performing batches. Additionally, scale-up and post-approval changes (SUPAC) guidance relies heavily on dissolution testing to assure that these routine post-approval activities do not impact product performance. Dissolution Analysis measures a drug's rate of release from its dosage form. Dissolution Analysis is routinely performed to provided critical drug release information for drug development and quality control purposes. It is also used in stability studies to determine effects of time, temperature, and humidity on a drug sample, as well as in comparator studies. Understanding of USP method <711> with dissolution apparatuses I, II, III, IV, V, and VII enable laboratories to deliver strong and reliable results for human bioequivalence studies as stated by the Food and Drug Administration (FDA). Well-equipped laboratory offers comprehensive testing services according to the pharmacopoeia (e.g. USP) and to client’s specifications. Various Dissolution Apparatus Services Offered: USP Dissolution Apparatus I – Basket, USP Dissolution Apparatus II – Paddle, USP Dissolution Apparatus III – Reciprocating Cylinder, USP Dissolution Apparatus IV – Flow-Through Cell, USP Dissolution Apparatus V – Paddle over Disk, USP Dissolution Apparatus VII - Reciprocating Holder Apparatus. Method Development & Validation of Dissolution Methods Developing the techniques and the steps of an analysis, or verifying client’s current methods can also be performed. Method Development projects can be custom-designed to meet client’s specific analytical requirements, or they can choose to use the methods developed according to laboratories proven methods. All methods are validated in compliance with USP and ICH guidelines, using client protocol, or customized protocols.