Dissolution testing is an important quality test for solid oral dosage forms. It supports the efficacy and safety of medicines by measuring the extent and rate of drug release. The aim of this two-day course is to explain the science behind drug dissolution, to set out a logical approach to the development and validation of dissolution tests, highlight common mistakes and current regulatory expectations for dissolution tests characteristics and biowaivers.
The Dissolution Testing & Biowaivers for Solid Oral Drug Products Masterclass starts by setting out dissolution theory: factors affecting solubility and dissolution rate for drugs and formulated product. This includes the influence of pH, surfactants and ionic strength on dissolution rate. Equipment options for testing solid oral dosage forms (USP Apparatus 1, 2, 3 & 4) will be discussed, as well as non-compendial approaches such as peak vessels and small-volume apparatus.
Common mistakes with operations such as sample introduction and sampling will be described, together with a logical approach to troubleshooting anomalous or out-of-specification results. The development of a dissolution method that will meet regulatory expectations requires an understanding of the biopharmaceutics classification system (BCS) and current guidance on the discriminating ability of methods. A systematic approach to dissolution method development will be described, together with a case study for a poorly soluble drug. The use of biorelevant media to derisk in vivo performance and dissolution method validation will also be covered, including demonstration of discriminating ability and robustness.
Situations where in vitro dissolution data may be used to demonstrate the bioequivalence of generic products will be described. This topic will include allowable test conditions and similarity calculations.
Each day ends with an interactive workshop sessions.
An overview of regulatory requirements for dissolution methods and biowaivers
A deeper insight into the science behind dissolution testing
An appreciation of the use of dissolution testing in pharmaceutical quality control
An understanding of how to develop and validate dissolution test methods
Improve your approach to dissolution method development
Answers to your questions on dissolution testing
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s AnalyticalDivision and led a working group on continuing professional development until July 2016.
He has worked at a senior level in several companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes, including stability evaluation.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved managing the analytical and stability aspects of early and late-stage pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, root cause analysis and stability/stress studies.