Pharmaceutical dissolution testing helps to ensure the safety and efficacy of a variety of different formulated drug products. This three-day course covers the theory behind drug solubility and dissolution rate, regulatory expectations, experimental technique, interpretation of test results, investigating anomalous data, setting suitable dissolution specifications and the development and validation of dissolution tests. It also includes details of the USP and US FDA approaches for equipment qualification as well as the use of in vitro dissolution testing to establish bioequivalence. The establishment and uses of in vitro-in vivo correlations (IVIVC) will also be discussed.
The focus of the course will be on solid oral dosage forms, but apparatus and techniques for other types of drug product will also be presented, including transdermal drugs and dosage forms designed for release over a period of weeks or months. The course consists of lectures and exercises/workshops designed to reinforce the taught component.
By the end of the course, you will understand the science underpinning dissolution/drug release testing, and have the knowledge required to:
- Avoid practical errors in the dissolution/release testing of drug products
- Select appropriate test conditions (dissolution medium, apparatus, agitation rate, time points)
- Validate dissolution methods in accordance with regulatory expectations
- Reduce dissolution result variability
- Troubleshoot anomalous results
- Set scientifically-sound acceptance criteria
- Implement a compliant dissolution equipment qualification strategy
- Use in vitro data to establish bioequivalence
- Understand the potential for establishing an in vitro-in vivo correlation (IVIVC) and the regulatory application of different IVIVC classes
Learning Objectives:
- Reasons for dissolution testing
- Factors affecting drug solubility and dissolution rate
- Apparatus for the dissolution/release testing of different dosage forms
- Instrument qualification approaches
- Dissolution tests for immediate-release and modified-release drug products
- Release testing of transdermal products
- Accelerated dissolution testing of novel dosage forms (e.g. implants, polymeric microspheres etc.)
- Calculation and interpretation of test results
- Dissolution method development
- Options for the analytical finish
- Dissolution method validation
- Troubleshooting anomalous data
- The role of dissolution testing in establishing bioequivalence (biowaivers)
- In vitro-in vivo correlation
Who will Benefit:
- Laboratory staff responsible for developing dissolution methods
- Personnel responsible for equipment qualification
- Quality control analysts
- Regulatory affairs professionals
- Quality management
- 08:30 AM – 09:00 AM – Registration Process, Meet & Greet
- 9:00 AM -10:30 AM
- Reasons for dissolution testing
- Safety
- Efficacy
- Dissolution testing in the context of other quality parameters
- Dissolution theory
- Factors affecting solubility
- Reasons for dissolution testing
- 10:30 AM -10:45 AM Break
- 10:45 AM -12:00 Noon
- Dissolution theory (continued)
- Dissolution rate
- Dissolution medium
- Intrinsic and apparent dissolution
- Dissolution theory (continued)
- 12:00 Noon -1:00 PM Lunch
- 1:00 PM -3:00 PM
- Dissolution apparatus
- Regulatory references
- Apparatus for solid oral dosage forms (USP apparatus 1, 2 3 and 4)
- Non-compendial options (e.g. small-volume apparatus and peak vessels)
- Apparatus for transdermal dosage forms (USP apparatus 5, 6 and 7)
- Dissolution apparatus
- 3:00 PM -3:15 PM Break
- 3:15 PM - 4:30 PM
- Dissolution apparatus (continued)
- Apparatus for topical semi-solid dosage forms (vertical diffusion cell)
- Intrinsic dissolution testing
- Ph. Eur. apparatus for medicated chewing gum
- Requirements for different release types
- Immediate release
- Delayed release
- Extended release
- Dissolution apparatus (continued)
- 8:30 AM-8:59 AM Attendees arrive
- 9:00 AM -10:30 AM
- Requirements for non-oral dosage forms
- Transdermal patches
- Topical semi-solids
- Dissolution testing for novel dosage forms
- Experimental options
- Accelerated release testing
- Requirements for non-oral dosage forms
- 10:30 AM -10:45 AM Break
- 10:45 AM -12:00 Noon
- Interpretation of results
- Meaning of Q
- Results calculation
- Immediate release
- Delayed release
- Extended release
- Interpretation of results
- 12:00 Noon-1:00 PM Lunch
- 1:00 PM-3:00 PM
- Equipment qualification
- Regulatory/industry body guidance
- USP approach (PV tablets)
- US FDA approach (enhanced mechanical qualification)
- Equipment factors influencing result variability
- Equipment qualification
- 3:00 PM -3:15 PM Break
- 3:15 PM - 4:30 PM
- Dissolution test troubleshooting
- Troubleshooting approach
- Records and observations that aid troubleshooting
- Dissolution test troubleshooting
- 8:30 AM - 8:59 AM Attendees arrive
- 9:00 AM - 10:30 AM Method development
- Choice of dissolution medium
- pH range
- Volume
- Surfactants
- Biorelevant media
- Choice of dissolution medium
- 10:30 AM-10:45 AM Break
- 10:45 AM -12:00 Noon
- Method development (continued)
- Apparatus
- Agitation rate
- Sampling points
- Assay
- Acceptance criteria
- Method development (continued)
- 12:00 Noon-1:00 PM Lunch
- 1:00 PM -3:00 PM
- Method validation
- Regulatory guidance
- Experimental approaches to method validation
- Justifying acceptance criteria
- System suitability tests
- Method validation
- 3:00 PM -3:15 PM Break
- 3:15 PM - 4:15 PM
- In vitro approaches to bioequivalence
- Regulatory guidance (including ICH M9)
- Solubility and permeability
- Measuring permeability in vitro – Caco-2 and PAMPA models
- Oral bioavailability and first-pass metabolism
- Limitations for in vitro bioequivalence
- In vitro-in vivo correlation (IVIVC)
- IVIVC classes
- Experimental methods for establishing IVIVCs
- Regulatory uses of IVIVCs
- In vitro approaches to bioequivalence
- 4:15PM-4:30 PM Final questions, feedback and close
Mark Powell
Director, Mark Powell Scientific Limited
Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.
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