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Dissolution TestingFOR THE FORMULATOR AND ANALYTICAL CHEMIST
This course is conducted in Hebrew
The assay of a pharmaceutical dosage form is only a part of the demonstration of its ability to deliver the drug substance to the patient. A drug product that does not release the drug substance is of the same value as a drug product that does not contain the drug substance at all! Dissolution testing was introduced officially almost 40...Continue reading
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Issues to be covered
INTRODUCTION
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The need for dissolution testing
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Historical perspective
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Theories of dissolution
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Intrinsic dissolution
THE PHARMACOPIAL STATUS OF DISSOLUTION TESTING
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USP v EP v JP
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Compendial testing equipment
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Factors affecting test results
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Calibration, chemical or mechanical
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Automation a blessing and a curse
QUALITY CONTROL ASPECTS OF DISSOLUTION TESTING
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Level 1,2 and 3 testing; what is it and what does it mean.
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Consideration of the design of an OOS SOP for dissolution
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How to conduct an investigation into a dissolution OOS
DEVELOPMENT OF VALIDATED DISSOLUTION TESTS
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Developing a dissolution test
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Simple formulations
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Modified release formulations
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Poorly soluble drugs
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Combination products
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Validation of the test method
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The dissolution test
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The analytical procedure
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Setting specifications
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The regulatory view
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The formulation development view
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Artifacts produced by the test system
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Hydrodynamics of the paddle and basket
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FORMULATION FACTORS AFFECTING DISSOLUTION
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The drug substance
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Particle size
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Polymorphs
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Excipients
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Structure and function
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Process validation and dissolution
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Stability issues
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Hardness effects
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Coatings and polymeric modified release
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REGULATORY ASPECTS OF DISSOLUTION TESTING
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Official guidances of the FDA and the EMEA
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The role of dissolution in the regulatory submission process
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Innovative
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Generic
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The role of dissolution in the regulatory process post approval
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SUPAC
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Filing variations
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DISSOLUTION AND BIOAVAILABILITY/BIOEQUIVALENCE
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Dissolution testing as a surrogate marker
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Biomimetic methods
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Gastrointestinal transit and drug absorption
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Test design based on gastrointestinal physiology
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In vivo/in vitro correlations
THE BIOCHEMICAL CLASSIFICATION SYSTEM [BCS]
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Its origins
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Description of the classification
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Its value in terms of development and regulation
NON ROUTINE TESTING METHODS
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The pharmacopial methods other than paddle and basket
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Some old ideas revisited
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New developments in dissolution testing
DISSOLUTION FOR DOSAGE FORMS OTHER THAN CONVENTIONAL TABLETS AND CAPSULES, INCLUDING
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Chewable tablets
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Combination products
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Creams and ointments
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Inhalers
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Transdermals
Who should attend
• Analytical chemists from both QC and R&D environment
• Regulatory affairs staff responsible for CMC preparation
• Quality assurance personnel
• Formulation chemists from both the branded and generics sector.
Benefits to the Participants
The course looks at the history of the dissolution test in order to understand how we have arrived at today’s situation. It will review the test methods, both official and unofficial and discuss the development and validation of dissolution tests.
Although the main emphasis of the course will concern solid dosage forms, both instant and modified release, there will be consideration of other forms requiring some form of release testing.
The course is designed to bring together aspects of the subject both from the analytical and the formulation development areas and will be illustrated with practical tips and examples.
Attention will be given to the regulatory aspects of dissolution particularly as related to regulatory submissions.
About The Lecturer
Malcolm Ross
Dr. Malcolm Ross is a consultant specialising in training, project management
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