Dissolution Testing


Category:  Analytical Chemistry ,
R&D
FOR THE FORMULATOR AND ANALYTICAL CHEMIST
Lecturer: Dr Malcolm Ross
 
Course Language: English
Course Name: Dissolution Testing
Duration: 2 - Day Course
Date: February 7-8, 2011
Hours: 9:00am - 5:00pm
Registration: 8:30am
Location: Corporate College East 4400 Richmond Road Warrensville Heights, OH / On Site
Price:  Basic Price: $595/day, Early bird registration- $495/day
Course ID : A10180

Registration Form
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 years ago and, for the majority of dosage forms requiring such testing little has changed in the mechanics of the test. However the understanding and interpretation of such testing has remained an area of much dispute with considerable over interpretation of the results both by the industry and the regulatory authorities.
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.
Issues to be covered
INTRODUCTION
  • The need for dissolution testing
  • Historical perspective
  • Theories of dissolution
  • Intrinsic dissolution
THE PHARMACOPIAL STATUS OF DISSOLUTION TESTING
  • USP v EP v JP
  • Compendial testing equipment
  • Factors affecting test results
  • Calibration, chemical or mechanical
  • Automation a blessing and a curse
QUALITY CONTROL ASPECTS OF DISSOLUTION TESTING
  • Level 1,2 and 3 testing; what is it and what does it mean.
  • Consideration of the design of an OOS SOP for dissolution
  • How to conduct an investigation into a dissolution OOS
DEVELOPMENT OF VALIDATED DISSOLUTION TESTS
  • Developing a dissolution test
    • Simple formulations
    • Modified release formulations
    • Poorly soluble drugs
    • Combination products
  • Validation of the test method
    • The dissolution test
    • The analytical procedure
  • Setting specifications
    • The regulatory view
    • The formulation development view
  • Artifacts produced by the test system
    • Hydrodynamics of the paddle and basket
FORMULATION FACTORS AFFECTING DISSOLUTION
  • The drug substance
    • Particle size
    • Polymorphs
  • Excipients
    • Structure and function
  • Process validation and dissolution
  • Stability issues
    • Hardness effects
    • Coatings and polymeric modified release
REGULATORY ASPECTS OF DISSOLUTION TESTING
  • Official guidances of the FDA and the EMEA
  • The role of dissolution in the regulatory submission process
    • Innovative
    • Generic
  • The role of dissolution in the regulatory process post approval
    • SUPAC
    • Filing variations
DISSOLUTION AND BIOAVAILABILITY/BIOEQUIVALENCE
  • Dissolution testing as a surrogate marker
  • Biomimetic methods
  • Gastrointestinal transit and drug absorption
  • Test design based on gastrointestinal physiology
  • In vivo/in vitro correlations
THE BIOCHEMICAL CLASSIFICATION SYSTEM [BCS]
  • Its origins
  • Description of the classification
  • Its value in terms of development and regulation
NON ROUTINE TESTING METHODS
  • The pharmacopial methods other than paddle and basket
  • Some old ideas revisited
  • New developments in dissolution testing
DISSOLUTION FOR DOSAGE FORMS OTHER THAN CONVENTIONAL TABLETS AND CAPSULES, INCLUDING
  • Chewable tablets
  • Combination products
  • Creams and ointments
  • Inhalers
  • 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.
About the Speaker

Dr. Malcolm Ross is the Managing Director of Generapharm-Consulting specialising in training, project management and research and development in the Generics industry.

Malcolm holds a B.Pharm and Ph.D from London University, was a lecturer in Pharmacognosy at the Welsh School of Pharmacy and a Senior Lecturer in the Dept. of Chemistry at Bar-Ilan University.

With over 25 years experience in the Pharmaceutical industry, the last 15 at corporate level, Malcolm has been intimately involved in strategy  planning and analysis, pipeline management and related activities. In his earlier career these activities were primarily US driven but, more recently, specific to the European market place.

Technically, Malcolm specialized in the development of finished dosage forms from both the analytical and formulation specialties and was responsible for establishing R&D in several companies in different international environments. Experience ranges from small CRO style to large corporate structures with multilevel reporting.  Malcolm has been responsible for the development of over 40 generic Rx formulations and several OTC formulations including a number of innovative products. He is an acknowledged expert in pharmaceutical analysis.

Over the years, in addition to R&D, Malcolm has had responsibility in areas of QA including worldwide auditing, and intellectual property, where he holds a number of innovative formulation patents. Recently he has been working in the CEE and has been involved with the introduction of Project Management systems and cultural issues related to change management and strategy.

He is a frequent presenter at international conferences and training courses.

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