Dissolution Testing Development - Quality Control - and in vivo Relevance

Dissolution Testing Development - Quality Control - and in vivo Relevance

Barcelona, Spain

Course No 15398


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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org


Dr Thomas Fürst
Boehringer Ingelheim
Dr Kerstin Pauli
Bayer AG
Dr Alexander Pontius
Bayer AG
Dr Ferdinand Steierhoffer
Boehringer Ingelheim


This GMP Education Course on Dissolution Testing aims at providing delegates with a sound understanding of the principles and best practices in dissolution testing. As dissolution testing has become increasingly important as a tool for predicting in vivo performance and for assessing drug product quality, this topic will be extensively discussed.


The dissolution test is a key performance indicator for solid and semi-solid dosage forms in both drug development and quality control. In these fields it is used to assure batch-to-batch quality as well as providing process control information as part of the new approach to Process Validation.

Dissolution testing is usually connected to in vivo performance because the API must be
released from the formulation in the gastro-intestinal tract (GIT) before in vivo absorption can occur. Therefore dissolution testing is generally employed during drug product development and optimization. Where dissolution testing data can be shown to be correlated to in vivo performance, clinical trials may be avoided by in vitro dissolution studies under certain circumstances, thereby reducing development time and costs.

There are a many dissolution testing guidances and associated guidelines (e.g. FDA, EMA and the Pharmacopoeias) dealing with Scale-up and Post-Approval Changes, Bioequivalence studies, Waiver of in vivo Bioavailability and Bioequivalence Studies. Additionally, there are some country-specific dissolution requirements which are very challenging for global pharmaceutical companies.

This GMP Education Course will therefore cover the following topics:

physicochemical and biopharmaceutical foundations,
dissolution method development,
validation of the dissolution methodology,
approaches for setting specifications,
OOS and OOE Results in dissolution testing,
statistical methods for comparing dissolution profiles,
approaches for substitution of BE-studies (biowaiver) and,
approaches to establish in vitro in vivo correlations (IVIVC),
country-specific dissolution requirements and challenges.

In addition, the expectations of the European Medicines Agency (EMA) and of the pharmacopoeias (Ph.Eur. 2.9.3 and USP Chapters <711> and <1092>) including USP Reference Standard Tablets and Mechanical calibration for the dissolution apparatus qualification will be discussed.

The objective of this course is to cover all aspects of dissolution testing with a focus on practical examples. Workshops are also part of the course in order to encourage the
exchange of experience and to allow interactive and in depth discussions of the subject.

Target Group

Scientists and managers in the pharmaceutical industry working in:
Quality control
Quality assurance
Analytical development
Research and development
Regulatory affairs

This course is also intended for participants from contract laboratories, regulatory
authorities, and inspectorates.


Fundamentals of Dissolution Testing: From Physicochemistry to Bioavailability
Mechanism and theories of solid dissolution (e.g. diffusion layer model)
Intrinsic dissolution rate
Sink conditions
Kinetics of drug release
Relationship between dissolution and bioavailability
Quality control dissolution testing and in vivo predictive dissolution testing
Biopharmaceutics Classification System
Hurdles and limitations of dissolution testing
Dr Ferdinand Steierhoffer, Boehringer Ingelheim

In vivo Relevance and Biowaivers
What is Biorelevance? Meaning and Misconceptions
How to establish a link between dissolution and bioavailability
The role of IVIVC
Setting biorelevant dissolution specifications
BCS based biowaivers
Waivers based on proportional similarity
Country specific regulatory differences
Case studies
Dr Thomas Fürst, Boehringer Ingelheim

Dissolution Testing – Regulatory Guidelines
Prerequisites of international and mostly harmonized pharmacopeia (USP, EP, Pharm Jap)
Miniaturization of dissolution tests
General guidelines for dissolution testing
Contents and differences in Chinese pharmacopeia
Validation of dissolution test methods
Bioequivalence considerations
Special in vitro bioequivalence applications in Japan
Waiving dissolution tests by disintegration tests
Dr Alexander Pontius, Bayer AG

Mechanical Calibration & Performance Verification Test (PVT)
Regulatory basis
Fundamentals of instrument qualification
Qualification and calibration of dissolution apparatuses
Mechanical calibration
USP Performance Verification Test (PVT)
Deviations and OOC
Dr Alexander Pontius, Bayer AG

Setting Specifications for Dissolution Methods
How to set adequate dissolution specifications for various types of formulations
Requirements of different Pharmacopoeias and Guidelines
Specifics and exceptions
Dr Kerstin Pauli, Bayer AG

OOS Results in Dissolution Testing
Regulatory aspects
Dissolution methods having appropriate discriminatory power
General OOS procedure for dissolution testing
Defining and handling of OOS results including CAPA
OOS evaluation for immediate release products, for capsules, for modified-release products
OOT/OOE results: Evaluating stability effects by applying dissolution testing
Dr Alexander Pontius, Bayer AG

Development of Dissolution Methods with regard to Quality Control
Method development for Immediate Release, Extended Release and
Delayed Release Formulations
Regulatory recommendations concerning method development
Dissolution apparatus and medium selection
Use of surfactants
Adequate discriminatory capability
Variability of dissolution results (stage/level testing)
Dissolution methods for developing an IVIVC
Case studies
Dr Ferdinand Steierhoffer, Boehringer Ingelheim

Automation in Dissolution Testing
Why and when is automation valuable?
Various types of dissolution systems
New products on the market
Dr Kerstin Pauli, Bayer AG

Analytical Validation of Dissolution Testing Methods
Pharmacopoeial and Regulatory Recommendations (e.g., ICH Q2 (R1) and USP <1092>)
Validation characteristics:
Specificity, Linearity, Precision, Accuracy and Robustness
Furthermore: filter-validation, selecting the right deaeration method, validation of automated methods
Some practical recommendations for performing the validation and recommended acceptance criteria
Dissolution method transfer
Dr Ferdinand Steierhoffer, Boehringer Ingelheim

Dissolution Profile Comparison; Approaches and Issues
Statistics of the dissolution test
Dissolution processes and data variability
What are we trying to compare?
What do the agencies specify?
Model dependent and independent approaches
Dr Thomas Fürst, Boehringer Ingelheim, Germany

Case Study: Application of Dissolution Testing in Industrial Drug Product Development
Special dosage forms
Fixed dose combinations
Extended release formulations
Coprecipitate formulations
Influence of stability testing on dissolution
Dr Kerstin Pauli, Bayer AG

How to Set Specifications: Sharing Information of the Learned Theories
Presentation of Case Studies and discussion of potential results
Q&A Session

Analytical Validation of Dissolution Methods
Putting theory to work (case studies):
Develop validation protocol for validation of dissolution methods for
different solid oral dosage forms
Pitfalls in performing the experiments
Moderator: Dr Ferdinand Steierhoffer, Boehringer Ingelheim
Moderator: Dr Kerstin Pauli, Bayer AG

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