Executive Development Programme in Dissolution Testing for Oral Solid Dosage Forms

This course is designed for pharmaceutical scientists, quality assurance managers, and regulatory affairs professionals involved in the development and testing of oral solid dosage forms. Participants will gain a comprehensive understanding of dissolution testing principles, methodologies, and regulatory requirements, enabling them to ensure product quality and compliance.

Attendees will learn to design and conduct effective dissolution tests, interpret results, and apply this knowledge to improve product development and manufacturing processes. The course also covers emerging trends and challenges in dissolution testing, preparing participants to address future industry demands.

1. 1. Introduction to Dissolution Testing: Learners will study the basic principles of dissolution testing, including its importance in pharmaceutical quality assurance. They will gain practical skills in setting up and operating a dissolution apparatus.
2. 2. Factors Influencing Dissolution Processes: This module covers the impact of various factors such as formulation, dissolution medium, and equipment on the dissolution process. Learners will learn how to design experiments to investigate these factors.
3. 3. Dissolution Method Validation: Learners will explore the validation process for dissolution methods, including selection of parameters and statistical analysis. Practical skills in writing validation protocols and interpreting results will be developed.
4. 4. Advanced Equipment and Technology: This module focuses on modern dissolution testing equipment and innovative technologies. Learners will gain hands-on experience with advanced dissolution testers and learn about their capabilities and limitations.
5. 5. Dissolution Testing for Special Dosage Forms: The module covers dissolution testing for specific dosage forms like tablets, capsules, and granules. Learners will understand the unique challenges and requirements for each form.
6. 6. In vitro-In vivo Correlation: Here, learners will study the relationship between in vitro dissolution data and in vivo bioavailability. Practical skills in developing predictive models and conducting dissolution studies will be enhanced.
7. 7. Regulatory Aspects of Dissolution Testing: This module delves into the regulatory requirements and guidelines for dissolution testing. Learners will learn about compliance with international standards and how to prepare regulatory submissions.
8. 8. Case Studies in Dissolution Testing: Through case studies, learners will analyze real-world scenarios in dissolution testing, including problem-solving techniques and decision-making processes in complex situations.
9. 9. Quality Control and Assurance in Dissolution Testing: The module covers quality control measures and assurance strategies in dissolution testing. Learners will learn how to implement and maintain robust quality systems.
10. 10. Emerging Trends in Dissolution Testing: This module explores current research and future trends in dissolution testing. Learners will gain insights into new methods and technologies that are reshaping the field.