Executive Development Programme in Oral Solid Dosage Form Design and Optimization

This program is tailored for pharmaceutical professionals, including R&D scientists, formulation scientists, and regulatory affairs managers. It aims to enhance their expertise in the design and optimization of oral solid dosage forms, covering latest trends, regulatory requirements, and innovative technologies.

Participants will gain in-depth knowledge of formulation science, drug delivery systems, and analytical techniques. They will also learn to apply design of experiments, understand regulatory guidelines, and develop strategies for product optimization, ensuring they stay ahead in the competitive pharmaceutical industry.

1. 1. Introduction to Pharmaceutical Science: Learners will study the fundamental principles of pharmacy and pharmaceutical science, including drug delivery systems and the importance of oral solid dosage forms. They will gain an understanding of how drugs interact with the biological system and the principles of formulation design.
2. 2. Formulation Science and Development: This module covers the basics of formulation science, including excipient selection, stability testing, and the development process for oral solid dosage forms. Learners will gain practical skills in formulating drugs and assessing the stability and efficacy of formulations.
3. 3. Advanced Excipient Properties and Selection: Learners will delve into the properties of various excipients used in oral solid dosage forms and the criteria for selecting appropriate excipients for specific drug delivery systems. Practical skills include evaluating excipient performance and optimizing excipient blends.
4. 4. Pharmaceutical Manufacturing Processes: This module focuses on the various manufacturing processes used in the production of oral solid dosage forms, including granulation, compression, and coating. Learners will learn about process control, equipment operation, and how to optimize manufacturing processes for efficiency and quality.
5. 5. Quality Control and Assurance: Learners will study the principles of quality assurance and control within the pharmaceutical industry, including quality management systems, regulatory compliance, and the implementation of quality control methods. Practical skills include conducting quality control tests and ensuring compliance with regulatory standards.
6. 6. Design of Experiments (DOE) in Formulation Development: This module introduces learners to the use of statistical methods in the design and optimization of formulations. They will learn how to design experiments to test different formulation variables and how to interpret the results to optimize formulations.
7. 7. In Vitro and In Vivo Evaluation Techniques: Learners will study various in vitro and in vivo evaluation techniques used to assess the performance of oral solid dosage forms. Practical skills include conducting in vitro dissolution tests and in vivo bioavailability and bioequivalence studies.
8. 8. Novel Drug Delivery Systems: This module covers the development of novel drug delivery systems for oral solid dosage forms, including osmotic pumps, mucoadhesive systems, and targeted drug delivery. Learners will explore the design and optimization of these systems for improved drug efficacy and patient compliance.
9. 9. Regulatory Affairs and Market Approval: Learners will study the regulatory environment for pharmaceutical products, including the process of obtaining market approval for new drug products. Practical skills include preparing regulatory submissions and understanding the requirements for clinical trials.
10. 10. Case Studies in Oral Solid Dosage Form Design and Optimization: This final module involves the analysis of real-world case studies in oral solid dosage form design and optimization. Learners will gain experience in applying the knowledge and skills acquired throughout the programme to solve complex pharmaceutical problems.