Pharmaceutical Development of Medicines

Recommended Prerequisites

Biopharmacy, Analytical Chemistry, Organic Chemistry.

Teaching Methods

Students are assessed upon final exam, which includes a theoretical and a practical part (which deals with the knowledge discussed in laboratory classes), corresponding, respectively, to 75 and 25% of the final grade. The student is considered approved upon reaching a rate equal to or greater than ten (out of 20).

Learning Outcomes

The theoretical and laboratory classes are organized so that the student: - Realizes what is the process of Pharmaceutical Development; - Understand the importance of preformulation on a medicine manufacturing and quality; - Distinguish the role of each class of excipients used in the formulation of dosage forms and the corresponding mechanism of action.
- Masters the aspects associated with the production of dosage forms. - Understand the basic aspects of dosage forms quality control.
The implementation of the objectives described will enable students to develop the following skills: problem solving; critical thinking; autonomous learning; oral and written communication; concern for quality.

Work Placement(s)

No

Syllabus

Theoretical component Contextualization. Pre-formulation. Powders: Unit operations, segregation and transfer of powders, Sampling, Material Sampling, Particle size analysis. Forms obtained by dividing post: medicated powders: advantages, formulation. Tablets: Formulation, compression, methods of preparation, coating of tablets, types of tablets, Quality Control. Capsules: Formulation, Production and Quality Control. Liquid and semi-solid dosage forms. Packaging. Laboratory component Preparation and control capsules. Production (direct compression) and quality control of tablets. Isotonicity of solutions Dissolution assay. Production and quality control of syrups.
Production and quality control of ointments.
Production and quality control of supositories.

Head Lecturer(s)

João José Martins Simões Sousa

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

Aulton's Pharmaceutics: The Design and Manufacture of Medicines, 4th edition, Churcill Livingstone, M. E. Aulton (Ed.), Kevin M. G. Taylor, 2013.
Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, Informa Healthcare Press, Mark Gibson (Ed.), 2009.