Applied Pharmaceutical Development

Recommended Prerequisites

Certified knowledge in Health Sciences. Knowledge of English language.

Teaching Methods

Exposing lectures.
Discussion of case studies
Bibliographical research.
Problems solving.

Learning Outcomes

Students are expected to gather knowledge about pharmaceutical development strategies of dosage forms, selection of drugs, and aspects related to pharmaceutical design and development. Knowledge about pre-formulation parameters, intrinsic properties and compatibility between drugs and excipients, as well as pharmacokinetic and biopharmaceutical aspects related to optimization of pharmaceutical formulations.

Work Placement(s)

No

Syllabus

Theory: Strategies for pharmaceutical development. Selection of drugs and use of concepts about design and development. Pre-formulation studies; analytical aspects; factorial design experiments; scientific relevance of pharmacokinetic and biopharmaceutical evaluation; pharmaceutical development of solid, liquid and semi-solid formulations; parenteral dosage forms .Practice: Each group will have the task of designing the development a pharmaceutical formulation for a specific dosage form, following the current guidelines and the updated state of art.

Head Lecturer(s)

Eliana Maria Barbosa Souto

Assessment Methods

Assessment
Exam: 100.0%

Bibliography

Souto, E.B. (Editor), Patenting Nanomedicines: Legal Aspects, Intellectual Property and Grant Opportunities, (http://www.springer.com/law/book/978-3-642-29264-4), July 2012, ISBN: ISBN 978-3-642-29264-4.
Souto, E.B. (Editor), Lipid Nanocarriers in Cancer Diagnosis and Therapy, by i Smithers - Creative Publishing Solutions (www.iSmithers.net), August 2011, ISBN: 78-1-84735-4-778 (Hardback); ISBN: 978-1-84735-4-785 (Softback).
Peraman R, Bhadraya K, Padmanabha Reddy Y. Analytical quality by design: a tool for regulatory flexibility and robust analytics. Int J Anal Chem. 2015;2015:868727.
Olivares-Morales A, Kamiyama Y, Darwich AS, Aarons L, Rostami-Hodjegan A. Analysis of the impact of controlled release formulations on oral drug absorption, gut wall metabolism and relative bioavailability of CYP3A substrates using a physiologically-based pharmacokinetic model. Eur J Pharm Sci. 2015;67:32-44.