Pharmaceutical Technology II

Recommended Prerequisites

Biopharmacy, Analytical Chemistry, Organic Chemistry, Pharmaceutical  Technology I.

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 uponreaching a rate equal to or greater than ten (out of 20).

Learning Outcomes

The course is organized so that the student:
- Realizes what is the process of Pharmaceutical Development and how does Pharmaceutical Technology I fit in;
- Understand the importance of preformulation on a medicine manufacturing and quality;
- Distinguish the role of each class of excipients used in the formulation of semi-solid, liquid and injectable dosage forms and the corresponding mechanism of action.

- Masters the aspects associated with the production of semi-solid, liquid and injectable dosage forms, including the specific problems inherent to each one of the dosage forms addressed in the course. In this respect, the student must develop the ability to know which preparation method best suits a particular formulation.
- Understand the basic aspects of semi-solid, liquid and injectable dosage forms quality control.

It is expected that students will develop skills of problem solving; critical thinking; autonomous learning; oral and written communication; concern for quality.

Work Placement(s)

No

Syllabus

Theoretical component.
1. INTRODUCTION: Development of liquid, semi-solid and sterile pharmaceutical dosage forms.
2. SOLUBILIZATION
Water as solvent and preferential carrier. Types of water and production systems. Solubility and solubilization.
3. ORAL SOLUTIONS
Formulation. Vehicles and other components. Quality control (QC). Preservative efficacy.

4. DOSAGE FORMS FOR NASAL ADMINISTRATION
5. DOSAGE FORMS FOR FORMS FOR EAR ADMINISTRATION

6. FORMS FOR RECTAL APPLICATION
7. FORMS FOR TOPICAL APPLICATION
8. STERILE DOSAGE FORMS
Injections. GMP. Sterilization.Validation. QC.

Eye drops and eye ointments: ocular route, formulation, manufacturing, packaging, QC.

Laboratory: Preparation and QC of: syrups, nasal and ear pharmaceutical dosage forms, injectables, ointments and suppositories. Isotony - calculation and determination.

Head Lecturer(s)

Olga Maria Fernandes Borges Ribeiro

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.
Complementar:
Swarbrick, J. and Boylan, J.C., Encyclopedia of Pharmaceutical Technology, Marcel Dekker, Inc. New York . Basel,
1990.
Nogueira Prista, L., Correia Alves, A. e Rui Morgado (com a colaboração de Sousa Lobo, J.M.), Tecnologia
Farmacêutica, I, II e III Volumes, Fundação Calouste Gulbenkian, Lisboa, 5ª Ed., 1995.
Kibbe, A.H., Handbook of Pharmaceutical Excipients, American Pharmaceutical Association and Pharmaceutical
Press, Washington, DC . London, 3ª Ed., 2000.
Lachman, L., Lieberman, H.A. and Kaning, J.L. (tradução Pinto, J.F. e Fernandes, A.I.), Teoria e Prática na Indústria
Farmacêutica, Volume I e II, Fundação Calouste Gulbenkian, Lisboa, 2001.