Pharmaceutical Technology II

Recommended Prerequisites

Biopharmacy, Analytical Chemistry, Organic Chemistry, Pharmaceutical technology I, Instrumental Methods of analysis.

Teaching Methods

Most theorectical classes are expository using the support of a slide projector to support the explanantions of the different subjects. Students during theoretical classes are invited to give examples reated to the subjects that are being presented. To illustrate the subjects, vídeos are shown ilustrating what is happening in the pharmaceutical industry. In laboratory classes, students prepare some of the pharmaceutical forms presented in the theoretical classses and perform quality control tests on these same forms.

Learning Outcomes

The course is organized so that the student:

- Realizes what is the process of Pharmaceutical Development and how does Pharmaceutical Technology II fit in;

- Understand the importance of performulation 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, 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.

Work Placement(s)

No

Syllabus

Theoretical: General principles for the development of Liquid, Semi-solid and Injectables Pharmaceutical Forms for all administration routes: nasal, auricular, oral, retal,  and injectables. Critical quality atributes of pharmaceutical dosage forms and quality control tests. Water as a solvent/ preferencial vehicle. Water types and obtaining systems. Strategies to increase drug solubilization in vehicles; Primary package material (glass, plastic and metal): advantages and disadvantages. Quality control of packaging material. GMP in injectables. Sterilization methods. Isotonicity of solutions.

Laboratory: Preparation and tests in quality control: nasal solution, ear solution, syrup; ascorbic acid injectable, suppositories. Study the effect oof sterilization on stability of the ascorbic acid.

Head Lecturer(s)

Amélia Catarina Fernandes Soares Vieira

Assessment Methods

Final assessment
Exam: 100.0%

Bibliography

Aulton M.Aulton’s Pharmaceutics. The design and manufacture of medicines.Third Edition 2007

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, FCG, Lisboa, 5 ª Ed 1995

Vila Jacto J L Tecnología Farmacéutica Aspectos Fundamentales de los Sistemas Farmacéuticos y Operacions Básicas Vol I, Editorial Sintesis Madrid, 1997

Lachman et al, Teoria e Prática na Indústria Farmacêutica, I II vol Fund C Gulbenkian 2001

Pharmaceutical dosage forms and drug delivery systems 8 ª Ed) Loyd V Allen, Nicholas G Popovich Howard C Ansel Ed Lippincott Williams and Wilkins Baltimore 2004

Kibbe A H Handbook of Pharmaceutical Excipients, APAPP, Washington, DC London, 3 ª Ed 2000