Pharmaceutical Technology IV

Code:

MI074131

Acronym:

TFARM4

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2016/2017 - 1S

Active?	Yes
Web Page:	http://moodle.up.pt/course/view.php?id=837
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	184	Official Curriculum	4	-	6	52	162

Teaching language

Portuguese

Objectives

To apply the knowledges that the student aquired during propedeutic lectures and in Tecnologia Farmacêutica I, Tecnologia Farmacêutica II and Tecnologia Farmacêutica III.
The student must study for 162 hours (6 ECTS x 27 hours), from which 26 correspond to theoretical lectures and 20 to laboratorial practices. From the other 116 hours, from 9 to 10 correspond to evaluation and the other 106 to 107 to study hours.
Besides Tecnologia Farmacêutica, the student must be aware of the following subjects: Surface phenomena and Macromolecules and colloids (from Applied Physics) and Coligative properties of solutions (from General and Inorganic Chemistry).

Learning outcomes and competences

To konw how to formulate and prepare, from the magistral or industrial points of view:
1 - ophtalmic, nasal and parenteric dosage forms,
2 - modified release dosage forms.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

The students should have obtained frequency, with success, of the courses on Tecnologia Farmacêutica I, Tecnologia Farmacêutica II and Tecnologia Farmacêutica III.

Program

1. Pharmaceutical preparations that require special manufacturing cares. Requirements: sterility; isotony; pH; apyrogeny; particle size.
1.1. Sterility. Sterilization: methods, criteria of use.
1.2. Isotony. Isotonization: concept, fundamentals. Tonicity adjustment.
1.3.pH
1.4. Apirogeny. Pyrogens. Types, origin, control.
1.5. Particle size.

2. Ophtalmic preparations.
2.1. Formulation: excipients and preparation techniques.
2.2. Control of ophtalmic preparations.
2.3. The monograph Ophtalmic preparations  from the Portuguese Pharmacopoeia.

3. Nasal preparations.
3.1. Formulation: excipients and preparation techniques.
3.2. Control of nasal preparations.
3.3. The monograph Nasal preparations from the Portuguese Pharmacopoeia.

4. Parenteral preparations. 
4.1. Formulation: excipients and preparation techniques.
4.2. Packaging: glass and plastic.
4.3. Control of parenteral preparations.
4.4. The monograph Parenteral preparations from the Portuguese Pharmacopoeia.

5. Modified release dosage forms.
5.1. Introduction. Terminology; dosage forms and availability; preparation (immediate dose and maintainance dose); physiological, physico-chemical and galenic methods.
5.2. Biotechnology. Definition. Application.
5.3. Biopharmaceutical products (Proteins, peptides, nucleic acids).
5.4. Routes of administration of biopharmaceutical products.
5.4.1. Parenteral route.
5.4.2. Oral route.
5.4.3. Buccal use.
5.4.4. Pulmonary route.
5.4.5. Nasal use.
5.4.6. Transdermal use.
5.4.7. Occular use.
5.5. Controlled release systems for biopharmaceutical products.
5.5.1. Lipossomes.
5.5.2. Lipidic nanoparticles (SLN and NLC).
5.5.3. Polymeric nanoparticles.
5.5.4. Micelles.
5.5.5. Micro and nanoemulsions.
5.5.6. Other systems.

6. Stability of medicines.
6.1. Drug produts instability.
6.2. Shelf-life.

7. Industrial pharmacy.
7.1. Introduction: the concept of Quality.
7.2. Industrial pharmacy organization: departments and/or sections; functions and connections. Organigram:flow of materials.
7.3. Good Manufacturing Practices; validations.

BIBLIOGRAPHY
1-Tecnologia Farmacêutica - L.Nogueira Prista, A. Correia Alves, R. Morgado, J.M.Sousa Lobo - 1º volume, 8ª edição, 2º volume, 7ª edição, 3º volume, 8ª edição, Fundação Calouste Gulbenkian, Lisboa, 2012-2013.

2-Crommelin, D.J., Sindelar, R.D., Meibohm, B., Pharmaceutical Biotechnology: Fundamentals and Apllications, Springer Science and Business Media, 2013.

3-Gad, S.C., Handbook of Pharmaceutical Biotechnology,, volume 2, John Wiley and Sons, 2007.

4-Mota, M., Biotecnologia: Fundamentos e Aplicações. Edições Lidel, 2003.

5-Walsh, G., Pharmaceutical Biotechnology: Concepts and Applications, John Wiley and Sons, 2007.

Mandatory literature

Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 978-972-31-0975-7
Crommelin Daan J. A. 340; Pharmaceutical biotechnology. ISBN: 978-1-4200-4437-9

Teaching methods and learning activities

Theoretical and laboratorial classes.

Software

Não aplicável

keywords

Health sciences > Pharmacological sciences > Pharmacy
Technological sciences > Technology > Nanotechonology

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	65,00
Prova oral	10,00
Trabalho escrito	10,00
Trabalho laboratorial	15,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	106,00
Frequência das aulas	46,00
Trabalho laboratorial	10,00
Total:	162,00

Calculation formula of final grade

Laboratorial evaluation is 35% of the final classification.
Theoretical evaluation is 65% of the final classification.

The questions asked to the students during the laboratorial classes are 10% of the laboratorial evaluation.
The laboratorial exam is 15% of the laboratorial evaluation.
The modified release project is 10% of the laboratorial evaluation.

Examinations or Special Assignments

Not applicable.

Internship work/project

Não aplicável.

Special assessment (TE, DA, ...)

As established by the "Normas de avaliação" for 2016/2017.

Classification improvement

As established by the "Normas de avaliação" for 2016/2017.