Pharmaceutical Technology IV

Code:

MI074131

Acronym:

TFARM4

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2017/2018 - 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	174	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 24 correspond to theoretical lectures and 20 to laboratorial practices. From the other 118 hours, from 9 to 10 correspond to evaluation and the other 108 to 109 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

THEORETICAL CLASSES

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.

LABORATORY CLASSES

1.Explication of laboratory work
2.Colyrium of zinc sulphate
3. Injectable solution of aminophylline
4. Injectable solution of ascorbic acid
5. Isotonic solution of glucose
6. Injectable solution of B complex
7. Extemporaneous injectable of benzathine penicillin
8.Development of modified release tablets of thiamine hydrochloride

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.

6-J.L.Vila Jato, Tecnologia Farmaceutica - 2º volume. Editorial Sintesis, Madrid, 1996.

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
Vila Jato José Luis 340; Tecnología farmacéutica. ISBN: 84-7738-539-4
Vila Jato José Luis 340; Tecnología farmacéutica
Gad, S.C.; Handbook of Pharmaceutical Biotechnology
Mota, M.; Biotecnologia: Fundamentos e Aplicações
Walsh, G.; Pharmaceutical Biotechnology: Concepts and Applications

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	15,00
Trabalho laboratorial	20,00
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

Eligibility for exams

Estimated number of theoretical classes per student - 24
Estimated number of laboratory classes per student - 10

To obtain attendance, the student must participate in at least 3/4 of the expected number of laboratory classes. In addition, it should have corresponded to the laboratory assessment set out below.


1-DISTRIBUTED LABORATORY EVALUATION

Components of laboratory evaluation:

 a) Evaluation during laboratory classes on ophthalmic preparations, parenteral preparations and modified release tablets.

During each of these classes, questions will be asked to the members of each group about the fundamentals of the work to be done.

At the end of each class, each group must submit the PREPARATION FORM of each of the works carried out, well presented and with sufficient information to make the lot traceable.

 b) Carry out a work drawn from among the work done in the laboratory classes.

Each student will be assigned a classification for the work done. To be approved in the laboratory evaluation, students will have to obtain in this component a classification equal or superior to 9.5 values.

2- DISTRIBUTED THEORETICAL EVALUATION

The theoretical evaluation consists of two intercalary evaluations (frequencies), to be carried out in the weeks of mid-term evaluation in dates fixed by the Pedagogical Council. The first frequency will be on the subject taught until the 12th theoretical class (inclusive) and the second frequency will be on the subject taught from the 13th to the 24th theoretical class.

It is mandatory to attend the frequencies of this UC, as there is no theoretical exam in the normal time.

If the student is absent from one of the frequencies or has an average frequency of less than 9.5, he/she must take a final exam at the time of resource, which will focus on the entire subject matter of the course.

Calculation formula of final grade

EVALUATION METHOD

The evaluation method of the course follows the Evaluation Rules for the 2017/2018 academic year approved by the Pedagogical Council.

The calculation of the final classification follows the templates set out in "Frequency acquisition".

Distributed laboratory evaluation

The final laboratory classification results from the weighted average of the components of the laboratory assessment a) (questions) and b) (work drawn) corresponding respectively to 15% and 20% of the total value of the final classification.

The students that in the laboratory evaluation have a classification lower than 9.5 values ​​will be able to carry out the 2nd theoretical frequency, being the note of the theoretical evaluations suspended until approval of the laboratory component that is performed in the normal time of exams defined by the Pedagogical Council.

Distributed theoretical evaluation

 There will be no minimum classification for the mid-term evaluations (frequencies).

The student waives the final theoretical exam if the average of the results of the classifications obtained in the two frequencies is greater than or equal to 9.5 values. 

Final theoretical exam

 The final theoretical exam of resource is constituted by a written test that focuses on all the material taught in theoretical classes. This examination will take place on the dates set by the Pedagogical Council for the time of resource exam.

Students will be required to have a classification higher or equal to 9.5 values on the theoretical exam to pass.

Final classification

Relative weight of the laboratory evaluation in the final classification - 35%

Relative weight of theoretical assessment in the final classification - 65%

Grade improvement

If the student wishes to improve the grade, he/she must take the final written exam at the time of appeal, abdicating the classification obtained in the two frequencies.

If the student wish, he/she can also improve the laboratory evaluation (abdicating the classification obtained in the distributed laboratory evaluation), and must notify the responsible teachers. In this case, the final grade is the weighted average of the scores obtained in these two new tests.

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.