Pharmaceutical Technology IV

Code:

MI074131

Acronym:

TFARM4

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2023/2024 - 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	179	MICF - Transition Study Plan 2023/24	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.

Acquire knowledge that will allow them to formulate, prepare and guarantee the quality of ophthalmic, nasal, parenteral and modified release preparations. Know the industrial production process of these types of pharmaceutical preparations.

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, 4 correspond to evaluation and the other 112 to study hours.

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.

Contribute to the development of the following transversal skills:
1 - Cognitive Skills: analytical, critical, reflective and creative thinking;
2 - Methodological Skills: time management, problem-solving skills, decision-making skills and planning skills;
3 - Social Skills: interpersonal communication and collaborative work.

Contribution of learning outcomes to the objectives of the MICF.
Contribution to the Pharmaceutical Act:
a) Development and preparation of pharmaceutical dosage forms of medicines;
c) Quality control of medicines and medical devices in a laboratory for quality control of medicines and medical devices;
d) Storage, conservation and wholesale distribution of medicines for human and veterinary use, medical devices;
f) Preparation of antiseptic solutions, disinfectants and intravenous mixtures;

Contribution to Table 2 of Directive 2005/36 / EC

(d) Adequate knowledge to evaluate scientific data on medicines, in order to be able to provide adequate information based on that knowledge

Contribution to the competencies defined in the document “FIP Global Competency Framework”:

1.2 Health promotion
1.2.2 Advice on health promotion, control and prevention of diseases and healthy lifestyles

1.3 Advice and Information on Medicines
1.3.1 Counseling the patient / population on the safe and rational use of drugs (including selection, use, contraindications, storage, and adverse effects of drugs with or without a prescription)

2.6 Patient diagnosis and counseling
2.6.4 Assess, validate and produce health education
information, medication counseling and health care
2.6.5 Discuss and agree with patients on the appropriate use of medicines, taking into account their preferences

4.1 Communication skills
4.1.2 Communicate effectively with healthcare professionals and patients' relatives
4.1.3 Adjust communication to the patient's needs
4.1.4 Appropriate communication skills, including through electronic and digital platforms.

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.
7.3. 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-Rámon Martinez Pacheco;Tratado De Tecnologia Farmaceutica. ISBN: 9788490770986

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

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

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

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

7-Comissão da Farmacopeia Portuguesa; Farmacopeia Portuguesa 9, 2009.

Mandatory literature

Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 978-972-31-0975-7
Rámon Martinez Pacheco; Tratado De Tecnologia Farmaceutica. ISBN: 9788490770986
Vila Jato José Luis 340; Tecnología farmacéutica
Comissão Permanente da Farmacopeia Portuguesa; Farmacopeia portuguesa 9.8
Crommelin Daan J. A. 340; Pharmaceutical biotechnology. ISBN: 978-1-4200-4437-9
Gad, S.C.; Handbook of Pharmaceutical Biotechnology
Walsh, G.; Pharmaceutical Biotechnology: Concepts and Applications

Complementary Bibliography

Mota, M.; Biotecnologia: Fundamentos e Aplicações
Alfonso R. Gennaro; Remington.s pharmaceutical sciences. ISBN: 0-912734-03-5

Teaching methods and learning activities

Theoretical classes using the expository and interrogative method. Laboratory classes using the demonstration method and the execution of tasks related to the topics taught in theoretical classes. E-learning.

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
Trabalho laboratorial	35,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	116,00
Frequência das aulas	46,00
Total:	162,00

Eligibility for exams

According to the Specific Regulation for the Evaluation of FFUP Students, a student must attend if his/her number of absences from practical/laboratory classes does not exceed 25% of the scheduled classes.

In theoretical classes, attendance is not mandatory.

The frequency is valid for the current academic year and for the following 2 academic years. Thus, for the current academic year, the frequencies obtained in the academic years 2021/2022 and 2022/23 are considered valid.

Calculation formula of final grade

EVALUATION METHOD

The evaluation method of the UC follows the Specific Regulation for the Evaluation of FFUP Students for the 2023/2024 academic year approved by the Pedagogical Council.

Laboratory evaluation

Components of the distributed 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 all elements of each group about the fundamentals of the work to be carried out. At the end of each class, each group must deliver the PREPARATION SHEET for each of the work carried out, well presented and with enough information to make the batch traceable.
- A project on modified-release tablets will be carried out, the results of which will be presented orally and discussed by all elements of the group.

b) Carrying out a work drawn from among the work carried out in laboratory classes on ophthalmic and parenteral preparations.

To pass the laboratory evaluation, students must obtain in component b) a classification equal to or greater than 9.5 values.

Failure to pass the laboratory evaluation is an impediment to the theoretical exam.

Students who do not pass the laboratory component will only be able to enjoy a second opportunity for laboratory evaluation during the normal exam period.


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


Theoretical evaluation

The final theoretical exam consists of a written test covering all the subjects taught in the theoretical classes. This exam will take place on the dates set by the Pedagogical Council for the exam season.

Students will have to obtain a classification greater than or equal to 9.5 in the theoretical exam to pass.

Final classification

Laboratory evaluation - 35%

Theoretical evaluation - 65%

Grade improvement

If the student intends to improve his grade, he must repeat the final written exam at the time of appeal.
If you wish, you can also improve the laboratory assessment (forgoing the classification obtained in the distributed laboratory assessment), having to notify the responsible teachers. In this case, the final classification is the weighted average of the classifications obtained in these two new tests.

 

Examinations or Special Assignments

Not applicable.

Internship work/project

Not applicable.

Special assessment (TE, DA, ...)

As established by the "Normas de avaliação" for 2023/2024.

Classification improvement

As established by the "Normas de avaliação" for 2023/2024.


If the student intends to improve his grade, he must repeat the final written exam at the time of appeal.
If you wish, you can also improve the laboratory assessment (forgoing the classification obtained in the distributed laboratory assessment), having to notify the responsible teachers. In this case, the final classification is the weighted average of the classifications obtained in these two new tests.

Observations

During the COVID pandemic, the procedure to obtain Eligibility for exams is the following:

The laboratorial classes will be divided in two groups: group A and group B.
Each group will participate in 5 laboratorial and presencial classes (1 for the explanation of the works to be performed and 4 classes for the execution of the works) and 4 classes by computer.
During the laboratorial classes, the students will prepare ophtalmic and parenteral formulations.
During the classes by computer, the studenst will perform a formulation study concerning a modofied release formulation.

Estimated number of theoretical classes per student – 26 
Estimated number of laboratory classes per student - 10 

To become eligible, the student must participate in at least 3/4 of the expected number of laboratory classes (maximum number of missing classe = 2). In addition, the student must have corresponded to the laboratory assessment set out below.

1-LABORATORY EVALUATION 

Components of the distributed laboratory evaluation:

a) Evaluation during laboratory classes on ophtalmic and parenteral preparations.

During each one of these classes, questions will be asked to all the members of the group concerning the rationale of the work to be done. These questions will be the basis of a qualitative information of the student.

b) Preparation of a formulation randomly drawn from the works performed during the laboartorial classes.

Each student will be assigned a classification equal or superior to 9.5 points.

The students that are not approved (classification less than 9.5 points) in the laboratory evaluation will not be able to be present in the theoretical exam.

The laboratorial classification can be influenced, negatively or positively, by the qualitative information described in point a).

The students that are not approved in the laboratorial component  will only be able to have a second opportunity of laboartory evaluation in the normal period of exams.

c) Trabalho executado nas aulas à distância
O trabalho desenvolvido pelos estudantes nas 4 aulas à distância será apresentado por ZOOM e será objecto de classificação.

2-THEORETICAL EVALUATION 

The final written exam will be held on the date set by the Pedagogic Council during the examination period. Students who have a classification equal or higher than 9.5 are approved. Students who obtain a score less than 9.5 are not approved.

During the COVID pandemic, the Evaluation method is the following:

EVALUATION METHOD

The evaluation method of the course follows the Students Specific Evaluation Rules (READ) FFUP.

The calculation of the final classification follows the procedure 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) (laboratorial work randomly performed) and b) (modified release formulation study) corresponding respectively to 20% and 15% of the total value of the final classification.

The students that in the distributed laboratory evaluation have a classification inferior to 9,5 points will be able to carry out laboratory exam in the period of normal exams.

 Theoretical evaluation

 The final theoretical exam 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 Pedagogic Council for the period of exams.

Students will be required to have a classification higher or equal to 9.5 points 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.