PHARMACEUTICAL TECHNOLOGY

Teachers: 
Credits: 
7
Site: 
PARMA
Year of erogation: 
2021/2022
Unit Coordinator: 
Disciplinary Sector: 
Applied Technological Pharmaceutics
Semester: 
Second semester
Year of study: 
3
Language of instruction: 

Italian

Learning outcomes of the course unit

The objective of the module is to give to the student the theoretical notions about exicpients, fabrication methods, controls, technological and biopharmaceutical properties of immediate release pharmaceutical forms.
Information about the key factors affecting absorption and bioavailability in relation to the pharmaceutical dosage form administered are given. The fundamentals of galenic production in pharmacy are treated as well.
The expected learning outcomes are:
1. Knowledge and understanding: knowledge of excipients, of fabrication methods, of controls, of technological and biopharmaceutical properties of immediate release pharmaceutical dosage forms and understanding of the different roles of excipient in the dosage forms
2. Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the identification of excipients and the preparation methods more suitable for the development of a given dosage form.
3. Communication skills: ability to use the specific language for this specialist discipline.
4. Making judgements: the capability to face the professional responsibilities of a pharmaceutical technologist. To be able to evaluate the implication and the result of studies made to clarify the influence of the dosage form on the activity of the active molecule.
5. Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as a pharmaceutical technologist. Capability of upgrade, through the scientific publications in the field of pharmaceutical technology.

Prerequisites

To take the exam, it is necessary to have passed the General Physiology and Organic Chemistry exams.

Course contents summary

The course deals with the modern approach at the preparation of medicines, at the comprehension of the characteristics of the different dosage forms, in particular with respect on the specific role of the various excipients as well as of the peculiarity of some administration route.

Course contents

Medicines and pharmaceutical dosage forms
Italian and European Pharmacopoeias
Pharmaceutical Processes: Particle size reduction, Mixing, Drying, Filtration, Sterilization, Dissolution, Granulation
Basic principles of biopharmaceutics
Pharmacokinetics
Pharmaceutical ingredients: active principles, excipients, packaging materials
Galenic development: pharmaceutical preformulation and formulation, packaging
Stability of pharmaceutical products
Conventional pharmaceutical dosage forms: Solid dosage forms (Powders, Granules, Capsules, Tablets, pellets, suppositories), liquid dosage forms (solutions, suspensions,e mulsions), semisolid dosage forms (ointments, gels, pastes, creams), sterile products
Administration routes and pharmaceutical dosage forms: oral, dermatological, parenteral, ocular, auricular, nasal, inhalation, rectal, vaginal.
Herbal Extracts

Recommended readings

Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2008);
-P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale Principi di Tecnologie Farmaceutiche, Casa Editrice Ambrosiana, II Ed. Milano (2015)
-M. Amorosa, Principi di Tecnica Farmaceutica, Libreria Universitaria L. Tinarelli, Bologna (1998).
Letture consigliate:
A.J. Winfield, R.M.E. Richards, Pharmaceutical Practice second edition, Churchill Livingstone London (1998).

Teaching methods

In case of persistence of the health emergency, it may be necessary to integrate the lessons with the remote modality, we will proceed as follows:
lectures in mixed mode (part of the students in presence and part at a distance) or totally remote (in the case of the worst scenario).

Assessment methods and criteria

TTo acquire the final grade of the exam, the student must show to be have learned and to be able to use the basic concepts of each subject. In particular he/she should:
a) pass a practical exam at the end of practical works (Module of Laboratorio di Tecnologia Farmaceutica, weight 40% of the overall grade). The test consists in the preparation of a galenic recipe, or in the preparation of a pharmaceutical form and in the compilation of the processing sheet:
once the practical test has been passed, take a written exam, which focuses on pharmaceutical calculation exercises and the recognition of a pharmaceutical form, and an oral one, relating to the topics of pharmaceutical technology (Pharmaceutical Technology Module, (weight 60% of the overall grade) The oral exam can be taken after passing the written exam, in the same session.

The grade, expressed in thirtieths, will be based on the following criteria:
1. knowledge and comprehension (theoretical and practical) capability of the subjects studied;
2. making judgement ability
3. communication skills and appropriate use of the technical language;
4. ability to learn.

In case of persistence of the health emergency, it may be necessary to integrate the conduct of the exams with the remote modality, we will proceed as follows:
practical test replaced by a remote written test;
remote written test;
remote oral exam.