PHARMACEUTICAL TECHNOLOGY/ PHARMACEUTICAL TECHNOLOGY LABORATORY
Learning outcomes of the course unit
The objective of the first 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.
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 specialistic 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.
The objective of the second module is to give to the student the practical notions about the preparations, controls and technological properties of most common immediate release dosage forms.
It is advised to have already passed the exams of general chemistry and organic chemistry.
Course contents summary
The first module 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.
The content of the second module are related to the modern and appropriate pharmaceutical compounding and galenical development, in particular with respect to the practical preparation in pharmacy and the professional responsibility of the pharmacist.
The first part of the course will focus on the fundamentals of metrology and of the unit operations. In the second part the student will learn how to compound the different dosage forms
In agreement with the Pharmacopoeial requirements.
Medicines and pharmaceutical dosage forms
Italian and European Pharmacopoeias
Pharmaceutical Processes: Particle size reduction, Mixing, Drying, Filtration, Sterilization, Dissolution, Granulation
Basic principles of biopharmaceutics
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.
Legal issues concerning the preparation, packaging and pricing of galenical preparation according to the Italian Pharmacopeia
• Preparation and characterization of conventional dosage forms:
o Oral powders
o Topical powders
o Liquid preparations for oral use
o Liquid preparation for topical use
o Topical semisolid dosage forms
o Vaginal preparations
o Rectal preparations.
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).
A.J. Winfield, R.M.E. Richards, Pharmaceutical Practice second edition, Churchill Livingstone London (1998).
ENRICO RAGAZZI, «Galenica pratica, formulazione e tecnologia», Libreria Internazionale Cortina Padova
FRANCO BETTIOL, «Manuale delle preparazioni galeniche», Tecniche Nuove
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992
International Journal of Pharmaceutical compounding
The first module is delivered through frontal lessons.
The second module will be carried out through frontal lessons (2CFU) during which the fundamentals, the theoretical and practical aspects of the compounding will be presented and discussed.
3 CFU will be devoted, then, to the practical preparation of different dosage forms with particular emphasis to the physico- chemical as well as legal aspects of the different operations
Assessment methods and criteria
To 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);
b) pass an exam (either oral and written), during the official dates established by the Dipartimento di Farmacia (both modules, weight 60% of the overall grade).
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 judgements ability
3. communication skills and appropriate use of the technical language;
4. ability to learn.