PHARMACEUTICAL TECHNOLOGY LABORATORY
Learning outcomes of the course unit
The objective of the course is to give to the student the practical notions about the preparations, controls and technological properties of most common immediate release dosage forms.
The expected learning outcomes are:
1) Knowledge and understanding: knowledge of excipients, fabrication methods, of controls, of technological properties of immediate release dosage forms.
2) Applying knowledge and understanding: ability to apply, in an independent way, the knowledge acquired for the preparation 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 the galenical pharmacist
5) Learning skills: capability of using the knowledge and the basic elements acquired in the conduction of the work as galenical pharmacist. Capability of update, through the scientific publications in the field of pharmaceutical technology.
To take the exam, it is necessary to have passed the General Physiology and Organic Chemistry exams.
Course contents summary
The contents of the course are related to the modern and appropriate pharmaceutical compounding and galenical development, also 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
• 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
ENRICO RAGAZZI, «Galenica pratica, formulazione e tecnologia», Libreria Internazionale Cortina Padova
FRANCO BETTIOL, «Manuale delle preparazioni galeniche», Tecniche Nuove
Farmacopea Ufficiale XII Ed.
PAOLO COLOMBO, et al. Principi di Tecnologia Farmaceutica, Seconda Ed.Casa Editrice Ambrosiana, Milano (2015)
It i salso advised the reading of:
Farmacopea Ufficiale XII Ed.
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992
International Journal of Pharmaceutical compounding
Per sostenere l’esame è necessario aver superato gli esami di Fisiologia Generale e Chimica Organica. To take the exam, it is necessary to have passed the General Physiology and Organic Chemistry exams.
Il corso si articola in lezioni frontali (2 CFU) nel corso delle quali vengono presentati e discussi gli aspetti teorico-pratici dell’allestimento di formulati farmaceutici e i fondamenti della pratica galenica, incluso le norme legislative riguardanti la preparazione, il confezionamento e la tariffazione (compilazione del foglio di lavorazione)..
3 CFU saranno quindi dedicati ad esercitazioni di laboratorio nelle quali lo studente apprenderà come allestire le diverse forme farmaceutiche con particolare riguardo agli aspetti chimico-fisici dei processi e agli aspetti normativi.
Qualora, a causa del perdurare dell’emergenza sanitaria, fosse necessario integrare con la modalità a distanza si procederà come segue:
lezioni frontali in modalità mista (parte degli studenti in presenza e parte a distanza) o totalmente a distanza (nel caso dello scenario peggiore);
esercitazioni di laboratorio in presenza a piccoli gruppi, o a distanza nel caso dello scenario peggiore.
In quest’ultimo caso, le esercitazioni potranno essere integrate con lezioni in presenza alle quali gli studenti potranno partecipare su base volontaria non appena le condizioni sanitarie lo permetteranno. In ogni caso, la partecipazione a dette esercitazioni non pregiudicherà la possibilità di sostenere l’esame da parte dello studente
The course 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.
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);
laboratory exercises in small groups of students or in remote modality in the worst-case scenario. In this latter case, the exercises can be integrated laboratory exercises in which students can participate on a voluntary basis as soon as the health conditions permit. In any case, the participation in these exercises will not affect the student's ability to take the exam.
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). 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.