GALENIC PREPARATIONS LABORATORY
Learning outcomes of the course unit
To provide the theoretical knowledge and the practical skills required to compound different dosage forms in a pharmacy laboratory (knowledge and understanding).
The student will learn how to discriminate the different dosage forms on the base of the prescription or the formulation, as well as to verify the formal and substantial correctness of the prescription according to the current laws and rules (applying knowledge and understanding).
The student will apply their knowledge of general, organic and analytical chemistry to understand the suitable compounding(applying knowledge and understanding).
The course aims at developing the capability of autonomously establish the proper way of compounding, and storing a dosage form in pharmacy (making judgments).
In order take the exam the student have to be already already passed both the exams of Organic Chemistry and Physiology.
Course contents summary
The content of the course are related to the modern and appropriate pharmaceutical compounding, 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.
The course will be focused on the following topics:
1. Regulatory framework and calculations related to compounding
- Good Compounding Practices;
- Compounding a prescription;
- National price list of medicines.
2. Unit operation in pharmaceutical compounding: grinding, mixing; dissolution, filtration.
3. Compounding in pharmacy lab of the following dosage forms:
- Powders and granules (multidose containers and cachets)
- Semisolid dosage forms (creams, pastes, ointments; gels);
- Suppositories and pessaries.
-P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale. Principi di Tecnologia Farmaceutica, Casa Editrice Ambrosiana, II Ed. Milano (2015);
-F.Bettiol, Manuale delle preparazioni galeniche, Tecniche Nuove, Milano (2010);
-Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto Poligrafico e Zecca dello Stato, Roma (2008);
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992.
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.
Assessment methods and criteria
In order to acquire the mark of the Laboratorio di Preparazioni Galeniche, the student will be required to demonstrate the understanding and the ability to apply the concepts related to the topics of the course. The student will have to pass both the following assessments:
• Practical exam consisting in the compounding of a preparation based on a prescription. The exams aims at verifying the practical skill acquired by the student as well as its capability to properly prepare a report on the compounded dosage form.
• Written exam, to be taken on the exam day of Tecnologia Farmaceutica/Laboratorio di Preparazioni Galeniche as reported in the online schedule of the Department. The exam is verifying the capability of the student to solve calculation problems related to the pharmaceutical compounding. The positive evaluation will be based on the correct solution of at least three of the five given exercises.
The marks will be given in fractions out of 30.