PHARMACEUTICAL TECHNOLOGY/GALENIC PREPARATIONS LABORATORY
Learning outcomes of the course unit
The module of Pharmaceutical Technology has the goal to provide the fundamental knowledge on the dosage forms, with particular emphasis on the role of the different components. The student will learn the nature and the classification of the excipients in order to be able to understand the role of the different their role in the different dosage forms and administration ways. At the end of the coarse the student should be able to understand and describe the various approaches for optimizing the therapeutic efficacy of an active ingredient.
The Galenic Preparations Laboratory aims at providing the theoretical knowledge and the practical skills required to compound different dosage forms in a pharmacy laboratory.
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.
The student will apply their knowledge of general, organic and analytical chemistry to understand the suitable compounding.
The course aims at developing the capability of autonomously establish the proper way of compounding, and storing a dosage form in pharmacy.
The subjects requires a good knowledge of the foundational subjects present in the first two years of the course of Pharmacy. In order to take the exam of Tecnologia Farmaceutica/Laboratorio di preparazioni galeniche it is required that the student has already passed the exams of:
- Chimica Organica Propedeutica / Chimica Organica
Course contents summary
The module of Pharmaceutical Technology deals with the modern approach at the preparation of medicines, at the comprehension of the characteristics of the different dosage forms and of the peculiarity of some administration route.
The content of the Laboratory of Galenic Preparations 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.
Galenic Preparations Laboratory
I Part (in class)
Good Compounding Practices
Compounding a medical prescription (Good Compounding Practices)
National Tarif of compounded medicines
Unit operations: milling, mixing; dissolution, filtration
II Part (in lab)
Compounding the following dosage forms:
Powders and granules; Capsules; Solutions; Emulsions;
Suspensions; Ointments; Suppositories.
• Definition of drugs, dosage forms and medicines
• Pharmacopoeia and Formulary, GMP
• Biopharmaceutic and pharmacokinetics
• Administration routes
• Pharmaceutical excipients: types, classification and functions
• Pharmaceutical Operations: Milling; Mixing; Dissolution; Filtration; Sterilization; Drying.
• Pharmaceutical packaging
• Pharmaceutical products stability.
• Liquid dosage forms: solutions (drops, syrups and elixir), suspensions, emulsions;
• Granules, pellets;
• Semisolid dosage forms (ointments, creams, pastes, gels);
• Suppositories and pessaries;
• Parenteral dosage forms;
• Eye drops;
• Nasal dosage forms (drops, sparys, powders)
• Pulmonary dosage forms (nebulizers, pMDI, DPI)
• Herbal and homeopatic products
-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, Milano (2004)
-F.Bettiol, Manuale delle preparazioni galeniche, Tecniche Nuove , Milano (2010).
-Medicamenta, Cooperativa Farmaceutica Milano, VII ED. 1992;
A.J. Winfield, R.M.E. Richards, Pharmaceutical Practice second edition, Churchill Livingstone London (1998);
Le Hir, Tecnica Farmaceutica, Edizione italiana a cura di G. Pifferi, Masson, Milano (1981).
International Journal of Pharmaceutical compounding.
The subject of Pharmaceutical Technology (7 CFU) will be carried out through frontal lessons during which the biopharmaceutical and pharmacokinetic aspects of the drug administration will be presented and discussed.
The most critical unit operations will be presented as well as the detailed description of the various classes of excipients and their role in the formulation.
Finally, to pursue the course goals the various dosage forms will be presented and discussed in agreement with the Pharmacopoeia classification.
The Galenic Preparations Laboratory 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
Oral exam with questions aiming at ascertain the knowledge, the comprehension capability and the competences acquired by the student. The results will be evaluated in 30th.
Galenic Preparations Laboratory
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 prepared dosage form.
Written exam aiming at verifying the capability of the student to carry out calculation usually necessary during the pharmaceutical compounding.
The positive evaluation will be based on the correct solution of at least half of the given exercises and it will be expressed in 30th.
The whole evaluation will be the average of the notes obtained in the two modules.