Learning objectives
Galenic Preparations Laboratory aims to provide the student with the knowledge and practical skills for compounding medications in community or hospital pharmacies.
The student at the end of the course will be able to apply the scientific method to the pharmaceutical research field.
In particular, the students will have to:
1) Identify the dosage form on the basis of a given prescription or formulation (Knowledge and understanding);
2) Ascertain the formal and substantial validity of a prescription on the basis of current legislation (Making judgements);
3) Apply the scientific knowledge acquired previously in organic and analytical chemistry to understand the operations necessary for the compounding of medications (Applying knowledge and understanding);
4) Develop the ability to correlate previous knowledge, laboratory skills and new guidelines and scientific literature to evaluate the design, compounding and stability of any medication compounded in a community or hospital pharmacy (Learning skills).
The module of Pharmaceutical Technology has the aim of providing the basic knowledge on formulation design, manufacturing and use of the most common dosage forms on the market.
Prerequisites
In order take the exam the student have to be already already passed both the exams of Organic Chemistry and Physiology.
Course unit content
The contents of the Galenic Extemporaneous Preparations Practical Laboratory are related to the norms and practices necessary for the modern and correct compounding and dispensing of extemporaneous preparations ordered by practitioner or in accordance to Pharmacopoeia monographs. The practicals are then focused on the compounding of extemporaneous pharmaceutical products and to the teaching of professional practice in this field, through two sections:
- in the first section some lectures delivered in presence will be dedicated to the fundamentals of pharmaceutical calculations and metrology, to the basic pharmaceutical operations and to the good compounding practice;
- in the second section the student in the practical laboratory (in presence) will compound different dosage forms according to the requirements of the Italian Official Pharmacopoeia.
Full programme
I Part (in class)
Metrology
Good Compounding Practices
Introduction to the concept of "Data Integrity"
Compounding a medical prescription (Good Compounding Practices)
National Tarif of compounded medicines
Unit operations: milling, mixing; dissolution, filtration
Calcoli Farmaceutici
II Part (in lab)
Compounding the following dosage forms:
Powders and granules; Capsules; Solutions; Emulsions;
Suspensions; Ointments; Suppositories.
Bibliography
P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale: "Principi di Tecnologie Farmaceutiche", 2° Ed. Casa Editrice Ambrosiana, Milano, 2015.
H. Ansel, S. Stockton: “Principi di calcolo farmaceutico” (A cura di: Gaia Colombo, Alessandra Rossi, Paola Russo, Fabio Sonvico) EDRA, 2017
Testi da consultare (presenti nella Biblioteca del Dipartimento di Scienze degli Alimenti e del Farmaco):
F. Bettiol. Manuale delle preparazioni galeniche: arte del preparare e attrezzature per oltre 1500 formulazioni magistrali, officinali, fitoterapiche e omeopatiche, 4. Ed
Tecniche nuove, Milano, 2016
Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto
Poligrafico e Zecca dello Stato, Roma (2008);
European pharmacopoeia 9 Ed. Strasbourg, Council of Europe, 2016
Medicamenta: guida teorico pratica per sanitari, 6. Ed. Milano, Cooperativa Farmaceutica, 1976
Slides of the teaching lesson will be uploaded weekly on the website Elly (http://elly2024.saf.unipr.it/).
Teaching methods
The Galenic Preparations Laboratory is organised in two separate parts: theoretical lectures (2 CFU, modality of teaching in presence) dedicated to theoretical parts (metrology, pharmaceutical calculations and theoretical aspects of compounding) and laboratory activities (3 CFU, in presence) focused on the compounding of medications.
All slides are made available online at the Elly website (elly2022.saf.unipr.it) together with support audio/video material.
Students will be constantly reminded the appropriate technical language, exposed to real-life examples, invited to understand the underlying connections between different parts of the course and other subjects and will be stimulated to actively participate to the lectures with interactive discussions.
The frequency of all the laboratory sessions in presence is compulsory.
Assessment methods and criteria
The overall evaluation of the student preparation will be carried out in two distinct assessments:
1) Practical exam consisting (in presence) 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 (mark out of 30; 20% of the overall mark);
2) A written exam in presence, through the solving of pharmaceutical calculations will evaluate the applying and understanding of knowledge of students. The exam (60 minutes) will consist in 5 pharmaceutical problems to be solved. The exam is passed solving at least 3 problems out of 5 (mark out of 30; 20% of the overall mark);
Students can register online for the exam using portal ESSE3 (https://unipr.esse3.cineca.it/Home.do) in the sessions available on the official exams calendar of the Department of Food and Drug.
Exams results are announced at the end of the oral exam and will be available online at ESSE3 portal (https://unipr.esse3.cineca.it/Home.do) within one week from the exam date.
Other information
The positive marks obtained at the end of the course (partial exams in December) will be kept valid for the student forever. In case of failure or absence, it will be possible to take the laboratory test as scheduled and the written test relating to calculation problems in each session of the global exam in pharmaceutical technology / laboratory of galenic preparations.
2030 agenda goals for sustainable development
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