PHARMACEUTICAL TECHNOLOGY/GALENIC PREPARATIONS LABORATORY
Learning outcomes of the course unit
Upon successful completion of the subject the student will acquire the knowledge and the practical skills required to identify, design, compound and use of the most common dosage forms.
Galenic Preparations Laboratory aims to provide the student with the knowledge and practical skills for compounding medications in community or hospital pharmacies.
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.
In particular, the students will have to:
1) Identify the nature and function of excipients in a medicinal product (Knowledge and understanding);
2) Recognize the most common dosage forms and understand their administration routes (Knowledge and understanding);
3) Propose a formulation design and manufacturing approach for common dosage forms (Applying knowledge and understanding).
4) Evaluate advantages and limitations of a specific dosage form or administration route (Making judgements)
5) Present and illustrate a medicinal product using the appropriate technical language in a way that is at the same time simple and understandable by patients (Communication skills).
In order to sit the exam in Pharmaceutical Technology/Galenic Preparations Laboratory the student has to pass the exam of Organic Chemistry and Physiology.
Course contents summary
The subject is organized in two separate Modules: the course of Pharmaceutical Technology and the Galenic Extemporaneous Preparations Practical Laboratory.
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 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 will compound different dosage forms according to the requirements of the Italian Official Pharmacopoeia.
The Module of Pharmaceutical Technology will provide the fundamental concepts on the design of medicinal products, on the manufacturing of dosage forms and their use by patients.
The Module is divided in three parts:
- An introduction to biopharmaceutics, pharmacokinetics and administration routes;
- A general part dedicated to excipients and to basic pharmaceutical operations (milling, mixing, dissolution, filtration, sterilization and drying);
- A section dedicated to single dosage forms, to their manufacturing and quality control according to the current norm (Good Manufacturing Practice, GMP)
Galenic Preparations Laboratory
I Part (in class)
Good Compounding Practices
Compounding a medical prescription
National Tarif of compunded 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 National 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
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
Support books (available at 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
Weekly lectures slides are made available through Elly website (http://elly.saf.unipr.it/).
The Galenic Preparations Laboratory is organised in two separate parts: theoretical lectures (2 CFU) dedicated to theoretical parts (metrology, pharmaceutical calculations and theoretical aspects of compounding) and laboratory activities (3 CFU) focused on the compounding of medications.
The Pharmaceutical Technology module is carried out through a series of lectures, integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class.
All slides are made available online at the Elly website (elly.saf.unipr.it). Slides are a integral part of the studying 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.
An attendance at least of 75% of lectures is required, while the frequency of all the laboratory sessions is compulsory.
Assessment methods and criteria
The overall evaluation of the student preparation will be carried out in three distinct assessments:
1) Practical exam consisting in the compounding of a medication on the basis of a medical prescription. Through the marking of the compounded product appearance and of the technical report prepared, it will be evaluated the applying and understanding of the knowledge acquired by the student (mark out of 30; 15% of the overall mark);
2) Written exam, through the solving of pharmaceutical calculations will evaluate the applying and understanding of knowledge of students. The exam will consist in 5 pharmaceutical problems to be solved in 1 hour and a half. The exam is passed by solving at least 3 problems out of 5 (mark out of 30; 25% of the overall mark);
3) Oral exam consisting in three questions to assess:
- student knowledge and understanding of the subject studied
- student judgement and understanding of the interconnections between different aspects of the course
- student communication skills in technical and scientific language;
- student ability to apply and use the knowledge acquired with independent and competent reasoning.
The opportunity to start the discussion with students is given by submitting them a pharmaceutical product. Up to 2 points out of 30 will be awarded on communication skills of the student (mark out of 30; 60% of the overall mark).
The final mark is obtained by the weighed average of the marks of the single assessments.
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 Dipartimento di Scienze degli Alimenti e del Farmaco.
Exams results are announced at the end of the oral exam and are availale online at ESSE3 portal (https://unipr.esse3.cineca.it/Home.do) within one week from the exam date.