Learning objectives
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) Know and understand the fundamental concepts of efficacy, safety and quality at the basis of the Good Manufacturing Practices (GMP) and the Good Compounding Practices (GCoP) (Knowledge and understanding).
6) Know and apply the tests required to evaluate the conformity of pharmaceutical products to the quality requirments of Pharmacopoeias, taking into account GMP o GCoP(Applying knowledge and understanding).
7) 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).
Prerequisites
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
-Fisiologia Generale
Course unit content
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)
Full programme
Pharmaceutical Technology
Introduction
• Definition of drugs, dosage forms and medicines
• Pharmacopoeia and Formulary, GMP
• Biopharmaceutic and pharmacokinetics
• Administration routes
General part
• Pharmaceutical excipients: types, classification and functions
• Pharmaceutical Operations: Milling; Mixing; Dissolution; Filtration; Sterilization; Drying.
• Pharmaceutical packaging
• Pharmaceutical products stability.
Dosage forms
• Liquid dosage forms: solutions (drops, syrups and elixir), suspensions, emulsions;
• Powders;
• Granules, pellets;
• Capsules
• Tablets;
• 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
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
Reference books (available at the 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
The slides of the lectures are made available weekly on the Elly website (http://elly.saf.unipr.it/).
Teaching methods
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.
Other information
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