PHARMACEUTICS AND QUALITY ASSURANCE
Learning outcomes of the course unit
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 or health product (Knowledge and understanding);
2) Recognize the most common dosage forms for the oral administration route (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 in relation to oral 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) (Knowledge and understanding).
6) Know and apply the tests required to evaluate the conformity of pharmaceutical products to the quality requirements of Pharmacopoeias (Applying knowledge and understanding).
7) Present and illustrate a medicinal or health product using the appropriate technical language in a way that is at the same time simple and understandable by consumers (Communication skills).
In order to attend the module of Pharmaceutics and Quality Control the student have to master the basic concepts related to Organic Chemistry, Biochemistry and General Physiology.
Course contents summary
The Module of Pharmaceutics and Quality Control will provide the fundamental concepts on the design of medicinal products, dietary supplements and medical foods, on the manufacturing of dosage forms and their use by consumers.
The Module, delivered with mixed method of teaching (in presence/online streaming), is divided in three parts:
- An introduction dealing with the differences between medicinal products, dietary supplements and medical foods, the basic concepts of biopharmaceutics and pharmacokinetics with special focus on the oral route of administration;
- A general part dedicated to quality, good manufacturing practices (GMP), excipients and basic pharmaceutical operations (milling, mixing, dissolution, filtration, sterilization and drying);
- A section dedicated to specific dosage forms (powder, granules, tablets, capsules etc.) to their manufacturing and quality control according to the current norm, including stability studies and the requirements related to packaging.
Introduction to Pharmaceutics
Medicinal products, Dietary supplements and Medical Foods.
Pharmaceutical Quality: Pharmacopeias, GMPs and Quality by Design.
Biopharmaceutics and Pharmacokinetics.
Pharmaceutical operations: Milling, Mixing, Filtration, Sterilization and Drying (including freeze-drying).
Excipients for oral dosage forms.
Liquid dosage forms: solutions, suspensions, emulsions.
Semisolid dosage forms: gels, creams, ointments and pastes.
Solid dosage foms: powders, granules, pellets, tablets, hard and soft capsules, film.
Controlled release dosage forms.
Microparticles, nanoparticles and liposomes.
Enteral and parenteral nutrition.
Stability of health 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
Other relevant texts availabe at the Library of the Food and Drug Department:
Farmacopea Ufficiale della Repubblica Italiana, XII Edizione, Istituto Poligrafico e Zecca dello Stato, Rome (2008);
The slides presented during the lectures are made available every week on the Elly portal.
The Pharmaceutics and Quality Control module is carried out through a series of lectures (mixed modality of teaching in presence/online streaming) integrated with scientific papers, documents and online materials useful for the understanding and enrichment of the subject discussed in class (uploaded on the portal Elly).
All slides are made available online at the Elly platform where video recordings of lectures will be available for a limited time (7 days).
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.
Assessment methods and criteria
The overall evaluation of the student preparation will be carried out in an oral exam (in presence or online upon request) 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 for their examination (mark out of 30; 50% of the overall mark of the exam).
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.