Learning objectives
The module of Pharmaceutical Technology and Quality Control has the aim of providing the basic knowledge on formulation design, manufacturing and use of the most common food supplements and medical foods on the market.
In particular, the students will have to:
1) Identify the nature and function of excipients in a 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 (Applying knowledge and understanding).
7) Present and illustrate a health product using the appropriate technical language in a way that is at the same time simple and understandable by consumers (Communication skills).
The module of Technologies and quality control of functional foods aims to provide to the student the necessary knowledge to be able to understand and analyze: the unit operations involved in the transformation of food products and ingredients, with particular focus on the case of functional products and the role technological / functional ingredients within a food formulation.
Specifically, the student must be able to:
1) Know and understand the unit operations involved in the transformation of food products and ingredients, with particular focus on the case of functional products and the technological / functional role of ingredients within a food formulation (Knowledge and understanding);
2) Be able to hypothesize the formulation of functional food product on the basis of the technological and functional characteristics of the different ingredients; be able to build a suitable production process for the production of functional ingredients and products (Applied knowledge and understanding);
3) Know how to evaluate the advantages and disadvantages of different unit operations and / or the choice of different ingredients for the production of a specific functional food in a multidisciplinary context, considering different qualitative aspects (Autonomy of judgment);
4) To be able to present and describe the functional and technological characteristics of the ingredients of a formulation, the technological processes for the production of a functional food, as well as the qualitative characteristics of the products using language specific of the discipline and a correct vocabulary. (Communication skills);
5) Be able to know how to modify the formulation or operations involved in the transformation of food formulations according to specific technological needs or product target characteristics (ability to learn);
Prerequisites
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.
In order to follow the module of Technologies and quality control of functional foods the student must have good knowledge of chemistry and microbiology of food.
Course unit content
The Module of Pharmaceutics and Quality Control will provide the fundamental concepts on the design of dietary supplements and medical foods, on the manufacturing of dosage forms and their use by consumers.
The Module, delivered in presence 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.
The teaching module of Technologies and Quality Control of Functional Foods aims to address the main unit operations of the food industry with exemplary and applicative references to the case of production processes for obtaining food products and functional ingredients.
The unit operations in the context of industrial process technologies will be studied through a multidisciplinary approach, in order to break down the technological problems into aspects related to the chemical, nutritional, microbiological, physical and sensorial quality of functional products. In this context, the course will deal with the functionality of the ingredients that can be used in food formulations not only from a nutritional, but also from a technological point of view.
Furthermore, a part of the course will address issues related to the aspects related to the control and quality assurance of the product and the process.
The course is divided into two parts:
- An introduction part that will deal in a general way aspects related to the factors that affect the shelf life and the quality of food and the differences between functional foods, food supplements and foods for special medical purposes.
- A part related to the criteria for choosing ingredients for the design of functional foods and the main unit operations of the food industry with application and example references to functional products. Moreover, self-control plans, quality assurance, voluntary regulations and analytical systems for quality control at an industrial level and for product’s optimization will also be covered.
Full programme
Pharmaceutics and Quality Control module:
Introduction to Pharmaceutics
Medicinal products, Dietary supplements and Medical Foods.
Pharmaceutical Quality: Pharmacopeias, GMPs.
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..
Solid dosage forms: 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
Packaging
Technologies and quality control of functional foods module
Notes on shelf life and the quality of food products;
Recalls on the factors that regulate the conservation and quality of food;
Hurdle technology;
Functional foods, supplements and foods for special medical purposes;
The design of a functional product: The technological and functional role of the ingredients, structure and functionality of the formulations;
Unit operations of mixing, modification of dimensions, separation and extraction;
Heat treatments: pasteurization, sterilization, cooking, blanching;
Outline of thermobacteriology and kinetics of chemical and enzymatic inactivation;
Unconventional and emerging technologies;
Refrigeration, freezing;
Packaging;
Analytical methods for industrial quality control and the optimization of functional formulations;
The quality of functional foods through self-control plans and voluntary certifications;
Bibliography
For the module of Pharmaceutics and Quality Control
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 available 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.
For the module of Technologies and quality control of functional foods, other than the material of the course, that will be weekly uploaded by the teacher on the Elly platform, it will be possible to study on the following suggested books:
Smith, J., & Charter, E. (2010). Functional Food Product Development. Blackwell Publishing Ltd. ISBN:9781444323351 DOI:10.1002/9781444323351
John Shi (2015). Functional Food Ingredients and Nutraceuticals Processing Technologies, Second Edition. CRC Press ISBN 9781482240641
Boye, J. I. (2015). Nutraceutical and functional food processing technology. John Wiley & Sons. ISBN:9781118504956 DOI:10.1002/9781118504956
Ahmed, J., & Rahman, M. S. (Eds.). (2012). Handbook of Food Process Design, 2 Volume Set. John Wiley & Sons.
Fellows, P. J. (2009). Food processing technology: principles and practice. Elsevier
Teaching methods
The Pharmaceutics and Quality Control module will be carried out in presence using slides projection, 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).
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 module of Technologies and quality control of functional foods is organized through lectures, possibly integrated with seminars, articles and video material useful for understanding and deepening the topics covered.
The slides of the lessons, which are an integral part of the teaching material, as well as all the supplementary teaching material, will be uploaded weekly on the Elly platform of the course.
Assessment methods and criteria
The overall evaluation of the student preparation will be carried out in an 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 commercial product for their examination (mark out of 30; 50% of the overall mark of the exam).
Validation of learning will be carried out with a written exam consisting of a first part with closed answers (30 minutes of time for 31 questions) and a second part with an open question (30 minutes of time). Both parts will be evaluated on a scale of marks out of thirty; the average of the votes of the two parts, rounded up, will make up the final vote.
Through the test, the theoretical knowledge gained through the study of the subject, the connection and reasoning skills between the subjects under study and the writing skills will be evaluated using an adequate and appropriate technical-scientific terminology.
Honors will be reserved for candidates who have gained the maximum score on both parts and who have shown an excellent command of the technical-scientific vocabulary and an excellent ability to connect and reason between the topics.
Students can register online for the exam using portal ESSE3 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 within one week from the exam date.
Other information
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