OVERVIEW

The class intends to complete the overview on pharmaceutical technology, by introducing aersols as dosage forms, and with sections relevant to all the industrial pharmaceutical formulations (rheology, stability studies, packaging, biopharmaceutics, modified release). Also the legislation applied to the industrial medicinal products is examined, in comparison to the laws disciplining other products of interest for the pharmacy profession. A brief outline of pharmacoeconomy completes the course.

AIMS AND CONTENT

LEARNING OUTCOMES

Objectives of this discipline are: to provide notions of biopharmaceutics, drug formulation and stability; to deal with pharmaceutical formulations for modified or controlled release; to impart good knowledge of the legislation disciplining production, control and monitoring of industrial medicinal products; to compare regulation of pharmaceuticals with the one of other product groups in the healthcare or medical fields; to describe the Italian National Health Service and convey the basics of socioeconomics.

AIMS AND LEARNING OUTCOMES

Objectives of this course are: to provide notions of biopharmaceutics (with specific reference to the parameters involved in determination of absolute and relative bioavailability and in bioequivalence studies), drug formulation (characterization of formulation rheology; specific focus on inhalation dosage forms, in particular pressurized formulations) and drug storage (active principle degradation kinetics; analysis of the main chemical and physical causes of dosage form instability, with specific focus on of the basics of hygrometry; dosage form stabilization, and role of pharmaceutical packaging); to deal with pharmaceutical formulations for modified or non-conventional release (sustained, controlled and targeted release); to impart good knowledge of the legislation disciplining production, control and monitoring of medicinal products, both for human and veterinary use; to compare regulation of pharmaceuticals with the one of other product groups in the healthcare or medical fields (medical devices, in-vitro diagnostics, medical supplies, cosmetics, food for special medical purposes, herbal supplements); to describe the Italian National Health Service (structure and functions); to convey the basics of socioeconomics (notions on the main pharmacoeconomic analysis methods).

At the end of the course the students will be able to: describe the rheological characteristics of a formulation; solve simple questions related to the development of pharmaceutical forms, also in relation to their stability and biopharmaceutical profile; recognize the different mechanisms by which a modified release of active ingredients is implemented. The students will also possess the bases of the regulations of the pharmaceutical industry and products with medical or health value and will be able to state the differences among them. Finally, the students will have a basic knowledge of the main aspects of the pharmaceutical market.

TEACHING METHODS

The class is organized in 80 hours of frontal lesson, and educational material is made available to the students through Aulaweb. The educational activities may be delivered remotely through synchronous on-line sessions .

SYLLABUS/CONTENT

Pharmaceutical technology

- Introduction to rheology and the rheological characteristics of pharmaceuticals

- Drug stability and storage: technological and normative aspects

- Pharmaceutical packaging: technological and normative aspects

- Hygrometry

- Pressurized dosage forms

- Fundamentals of preformulation and biopharmaceutics

- Pharmaceutical formulations and therapeutics for modified release

Legislation

- Definition of medicinal product

- Normative and administrative classification of medicines

- Presentation of medicines: Product Information Leaflet and labeling

- Organogram of EMA and functions within the European system for control of medicines

- EU normative for Manufacturing and Marketing Authorization of active principles and medicines for human use

- Generic products

- Pharmacovigilance: functions and system implementation in Italy within the EU. Mentions on "WHO International Drug Monitoring Programme".

- Medical scientific information and advertising of drugs

- Legislation on veterinary products

- Legislation on homoeopathic products

- Medical devices

- In-vitro diagnostics

- Biocides and medical supplies

- Legislation regarding the commercial activity of pharmacies: dietary products, mineral waters, herbal remedies obtained from non-medicinal plants, sweeteners, alcohols and cosmetics

- Legislation on environment protection: waste classification, deposit and disposal with specific reference to the pharmaceutical and sanitary aspects

- Professional ethics

Socioeconomics

- Health assurances

- The National Health Service with specific reference to the pharmaceutical system: structure and functions

- Composition of public health expenditure: fiscal costs and public role of health expenses

- Pharmaceutical market characteristics in comparison with the competitive one.

- Drug price: general aspects of cost analysis

- The pharma industry and investment strategies: orphan drugs

- Review of the main methodologies for pharmacoeconomic analysis

RECOMMENDED READING/BIBLIOGRAPHY

• The Theory and Practice of Industrial Pharmacy, III Ed., Lachman L. et coll., Lea & Febiger ed., 1993.
• Physical Pharmacy, IV Ed., Martin A. et coll., Lea & Febiger ed., 1993.
• Remington: the Science and Practice of Pharmacy, XXII Ed., Allen Loyd V. ed., 2000. 
• Tecnologie farmaceutiche, I Ed., Aulton M. et coll., Edra ed., 2015.
• Legslazione farmaceutica, IX ed., Minghetti P., Casa Editrice Ambrosiana, 2018 and relevant updates.

TEACHERS AND EXAM BOARD

Exam Board

SARA BALDASSARI (President)

GABRIELE CAVIGLIOLI

GIANCARLO GROSSI

ELEONORA RUSSO

GUENDALINA ZUCCARI

LESSONS

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam is normally taken in person (written exam), but, if circumstances require, may be also performed remotely through an on-line session (mixed written+oral exam). The assessment aims at evaluating the knowledge of the theoretical aspects and the capacity of applying the acquired concepts. The exam consists of solving one technology problem, answering one question on either a technology or a legislation subject, and taking 16 multiple choice quizzes relevant to technology and legislation topics.

The assigned grades are: 9 for solving the problem correctly; up to 6 for answering the question thoroughly; 1 for each correct answer to the quizzes; -1 for each wrong answer (the first wrong answer will not be considered).

The exam is carried out in maximum two hours. In the case of exam taken in person, after blind correction, the exams are publicly discussed with the students. 

One mid-term and one final examinations are normally scheduled for those students who have regularly signed in to the course for the first time.

ASSESSMENT METHODS

The exam assesses the student's ability to solve simple questions on technology topics and the knowledge of the legislation inherent to the pharmaceutical industry and the products with a medical or health value.

Exam schedule