OVERVIEW

The class intends to complete the education of the student on pharmaceutical technology, by introducing dosage forms not described in previous classes (aersols, powders for inhalation), 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 socioeconomy 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 the 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) and drug storage (active principle degradation kinetics; analysis of the main chemical and physical causes of dosage form instability, with specific focus on the basics of hygrometry; dosage form stabilization, and role of pharmaceutical packaging); to deal with inhalation dosage forms, in particular pressurized formulations and aerosols, and pharmaceutical formulations for 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 the 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 organization of the Italian National Health Service (structures and relevant 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 socioeconomic aspects of the pharmaceutical market.

Moreover, the students may improve the following basic soft skills: to communicate effectively in written and oral form, adapting their communication to the context; to manage their social interactions and to communicate productively in different settings; to organize and evaluate their own personal education according to what they have understood and learnt.

PREREQUISITES

Several chemical kinetics and general chemistry notions, already introduced in previous classes, are assumed and represent the necessary bases to understand the themes of this class and to pass the exam.

TEACHING METHODS

The class is organized in 80 hours of frontal lesson, with frequent support of instant poll instruments, and educational material is made available to the students through Aulaweb. The class may include flipped classroom educational activities or scenario-based activities with peer evaluation.

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 and aerosols

- 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

- 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

In general, notes taken during the lessons and the educational material supplied on Aulaweb are sufficient to take the exam. The following texts are suggested for support.

• 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.
• Legislazione farmaceutica nella pratica professionale, Barberini G. e Casettari L., Casa Editrice Piccin, 2021.

TEACHERS AND EXAM BOARD

Exam Board

SARA BALDASSARI (President)

GIORGIA AILUNO

GABRIELE CAVIGLIOLI (Substitute)

GIANCARLO GROSSI (Substitute)

ELEONORA RUSSO (Substitute)

GUENDALINA ZUCCARI (Substitute)

LESSONS

Class schedule

The timetable for this course is available here: Portale EasyAcademy

EXAMS

EXAM DESCRIPTION

The exam, normally taken in person as a written exam, aims at evaluating the knowledge of the theoretical aspects and the capacity of applying the acquired concepts. 

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