OVERVIEW

The course of Pharmaceutical Technology and Legislation II is a professional teaching oriented to the formation of the CTF that intends to carry out its activity in the industrial field both in the functions of production worker and control of the preparation of active ingredients and medicines as well as those employed to preclinical and clinical research in GMP system.

LEARNING OUTCOMES

The learning outcomes is the study of  the organization of pharmaceutical industry, through the in-depth understanding of the processes and equipment used in the industrial manufacturing of active ingredients and medicinal products. The regulatory aspects of the production and vigilance of the drugs and of other products having medical or healthy significance are also presented and discussed. Furthermore, a large number of individual practice exercises for the preparation of main dosage forms involving the use of laboratory instrumentation are provided.

Teaching methods

The course takes place in 120 hours of frontal teaching activities and individual laboratory exercises. These tutorials are guided and assisted by the teacher. In the classroom during the lectures the teacher carries out the whole teaching program. On Aulaweb, the lecturer notes of the course are provided on request to the students attending, divided into the different chapters of the program and updated annually by the teacher, where all the topics dealt with in the classroom are widely reported.

SYLLABUS/CONTENT

Pharmaceutical Technology

The pharmaceutical industry

Organization: local, working environment and centralized technical services

Equipment and plants of pharmaceutical industry

Process and production water

Drying

Grinding of solids, sieving and mixing of the powders

Hard capsule filling process and equipment

Compaction, Mixing and Granulation

Tablet compression machines

Coating process and equipment

Semisolid production and filling equipment

Suppository process and equipment

Dosage liquid form production and filling equipment

Sterilization and sterile dosage form production

Pressurized dosage form production

Biotechnological equipment and processes

Packaging

Pharmaceutical Law

Sources of law.

Organization of national health service (SSN) and basics of Pharmacoeconomy.

Supranational bodies and organizations for the protection of health.

Juridical definition of medicinal product

Regulatory and administrative classification of medicines

AIFA and EMA and their functions within the European Medicines Control System

EU rules for authorizing the production and marketing of the Api and medicinal products for human use

Patents

Clinical trials

Orphan Medicinal and compassionate use

Generic name medicinal products.

EU Regulation of homeopathic medicines.

Presentation of medicines: label and leaflet.

Pharmacovigilance.

The medical-scientific information and advertising in the pharmaceutical field.

Discipline of veterinary medicines.

Medical devices.

In vitro diagnostic medical devices.

Biocides, ECA and Plant protection products.

Regulatory issues concerning: special foods, mineral water, herbal products from non-medicinal plants, sweeteners, alcohol, cosmetics.

Standards concerning environmental protection: classification, storage and disposal of waste with particular reference to the pharmaceutical and health aspects.

Laboratory of Galenic dosage form preparation and industrial microscale production: the course includes a series of individual laboratory session for the preparation of classical dosage forms and for use of lab equipment for the pharmaceutical R&D.

RECOMMENDED READING/BIBLIOGRAPHY

Remington: The Science and Practice of Pharmacy. Edited by Allen, Loyd V., Jr

Pharmaceutical Press; 22th edition (Septmber 2012).   

The Theory and Practice of Industrial Pharmacy, III Ed. - Lachman L. e coll.- Lea & Febiger, Philadelphia 1986.

Suggested consultation textbooks are:

Aulton Tecnologie farmaceutiche [Aulton's pharmaceutics]  Aulton, Michael E. ; Taylor, Kevin M. G. ; Milano : Edra, 2015.

La Fabbricazione Industriale Dei Medicinali- L. Fabris, A. Rigamonti- Società Editrice Esculapio-2008.

Legislazione Farmaceutica - P.Minghetti – nona edizione CEA, Milano 2018.

Exam Board

GABRIELE CAVIGLIOLI (President)

GUENDALINA ZUCCARI

ELEONORA RUSSO

GIANCARLO GROSSI

SARA BALDASSARI

Teaching methods

The course takes place in 120 hours of frontal teaching activities and individual laboratory exercises. These tutorials are guided and assisted by the teacher. In the classroom during the lectures the teacher carries out the whole teaching program. On Aulaweb, the lecturer notes of the course are provided on request to the students attending, divided into the different chapters of the program and updated annually by the teacher, where all the topics dealt with in the classroom are widely reported.

Exam schedule