37189 - Industrial Manufacturing of Medicines

Course Unit Page

Academic Year 2018/2019

Learning outcomes

At the end of the course the student - knows the aspects related to the development and industrial manufacturing of medicinal products; - acquire knowledge relating to other aspects peculiar to the industrial practice such as the validation of a manufacturing process and the European legislation about the production and marketing of medicines - is able to overcome the various problems that occur in all stages of production of the medicine.

Course contents

Part 1 (prof. Beatrice Albertini ) (40 h)

- Pharmaceutical industry: organization, facilities and manufacturing activities. 

- Water for pharmaceutical use.

- Production of liquid dosage forms: stirrers, mixers, homogenizers, filters.

- Production of solid dosage forms: bottle washing machine, vial washing machine, liquidfilling machine, drying apparatus and pre-filled syringes.

- Freeze-drying: theory and equipment

- Sterilization: theory and equipment

- Production of solid dosage forms: milling, sieving, mixing, granulation, pellettization, drying, tableting, capsule filling, coating.

- Production of aerosol and inhaler devices

- Production of semi-solid dosage forms: equipment

- Distribution of semi-solid dosage forms

- Transdermal patches

- Packaging

 Part 2 (prof. Nadia Passerini) (24h)

- Structure and organization of the pharmaceutical industry.

- General overview of the European Union pharmaceutical legislation concerning medicinal products for human use; Good Manufacturing Practice; procedures for Marketing authorisation, the Common Technical Document.

- Preformulative and formulative studies

- Technological tests on the final drug product (medicine): solid dosage forms (granules, tablets, capsules); liquid dosage forms (solutions, emulsions, suspensions); semi-solid dosage forms for cutaneous application (ointments, creams, gels and pastes); parental preparations; preparation for inhalation.

- Stability studies: stability of a drug product; ICH/CPMP guidelines for stability tests (long-term, accelerated and stress studies).

- The concept of validation for the pharmaceutical industry.

- Technology Trasfer And process Analytical technologies (PAT)

- Patents

- Bioequivalence studies.

 

 

Teaching methods

Lectures

Assessment methods

The examination aims to verify the achievement of the necessary skills to perform the professional activity in the pharmaceutical industry. In particular we examine:
• An understanding of the fundamental aspects related to the development and formulation processes of industrial production of medicines
• Knowledge of EU legislation concerning the manufacture, quality assurance of medicines
• The ability to use the above knowledge in order to understand and overcome the problems of formulation and manufacturing of medicines from industrial sources.
The exam takes place only through the final exam, which consists of an oral interview.

Teaching tools

Material: the material presented in class will be available to the student in electronic format through the web site: http://campus.unibo.it/

Office hours

See the website of Beatrice Albertini

See the website of Nadia Passerini