79013 - Elements of Galenical Pharmaceutics

Learning outcomes

Elements of Galenical pharmaceutics (or medicine)

Requirements and outcomes

After completion of the course, the student will be able to handle raw materials in a galenical laboratory to obtain preparations through pharmaceutical techniques and formulas, including the most recent ones as required by the market, as well as consulting official reference texts.

The student will be in a position to assess the validity and legality of a medical prescription, acknowledging and applying the pharmaceutical legislation, to record the herbal medicinal products according to the current legislation and to perform the required technological controls of the pharmaceutical techniques according to the Official Italian Pharmacopoeia 12° edition.

Finally, the student will plan and prepare a galenical preparation meeting the requirements imposed by the Good Manufacturing Practice (GMP) and dispense correctly. Also, the student will acquire the basic knowledge to properly counseling in health care by playing an intermediary role between patient, doctor and health facilities.

Course contents

• Galenical Preparation Handbook • European Galenical Preparation Handbook • Galenical Preparation Handbook for Veterinary use• Good Manufacturing Practice (GMP) and Italian Ministerial Decree 22/06/2005• Definition of medicinal products and their classification: industrial pharmaceutics, magisterial and officinal Galenical preparations.• Definition of herbal product. Requirements for herbal medicines and related legislation (Belfrit List, Bill 03/27/2014). Definition of phytotherapy.• Set-up of a Galenical laboratory within the pharmacy.• Purchase and management of raw materials: the supervision conducted by the pharmacist on the raw materials in order to prove the quality and suitability. Certificates of analysis and requirements for raw materials. • Galenical preparation: working sheet, manufacturing pharmaceutical formulas and control over the finished product.• Cannabis plant-based medicines: prescribing modality and technical manufacturing of preparations.• Magisterial and officinal formulas for human use.• Formulas for the treatment of pain

• Magisterial and officinal formulas for veterinary use

Teaching methods

Lectures (16) and individual practical exercises (12)

Assessment methods

The exam consists of a written multiple-choice test at the end of the lectures, a laboratory test at the end of the practical exercises and a final oral test aimed at assessing the achievement of required knowledge of theoretical and applied pharmaceutical technology.

Office hours

See the website of Gianfrancesco Carbini