Pharmaceutical Technology and Legislation I and Laboratory of Pharmaceutical Technology I

The fundamental learning objective of the course is to introduce the principles of the design, preparation and control of immediate- and modified-release dosage forms, with particular reference to solid and liquid ones administered by the oral route, and those administered by the nasal and pulmonary route, either pressurized and not. The course aims to provide students with the necessary knowledge to understand the relationships between the dosage form in which the active principle is formulated, its physico-technological characteristics as well as its route of administration, and the drug availability in the biophase (bioavailability). The legislation concerning the production and quality control of industrial drug products, as well as the preparation of medicines within a pharmacy, are also addressed. The practical exercises carried out in the Laboratory module aim to consolidate the main learning objectives through the characterization of raw materials, control of the product quality, preparation of oral magistral and officinal formulae and drafting of the relevant documentation in compliance with current laws.

At the end of the course the student will know the role played by the dosage form in determining bioavailability of the active ingredient in the organism. In particular, the student will have the tools to identify problems related to the administration of drugs by the oral route in a form that guarantees their acceptability and therapeutic activity. Specifically, the student will know how to i) apply formulation strategies for the manufacturing of solid (powders, granules, tablets, capsules) and liquid (solutions, syrups) dosage forms, as well as aerosols; ii) conduct unitary pharmaceutical operations such as milling, mixing, granulation, drying, compression and coating; iii) assess the physical-technological quality, performance and stability of the aforementioned dosage forms; iv) manage the activities connected with the preparation and dispensing of medicines in Pharmacy.