Ateneo - UPO

Introduction
Pharmaceutical powders
Granules
Tablets
Capsules
Multi-unit systems
Modified release drug delivery systems
Galenic preparations
Practical exercises in laboratory

Colombo, P et al.: Principi di tecnologie farmaceutiche. Ed. Ambrosiana.
Aulton, ME and Taylor, KMG: Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali, Ed. Edra. Michele Amorosa (ed. a cura di F. Barbato): Principi di Tecnica Farmaceutica, Ed. Piccin.
Minghetti, P; Marchetti, M.: Legislazione farmaceutica, Ed. Ambrosiana.
Ansel HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. Ed. Edra;
Farmacopea Ufficiale Italiana edizione vigente; Farmacopea Europea edizione vigente.
Bettiol F.: Manuale delle preparazioni galeniche. Ed. Tecniche nuove;
Frongia M e Casettari L, Il galenista e il laboratorio. Edra Ed.

The couse is divided in two parts: theoretical lessons and practical exercises.
The aim of the course is to provide the theoretical notions about the main conventional and unconventional solid dosage forms and about their specific characteristics, manufacturing methods and the technological tests used to assess their quality according to Pharmacopoeia requirements. Moreover, the course provides theoretical and practical information about methods of preparation, price determination, labelling and quality control of galenic products.
The student uses the knowledge acquired to face problems about drug formulation and dosage forms (excipients, fabrication methods, quality control tests) using the specific language for this specialistic discipline.
Moreover, the course gives to the student skills to manage an advance conversation on dosage forms and galenic products and supplies basic expertise to carry out the professional activity in Pharmacy. The course gives tools to apply the knowledge acquired in the conduction of the work as pharmaceutical technologist or pharmacist and to face the professional responsabilities.

A good knowledge of the course of the previous years is recommended

Pharmaceutical technology: frontal lectures.
Galenicals: frontal lectures and practical exercises in laboratory.

Written and oral examination. Written test: dispensation of a galenic prescription and questions about topics reported in the program of the course. Oral examination, is optional: verification of the capability to hold a conversation (using the appropriate technical language) about pharmaceutical dosage forms and related problems.
The access to the oral examination is allowed only if the student passes both parts of the written test.

Introduction: Principles of biopharmaceutic. Conventional and unconventional drug delivery systems. Concept of preformulation.
Pharmaceutical powders: Powders as dosage form.
Granules: Introduction to granulation, granulation methods and mechanisms; formulation of granules; specific technological assays.
Tablets: Definition; classification; tablet excipients and formulations; tablet production; specific technological tests; coating of tablets.
Capsules: Definition; hard and soft capsules: preparation, formulation and specific technological tests.
Multi-unit systems: Microparticles and pellets; preparation, formulation and specific technological tests. Nanoparticles for drug targeting.
Modified release drug delivery systems: Unconventional oral dosage forms: characteristics and drug release mechanisms. Reservoir systems, matrix systems, osmotic pump systems; site-specific drug delivery systems and time-specific drug delivery systems; fast release systems. Transdermal drug delivery systems. Intravaginal and intrauterine drug delivery systems. Intraocular drug delivery systems.
Galenic preparations: Magistral and officinal galenic products: preparation; composition of price according to National Price List for galenic preparations (statute articles and enclosures A and B - D.M. 18 agosto 1993); composition of label of galenic preparations.

Laboratory practical exercises: Galenic preparations: preparation of galenic formulations (suppositories, ovules, syrups, solutions, emulsions, creams, ointments, gels, pastes). Composition of the price and labelling of the galenic preparations. Quality assurance: preparation of solid dosage forms (capsules and tablets) and quality assurance tests according to the Pharmacopoeia specifications.
Use of software for the management of the professional activity in Pharmacy.

The aim of the course is to provide the theoretical notions about the main conventional and unconventional solid dosage forms and about their specific characteristics, manufacturing methods and the technological tests used to assess their quality according to Pharmacopoeia requirements. Moreover, the course provides theoretical and practical information about methods of preparation, price determination, labelling and quality control of galenic products.
The student uses the knowledge acquired to face problems about drug formulation and dosage forms (excipients, fabrication methods, quality control tests) using the specific language for this specialist discipline.
Moreover, the course gives to the student skills to manage an advance conversation on dosage forms and galenic products and supplies basic expertise to carry out the professional activity in Pharmacy. The course gives tools to apply the knowledge acquired in the conduction of the work as pharmaceutical technologist or pharmacist and to face the professional responsability.