PHARMACEUTICAL TECHNOLOGY AND DRUG LEGISLATION WITH GALENIC PREPARATION LABORATORY
TECNOLOGIA E LEGISLAZIONE FARMACEUTICA CON LABORATORIO DI PREPARAZIONI GALENICHE
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|Teaching in foreign languages|
Course with optional materials in a foreign language
This course is entirely taught in Italian. Study materials can be provided in the foreign language and the final exam can be taken in the foreign language.
Assigned to the Degree Course
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The course aims to provide the theoretical and practical principles, relating to the development, marketing and distribution of drugs. The course aims, also, to obtain the mastery of the concepts and procedures for the characterization of the substances used in the pharmaceutical and related formulations. The knowledge acquired during the course are of fundamental importance for the exercise of the profession of pharmacist, both in pharmacy and industry.
- PHARMACEUTICAL TECHNOLOGY
Grinding. Mixing. Filtration. Drying . Sterilization . Isotonicity . Dissolution and solubilization.
Chemico-physical principles and technology of pharmaceutical preparations:
Powders: methods for obtaining pharmaceutical powders. Properties of the powders. Powder as dosage forms, incompatibility. Tablets: definition and classification. Compression methods and compressing machines. Physical phenomena of compression process. Controlled release tablets and coating. Specifications and final control tests. Capsules: hard and soft capsules. Others capsules. Manufacturing process. Specifications and final control tests. Granules and pellets: granulation process. Production methods. Technological properties of the granules. Liquid preparations: properties of the solutions. Physical-chemical bases of dissolution. Dissolution rate and bioavailability. Factors affecting the solubility. Parenteral formulations: definition, general characteristics and routes of administration. Dispersed systems: colloidal systems, suspensions and emulsions. Stability and formulation. Surfactants: definition and classification. HLB. Wettability. Zeta potential. Dermatological pharmaceutical forms: ointments, gels, creams, pastes, excipient and preparation. principles of rheology: a rational basis, the definition of viscosity, Newtonian and non-Newtonian systems. Suppositories: classification, preparation of suppositories and ovules. Excipients.
Design and production of dosage forms for the different routes of administration:
pharmaceutical preformulation. Classification and characterization of the main oral, dermal, transdermal, ophthalmic, nasal, pulmonary, parenteral, rectal and vaginal dosage forms. Modified release drug delivery systems. Innovative dosage forms: micro-and nanoparticles, liposomes, micelles and cyclodextrins inclusion complexes. Instruments and methods of preparation. Excipients and polymeric materials. Pharmaceutical stability. Specifications and final control tests.
- PHARMACEUTICAL LEGISLATION
Supranational legislation. European Medicines Agency (EMA). Italian health organization. National Health Service (SSN). Italian Medicines Agency (AIFA). Italian Pharmacopoeia and European Pharmacopoeia (FUI). National Health Plan (PNS) and Essential Levels of Assistance (LEA). Territorial administrative system and pharmacies classification. Territorial and hospital pharmacy and service. Pharmacovigilance. Pharmacist: skills, dispensing and professional responsibilities. Administrative classification of medicines. Medicinal products, industrial manufacturing authorization (AP), marketing authorization (AIC) dossier (CTD). Generic drugs. Medical and surgical devices (PMC). Drugs prepared in the pharmacy laboratory. Rules of Good Preparation of medicines in pharmacies (NBP). Dispensing discipline to the public of drugs. Prescription (human and veterinary). RR , RNR , RL and RMR. Drugs not subject to medical prescription (OTC and SOP).
- PPHARMACEUTICAL COMPOUNDING LABORATORY:
Practical formulation of galenic dosage forms.
Medicinal Chemistry I
Learning Achievements (Dublin Descriptors)
- The student must show the possession of basic skills related to pharmaceutical technology and pharmaceutical legislation.
- The student must acquire the ability to understand the formulation strategies and the instrumental techniques to characterization them.
- It must also highlight the possession of the ability to use knowledge and concepts related to pharmaceutical legislation. In particular, as it regards the drug dispensing and the regulatory activity at the industrial level.
The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it
The educational activities can be supported by experts in the field of pharmaceutical technology or legislation through seminars or lectures.
Didactics, Attendance, Course Books and Assessment
- Course books
- TESTI DI RIFERIMENTO:
Minghetti P. - Legislazione farmaceutica - CEA Edizioni
Loliscio N. - La Farmacia: un Campo Minato: Il Manuale del Farmacista - Società Editrice Esculapio
Aulton M.E. - Tecnologie farmaceutiche - Progettazione e allestimento dei medicinali - EDRA
Colombo P. - Principi di tecnologie farmaceutiche - CEA Edizioni
Bettiol F. - Manuale delle preparazioni galeniche - Ed. Tecniche Nuove
Ragazzi E. - Galenica pratica - Ed. Libreria Cortina
- TESTI DI APPROFONDIMENTO:
Amorosa M. - Principi di tecnica farmaceutica - Ed. Libreria Universitaria L. Tinarelli
Florence A.T. e Attwood D. - Le basi chimico-fisiche della Tecnologia farmaceutica - EdiSES
Aulton M.E. - Aulton's Pharmaceutics: The Design and Manufacture of Medicines - Churchill Livingston ELSEVIER
Florence A.T. e Attwood D. - Physicochemical Principles of Pharmacy, 4th Edition - Pharmaceutical Press
Felton L. - Remington: Essentials of Pharmaceutics - Pharmaceutical Press
Gaisford S. e Saunders M. - Essentials of Pharmaceutical Preformulation - Wiley-Blackwell
Perrie Y. and Rades T. - Pharmaceutics: Drug Delivery and Targeting - Pharmaceutical Press
- TESTI DI RIFERIMENTO:
Practical, written exam (open questions) and/or oral exam.
The student can request to sit the final exam in English with an alternative bibliography. (Course with optional materials in a foreign language)
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