PHARMACEUTICAL TECHNOLOGY, SOCIOECONOMICS AND ITALIAN DRUG LEGISLATION mutuato
TECNOLOGIA, SOCIO-ECONOMIA E LEGISLAZIONE FARMACEUTICA
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Assigned to the Degree Course
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The course aims to provide the basic theoretical 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.
PHARMACOECONOMICS AND 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.
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).
Grinding. Mixing. Filtration. Drying . Sterilization . Isotonicity . Dissolution and solubilization. Granulation. Extrusion/Spheronization. Tabletting. Film technology. Lyophilization. Atomization .
Dosage forms (oral, parenteral, other routes of administration): classification and main features, instrumentation and methods of preparation; excipients and polymeric materials, microbiological, stability, conservation.
Methods for obtaining pharmaceutical powders. Particle size analysis, density, porosity, smoothness. Powder as dosage form, formulation, incompatibility. Polymorphism.
Definition and classification . Compression methods and compressing machines. Physical phenomena of compression process. Controlled release tablets and coating.
Hard and soft capsules. Manufacturing process.
Granules and pellets.
Physical-chemical bases of dissolution, solubility, dissolution rate, bioavailability. Factors affecting the solubility. Physical properties of the solutions. Oral liquid preparations. Simple and medicated syrup. Ethyl alcohol and its dilution. Parenteral drug: definition, general characteristics and routes of administration.
Colloidal systems, suspensions and emulsions. Stability and formulation. Surfactants: definition and classification. HLB. Wettability. Zeta potential.
Dermatological pharmaceutical forms:
Principles of rheology: a rational basis, the definition of viscosity, Newtonian and non-Newtonian systems.
Ointments, gels, creams, pastes, excipient and preparation. Medicated plasters: definition, formulation problems, absorption promoters.
Classification, preparation of suppositories and ovules. Excipients.
Alternative pharmaceutical dosage forms:
Nasal and inhalation dosage forms.
Innovative pharmaceutical drug delivery systems: micro-and nanoparticles, liposomes, micelles and cyclodextrins inclusion complexes.
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
Aulton M.E. - TECNOLOGIE FARMACEUTICHE - Progettazione e allestimento dei medicinali - EDRA
Minghetti P. - Legislazione Farmaceutica - CEA Edizioni
Colombo P. - Principi di tecnologie farmaceutiche - CEA Edizioni
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
Written exam (open questions) and/or oral exam.
The student can request to sit the final exam in English with an alternative bibliography.
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