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
  Pharmaceutical operations: 
  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

- 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.

Teaching

Lectures.

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

Assessment

Practical, written exam (open questions) and/or oral exam.

Disabilità e DSA

Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.

A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.

www.pharmatech.uniurb.it

The student can request to sit the final exam in English with an alternative bibliography. (Course with optional materials in a foreign language)