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PHARMACEUTICAL TECHNOLOGY AND DRUG LEGISLATION WITH GALENIC PREPARATION LABORATORY mutuato
TECNOLOGIA E LEGISLAZIONE FARMACEUTICA CON LABORATORIO DI PREPARAZIONI GALENICHE

A.Y. Credits
2018/2019 14
Lecturer Email Office hours for students
Luca Casettari Every weekday, except Saturday, by appointment via e-mail.
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

Pharmacy (LM-13)
Curriculum: PERCORSO COMUNE
Date Time Classroom / Location
Date Time Classroom / Location

Learning Objectives

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.

Program

  • 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.

Bridging Courses

To be able to attend the practical laboratory it is necessary to have passed Organic and attended Chemistry Analysis of Medicines II.

To take the final examination you must have passed the exams of Pharmaceutical and Toxicological Chemistry I, Medicinal Analysis I and Medicinal Analysis II.

Learning Achievements (Dublin Descriptors)

D1 - KNOWLEDGE AND UNDERSTANDING
At the end of this training activity, the student must demonstrate that he is able to:
1) to know in depth the chemical-physical principles underlying pharmaceutical technology;
2) know the fundamental principles for the formulation and preparation of the different dosage forms;
3) know the most commonly used methods for the characterization of active ingredients and excipients, as well as the final formulation;
4) know the fundamental bases of pharmaceutical legislation;
5) to know the main databases of pharmaceutical, legislative and galenic technological interest.


D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING
At the end of this training activity, the student must demonstrate that he is able to:
1) describe the fundamental aspects of pharmaceutical technology;
2) classify and describe the different pharmaceutical forms;
3) prepare and dispense magisterial and officinal galenic preparations;
4) describe the main notions of pharmaceutical legislation;
5) describe the qualitative and quantitative aspects that allow us to correctly predict the experimental results.

D3 - AUTONOMY OF JUDGMENT:
At the end of this training activity, the student must demonstrate that he is able to:
1) acquire the fundamental principles underlying pharmaceutical technology;
2) ability to apply the acquired knowledge and the understanding of the different formulation strategies;
3) evaluation of the formalities and correctness of the different types of medical prescriptions;
4) ability to prepare and dispense a galenic preparation;
5) ability to work in laboratories and to draw up a report.

D4 - COMMUNICATION SKILLS
At the end of the course, students will have to demonstrate that they are able to clearly describe the use of the various notions learned in the course of the training activity.

D5 - LEARNING SKILLS
At the end of this training activity, the student must demonstrate that he is able to find and apply new information, compared to that provided during the training activity, necessary to design, prepare and characterize all the different types of pharmaceutical forms. Furthermore, he / she must be able to find information and update his / her knowledge of pharmaceutical legislation.

Teaching Material

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

Supporting Activities

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

Didactics

Frontal lessons and practical exercises.

Attendance

Check the bridging courses required by your study plan. It is also necessary to pass the practical test before entering the written exam.

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 exam (production of an extemporaneous formulation, 120 minutes), written exam (10 open questions, 90 minutes) and oral exam (15/30 min). To access the written test you must pass the practical test. To access the oral test you must pass the written test.

Notes

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)

« back Last update: 08/09/2021

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