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PHARMACEUTICAL TECHNOLOGY SOCIOECONOMY AND LAW I (WITH PRACTICE)

CODE 67449
ACADEMIC YEAR 2022/2023
CREDITS
  • 12 cfu during the 4th year of 8452 FARMACIA (LM-13) - GENOVA
  • SCIENTIFIC DISCIPLINARY SECTOR CHIM/09
    LANGUAGE Italian
    TEACHING LOCATION
  • GENOVA
  • SEMESTER 1° Semester
    PREREQUISITES
    Prerequisites
    You can take the exam for this unit if you passed the following exam(s):
    • Pharmacy 8452 (coorte 2019/2020)
    • GENERAL AND INORGANIC CHEMISTRY (PHAR)(MD) 55413
    • PHYSICS (PHAR)(MD) 55422
    • ORGANIC CHEMISTRY 60795
    • GENERAL MEDICINAL CHEMISTRY AND MEDICINAL CHEMISTRY I 80319
    • ELEMENTS OF MATHEMATIC 95338
    Prerequisites (for future units)
    This unit is a prerequisite for:
    • Pharmacy 8452 (coorte 2019/2020)
    • PHARMACEUTICAL TECHNOLOGY, SOCIOECONOMY AND LAW II (PHAR MD) 67522
    TEACHING MATERIALS AULAWEB

    OVERVIEW

    Pharmaceutical Technology studies the preparation of different pharmaceutical forms, useful for the drug delivery for a given route of administration. The pharmaceutical legislation is in charge of dealing with the legislation on the medicinal product, from its marketing to the methods of supply and the organization of the Pharmaceutical Service also in relation to the National Health Service.

    AIMS AND CONTENT

    LEARNING OUTCOMES

    The course provides  students with the basic elements of knowledge of the pharmaceutical dosage forms and the main methods used to produce and control them, both industrial and laboratory scale. The normative  section  is directed to the acquisition of the general organization of the National Health Service with particular regard to the  Italian Pharmaceutical Services and the Pharmacy Profession.

    The course also includes laboratory practices concerning the practical preparation of pharmaceutical forms most commonly used.

    AIMS AND LEARNING OUTCOMES

    The student must be able to recognize oral formulations (tablets, capsules, granules, syrups), eye drops, parenteral preparations, preparations for topical use and suppositories that are illustrated starting from the structural description of the excipients present and their properties useful for development of specific formulations.

    The student during the laboratory exercises must be able to individually prepare the dosage forms described in the theoretical part.

     

    PREREQUISITES

    The requirements requested by the student to study  Technology, Socioeconomics and Pharmaceutical Legislation are:

    • knowledge of general chemistry, mathematics and physics, basic subjects provided in the first years of the course
    • knowledge of Pharmaceutical Chemistry.

    These subjects are reported in the "Manifesto degli Studi " in the Pharmacy  course.

    TEACHING METHODS

    The lectures, workshops and exercises will be carried out both remotely via videoconferencing or activities to be carried out on the AulaWeb online platform, and in presidential mode. (according to the indications of the University guidelines foreseen for phase 3- FIRST HALF)

    SYLLABUS/CONTENT

    Pharmaceutical technology

    Incompatibility and interactions.

    Drugs and dosage forms. Active Pharmaceutical Ingredients and Excipients.

    Pharmaceutical processes: particle-size reduction, mixing, granulation, dissolution, filtration, drying, freeze-drying, sterilization.

    Micromeritics: particle size and spherical equivalent diameters. Surface area of powders.  Powders properties: density, porosity, wettability, flowability, hygroscopicity. Polymorphism.

    Solid dosage forms: powders, granules, pellets, tablets, coated tablets, capsules, microcapsules.

    Tablets: compression methods and compressing machines. Physical phenomena of compression process.

    Hard and soft capsules. Manufacturing process.

    Herbal drugs. Preparation and control of extracts, tinctures, alcoholates, hydrolates, essences.

    Liquid dosage forms: solutions, dissolution rate, isotonic solutions.

    Water for pharmaceutical use.

    Syrups.

    Nasal drug delivery.

    Oily formulations:  autoxidation reaction, free radical chain reaction.

    Sterile dosage forms: parenteral dosage forms, ophthalmic dosage forms

    Surface and interfacial tension: methods of determination.

    Zeta potential.

    Disperse systems: colloidal dispersions, emulsions, microemulsions, suspensions. DLVO theory

    Surfactants: definition and classification. HLB values.

    Semi-solid dosage forms:  ointments, creams, gels, pasts.

    Rectal and vaginal drug delivery.

     

    Practicals

    Solid dosage forms: preparation of powders, cachets, capsules.

    Liquid dosage forms: preparation of aqueous solutions, syrups, non aqueous solutions, emulsions, suspensions.

    Semi-solid dosage forms:  preparation of ointments, creams, gels, pasts.

    Rectal and vaginal dosage forms: preparation of rectal and vaginal suppositories.

    Preparation of isotonic eye drops.

    Preparation of polyelectrolyte solutions.

     

    Pharmaceutical Legislation

    Supranational legislation.

    Italian health organization.

    Italian and European Pharmacopoeia.

    Territorial administrative system and pharmacies classification.

    Territorial and hospital pharmacy and service.

    Pharmacist: skills, dispensing and professional responsibilities.

    Dispensing discipline to the public of drugs.

    Human prescription: RR , RNR , RL and RMR.

    Drugs not subject to medical prescription (OTC and SOP).

    Drugs prepared in the pharmacy laboratory. Rules of Good Preparation of medicines in pharmacies (NBP).

    Dispensing discipline to the public of narcotics and psychotropic drugs: DPR 309/90.

    Supervision and control of the pharmacies.

    Ethics of the pharmacist: professional order.

    RECOMMENDED READING/BIBLIOGRAPHY

    Farmacopea Ufficiale Edizione in vigore

    Pharmaceutical Technology Books:

    Michele Amorosa "Principi di Tecnica Farmaceutica", Lib.Universitaria Tinarelli (Bologna)

    P. Colombo e coll.: "Principi di Tecnologie Farmaceutiche", Casa Editrice Ambrosiana (Milano)

    Alfred Martin "Physical Pharmacy", Lea e Febiger. Philadelphia

    H. C. Ansel, S.J. Stockton, Principi di calcolo farmaceutico (Quindicesima edizione),  EDRA (Milano)

    Pharmaceutical legislation books:

    M.Marchetti, P.Minghetti "Legislazione Farmaceutica", Casa Editrice Ambrosiana (Milano)

    Francesca Baratta, Davide Valle e Paola Brusa:“MANUALE DI NORMATIVA DEI MEDICINALI E DEI PRODOTTI PER LA SALUTE” ,  Edizioni Libreria Cortina di Torino.

    M. Cini e P. Rampinelli, Principi di Legislazione farmaceutica II Edizione, Edizioni Minerva Medica

    TEACHERS AND EXAM BOARD

    Exam Board

    ELEONORA RUSSO (President)

    GABRIELE CAVIGLIOLI

    SARA BALDASSARI (Substitute)

    GIANCARLO GROSSI (Substitute)

    CARLA VILLA (Substitute)

    GUENDALINA ZUCCARI (Substitute)

    LESSONS

    Class schedule

    All class schedules are posted on the EasyAcademy portal.

    EXAMS

    EXAM DESCRIPTION

    The exam is oral, as suggested by the rectoral guidelines of 4 May 2020, and follows the indications provided in the following link https://cedia.unige.it/didattica-a-distanza

    Exam schedule

    Date Time Location Type Notes
    05/04/2023 09:30 GENOVA Orale
    21/06/2023 09:30 GENOVA Orale
    05/07/2023 09:30 GENOVA Orale
    19/07/2023 09:30 GENOVA Orale
    06/09/2023 09:30 GENOVA Orale
    20/09/2023 09:30 GENOVA Orale
    05/01/2024 09:30 GENOVA Orale
    07/02/2024 09:30 GENOVA Orale
    21/02/2024 09:30 GENOVA Orale