32044 - Technology, Socio-economics and Pharmaceutical Legislation I

Learning outcomes

At the end of the course the student-has the specific knowledge for the formulation of pharmaceutical forms both pharmaceutics and industrial. It? also aware of the legislation that regulates the industrial production of medicines and their dispensing in pharmacies open to the public and hospital. - Is physically able to perform any dosage form as well as to assess the legality of a prescription and to interpret the provisions governing the pharmaceutical service. -is able to use the main official texts such as the Pharmacopoeia of the Italian Republic and the European Pharmacopoeia. -is able to plan the production of a medicine as well as to understand and critically evaluate the sector regulations.

Course contents

PHARMACEUTICAL TECHNOLOGY (module 1 - Dott.ssa Guendalina Zuccari)

The pharmaceutical form as a means for the administration of medicines. Characteristics of the pharmaceutical form that affect the therapeutic response. Basic elements of biopharmaceutical. The excipients in pharmaceutical forms and their influence on the release of the active principle. The Official Pharmacopoeia.
  The pharmaceutical solid dosage forms: powders, methods of spraying, preparation of freeze-dried powders, granules, tablets, capsules, tablets, medicated chewing gum, coated tablets (caplets and confetti), pills, boluses and granules.
  The solutions: theory of dissolution, solubility and dissolution rate, aqueous, alcoholic, oily, gliceriche, syrups. Preservation of microbial pollution solutions: control of microbial contamination of products not necessarily sterile.
  The rheology: theoretical basis of rheology: shear stress and viscosity, rheological behavior of dosage forms, Newtonian and non-Newtonian fluids, fluids, plastic and pseudoplastic, thixotropic, capillary and rotational viscometers.
  The dispersed systems: suspensions and colloidal dispersions, flocculated and deflocculated suspensions, zeta potential, surface tension and interfacial, surfactants, emulsions and budget hydrophilic / lipophilic (HLB), oil / water emulsions and water / oil emulsion stability, oral emulsions and their stabilization.
  The pressurized preparations: propellants, containers, spray devices.
  The semi-solid preparations for cutaneous application (ointments): ointments, pastes, creams, gels, hydrophilic and lipophilic ingredients, excipients that incorporate water, methods of preparation and cold fusion.
  Suppositories: rectal and vaginal preparations, lipophilic and hydrophilic excipients, methods of preparation.
  Sterile Preparations: parenteral preparations, aseptic preparation, water for injections, sterilization, sterilization methods with heat with gas, with radiation.
  Ophthalmic preparations: eye drops, eye baths, ophthalmic inserts, ownership of eyedrops: Sterility, isoidria, isotonic.
  Prepared from vegetable drugs: extraction methods, fluid extracts, soft and dry, tinctures, infusions, decoctions, essential oils.
  Controlled release preparations: techniques for controlling the release of active ingredient in pharmaceutical dosage forms, therapeutic systems, transdermal therapeutic systems.
  The rules of good preparation of medicines in pharmacies: official formula and masterful organization of a workshop in galenic pharmacy.
  Homeopathic preparations: basics of homeopathy, homeopathic dilutions of technology.

PHARMACEUTICAL LEGISLATION (Form 2 - Dott.ssa P. Rampinelli)

Socioeconomics - The pharmaceutical market, pharmaceutical expenditure within the total health expenditure, the pharmaceutical cost containment policies, outline of brevettistica pharmaceutical industry.
  Legislation - General principles of national and Community law. The Italian Health Organisation. The health professions. The professional responsibilities of the pharmacist. Articulation of the pharmaceutical service: staffing plan of pharmacies, pharmacies urban and rural allocation of seats pharmaceutical forms of management of pharmacies (individuals, partnerships, cooperatives), private pharmacies and public forms of management of public pharmacies, management Safe, pharmacies branches, pharmacies, pharmacists National Health Service. The exercise of the profession of pharmacist: the practice of pharmacy, shipment of recipes, the Farmacoopea Officer, the National Rate, drugs, poisonous substances, the definition of a medicinal product, the marketing authorization of medicinal products the classification in the supply of medicinal products for human use subject to medical prescription medicines (Tables 4:05 FU), recipes and privacy, the wholesale distribution of medicinal products for human use, labeling and package leaflet for the medicines, the advertising of medicinal products for human use, supervision of the pharmaceutical service, relations with the national health service, pharmacovigilance, medicinal products with performance-enhancing drugs, veterinary medicines, medicinal plants, medical devices, medical devices, foodstuffs intended for particular nutritional uses , cosmetics.

Readings/Bibliography

RECOMMENDED BOOKS
- Principles of Pharmaceutical Technology - Casa Editrice Ambrosiana - Milan.
- Compendium of Pharmaceutical Legislation - M. Cini, P. Rampinelli - Edizioni Minerva Medica - Turin (with updates on AMS Campus)
- Principles of Pharmaceutical Technology - M. Amorosa - University Library Tinarelli, Bologna. 

Teaching methods

Theorical lessons (72 h) and laboratory practise (48 h).

Assessment methods

Form technology
  The exam is designed to assess the achievement of essential knowledge of pharmaceutical technology. This knowledge is preparatory to the apprenticeship in pharmacy. In particular, the student must demonstrate:
  a) know pharmaceutical forms to fit, both industrially and in a galenic laboratory with particular reference to the role played by excipients and procedures for the issuance of the active ingredients.
  b) knowledge of testing according to the Pharmacopoeia in force for the control of finished dosage forms.
  Pharmaceutical technology and legislation I - Form pharmaceutical legislation
  The student must demonstrate full knowledge of the rules governing the marketing of medicines and other health products. Must have knowledge about the organization of the pharmaceutical service in Italy in accordance with the legislation in force.

Laboratory module (exercises)
  At the end of the practical exercises in a single place the student takes a practical test consisting in the delivery of a prescription. The test has no expiry date, and is preliminary oral examination. The test is evaluated as a whole through a judgment is the final proof that the experiences carried out daily. The result will be worth as an element of evaluation for the purposes of the final grade.

Teaching tools

Slides and laboratory for practical exercises.

Office hours

See the website of Guendalina Zuccari

See the website of Patrizia Rampinelli