TECNOLOGIA FARMACEUTICA - LABORATORIO GALENICO A - L

Learning Objectives

• Pharmaceutical Technology and Laboratory of Pharmaceutical Technology

  The course aims to deepen technological, biopharmaceutical and formulative aspects of both traditional and innovative pharmaceutical formulation, now available to the medical therapy.

  In particular, it will be pay great attention to the fields of interest concerning the preparation of both magistral and officinal galenic medicines, and controls assay provided by the NBP (Guidelines of good preparation) and the Pharmacopoeia in force.

• Laboratory of Pharmaceutical Galenic

  The main objective of the course is to provide students with the basic knowledge for the shipment of a galenic recipe and to deepen their knowledge on galenic preparations, main pharmaceutical operations and current legislation.

  The course is organized in lectures and laboratory exercises, both single and group.

  During the laboratory exercises the student will have the opportunity to face in itinere tests (evaluation to feedback) on the shipment of a galenic recipe, in order to facilitate the learning process.

   

  EXPECTED LEARNING OUTCOMES - GALENIC LABORATORY A-L

  At the end of the course the student will be able to:

  - Acquire awareness of the pharmacist's responsibilities within the galenic laboratory;
  - Understand the correct way to complete the documentation supplied with the shipment of a galenico;
  - Apply the current legislation for the correct pricing of a galenic;
  - Recognize the mandatory formal aspects in a masterly prescription for the purposes of its acceptance;
  - Evaluate the checks to be carried out when shipping a magistral galenic prescription;
  - Establish the main galenic pharmaceutical forms in the solid, liquid and semisolid state;
  - Organize the activity within the galenic laboratory in compliance with the NBP.

Detailed Course Content

• Pharmaceutical Technology and Laboratory of Pharmaceutical Technology

  PART 1 (5 CFU)

  SECTION 1A

  Stability and biopharmaceutic (1 CFU)

  Stability and stabilization of medicinal

  Rules for the proper preservation, preservatives (antimicrobials and antioxidants), general characteristics of the containers for medicines.

  Concepts of biopharmaceutic

  Influence of selected formulation on the bioavailability and activity of drugs. Preformulation.

  Conventional pharmaceutical preparations (4 CFU)

  Water for pharmaceutical use; aqueous and hydroalcoholic solutions in pharmacy; suspensions, emulsions, surfactants.

  Liquid preparations for oral use (syrups, powders and granules for syrups, solutions, emulsions, suspensions, powders for solutions or suspensions, drops, powders drops).

  Ophthalmic preparations (eye drops, eye baths, powders for eye drops and eye baths, ophthalmic semisolid preparations, ocular inserts).

  Parenteral preparations: classification, routes of administration, requirements, chemico-physical and biological assays.

  Pressurized pharmaceutical forms.

  The solid dosage forms: classification, routes of administration, requirements, chemico-physical and biological assays of powders, granules, tablets and capsules. Coating of tablets: pelleting, filming, enteric coatings.

  Semi-solid and topical pharmaceutical forms.

  Semi-solid preparations for cutaneous application (ointments, creams, gels, pastes, poultices, medicated plasters).

  Rectal preparations (suppositories).

  Vaginal preparations (ovules)

  Nasal and headsets preparations.

   

  PART 2 (4 CFU)

  Unconventional and innovative pharmaceutical preparations (3 CFU)

  Pharmaceutical preparations to achieve modified release

  Oral forms, trans-mucosal, ophthalmic, subcutaneous grafting plants, transdermal systems.

  Drug Delivery System (DDS) for drug release

  Vesicular systems (liposomes, niosomes). Micro and nanoparticulate polymeric systems. Lipidic nanoparticulate systems (SLN and NLC).

  Chemical approach for the improvement of drug physico-chemical properties

  Prodrugs and polymeric prodrugs, drug-polymer conjugates, molecular inclusion systems (cyclodextrins).

  Complementary fields of pharmaceutical interest (1 CFU)

  Traditional and modern herbal preparations.

  Outline of the theoretical fundamentals and the technology of homeopathic preparations.

   

  LABORATORY OF PHARMACEUTICAL GALENIC (5 CFU)

  Fundamental pharmaceutical operations

  Basic operations in pharmaceutical technology

  Solution, filtration, concentration, drying, freeze drying, sterilization, grinding and pulverizing, granulating.

  Definition and development of medicines. Galenic and industrial medicines. Official Italian Pharmacopoeia (F.U.I.) XII edition. European Pharmacopoeia VIII Edition. Guidelines of good preparation (N.B.P.).

  The magistral preparation (exercises to individual place)

  Exam concerning the delivery of prescriptions. Incompatibility. Rate National of Medicines. Techniques for the preparation of the most common galenic pharmaceutical forms.

  Lessons will be supplemented by group seminars.

• Laboratory of Pharmaceutical Galenic

  Galenic and industrial medicine, masterly and officinal Galenic. Rules of good preparation. National Tariff of Medicines. F.U. XII Edition and related updates, European Pharmacopoeia 9 Edition.

  Basic operations in pharmaceutical technology: solution, filtration, concentration, drying, freeze-drying, sterilization, pulverization, granulation.

  Single-seat exercises with ongoing evaluation on feedback related to the shipping of a masterly galenic recipe: techniques for the preparation of the most common pharmaceutical forms galenical, controls on the recipe and preparation, documentation. Group exercises will be dedicated to specialized topics.

Textbook Information

• Pharmaceutical Technology and Laboratory of Pharmaceutical Technology

  SUGGESTED BOOKS FOR STUDY
  1. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda
  edizione – Casa Editrice Ambrosiana, 2015.
  2. M. Amorosa – PRINCIPI DI TECNICA FARMACEUTICA - Libr. Univ. Tinarelli,
  Bologna 1998.
  3. M.E. Aulton – TECNOLOGIE FARMACEUTICHE Progettazione e allestimento dei
  medicinali. Edizioni EDRA, 2013.
  4. Medicamenta VII Ed. (1° vol.) - Cooperativa Farmaceutica, Milano.
  5. Enrico Ragazzi “Galenica Pratica” Formulazione e Tecnologia. – Ed. 2006 – Libreria
  Internazionale Cortina Padova.
  6. Franco Bettiol - Manuale delle preparazioni galeniche Tecniche Nuove Ed. 2003.

  Updates are available on the site Lecturer: https://sites.google.com/site/puglisipharmtech/home/materiale-didattico/tecnologia-farmaceutica

  
  BOOKS TO BE CONSULTED
  7. F.U.I. XII Ed. and supplements.
  8. Farmacopea Europea VIII Ed. and supplements.
  9. T.A. Florence & D. Attwood – Le basi chimico-fisiche della tecnologia farmaceutica -
  McMillan Press 2002.
  10. Martin - Physical Pharmacy - Lea & Febiger, Philadelphia, London.
  11. Remington’s Pharmaceutical Sciences, 19th Ed.
  12. Livingstone – Pharmaceutics. The science of dosage form design- Ed. ME Aulton.
  13. Teacher's online slides.

• Laboratory of Pharmaceutical Galenic

  1. Farmacopea Ufficiale Italiana XII Edizione e relativi aggiornamenti.

  2. Decreto Ministero della Sanità del 22 settembre 2017 (Tariffa Nazionale dei Medicinali), Allegati A e B, secondo aggiornamento del 30.01.2018

  3. Farmacopea Europea 9° edizione.

  4. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.

  5. Enrico Ragazzi “Galenica Pratica” Formulazione e Tecnologia. – Ed. 2006 – Libreria Internazionale Cortina Padova.

  6. Franco Bettiol - Manuale delle preparazioni galeniche Tecniche Nuove Ed. 2003.