TECNOLOGIA FARMACEUTICA -LABORATORIO GALENICO M - Z

Learning Objectives

• Pharmaceutical Technology

  The goal of the course is to provide the fundamental knowledge on the dosage forms, with particular emphasis on the role of the different components and quality controls on the final pharmaceutical form. The student will learn the nature and the classification of the excipients in order to understand the their role in the different dosage forms and administration ways. At the end of the coarse the student should be able to understand and describe the various approaches for optimizing the therapeutic efficacy of an active ingredient.

  EXPECTED LEARNING RESULTS

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

  - Acquire knowledge on the categories and properties of the excipients and how they influence the final characteristics of a medicinal product in terms of quality. Overview of some industrial procedures for the production of pharmaceutical forms. Basic knowledge of quality control tests to be applied to the finished product.
  - Understand the difference between the different pharmaceutical forms (liquid, solid, semi-solid) and their therapeutic purposes.
  - Use the acquired knowledge in the phase of completion of the compulsory pre-degree professional internship.

• GALENIC PREPARATIONS LABORATORY

  The goal of the course is to provide the theoretical knowledge and the practical skills required to compound different dosage forms in a pharmacy laboratory.
  The student will learn how to discriminate the different dosage forms on the base of the prescription or the formulation, as well as to verify the formal and substantial correctness of the prescription according to the current laws and rules.
  The student will apply their knowledge of general, organic and analytical chemistry to understand the suitable compounding.
  The course aims at developing the capability of autonomously establish the proper way of compounding, and storing a dosage form in pharmacy.

  EXPECTED LEARNING OUTCOMES for the module - M-Z Course (A.A. 2018/2019) (4th Year - Master's Degree in Pharmacy - 6 CFU)

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

  Acquire rules of Good Preparation Practice of galenic products in Pharmacy;
  Understand how to complete the product's documentation;
  Apply the current legislation for the correct pricing of a galenic product;
  Verify the quality of the galenic preparation.
  Organize the activity within the galenic laboratory in compliance with the Good Preparation Practice.

Course Structure

• Pharmaceutical Technology

  The course is organized in frontal lessons.

• GALENIC PREPARATIONS LABORATORY

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

Detailed Course Content

• Pharmaceutical Technology

  MODULE 1 (5 credits)
  Stability and biopharmaceutical (1 credit)
  Stability and stabilization of medicinal products, storage, antimicrobials and antioxidants.
  Biopharmaceutical concepts.
  Influence of the type of pharmacutical product on the bioavailability and the activity of the drugs. Preformulation.

  Conventional pharmaceutical forms (4 CFU)
  Water for pharmaceutical use; Suspensions, emulsions, surfactants.
  Liquid preparations for oral use (syrups, powders and granulates for syrups, solutions, emulsions, suspensions, powders for solutions or suspensions, drops, powder for drops).
  Ophthalmic preparations (eye drops, eye baths, eye drops and eye baths, semi-solid ophthalmic preparations, eye inserts).
  Parenteral preparations: classification, routes of administration, physico-chemical properties, excipients and controls.
  Pulmonary pharmaceutical preparations; Pressurized preparations.
  The solid pharmaceutical forms (powders; granules; capsules, tablets): classification, routes of administration, chemical-physical and biological requirements and controls of powders, granules, tablets and capsules. Tablet coating.
  Semi-solid and topical pharmaceutical forms for skin application (ointments, creams, gels, pastes, cataplasms, medicated plasters).
  Rectal Preparations (suppositories).
  Vaginal preparations.
  Nasal and Ear Preparations.

  
  MODULE 2 (4 credits)
  Unconventional and innovative pharmaceutical forms (3 credits)
  Modified-release pharmaceutical forms
  Drug Delivery System: Microemulsions. Vesicular systems (liposomes, niosomes). Micro and nanoparticulate polymeric systems. Lipid nanoparticulate systems (SLN and NLC).
  Chemical approach for the improvement of the chemical-physical properties of drugs: Prodrug and polymeric prodrug; drug-polymer conjugates. Molecular inclusion systems (cyclodextrins).

  Complementary sectors of pharmaceutical interest (1 credits)
  Traditional and modern herbal and herbal preparations.
  Notes on the theoretical foundations and technology of homeopathic medicines.

• GALENIC PREPARATIONS LABORATORY

  Rules of Good Preparation Practice. National Tariff of Medicines to establish the price of galenic product. F.U.I XII Edition and its amendments / supplements, European Pharmacopoeia 9 Edition.

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

  Single-seat exercises with ongoing feedback; techniques for the preparation of the most common pharmaceutical forms galenical, controls on the preparation, documentation. Group exercises will be dedicated to specific topics.

Textbook Information

• Pharmaceutical Technology

  RECOMMENDED TEXTS
  1. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA - second edition - Ambrosiana Publishing House, 2015.
  2. M. Amorosa - Principi di Tecnologia Farmaceutica- Libr. Univ. Tinarelli, Bologna 1998.
  3. M.E. Aulton - PHARMACEUTICAL TECHNOLOGIES Design and preparation of medicines. EDRA editions, 2013.
  4. Medicament VII Edition (1st vol.) - Pharmaceutical Cooperative, Milan.
  
  TEXTS TO CONSULT
  7. F.U.I. XII Ed. And related supplements and updates.
  8. European Pharmacopoeia
  
  9. T.A. Florence & D. Attwood - The chemical-physical bases of pharmaceutical technology - 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. Educational material made available online by teachers.

• GALENIC PREPARATIONS LABORATORY

  1. Farmacopea Ufficiale Italiana XII Edizione e relativi supplementi e 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 in vigore.

  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.