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 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 M-Z

  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.

Course Structure

• Pharmaceutical Technology

  The course is organized in frontal lessons.

• GALENIC PREPARATIONS LABORATORY

  The GALENICO LABORATORY course will be divided into lectures (2 CFU), participated and cooperatives, during which students will be invited to participate in feedback evaluation activities. The course includes practical exercises in single-place laboratory (2 CFU) and group laboratory exercises dedicated to quality controls (2 CFU).

  Attendance at the course is compulsory and is acquired by attending at least 70% of the practical laboratory exercises, which will be held during the first semester.

  The attendance at the FIRST PRACTICAL LABORATORY LESSON is MANDATORY, as students will be trained / informed about the minimum safety procedures related to the Galenic Laboratory. The practical laboratory lessons will take place from November to January on a weekly basis. The calendar of practical laboratory lessons will be published at the end of October on the Studium page of the course. The starting date of practical exercises will be communicated by the teacher (in the classroom and by means of an online notice on the Pharmacy / DSF website) by the end of October. Considering the limited number of places available in the laboratory, in order to allow an adequate organization of the exercises, it is mandatory to enroll each student in the Studium platform for the Galenico Laboratory module and the simultaneous online booking for practical exercises (to be carried out at starting from the first frontal lesson).

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

  Galenic and industrial medicine, masterly and officinal Galenic. Rules of good preparation. National Tariff of Medicines. Italian F.U. in force and related updates, European Pharmacopoeia in force.

  Basic operations in pharmaceutical technology: dissolution, filtration, drying, freeze-drying, sterilization, pulverization.

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

Textbook Information

• Pharmaceutical Technology

  RECOMMENDED TEXTS
  1. P. Colombo et al. - PRINCIPI DI TECNOLOGIA FARMACEUTICA – seconda edizione – Casa Editrice Ambrosiana, 2015.
  2. M.E. Aulton – TECNOLOGIE FARMACEUTICHE Progettazione e allestimento dei medicinali. Edizioni EDRA, 2013.
  3. Medicamenta VII Ed. (1° vol.) - Cooperativa Farmaceutica, Milano.

  
  TEXTS TO CONSULT

  1. F.U.I. XII Ed. And related supplements and updates.
  2. European Pharmacopoeia
  3. T.A. Florence & D. Attwood - The chemical-physical bases of pharmaceutical technology - McMillan Press 2002.
  4. Martin - Physical Pharmacy - Lea & Febiger, Philadelphia, London.
  5. Remington's Pharmaceutical Sciences, 19th ed.
  6. Livingstone - Pharmaceutics. The science of dosage form design - Ed. ME Aulton.
  7. 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. Paola Minghetti “Legislazione farmaceutica”. Casa Editrice Ambrosiana. Ed. 2018.
  7. Francesca Baratta, Irene De Pellegrini, Maria Beatrice Iozzino, Paola Brusa. Manuale di galenica a uso umano e veterinario. Casa Editrice Ambrosiana (Ed. 2019).