Università degli Studi di Roma "Tor Vergata"

DESCRIPTION OF TEACHING MODULE: Pharmacopoeias: their significance and use. Active substances: specifications and physical, chemical, mechanical and biological properties, reference and working standards. Excipients: Anticaking agents, antioxidants, binders, coating & colouring agent, diluents, disintegrants, dissolution retardants, flavouring agents, glidants, lubricants, preservative & solubilising agents, sweetening agents, wetting agents, fillers. Composition and control test for conventional oral pharmaceutical formulations: coated and uncoated tablets, hard and soft-shell capsules, granules, and powders. Ophthalmics: immediate and sustained release formulations. Suppositories and pessaries. Pharmaceutical manufacturing processes: milling, mixing, sieving, granulation and drying, compaction. Pharmaceutical development: concept of preformulation, choice of the pharmaceutical dosage form, excipient compatibility, stress tests, stability indicating purity test; Assay, development and validation. Biopharmaceutical Classification System of active principles. In vivo/in vitro correlations. Packaging and ICH stability studies: stress, accelerated and long term stability studies. Pharmaceutical project planning and management

DIDACTIC MATERIALS: lesson slides STRUCTURE OF TEACHING MODULE (CFU/ TIMETABLE): 6 CFU / Tuesday and Thursday 9.00-11.00 REFERENCES: "Pharmaceutics: The science of Dosage Form Design", Edited by M.E.Aulton, Churchill Livingstone, N.Y. "Principi di tecnologie farmaceutiche", P.Colombo, P.L.Catellani, A.Gazzaniga, E.Menegatti, E.Vidale, Casa Editrice Ambrosiana "Physical Pharmacy", A.Martin Ed., Williams & Wilkins, Baltimore “La fabbricazione industriale dei medicinali”; Fabris l: Rigamonti A. . Casa Editrice Esculapio, 2008 Farmacopea Ufficiale della Repubblica Italiana (current edition) European Pharmacopoeia (Current edition)

DESCRIPTION OF TEACHING MODULE: Introduction to biopharmaceutics Blood levels and therapeutic effects. Routes of administration. Mechanisms of drug dissolution and absorption. Compartment models and pharmacokinetic parameters. Apparent distribution volume. Drug-protein interaction. Drug and dosage form degradation. Expiring date of medicines. Sterilization processes. Bacterial endotoxins. Limulus test. Glass for pharmaceutical uses. Isotonic and iso-osmotic solutions and calculations. Alcohol in pharmaceutical formulations. Ethyl alcohol dilution. Alcohol determination in pharmaceutical preparations. Lyophilization. Interfacial phenomena. Surface tension. Surfactants. Wetting. Micelles. Disperse systems: emulsions and suspensions. Basic principles of rheology. Classification of dosage forms. An overview on the various dosage forms. Innovative dosage forms. Modified release dosage forms. Drug targeting.

DIDACTIC MATERIALS: Copies of the slides presented during the lessons "Pharmaceutics: The science of Dosage Form Design", Edited by M.E.Aulton, Churchill Livingstone, N.Y. "Principi di tecnologie farmaceutiche", P.Colombo, P.L.Catellani, A.Gazzaniga, E.Menegatti, E.Vidale, Casa Editrice Ambrosiana "Physical Pharmacy", A.Martin Ed., Williams & Wilkins, Baltimore Italian Pharmacopoeia (Last Edition and supplements) European Pharmacopoeia (Last Edition and supplements)