PHARMACEUTICAL TECHNOLOGY, SOCIOECONOMY AND REGULATIONS WITH LABORATORY EXERCISES M - Z

To give the basic knowledge for the preparation and control of dosage forms together with the basic concepts relating to the pharmaceutical legislation and socioeconomic aspects of the drug.

Frontal lectures and laboratory exercises

Pharmaceutical Technology: The Pharmaceutical dosage form concept: overview and evolution of pharmaceutical dosage forms. Choice of the dosage form according to the therapeutic goals. Pre-formulation studies: objectives and drug chemical-physical characterization. Drug-excipients interaction. Drug stability. Pharmaceutical dosage form and routes of administration. Drug pharmacokinetic (absorption, distribution, metabolism, elimination). Bioavailability and bioequivalence of pharmaceutical dosage forms and determination methods. Powders: preparation methods. Particle size analysis. Powder density. Porosity. Adsorption phenomena. Powder mixing and granulation. Evaluation methods of powders and granulates. Tablets. Preparation methods. Excipients. Quality assurance. Disintegration, disaggregation and dissolution phenomena. Coating: aim, materials and instrumentation required. Checks on coated tablets. Hard and soft capsules, microcapsules, nanocapsules. Technological and biopharmaceutical features. The features of water as solvent: preparation of deionized and distilled water. Water and Italian Pharmacopeia. Solid solubility and solubilization; pH and isotonia. Solution colligative properties. Rheology. Newtonians and no-newtonians fluids. Viscosity determination. The colloid state – colloids. Colloidal systems of pharmaceutical interest. Z potential. Emulsions. Stability of emulsions. Surfactants. The HLB system and the HLB determination. Chemical and physical characteristics of surfactants. Pharmaceutical suspensions. Settling of suspended particles. Suspension stability. Application of suspensions in pharmaceutical field. Gels: rheological features, preparation and application. Dermatological preparations; Drug percutaneous absorption. Formulation strategies. Penetration enhancers. Main features of the vehicles and excipients. Suppositories: Biopharmaceutical aspects of rectal absorption. The choice and the control of excipients. Preparation and control of suppositories. Sterilization techniques: physical, chemical and thermal methods. Microorganisms: main characteristics and resistance phenomena. Medication of the eye; Anatomy of the eye; Absorption of drugs applied to the eye. Influence of formulation. Parenteral formulations. Vehicles; sterile containers and quality assurance; chemical, chemical-physical and biological requirements of parenteral formulations. Powders for parenteral injections. Drying of herbal drugs; Main techniques of extraction and processing of plant extracts. Definition of plant complex. Quality assurance and control methods. Controlled release pharmaceutical forms and therapeutic systems. Drug targeting.

Pharmaceutical socioeconomy and regulations: National and supranational health organization. The pharmaceutical service and its territorial organization. Drug classification (Dlvo 219/2006). Regulations on medicinal selling. The authorization system for the manufacturing and selling of drugs. Medicinal prices. Regulation on narcotic and psychotropic substances. Good manufacturing procedures. Regulations on the market of cosmetics, homeopathics, phytotherapeutics, dietary supplements, and medical devices.

Laboratory exercises: Lessons and exercises about the formulation and the prices of galenic and evaluation of shipment of a medical recipe according to the recent regulations; individual practical formulation of the major pharmaceutical forms dispensable in pharmacies; quality control of some pharmaceutical forms prepared in the laboratory, according to Eur. Ph.

1. P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale – Principi di Tecnologie Farmaceutiche (seconda ed.) – Casa Editrice Ambrosiana
2. M. AMOROSA - Principi di Tecnica Farmaceutica - Libr. Univ. Tinarelli. Bologna.
3. P. MINGHETTI - Legislazione Farmaceutica – nona edizione - Casa Editrice Ambrosiana
4. REMINGTON - Remington's Pharmaceutical Sciences - Ed. Mack Pul. co.
5. MARTIN, J. Swarbrick, A. Cammarata - Physical Pharmacy - Lea & Febiger, Phil., USA.
6. L.. SHARGEL. A.BC. YU - Biofarmaceutica e Farmacocinetica - Masson.
7. F.U.I. XII Ed.
8. BOOTMAN, TOWNSEND, Mc Ghan - Introduzione alla Farmacoeconomia- OEMF, Milano