PHARMACEUTICAL TECHNOLOGY SOCIOECONOMY AND LAW I (WITH PRACTICE)
Pharmaceutical Technology studies the preparation of different pharmaceutical forms, useful for the drug delivery for a given route of administration. The pharmaceutical legislation is in charge of dealing with the legislation on the medicinal product, from its marketing to the methods of supply and the organization of the Pharmaceutical Service also in relation to the National Health Service.
The course provides students with the basic elements of knowledge of the pharmaceutical dosage forms and the main methods used to produce and control them, both industrial and laboratory scale. The normative section is directed to the acquisition of the general organization of the National Health Service with particular regard to the Italian Pharmaceutical Services and the Pharmacy Profession.
The course also includes laboratory practices concerning the practical preparation of pharmaceutical forms most commonly used.
AIMS AND LEARNING OUTCOMES
The student must be able to recognize oral formulations (tablets, capsules, granules, syrups), eye drops, parenteral preparations, preparations for topical use and suppositories that are illustrated starting from the structural description of the excipients present and their properties useful for development of specific formulations.
The student during the laboratory exercises must be able to individually prepare the dosage forms described in the theoretical part.
The requirements requested by the student to study Technology, Socioeconomics and Pharmaceutical Legislation are:
- knowledge of general chemistry, mathematics and physics, basic subjects provided in the first years of the course
- knowledge of Pharmaceutical Chemistry.
These subjects are reported in the "Manifesto degli Studi " in the Pharmacy course.
Incompatibility and interactions.
Drugs and dosage forms. Active Pharmaceutical Ingredients and Excipients.
Pharmaceutical processes: particle-size reduction, mixing, granulation, dissolution, filtration, drying, freeze-drying, sterilization.
Micromeritics: particle size and spherical equivalent diameters. Surface area of powders. Powders properties: density, porosity, wettability, flowability, hygroscopicity. Polymorphism.
Solid dosage forms: powders, granules, pellets, tablets, coated tablets, capsules, microcapsules.
Tablets: compression methods and compressing machines. Physical phenomena of compression process.
Hard and soft capsules. Manufacturing process.
Herbal drugs. Preparation and control of extracts, tinctures, alcoholates, hydrolates, essences.
Liquid dosage forms: solutions, dissolution rate, isotonic solutions.
Water for pharmaceutical use.
Nasal drug delivery.
Oily formulations: autoxidation reaction, free radical chain reaction.
Sterile dosage forms: parenteral dosage forms, ophthalmic dosage forms
Surface and interfacial tension: methods of determination.
Disperse systems: colloidal dispersions, emulsions, microemulsions, suspensions. DLVO theory
Surfactants: definition and classification. HLB values.
Semi-solid dosage forms: ointments, creams, gels, pasts.
Rectal and vaginal drug delivery.
Solid dosage forms: preparation of powders, cachets, capsules.
Liquid dosage forms: preparation of aqueous solutions, syrups, non aqueous solutions, emulsions, suspensions.
Semi-solid dosage forms: preparation of ointments, creams, gels, pasts.
Rectal and vaginal dosage forms: preparation of rectal and vaginal suppositories.
Preparation of isotonic eye drops.
Preparation of polyelectrolyte solutions.
Italian health organization.
Italian and European Pharmacopoeia.
Territorial administrative system and pharmacies classification.
Territorial and hospital pharmacy and service.
Pharmacist: skills, dispensing and professional responsibilities.
Dispensing discipline to the public of drugs.
Human prescription: RR , RNR , RL and RMR.
Drugs not subject to medical prescription (OTC and SOP).
Drugs prepared in the pharmacy laboratory. Rules of Good Preparation of medicines in pharmacies (NBP).
Dispensing discipline to the public of narcotics and psychotropic drugs: DPR 309/90.
Supervision and control of the pharmacies.
Ethics of the pharmacist: professional order.
Farmacopea Ufficiale Edizione in vigore
Pharmaceutical Technology Books:
Michele Amorosa "Principi di Tecnica Farmaceutica", Lib.Universitaria Tinarelli (Bologna)
P. Colombo e coll.: "Principi di Tecnologie Farmaceutiche", Casa Editrice Ambrosiana (Milano)
Alfred Martin "Physical Pharmacy", Lea e Febiger. Philadelphia
H. C. Ansel, S.J. Stockton, Principi di calcolo farmaceutico (Quindicesima edizione), EDRA (Milano)
Pharmaceutical legislation books:
M.Marchetti, P.Minghetti "Legislazione Farmaceutica", Casa Editrice Ambrosiana (Milano)
Francesca Baratta, Davide Valle e Paola Brusa:“MANUALE DI NORMATIVA DEI MEDICINALI E DEI PRODOTTI PER LA SALUTE” , Edizioni Libreria Cortina di Torino.
M. Cini e P. Rampinelli, Principi di Legislazione farmaceutica II Edizione, Edizioni Minerva Medica
ELEONORA RUSSO (President)