LEARNING OUTCOMES

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.

PREREQUISITES

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.

TEACHING METHODS

The lectures, workshops and exercises will be carried out both remotely via videoconferencing or activities to be carried out on the AulaWeb online platform, and in presidential mode. (according to the indications of the University guidelines foreseen for phase 3- FIRST HALF)

SYLLABUS/CONTENT

Pharmaceutical technology

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.

Syrups.

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.

Zeta potential.

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.

Practicals

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.

Pharmaceutical Legislation

Supranational legislation.

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.

RECOMMENDED READING/BIBLIOGRAPHY

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