Università degli Studi di Perugia

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Unit PHARMACEUTICAL TECHNOLOGY, SOCIO-ECONOMICS AND LEGISLATION I AND PHARMACEUTICAL TECHNOLOGY, SOCIO-ECONOMICS AND LEGISLATION II

Course
Pharmacy
Study-unit Code
65082014
Location
PERUGIA
Curriculum
In all curricula
Teacher
Valeria Ambrogi
CFU
14
Course Regulation
Coorte 2015
Offered
2018/19
Type of study-unit
Obbligatorio (Required)
Type of learning activities
Attività formativa integrata

PHARMACEUTICAL TECHNOLOGY, SOCIO-ECONOMICS AND LEGISLATION I

Code 65080008
Location PERUGIA
CFU 8
Teacher Valeria Ambrogi
Teachers
  • Valeria Ambrogi - Didattica Ufficiale
Hours
  • 79 ore - Didattica Ufficiale - Valeria Ambrogi
Learning activities Caratterizzante
Area Discipline chimiche, farmaceutiche e tecnologiche
Sector CHIM/09
Type of study-unit Obbligatorio (Required)
Language of instruction Italian
Contents Conventional dosage forms for drug administration.
Reference texts P. Colombo et al., Principi di Tecnologie Farmaceutiche, Casa Editrice Ambrosiana, Milano, 2015;

reference material given by the teacher.

M.E. Aulton, K.M.G. Taylor, Tecnologie farmaceutiche, Progettazione e allestimento dei medicinali, eds Aulton
Educational objectives The course represents the first teaching of Pharmaceutical Technology. The aim of the course is giving the necessary expertise in the field of conventional dosage forms for drug administration. The student will be able to apply the knowledge of the technological pharmaceutics to the preparation and control of conventional industrial pharmaceutical products and galenics.
Prerequisites The student has to posses the basic notions of the conventional pharmaceutical dosage forms.
Teaching methods Lessons face-face and practical training
Learning verification modality The exam is one exam with Pharmaceutical Technology II. The exam consists of a written and an oral test. The written test is passed if the student reaches 18/30 and is valid for six months, within which the student must pass the oral examination. The written exam is divided as follows:

- Multiple choice quiz concerning topics discussed during course. This kind of test allows to verify the student's ability to apply theoretical knowledge by adopting a mode of examination similar to that provided in many public selections.
- Simulation of a prescription concerning a galenic formulation. For passing the test, students must correctly identify the type of prescription and indicate its formalism, correctly describe the preparation of the prescribed formula and quality controls which must be performed, indicate all aspects inherent the Good Manifacturing Practice Guidelines for the pharmacist. This test allows to evaluate the acquisition of theoretical and practical knowledge regarding the dispensing of medicines in the pharmacy.

The oral test can be taken after the written test. It consists on a discussion-interview on the topics discussed during the course. The test lasts about 30 minutes , but it depends on the performance of the test itself. The oral test aims at verifying the level of knowledge and understanding, as well as synthesis, achieved by the student. Moreover this oral test will verify if the student is able to communicate, his property of language and exposure on the topics studied.
Extended program Drug and dosage forms, excipients in pharmaceutical dosage forms: functions and classification. Characteristics of the dosage forms which influence the therapeutic response: bioavailability.

Solid dosage forms: powders, polverization, lyophilization, fundamental and derivative powder properties, granulometric determination; - granulates: methods of granulation; - tablets: compression phases, alternative and rotating tablettings; - capsules; - medicated chewing gum; - coated tablets.

Liquid dosage forms: solutions, dissolution, solubility, concentration, colligative properties, pH; different kinds of solutions: aqueous, alcoholic , glyceric, oily solutions, Syrops. Stability.

Rheology: general aspects, reology behaviour of pharmaceutical dosage forms, plastic and pseudoplastic fluids, tissotropic behaviour, viscosimetry,

Disperse systems: colloidal dispersions, zeta potential, emulsions, suspensions, surfactant agents, hydrophilic/lipophilic balance. Suspensions: Stokes law, flocculation and deflocculation. Emulsions oli in water and water in oil. Stability.

Semisolid dosage forms for cutaneous application: ointment, ceam, gel, paste. Lipophilic and hydrophilic excipients. Preparation methods.

Parenteral forms, sterilization.

Ophthalmic dosage forms and their properties.

Rectal, vaginal formulations.

Technological tests according to Pharmacopoeia.

Extractive formulations from botanicals: fluid, dried extracts, tinctures, infusion, decoction, essential oils.

Technological controls according to Italian Pharmacopoeia.

Overview of pharmacoeconomics

Practical part: main tecnological operations: polverization, granulometric exam of a powder, mixing, granulation. Oromucosal galenic preparations, novel dermatological semisolid formulations Written comments on a prescription.

PHARMACEUTICAL TECHNOLOGY, SOCIO-ECONOMICS AND LEGISLATION II

Code 65088006
Location PERUGIA
CFU 6
Teacher Maria Cristina Tiralti
Teachers
  • Maurizio Ricci - Didattica Ufficiale (Codocenza)
  • Cinzia Pagano - Didattica Ufficiale (Codocenza)
  • Maria Cristina Tiralti - Didattica Ufficiale
  • Maria Cristina Tiralti - Didattica Integrativa
Hours
  • 16 ore - Didattica Ufficiale (Codocenza) - Maurizio Ricci
  • 74 ore - Didattica Ufficiale (Codocenza) - Cinzia Pagano
  • 21 ore - Didattica Ufficiale - Maria Cristina Tiralti
  • 3 ore - Didattica Integrativa - Maria Cristina Tiralti
Learning activities Caratterizzante
Area Discipline chimiche, farmaceutiche e tecnologiche
Sector CHIM/09
Type of study-unit Obbligatorio (Required)
Language of instruction Italian
Contents Galenic pharmacy. The galenic laboratory. Principales pharmacopoeias. Good Practice Galenic Preparation. Classifications of medicinal products. Sending prescriptions. - D.L.vo 219/2006. Classification of pharmacies. Organization of NHS and pharmacist's role. Inspections in pharmacy

Traditional Galenic preparations laboratory
Reference texts Minghetti P., - Legislazione Farmaceutica, CEA, IX ed.,2018
Educational objectives Acquisition of theoretical and practical knowledge regarding preparation and dispensing of medicines in the pharmacy.

Knowlegde of pharmaceutical Legislation
Prerequisites Basic notions of general and organic chemistry, anatomy, biology and physiology
Teaching methods Face to face and practical lessons
Learning verification modality Written and oral test
Extended program Galenic pharmacy. Legal rules for the preparation and dispensing of compouded medicines. The galenic laboratory. Principales pharmacopoeias. Good Practice Galenic Preparation. Definition of medicinal procuct. Classifications of medicinal products. Sending prescriptions. Manufacturing Authorization and medicinals placing of marketing procedures, EMA and AIFA role. Labelling, package leaflet, advertising and information - D.L.vo 219/2006. Classification of pharmacies. Organization of NHS , the pharmacy and pharmacist's role in NHS. Inspections in pharmacy

Galenic preparations laboratory: simple and compound powders, powder papers, capsules, tablets, suspensions, emulsions, solutions, syrups, ointments, creams, pastes, gels. Herbal medicines
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