METHODOLOGY OF GALENICAL DEVELOPMENT

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Single discipline educational activity

Course Sheet

Course code:

MSG010

Academic Year of enrolment:

2020

Year of supply:

2024/2025

Type of Course:

Related/Supplementary

Degree:

Course of Single Cycle Degree 5 years in MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY

Disciplinary Sector:

Applied Technological Pharmaceutics

Language:

Italian

Location:

CHIETI

Credits:

Programme Year:

Professor and Collaborators:

CILURZO FELISA

Cycle:

First semester

Obligatory attendance:

Yes

Minimum hours of attendance:

Hours of classroom activity:

Individual study hours:

Prerequisites:

Tecnologia e Legislazione Farmaceutiche con Laboratorio

Objectives

The course offers the basis for the design, preparation and chemical-physical characterization of galenic dosage forms.

Contents

Italian Official Pharmacopea (F.U.I), fundamentals, ethical, practical and professional implications for pharmacists. Connection between Italian Official Pharmacopea and European Pharmacopea, British Pharmacopea, United States Pharmacopea.
Mixing and milling of solid dosage forms.
Grinding and physicochemical tests of solid dosage forms.
Pre-formulations and tableting of solid dosage forms.
Capsule machines and preparation of hard capsules containing solid dosage forms.
Physicochemical characterization and technological parameters of solid dosage forms.
Film and sugar coating of tablets and capsules.
Disaggregation and dissolution tests of capsules and tables.
Liquid dosage forms.
Physicochemical characterization and technological properties of liquid dosage forms.
Liquid and semisolid formulations for skin delivery of drugs.
Physicochemical characterization and technological properties of liquid and semisolid formulations for skin delivery.
Synthesis and physicochemical characterization of lipid colloidal nanoparticles and vesicles for pharmaceutical use

Extended Syllabus

Recommended Bibliography

Farmacopea Ufficiale Italiana (F.U.I.) XII Edizione. Farmacopea Europea. Preparati galenici per uso umano, Ultima edizione. - AMOROSA M., Principi di tecnica farmaceutica, Libreria Universitaria Tinarelli, Bologna, Ultima edizione. - RAGAZZI E., Principi di Tecnica Farmaceutica, Libreria Cortina, Padova, Ultima edizione. - REMINGTON'S PHARMACEUTICAL SCIENCE, Ultima edizione. - MEDICAMENTA, Cooperativa Farmaceutica, Milano, Ultima edizione. - MARCHETTI M., MINGHETTI P., Legislazione Farmaceutica, Casa Ed. Ambrosiana, Ultima Edizione. - COLOMBO P., CATELLANI P.L., GAZZANIGA A., MENEGATTI E., VIDALE E., Principi di tecnologie farmaceutiche, Ambrosiana, Milano, Ultima edizione, - AULTON Tecnologie Farmaceutiche, Progettazione e allestimento dei medicinali, Caviglioli G., Coviello T., De Rosa G., Modena T., Ultima edizione; A.T. FLORENCE, D. ATTWOOD Le basi chimico-fisiche della tecnologia farmaceutica. Edises Ultima edizione.

Methods of Provision

Conventional

Teaching Methods

The course includes laboratory work individual activity that aims to make the galenic dosage forms and to study chemical-physical and technological characteristics of dosage forms. In all laboratory activities, the students are supervised and assisted by the teachers, who help in their training. Students are divided in five different groups. Each group represents a working group that each group represents a work group that must write a report, according to a pre-formed model, at the end of the laboratory. The report does not affect the final score of the student.

Evaluation methods

Verification of learning:

The examination preparation study consists of the development of five galenic dosage forms and relative evaluation of the physical-chemical characteristics. The galenic formulations obtained must satisfy the chemical-physical and technological characteristics reported in F.U.I. XII Edition and in European Pharmacopoeia. Furthermore, they must satisfy their assays reported in the aforementioned Pharmacopoeias. The results obtained from the preparation and characterization of five formulations are a fundamental requirement to access the written test, but do not affect the final score of the student.
The exam includes a written test in which the student must demonstrate that he / she has acquired skills on the F.U.I. XII Edition and the European one and must be able to prepare and characterize one of the different galenic formulations developed during the course. The written test includes 2 questions each with a value of 15 points. Students who acquire a minimum score of 18 points can verbalize the obtained score or request to carried out the oral exam.

Contacts/More Information

Individual laboratories activity.
Individual meetings after scheduled appointments and interactive discussion during teaching activities

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

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