GALENIC PREPARATIONS LABORATORY
LABORATORIO DI GALENICA
Galenic laboratory
Laboratorio di galenica
| A.Y. | Credits |
|---|---|
| 2015/2016 | 6 (2 Lez. + 4 Lab.) |
| Lecturer | Office hours for students | |
|---|---|---|
| Massimo Frongia |
Assigned to the Degree Course
| Date | Time | Classroom / Location |
|---|
Learning Objectives
Acquisition of theoretical knowledge and practices relating to the management of a galenic laboratory, preparation and dispensing of medicine galenic and herbal galenic.
Program
GENERAL PART
Italian official pharmacopoeia, European and UE countries, contained and validity
Definition of Galenic Laboratory
The staff
General production rules
Galenica production specific rules: N.B.P (good practices) "Integral and Simplified Procedures"
Art. 37 of the R.D., September 30, 1938 n. 1706, Ministerial Decree of 18 November 2003
Ministerial Decree of 22 June 2005, Law 94/98 , F.U.I. Table N. 8 "Maximum", Physical-chemical interactions, Orphan drug
Compounding
Medicinal Preparations
Herbal products legislation
Differences between production and dispensing
Choosing a medicinal formulation
Responsibility for the commercial yield
ISO-the International Organization for Standardization, general principles
NBP-good preparation standards in pharmacy
SAQ-quality assurance system
Objectives and planning
Responsibility
Rules of conduct
Documentation and archives
Hygiene and cleanliness of rooms
Dressing and washing hands
Purchasing and warehousing
How to evaluate a supplier
Set-up procedures of preparations
Worksheet
High quality raw materials
Drugs and herbal extracts: requirements
Recipe control
Preparation
Stability of prepared
Controls (equipment, substances, finished products)
Pricing, packaging and labeling
THEORY AND PRACTICE OF GALENIC FORMULATIONS
Solutions, syrups, emulsions, suspensions, powders multi-dose and single-dose, capsules, semi-solid preparations for cutaneous use (ointments, creams, gels, pastes), rectal and vaginal suppositories.
Bridging Courses
Study regulations of the academic year
Learning Achievements (Dublin Descriptors)
-student will show to possess knowledge about the organisation of a galenic laboratory, the technique of preparing and galenic legislation.
-to posses the ability to understand the formulation strategies and their instrumental techniques.
-Must also highlight the possession of the ability to apply knowledge and concepts related to technical and legislature activities of a galenic laboratory.
Teaching Material
The teaching material prepared by the lecturer in addition to recommended textbooks (such as for instance slides, lecture notes, exercises, bibliography) and communications from the lecturer specific to the course can be found inside the Moodle platform › blended.uniurb.it
Supporting Activities
Teaching activities can be supported by management programs for galenic laboratory, technology and professionals through seminars and lectures for legislative support
Teaching, Attendance, Course Books and Assessment
- Teaching
Frontal theoretical lessons, theoretical-practical lessons in the lab.
- Attendance
Compulsory attendance
- Course books
F.U.I. last edition
Ragazzi E. - Galenica pratica - Ed. Libreria Cortin
Minghetti P. - Legislazione Farmaceutica - CEA Edizioni
Bettiol F. - Manuale delle preparazioni galeniche - Ed. Tecniche Nuove
- Assessment
Practical test: galenic product, written report, label.
Oral examination: questions about program topics
- Disabilità e DSA
Le studentesse e gli studenti che hanno registrato la certificazione di disabilità o la certificazione di DSA presso l'Ufficio Inclusione e diritto allo studio, possono chiedere di utilizzare le mappe concettuali (per parole chiave) durante la prova di esame.
A tal fine, è necessario inviare le mappe, due settimane prima dell’appello di esame, alla o al docente del corso, che ne verificherà la coerenza con le indicazioni delle linee guida di ateneo e potrà chiederne la modifica.
| « back | Last update: 12/05/2016 |
