Acquisition of theoretical knowledge and practices relating to the management of a galenic laboratory, preparation and dispensing of medicine galenic and herbal galenic.

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.

Study regulations of the academic year    

-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.

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

Teaching activities can be supported by management programs for galenic laboratory, technology and professionals through seminars and lectures for legislative support    

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

Disability and Specific Learning Disorders (SLD)

Students who have registered their disability certification or SLD certification with the Inclusion and Right to Study Office can request to use conceptual maps (for keywords) during exams.

To this end, it is necessary to send the maps, two weeks before the exam date, to the course instructor, who will verify their compliance with the university guidelines and may request modifications.