DRUGS MANITORING WITH GALENIC PREPARATION LABORATORY

General Module

Course Sheet

Course code:

TL22B44D

Academic Year of enrolment:

2018

Year of supply:

2019/2020

Type of Course:

Characterising

Degree:

Course of 1st Cycle Degree in BIOMEDICAL LABORATORY TECHNIQUES

Disciplinary Sector:

Pharmacology

Is part of:

PHARMACOTOXICOLOGY AND GALENIC PHARMACEUTICAL FORMULATIONS

Location:

CHIETI

Credits:

Programme Year:

Professor and Collaborators:

ZUCCARINI MARIACHIARA

Cycle:

Second semester

Obligatory attendance:

Yes

Hours of classroom activity:

Individual study hours:

Prerequisites:

have passed all the exams of the first year of the course as well as the exam related to Microbiology

Objectives

PHARMACEUTICAL GALENIC
Educational objectives:
Objectives of this part of the course are to provide students with the theoretical bases for the preparation of galenic drugs and to allow them to carry out practical exercises related to their preparation. This in order to favor a possible inclusion of such students in the pharmaceutical manufacturing world.
MONITORING OF DRUGS
Educational objectives
This part of the integrated course is aimed at providing the Laboratory Technician with the knowledge that could be useful to his/her profession if he/she were to work in specific laboratories for detecting toxic substances and for monitoring biochemical-clinical parameters that can be altered to following exposure to toxicants or drugs.

Contents

Topics related to galenic preparations and the therapeutic monitoring techniques for drugs and drugs of abuse will be discussed

Extended Syllabus

PHARMACEUTICAL GALENIC
Program
THE COMPONENTS OF MEDICINAL PRODUCTS
- Active ingredients
• Definition
• Origins and sources
- Excipients
• Definition
• Origins and sources
• Requirements
• Classification

PHARMACEUTICAL FORMS: definition and classification

DEFINITION OF INDUSTRIAL PREPARATIONS vs GALENICS (magistral and officinal)

LA FARMACOPEA
- The role of the Pharmacopoeia
- The European Pharmacopoeia
- The Italian Official Pharmacopoeia XII ed.
- The Rules of Good Preparation (NBP)
QUALITY OF RAW MATERIALS IN PREPARATION OF PREPARATIONS (ref. Presence of impurities)
THE GALENIC LABORATORY AND EQUIPMENT
THE MAIN CAUSES OF DEGRADATION OF MEDICINAL PRODUCTS AND THE RULES FOR THE CORRECT CONSERVATION OF MEDICINAL PREPARATIONS
STERILITY AND STERILIZATION METHODS

PRINCIPLES AND METHODS FOR DIFFERENT GALENIC PREPARATIONS
PARENTERAL PREPARATIONS
- The routes of parenteral administration
- Definition and classification according to the F.U.
- Components and containers
- Set-up procedures
- Injectable preparations
- Infusions
- Technological requirements of parenteral preparations (ref. Osmolarity and tonicity of a solution)
OPHTHALMIC PREPARATIONS
- Definition and classification according to the F.U.
- The main classes of ophthalmic drugs
- Overview of ocular anatomy and physiology
- The eye drops
- Components of ophthalmic preparations
- Procedure for preparation of ophthalmic preparations
- Technological requirements for ophthalmic preparations
METHODS FOR THE PREPARATION OF ISOTONIC SOLUTIONS
LIQUID PREPARATIONS FOR ORAL USE
- Definition and classification according to FU
- Syrups
 Definition and classification according to the F.U.
 Features and setup procedure of the simple syrup

MONITORING OF DRUGS
Program
THERAPEUTIC MONITORING OF DRUGS
Definition and rational basis of Therapeutic Drug Monitoring (TDM);
• general criteria for carrying out monitoring and interpretative aspects;
• main analytical methods used for drug monitoring;
• TDM rationale for the most frequently monitored drugs (antibiotics, antiepileptics, bronchodilators, digitalis, immunosuppressants, antineoplastics and psychoactive drugs).

MONITORING OF ABUSE DRUGS
• Main substances subject to monitoring
• Evaluation of the samples to be dosed
• Main methods used

Recommended Bibliography

Le basi della Farmacologia. M. A. Clark, R. Finkel, J. A. Rey, K. Whalen. Ed. Zanichelli. II edizione italiana
 Farmacologia. H.P. Rang, M.M. Dale, J.M. Ritter, R. J. Flower, G. Henderson. Ed. Elsevier. Settima Edizione Italiana
 Farmacologia: principi di base e applicazioni terapeutiche. F. Rossi, V. Cuomo, C. Riccardi, Edizioni Minerva Medica. II edizione.

Teaching Methods

Frontal lessons

Evaluation methods

Verification of learning:

Regarding the PHARMACEUTICAL GALENIC Program, the oral examination will focus on the main classes of excipients used for the preparation of the different pharmaceutical compounds, as well as on the good manufacture and laboratory practice guidelines (e.g. sterilization, storage, laboratory devices, DPI).
Regarding the
MONITORING OF DRUGS Program, the oral examination will focus on the knowledge of the main analytical methods to monitor the dosage of therapeutic and abuse drugs.

Contacts/More Information

Reception timetable: From Monday to Friday 11:00 - 12:00, Section of Pharmacology Building B, level 2, NPD, Via dei Vestini 29.

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

Aree