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PHARMACOTOXICOLOGY ANF GALENIC PHARMACEUTICAL PROCESSES Course Sheet Academic Year of enrolment:
Professor and Collaborators:
Hours of classroom activity:
Objectives
Contents Learning of galenic preparations and the therapeutic drug monitoring techniques
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
Evaluation methods Verification of learning:
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.