PHARMACOTOXICOLOGY AND GALENIC PHARMACEUTICAL FORMULATIONS

Integrated educational activity

Course Sheet

Course code:

TLB22B44

Academic Year of enrolment:

2018

Year of supply:

2019/2020

Degree:

Course of 1st Cycle Degree in BIOMEDICAL LABORATORY TECHNIQUES

Moduls:

PHARMACOLOGY AND TOXICOLOGY - 3 credits
DRUGS MANITORING WITH GALENIC PREPARATION LABORATORY - 2 credits

Location:

CHIETI

Credits:

Programme Year:

Cycle:

Second semester

Hours of classroom activity:

Prerequisites:

To have passed all the exams of the first year of the course as well as the one related to Microbiology (II year, I semester)

Objectives

1. PHARMACOTOXICOLOGY
Educational objectives of the course:
• to know the fundamental principles of pharmacokinetics and pharmacodynamics;
• to provide the general concepts of pharmacology and toxicology;
• to know the mechanism of action, the drug interactions, the therapeutic and toxic effects related to the main classes of drugs treated.
2. 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.
3. DRUG MONITORING
Educational objectives
This part of the integrated course is aimed at providing the Laboratory Technician with the knowledge that could be useful to his profession if he 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

Notions related to General Pharmacology and Toxicology, to Special Pharmacotoxicology (with explanation of the main pharmacological and toxicological characteristics of the substances used in therapy).
Fundamental concepts related to galenic preparations and monitoring of drugs and substances of abuse.

Extended Syllabus

1.1 PRINCIPLES OF GENERAL PHARMACOLOGY AND TOXICOLOGY
• definition of drug and classification;
• generic drugs and medicinal specialties;
• pharmaceutical forms;
• pharmacokinetic elements:
- routes of administration, absorption, distribution, biotransformation and elimination of drugs,
- bioavailability, plasma half-life, therapeutic index;
• elements of Pharmacodynamics:
- drug-receptor interactions,
- membrane and intracellular receptors,
- main signal transduction pathways,
- receptor agonists and antagonists,
- desensitization, upregulation, downregulation and hypersensitivity,
- dose-effect curves, ED50, LD50, DT50, therapeutic index, therapeutic range;
• drug interactions (pharmacokinetic and pharmacodynamic interactions) and possible clinical therapeutic consequences;
• general principles of toxicology; acute, subacute and chronic toxicity; mutagenesis, carcinogenesis and reproductive toxicology.

1.2 PRINCIPLES OF SPECIAL PHARMACOLOGY
• Framework of the vegetative nervous system with particular reference to the sympathetic nervous system (types of receptors, transmitters, effects)
• Main drugs and drugs of abuse active in the central nervous system and subject to therapeutic or toxicological monitoring:
- stimulants (amphetamine, cocaine, ectasy and related substances);
- inhibiting the activity of the CNS: GHB, ketamine, anxiolytics / hypnotics (benzodiazepines, barbiturates); cannabinoids; anticonvulsant drugs; analgesic drugs (opiates).
• Other drugs subject to monitoring:
- anabolic; erythropoietin
- immunosuppressant; glucocorticoids
- Digital
- Anti-aggregants, anticoagulants, fibrinolytics
• Antibiotic chemotherapy: general principles, different classes (beta-lactams, aminoglycosides, tetracyclines; macrolides; chloramphenicol; fluoroquinolones; trimethoprim sulfonamides)
• Antifungal, antiviral drugs; disinfectants.

2. PHARMACEUTICAL GALENIC
2A. 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)

2B. LA FARMACOPEA
- The role of the Pharmacopoeia
- The European Pharmacopoeia
- The Italian Official Pharmacopoeia XII ed.
- The Rules of Good Preparation (NBP)
2B1. QUALITY OF RAW MATERIALS IN PREPARATION OF PREPARATIONS (ref. Presence of impurities)
2B2. THE GALENIC LABORATORY AND EQUIPMENT
2B3. THE MAIN CAUSES OF DEGRADATION OF MEDICINAL PRODUCTS AND THE RULES FOR THE CORRECT CONSERVATION OF MEDICINAL PREPARATIONS
2B4. STERILITY AND STERILIZATION METHODS

2C. PRINCIPLES AND METHODS FOR DIFFERENT GALENIC PREPARATIONS
2C1. 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)
2C2. 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
2C3. METHODS FOR THE PREPARATION OF ISOTONIC SOLUTIONS
2C4. 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
3. DRUG MONITORING
3A. 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).

3B. 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:

Oral examination

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