Ateneo - UPO

Principles of General Pharmacology-Toxicology. Methodology and regulatory principles for preparing pharmaceutical forms. Clinical risk prevention and safety standards. Analytical techniques for evaluating substances of abuse and the main drugs included in therapeutic drug monitoring programs.

Suggested books:
• Farmacologia generale e molecolare. Clementi & Fumagalli, IV Ed, UTET
• Elementi di tossicologia, Lu Frank C. - Kacew Sam, Ed EMSI

Farmacopea Ufficiale XII edizione. Medicamenta.

R. Needle e T. Sizer, Il Manuale CIVAS, Principi Generali, Ed. Italiana, 2001
Beaney, Controllo di Qualità nei servizi di preparazione asettica, Ed. Italiana, 2003
Le Norme di Buona Preparazione dei Medicinali in Farmacia , Farmacopea Ufficiale XII ed., 2008
ASHP Guidelines on Compounding Sterile Preparations, American Society of Health-System Pharmacists, 2013

The course is worth 8 credits (CFU) for a total of 80 hours of lectures. The course aims to equip students with the fundamentals of pharmacology and toxicology, to understand the toxicological effects of therapeutic and environmental agents on living organisms, preparation methods and excipients in pharmaceutical forms, and to understand how to produce a qualitatively valid product. To this end, knowledge of the main technical operations is essential, drawing inspiration from the Rules for Good Preparation of Medicinal Products in Pharmacy, published in the 12th edition of the Italian National Pharmaceutical Federation. Specifically, the course presents the basic principles and applications of centralized preparation of pain therapy for acute and chronic pain, perioperative antibiotic prophylaxis, oncology therapies, parenteral nutrition, as well as aspects related to operator safety and the quality of preparations. The role of clinical galenics is framed within the context of clinical pharmacy, drug policies, and the professional development of the pharmacist. Acquire knowledge relating to chromatographic and mass spectrometric analysis techniques in the field of clinical and forensic pharmaco-toxicology

The student must be in possession of the concepts of chemistry, biochemistry, anatomy, physiology and general pathology. For Preparazioni farmaceutiche the student must be in possession of the basic notions of Chemistry, Biochemistry and General Pharmacology. Per Farmacia clinica the student must be in possession of the notions of Pharmacology. For Analisi tossicologiche: Knowledge of inorganic and organic chemistry and basic laboratory instrumentation

Lessons will be held primarily in the classroom, and PDFs of the lessons will always be available on the DIR platform.A 5-hour guided tour of a pharmaceutical plant will be conducted to explore the industrial preparation methods of tablets and to understand the concept of quality in drug production. For Analisi tossicologiche: PC with projector, blackboard and felt-tip pens

Students with disabilities, Specific Learning Disabilities (SLD), or Special Educational Needs (SEN) can request specific services and tools for them by visiting the dedicated page on the University website: https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-fragilità-disabilità-dsa-bes. Students with disabilities, SLD, or SEN, after contacting the University staff, can contact the professor in charge.

The exam consists of an oral exam on the topics covered in class. During this exam, students must demonstrate good knowledge of the topics, as well as their ability to communicate and associate them with other topics. For Preparazioni farmaceutiche students will have to take an oral exam on subjects concerning pharmaceutical preparations. They will have to demonstrate that they have assimilated the basic notions of the Pharmaceutical Technique and how to prepare a qualitatively valid preparation. To this end a formula will be submitted and the student will have to comment on it, proving to know the excipients, their main chemical and physical characteristics and incompatibility and will have to describe which pharmaceutical operations apply to produce a finished galenic product, in possession of the necessary qualitative requirements and properly packaged and labeled. The Clinical Pharmacy exam consists of a written test: 20 multiple-choice questions, one of which is correct; each correct answer is worth 1.5 points, the maximum score is 30 points. The final course grade is the weighted average of the individual module grades.

Pharmacology: Principles of Pharmacology-General Toxicology: • Drug-toxicokinetics: absorption, metabolism, distribution and excretion of xenobiotics; administration routes; pharmacokinetic parameters: half-life, bioavailability, renal clearance, volume of distribution. • Drug-toxicodynamics: concept of agonist and antagonist, types of receptors, dose-response curve • Toxic effects and molecular targets of toxicity • Toxicity mechanisms • Antidotism and drug therapy Hematotoxicity: carbon monoxide and methaemoglobin. Toxicity of the nervous system: glutamatergic and GABAergic system, cholinergic system, toxins that act on the release of neurotransmitters Substances of abuse: molecular mechanisms of tolerance, dependence and gratification • Opiates • Barbiturates and benzodiazepines • Cocaine and amphetamines • Hallucinogens • Ethanol and alcoholism. Prions and prion diseases Doping and doping substances.Preparazioni farmaceutiche: Pharmaceutical operations. Grinding, mixing, solubilization, aseptic technique, sterilization, filtration. Labeling and packaging. Good Preparation Standards and quality in the production of medicines. Classification of pharmaceutical forms according to the route of administration. Oral way. Syrups, emulsions, suspensions, tablets, capsules, powders and granules, sachets. Bioavailability of oral forms. Rectal way. Suppositories. Penetration of the active substance through the mucosa, excipients, preparation. Dermal route. Ointments. Penetration of the active substance through the skin, excipients, preparation. Ocular way. Eye drops. Requirements required for an ocular formulation, preparation. Parenteral route. Properties of injectable preparations, formulations, preparation, aseptic packaging, sterile environments, vertical and horizontal laminar flow hoods. Preparation of bags for total parenteral nutrition, anticancer drugs.Toxicological analysis: Principles of chromatography, equations inherent to chromatographic processes, separation mechanisms. Liquid chromatography, principles, HPLC, instrumentation, components. Gaschromatography, principles, instrumentation, components. Mass spectrometry, principles, sources, analyzers, detectors. Biological matrices, sample preparation tecniques, liquid-liquid extraction, solidphase extractio, calibration methods. Basic knowledge of Art.186 and 187 of the traffic law. Drugs of abuse, toxic substances.Examples of analysis protocols.Farmacia clinica: Farmacopea Ufficiale XII edizione e Norme di Buona Preparazione. Allestimento delle terapie con tecnica asettica. Aspetti collegati alla sicurezza del Laboratorio di Farmacia Ospedaliera e Dispositivi di Protezione Individuale. Classificazione Nazionale Dispositivi Medici. Allestimento terapie sterili: profilassi antibiotica, terapia antalgica, nutrizione artificiale, chemioterapia antitumorale.Clinical pharmacy: Italian Official Pharmacopoeia (XII Edition) and Good Manufacturing Practices in Hospital Pharmacy. Sterile compounding and aseptic technique. Safety in sterile compounding and devices for the individual protections inside the Laboratory of an Hospital Pharmacy. National Classification of the medical devices used in the compounding. Galenic drugs, antibiotics prophylaxis, preparation of compounded sterile analgesia infusions, parenteral nutrition, chemotherapy.

The Dublin descriptors will be the terms of assessment: D1 - KNOWLEDGE AND UNDERSTANDING: The student will know and understand the basic concepts of general pharmacology and the pharmaco-toxicological characteristics of substances of abuse and various drug classes, the analytical methods of substances in biological samples, the most common pharmaceutical preparations and the regulations that regulate them. Students are able to prepare a galenic medicine using the correct technique, using the appropriate equipment, choosing the most appropriate excipients, and completing the label completely. D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING: The student will acquire the ability to use the theoretical knowledge taught in class to reason critically, demonstrating the ability to make connections between different topics and to apply the acquired knowledge in the context of clinical analyses of various drugs or toxic substances. D3 - JUDGMENT ABILITY: The student will acquire the ability to critically examine the theoretical concepts acquired and to be able to independently argue the problems arising from their practical application. D4-COMMUNICATIVE SKILLS: Students will acquire the ability to communicate their acquired knowledge using specific and appropriate vocabulary in order to communicate professionally and competently in both academic and professional settings. D5-LEARNING SKILLS: Students will acquire learning skills useful for ongoing and ongoing training on the procedures to be performed in a clinical analysis laboratory.