LEGISLATION AND TECHNOLOGY AND GALENIC LABORATORY
Academic year and teacher
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- Versione italiana
- Academic year
- 2022/2023
- Teacher
- RITA CORTESI
- Credits
- 9
- Didactic period
- Secondo Semestre
- SSD
- CHIM/09
Training objectives
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Modulo: 56232 - FORMULAZIONI GALENICHE E LEGISLAZIONE
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LEGISLAZIONE e LABORATORIO di TECNOLOGIA e GALENICA represents the latest pharmaceutical technology teaching of the Pharmacy course and includes two important aspects of the pharmacist's professionalism such as Pharmaceutical Legislation and Galenic Preparation with the application of Pharmaceutical Technology in the preparation of formulations.
The main objective of the course is to provide students with the foundation to address the galenic preparation in the laboratory of the pharmacy and an overview of the main Italian laws that regulate the profession of the pharmacist with particular regard to the management of narcotic medications.
The course contents are relevant in terms of skills and modern and correct approach to the pharmaceutical formulation with particular attention to the preparation of the various dosage forms and the responsibility of the pharmacist.
The main knowledge gained will be:
1. LABORATORIO DI GALENICA: galenic preparations and essays on liquid and solid dosage forms for oral administration through rectal, vaginal according to the Official Italian Pharmacopoeia and the European Pharmacopoeia.
2. LEGISLAZIONE: to provide the basics of pharmaceutical legislation relating, in particular, the exercise of the profession of pharmacist in pharmacies open to the public and hospital, as well as activity in the industry.
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Modulo: 63960 - LABORATORIO DI TECNOLOGIA E GALENICA
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LEGISLAZIONE e LABORATORIO di TECNOLOGIA e GALENICA represents the latest pharmaceutical technology teaching of the Pharmacy course and includes two important aspects of the pharmacist's professionalism such as Pharmaceutical Legislation and Galenic Preparation with the application of Pharmaceutical Technology in the preparation of formulations.
The main objective of the course is to provide students with the foundation to address the galenic preparation in the laboratory of the pharmacy and an overview of the main Italian laws that regulate the profession of the pharmacist with particular regard to the management of narcotic medications.
The course contents are relevant in terms of skills and modern and correct approach to the pharmaceutical formulation with particular attention to the preparation of the various dosage forms and the responsibility of the pharmacist.
The main knowledge gained will be:
1. LABORATORIO DI GALENICA: galenic preparations and essays on liquid and solid dosage forms for oral administration through rectal, vaginal according to the Official Italian Pharmacopoeia and the European Pharmacopoeia.
2. LEGISLAZIONE: to provide the basics of pharmaceutical legislation relating, in particular, the exercise of the profession of pharmacist in pharmacies open to the public and hospital, as well as activity in the industry. Prerequisites
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Modulo: 56232 - FORMULAZIONI GALENICHE E LEGISLAZIONE
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The following concepts and the knowledge provided by the courses of Physics, General Chemistry, Organic Chemistry, Pharmaceutical Chemistry with General Laboratory, Biochemistry, Analytical Chemistry and the following knowledge provided by the courses of Pharmaceutical Technologies I and Pharmaceutical Technologies II
To take the final examination (learning assessment procedures), students must have passed the exam of Pharmaceutical Technology I
• Medicine packaging
• liquid preparations and solutions
• dispersed systems (suspensions, emulsions) and their chemical-physical characteristics, excipients, stability
• surfactants and emulsifiers
• powders, granules, pellets, capsules, tablets
• rectal and vaginal preparations
Such knowledge being part of the cultural background of the student would be required during the examination.
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Modulo: 63960 - LABORATORIO DI TECNOLOGIA E GALENICA
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The following concepts and the knowledge provided by the courses of Physics, General Chemistry, Organic Chemistry, Pharmaceutical Chemistry with General Laboratory, Biochemistry, Analytical Chemistry and the following knowledge provided by the courses of Pharmaceutical Technologies I and Pharmaceutical Technologies II
To take the final examination (learning assessment procedures), students must have passed the exam of Pharmaceutical Technology I
• Medicine packaging
• liquid preparations and solutions
• dispersed systems (suspensions, emulsions) and their chemical-physical characteristics, excipients, stability
• surfactants and emulsifiers
• powders, granules, pellets, capsules, tablets
• rectal and vaginal preparations
Such knowledge being part of the cultural background of the student would be required during the examination. Course programme
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Modulo: 56232 - FORMULAZIONI GALENICHE E LEGISLAZIONE
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The course forecasts 9 CFU of teaching divided in frontal lectures (5 CFU) and guided tutorial in the labs (4 CFU).
The course consists of 9 credits of which
- 4 CFU Technological and Galenic Lab divided into a theoretical classes (8 hours), guided exercises in the laboratory with possible additions on some topics with seminars held by professionals in the sector (40 hours)
- 5 credits (40 hours) of Legislation through lectures in the classroom and seminars.
Topics in Pharmaceutical Legislation (5 credits, 40 hours)
Supranational legislation. AIFA. AIC. Administrative classification of pharmacies. Ownership of the pharmacy. System Pharmacy: Activities of professional and business operation and legal controls. SSN, ASL, Regional Hospital, NHS cookbook, recipe paperless, Sanitary Badge, administrative classification of medicines. SOP, OTC, generics, defects of medicines. discipline of dispensing to the public, types of prescriptions for human and veterinary use.
Rules governing the field of drugs and poisons in pharmacy. Register drugs. Regulation of health protection of sports activities and the fight against doping. Herbal products. Veterinary prescription and documentation required of pharmacy. Presidential Decree 128/1986 and the following European Directives.
TECHNOLOGICAL AND GALENIC LAB (4 CFU, 48 hours) divided as follows:
8 hours : Theory of galenic preparations. Galenic preparations. Fundamentals of pricing. National tariff. Shipping recipe. FU XII: Tables, monographs and NBP.
Theory for the preparation of the following galenic formulations: Syrup antimalarial, antiseptic mouthwash, mucilage anesthetic, Antibiotic suspension, emulsion laxative, Frost Emollient Cream antirheumatic, antifungal ointment, zinc paste watery, ova of Chloramphenicol, suppositories of Sulfathiazole, Papers analgesic, Capsules analgesic
36 hours: Shipment of the above mentioned recipes through implementation of
1- preparation protocol of each formulation with description of the active ingredients, excipients - Issues of formulation - stand the following galenic formulations: antimalarial syrup, antiseptic mouthwash, anesthetic mucilage, antibiotic suspension, emulsion laxative, gels, anti-rheumatic cream, antifungal ointment, Zinc aqueous cream, chloramphenicol pessaries, suppositories, analgesic powders, analgesic capsules
2 - pricing
3- filling out of the label and recipe of the galenic formulations produced
Simulation of the written examination.
4 hours: simulated laboratory practice on theoretical and practical aspects concerning
1- production of tablets.
2- dissolution in vitro assays from pharmacopoeia on solid pharmaceutical dose forms
3- sample test in the service pharmacy sector
4- seminars of professional pharmacists
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Modulo: 63960 - LABORATORIO DI TECNOLOGIA E GALENICA
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The course forecasts 9 CFU of teaching divided in frontal lectures (5 CFU) and guided tutorial in the labs (4 CFU).
The course consists of 9 credits of which
- 4 CFU Technological and Galenic Lab divided into a theoretical classes (8 hours), guided exercises in the laboratory with possible additions on some topics with seminars held by professionals in the sector (40 hours)
- 5 credits (40 hours) of Legislation through lectures in the classroom and seminars.
Topics in Pharmaceutical Legislation (5 credits, 40 hours)
Supranational legislation. AIFA. AIC. Administrative classification of pharmacies. Ownership of the pharmacy. System Pharmacy: Activities of professional and business operation and legal controls. SSN, ASL, Regional Hospital, NHS cookbook, recipe paperless, Sanitary Badge, administrative classification of medicines. SOP, OTC, generics, defects of medicines. discipline of dispensing to the public, types of prescriptions for human and veterinary use.
Rules governing the field of drugs and poisons in pharmacy. Register drugs. Regulation of health protection of sports activities and the fight against doping. Herbal products. Veterinary prescription and documentation required of pharmacy. Presidential Decree 128/1986 and the following European Directives.
TECHNOLOGICAL AND GALENIC LAB (4 CFU, 48 hours) divided as follows:
8 hours : Theory of galenic preparations. Galenic preparations. Fundamentals of pricing. National tariff. Shipping recipe. FU XII: Tables, monographs and NBP.
Theory for the preparation of the following galenic formulations: Syrup antimalarial, antiseptic mouthwash, mucilage anesthetic, Antibiotic suspension, emulsion laxative, Frost Emollient Cream antirheumatic, antifungal ointment, zinc paste watery, ova of Chloramphenicol, suppositories of Sulfathiazole, Papers analgesic, Capsules analgesic
36 hours: Shipment of the above mentioned recipes through implementation of
1- preparation protocol of each formulation with description of the active ingredients, excipients - Issues of formulation - stand the following galenic formulations: antimalarial syrup, antiseptic mouthwash, anesthetic mucilage, antibiotic suspension, emulsion laxative, gels, anti-rheumatic cream, antifungal ointment, Zinc aqueous cream, chloramphenicol pessaries, suppositories, analgesic powders, analgesic capsules
2 - pricing
3- filling out of the label and recipe of the galenic formulations produced
Simulation of the written examination.
4 hours: simulated laboratory practice on theoretical and practical aspects concerning
1- production of tablets.
2- dissolution in vitro assays from pharmacopoeia on solid pharmaceutical dose forms
3- sample test in the service pharmacy sector
4- seminars of professional pharmacists Didactic methods
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Modulo: 56232 - FORMULAZIONI GALENICHE E LEGISLAZIONE
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The course will be delivered through theoretical lessons aimed at exposing and explaining the contents of the program, integrated with practical examples, case studies, exercises and moments of study.
As regards the laboratory lessons of Technology and Galenica, the shipment of a recipe will be simulated through the learning of the preparation and control methods of master and officinal formulations.
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Modulo: 63960 - LABORATORIO DI TECNOLOGIA E GALENICA
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The course will be delivered through theoretical lessons aimed at exposing and explaining the contents of the program, integrated with practical examples, case studies, exercises and moments of study.
As regards the laboratory lessons of Technology and Galenica, the shipment of a recipe will be simulated through the learning of the preparation and control methods of master and officinal formulations. Learning assessment procedures
- The aim of the exam is to verify at which level the learning objectives previously described have been acquired.
The examination is divided in 2 sections (written and oral) that will take place in two different moments. The time allowed for the written test is 60 min. The test is intended to evaluate the study of matter and the basic understanding of the subjects and character selection (the student who does not show sufficient knowledge of the subjects is not allowed to successive tests). Therefore, passing the written test allows participation in the oral test.
The written exam will simulate a shipment of galenic prescription with the objective of evaluating if the student has the ability to carry out the preparation, knowing the law, apply the appropriate pricing and draw the label of pharmaceutics to be delivered to the hypothetical client.
During the written test, the National Tariff and the Pharmacopoeia (edition in force) will be made available by the teacher as well as all the practical information necessary for the performance of the simulation.
In the oral examination will focuse on topics of pharmaceutical legislation, and in general all the topics of the course. Moreover it will not be just considered the ability to "repeat" some argument or law covered in class, as the ability to connect various aspects covered during the course of example and transpose them as part of the pharmacist in the pharmacy. In this perspective, the knowledge that forms part of the student's cultural background, including for example the basic concepts of the "Pharmaceutical Technologies I" and "Pharmaceutical Technologies II" courses, may obviously be required.
The score of the final evaluation will therefore be given by the contribution of the following parameters:
1- 50% written test (up to 16 points)
2- 30% oral exam (up to 8 points)
3- register of laboratory activities for 10% (up to 3 points)
4- dialectic, processing and connection skills of the various topics for 10% (up to 3 points) Reference texts
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Modulo: 56232 - FORMULAZIONI GALENICHE E LEGISLAZIONE
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Reference texts integrated by the notes taken in class
Legislation topics have to be further developed in the following texts.
1. P. Minghetti Legislazione Farmaceutica, 9a ed. Casa Editrice Ambrosiana, MI, 2018.
2. Farmacopea Ufficiale Italiana (FUI), European Pharmacopoeia (EP), United States Pharmacopoeia (USP): current editions.
Specific topics can be further developed in the following texts.
Pharmaceutical practice edited by D.M. Collett, M.E. Aulton Churchill Livingstone Elsevier, 2007
Handbook of pharmaceutical excipients, 5th ed. Edited by Raymond C. Rowe, Paul J. Sheskey, Sian C. Owen, Pharmaceutical Press and American Pharmacists Association, Chicago, 2006.
E. Ragazzi, Galenica pratica, formulazione e tecnologia Liberia Internazionale Cortina Padova, 2006
A. Martins, Physical pharmacy and pharmaceutical sciences: physical chemical and biopharmaceutical principles in the pharmaceutical sciences, 5th ed. Editor: Patrick J. Sinko, Lippincott Williams & Wilkins, Philadelphia, 2006.
Pharmaceutics: The design and manufacture of medicines, edited by Aulton ME, Churchill Livingstone Elsevier, 2007
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Modulo: 63960 - LABORATORIO DI TECNOLOGIA E GALENICA
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Reference texts integrated by the notes taken in class
Legislation topics have to be further developed in the following texts.
1. P. Minghetti Legislazione Farmaceutica, 9a ed. Casa Editrice Ambrosiana, MI, 2018.
2. Farmacopea Ufficiale Italiana (FUI), European Pharmacopoeia (EP), United States Pharmacopoeia (USP): current editions.
Specific topics can be further developed in the following texts.
Pharmaceutical practice edited by D.M. Collett, M.E. Aulton Churchill Livingstone Elsevier, 2007
Handbook of pharmaceutical excipients, 5th ed. Edited by Raymond C. Rowe, Paul J. Sheskey, Sian C. Owen, Pharmaceutical Press and American Pharmacists Association, Chicago, 2006.
E. Ragazzi, Galenica pratica, formulazione e tecnologia Liberia Internazionale Cortina Padova, 2006
A. Martins, Physical pharmacy and pharmaceutical sciences: physical chemical and biopharmaceutical principles in the pharmaceutical sciences, 5th ed. Editor: Patrick J. Sinko, Lippincott Williams & Wilkins, Philadelphia, 2006.
Pharmaceutics: The design and manufacture of medicines, edited by Aulton ME, Churchill Livingstone Elsevier, 2007
