Pharmaceutical Technology and Legislation Ii and Lab of Pharmaceutical Technology Ii Medical Devices and Cosmetic Prod
A.Y. 2024/2025
Learning objectives
The objective of this course is to provide basic principles of the design, production and testing of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. The course aims to help students gain knowledge and comprehension of the relationships linking technological, biopharmaceutical and pharmacokinetic properties of drug formulations. Regulatory aspects relevant to production and marketing of drug and health products, including cosmetics and medical devices, are addressed. Fundamentals of pharmaceutical legislation and of pharmacist practice ethics are also covered. Single-bench laboratory practicals are aimed at strengthening the knowledge acquired through preparation and control of magistral and officinal formulae intended for the concerned routes of administration and drafting of the relevant documentation in compliance with current laws.
Expected learning outcomes
Through this course, the student gains fundamental skills in the design, preparation/production and control of the main dosage forms, either for immediate or modified release, with special reference to injectable and topical ones. Thanks to the knowledge acquired, he will be able to correlate formulation characteristics of the covered drug preparations/products with their biopharmaceutical and pharmacokinetic properties, and to critically evaluate how to modulate the latter through purposely implemented technological activities. In addition, he will manage to understand and apply regulations relevant to the production and marketing of medicinal and health products for professional practice purposes, particularly within a pharmacy.
Lesson period: year
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Linea Unica
Responsible
Lesson period
year
Course syllabus
CLASSES
Physicochemical principles: interfacial phenomena; disperse systems: colloids, emulsions, and suspensions; rheology. The sterilization.
Biopharmaceutical aspects, formulation, preparation and control of immediate and modified release dosage forms: parenteral, topical and transdermal, ocular, rectal and vaginal drug delivery.
Introduction to homoeopathic preparations.
Italian and UE forms of law. National Health Service. The rules governing the production and the marketing of the medicinal products. The case of generics, OTC, veterinary and homeopathic products. The regulation of the controlled substances. Prescription requirements. The ethic and the role of the Pharmacy Board. The organization of the pharmacy system. The law of health foods.
SINGLE-BENCH PRACTICALS (TEACHING UNIT: Pharmaceutical Technology Laboratory II)
· Dispersed systems and surfactants (HLB system).
· Compounding in pharmacy and the compilation of labels.
· Medicines dispensing regime. Legislation relating to medical prescription. Dispension of a recipe.
· Preparation of a suspension.
· Semi-solid preparations for cutaneous use and relative controls (recognition of the emulsion type; measurement of consistency by penetrometry).
· Preparation of powders for skin application.
· Liquid preparations for skin application and control of the alcohol content.
· Rectal preparations.
· Sterile preparations. Compilation of setup procedures for sterile preparations.
· Good preparation Rules in Pharmacy.
· Preparation of oral divided powders (wrapped in parchment paper)
· Cosmetic preparations.
Physicochemical principles: interfacial phenomena; disperse systems: colloids, emulsions, and suspensions; rheology. The sterilization.
Biopharmaceutical aspects, formulation, preparation and control of immediate and modified release dosage forms: parenteral, topical and transdermal, ocular, rectal and vaginal drug delivery.
Introduction to homoeopathic preparations.
Italian and UE forms of law. National Health Service. The rules governing the production and the marketing of the medicinal products. The case of generics, OTC, veterinary and homeopathic products. The regulation of the controlled substances. Prescription requirements. The ethic and the role of the Pharmacy Board. The organization of the pharmacy system. The law of health foods.
SINGLE-BENCH PRACTICALS (TEACHING UNIT: Pharmaceutical Technology Laboratory II)
· Dispersed systems and surfactants (HLB system).
· Compounding in pharmacy and the compilation of labels.
· Medicines dispensing regime. Legislation relating to medical prescription. Dispension of a recipe.
· Preparation of a suspension.
· Semi-solid preparations for cutaneous use and relative controls (recognition of the emulsion type; measurement of consistency by penetrometry).
· Preparation of powders for skin application.
· Liquid preparations for skin application and control of the alcohol content.
· Rectal preparations.
· Sterile preparations. Compilation of setup procedures for sterile preparations.
· Good preparation Rules in Pharmacy.
· Preparation of oral divided powders (wrapped in parchment paper)
· Cosmetic preparations.
Prerequisites for admission
To access the exam it will be necessary to have acquired knowledge of the topics covered in Pharmaceutical Technology I and Pharmaceutical Chemistry II exams and to have attended Pharmaceutical Technology Laboratory II.
Teaching methods
Classes and single-bench practicals.
Innovative teaching methodologies will be proposed such as "role playing" and "simulation" activities.
Innovative teaching methodologies will be proposed such as "role playing" and "simulation" activities.
Teaching Resources
1. Principi Di Tecnologie Farmaceutiche. P Colombo, F Alhaique, C Caramella, B Conti, A Gazzaniga, E Vidale. C.E.A. Casa Editrice Ambrosiana Ed. 2015.
2. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Legislazione Farmaceutica. P. Minghetti. CEA, 2018.
Lessons slides and supplementary material available on ARIEL website.
Lessons slides and additional material available on ARIEL
2. Tecnologie Farmaceutiche. ME Aulton, KMG Taylor. IV Edizione Edra Ed. 2015.
3. Legislazione Farmaceutica. P. Minghetti. CEA, 2018.
Lessons slides and supplementary material available on ARIEL website.
Lessons slides and additional material available on ARIEL
Assessment methods and Criteria
The exam is divided into three parts. 1) Preparation of a magistral formula and related regulatory aspects inherent in its dispensing. 2) Three-hour written test (technology topics), with recognition and comment of a pharmaceutical formulation and open questions. The written test includes five queries, and it is considered passed if the candidate answers positively to at least four of these. 3) Oral test (legislation: dispensing of a recipe and three open questions) to be taken within 12 months after passing the written test.
For attending students, the written test can be replaced by an oral test to be taken within the end of May of the academic year of attendance.
The Technology exam (including the written test and the laboratory assessment) will contribute to the final assessment for 50%, the legislation exam for 40% and a further 10% will be awarded on the basis of coordinated interventions carried out during the lessons.
For attending students, the written test can be replaced by an oral test to be taken within the end of May of the academic year of attendance.
The Technology exam (including the written test and the laboratory assessment) will contribute to the final assessment for 50%, the legislation exam for 40% and a further 10% will be awarded on the basis of coordinated interventions carried out during the lessons.
Laboratory of Pharmaceutical Technology II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Single bench laboratory practical: 48 hours
Shifts:
Turno 1
Professor:
Maroni Alessandra
Medical Devices and Cosmetic Products
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 3
Lessons: 24 hours
Professor:
Gennari Chiara Grazia Milena
Pharmaceutical Technology and Legislation II
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Lessons: 48 hours
Professor:
Minghetti Paola
Professor(s)
Reception:
By appointment
Dipartimento di Scienze Farmaceutiche, Sezione di Tecnlogia e Legislazione Farmaceutiche "M.E. Sangalli", Via G. Colombo 71