13122 - PHARMACEUTICAL TECHNOLOGY AND LEGISLATION 1 WITH LABORATORY PRACTICE
Academic Year 2021/2022
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CHIARA SINICO (Tit.)
Ciclo Annuale Unico
- Teaching style
- Lingua Insegnamento
|[50/21] PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY||[21/00 - Ord. 2014] PERCORSO COMUNE||12||112|
Knowledge and understanding
The course aims to direct students to the most relevant aspects of the profession of pharmacist and Technical Director of a Pharmaceutical Industry through knowledge of: a) the legislation in force concerning the sphere of the drug, both in terms of the rules of production, marketing and dispensing b) the technological aspects that lead to the transformation of a therapeutically active molecule in a form which allows it the administering and the role of the raw materials used in their formulation. Knowledge and understanding of the basic principles of biopharmaceutical and therefore the bioavailability of an active ingredient in several pharmaceutical forms, depending on the different routes of administration: oral, parenteral, ophthalmic, rectal, for topical application. Through practical exercises the student will can also gain knowledge of techniques for the preparation and the control of medicinal products in galenic pharmacy and the laws and ethics governing the profession of pharmacist.
Applying knowledge and understanding
Demonstrate that they have the ability to apply knowledge and understanding when evaluating the technological project and the therapeutic efficacy of a medicinal product by understanding the composition of raw materials used in the formulations of drugs, applying the basics and modern pharmaceutical technology during the step of preparation of galenic formulations.
To have the ability to collect and interpret data obtaining original solutions through also the research activity for the preparation of the experimental thesis.
Being able to evaluate and judge the quality and technological suitability of a pharmaceutical product prepared in the laboratory, having gained the ability to apply the technological and quality controls of dosage forms according to reports in the Italian and European Pharmacopoeia.
Being able to communicate information, ideas and to discuss problems and design relevant solutions to the professional context of reference.
It is important to have knowledge of the notions acquired in previous years in biological matter (structure of plant and animal cell, anatomy and physiology of the human body, microbilology and pathology) and physical chemistry (structure of inorganic and organic molecules and reaction mechanisms, properties of different physical states: solid, liquid and gas, thermodynamic processes) at the beginning of the teaching activity (or at the beginning of the study for students who do not attend), to deal with the content provided by the teaching.
The required pre-requisites are:
To have attended the examination of Organic Chemistry 1 for the frequency of practical laboratory exercises;
To have supported the Biochemistry and Biochemistry examination applied to support the final exam.
INTRODUCTION TO THE COURSE Educational development - THEORY LESSONS
Function of the Technical Director in the Pharmaceutical Industry, Glossary-2h
Principles of biopharmaceutical: Bioavailability: kinetic and quantitative aspects; LADME-2h
Dissolution rate and the factors influencing it-2h
Absorption processes. Routes of administration-2h
Pulverization Particle size analysis-2h
Characteristics of the powders apparent density, porosity, specific surface area, adsorption capacity, smoothness Mixing-2h
The Granules granulation dry, wet, fluid bed. Controls-1h
Capsules Hard capsules: starchy, operculate. Problems concerning the capsules formulation. Soft capsules; Essays and controls F.U.-2h
Tablets Tablet presses: stages of the compression process and of physical phenomena involved. Excipients for tablets. Coated tablets. Essays and controls FU-4h
The pharmaceutical solutions: the physical basics of the solutions. The solvents in the pharmaceutical solutions. Factors that influence the dissolution rate of the active principles-3h
The Emulsions: Surface phenomena and interfacial phenomena. Thermodynamic aspects. Emulsifiers: requirements and classification. Multiple emulsions-3h
The Suspensions: definition and physical and chemical properties. Flocculated and deflocculated suspensions. Stabilization of the suspensions-2h
Parenteral preparations, ophthalmic solutions-3h
Preparations obtained from herbal drugs-2h
Preparations for topical use: classification F.U. Dermatological preparations: various types and their therapeutic purposes. Percutaneous absorption and factors that influence it. Excipients for ointments. Controls. Otologic preparations. Nasal preparations. Oromucosal preparations-3h
Preparation for rectal use: Suppositories. Excipients for suppositories; Essays and controls F.U.-2h
Supranational health organization: Organs of the European Union and Community legislation
Italian health organization: background. Central and local organisms. Legislative sources-3h
The Pharmacopoeia: International, European. The F.U. Italian XIIa Ed-4h
Exercise of the arts and health professions: Examination of State for authorization to practice the profession of pharmacist. Order and professional association. Vigilance of the pharmaceutical service-1h
Laws and regulations in the pharmaceutical field: Administrative Classification of pharmacies. Competition ordinary and extraordinary (Law 27/2013); Provisions on ownership-3h
Classification of medicinal products according to the production-2h
Sphere of the activity in pharmacy. DPC medicines PHT L. 405/2001-1h
Discipline dispensing of the medicinal products: SOP and OTC drugs-1h
Various types of prescriptions and rules applicable: RR, RNR, RMR RL Dispensing of drugs subject to medical prescription, without medical recipe, in emergency situations (DM 31.03.2008)-4h
National Health Service Pharmaceutical Support: the SSN prescription-1h
Rules governing the poisonous substances. Identification of poison from a regulatory point CE.2006 Regulation (REACH) CE 2008 (CLP). Housing, dispensing and sale of poisonous substances in the pharmacy-2h
Rules governing narcotic and psychotropic substances (DPR 309/90; L12/2001; L49/2006; L38/2010; L79/2014)-6h
Rules governing Harmful Toxic Waste and Doping substances-1h
PRACTICAL LABORATORY LESSONS AND EXERCISES-2nd SEM
Rules governing the shipment of a masterly prescription-4h
Single-dose active ingredient low-dosed-3h
Capsules active ingredient low-dosed-3h
The course develops into two semesters: 1st Semester: according to the Didattic Regulations for the Course of Studies CTF it is required attendance obligatory for at least 65% of class hours, otherwise you can not access the frequency of laboratory lessons to be carried out in the 2nd half. The course has a duration of approximately 10 weeks (6 hours per week in the classroom) in which they are explained theoretical aspects regarding both the topics of Technology as the Pharmaceutical Legislation. At the conclusion of one or more topics will be devoted part of the lessons to Question Time. During the 1st Semester the students can enroll in the course via e-mail to have the opportunity to receive ongoing the slides of the lessons given in the classroom, as well as communicate with the teacher for any information concerning the course.
2nd Semester, attendance is obligatory, lasts for about 6 weeks in which students will be engaged for 6 hours per week as follows: 2 hours in the classroom for the practical explanation concerning two pharmaceutical forms that will be performed in the practical laboratory lessons on two different days of the week, lasting approximately of 2 hours each. For each practical laboratory lesson, the students must draw up a work sheet, according to the NBP FU, where they must to report the regulatory aspects relating to the medicinal produced and the technological aspects applied to the particular dosage form. This worksheet will be returned the next practical laboratory lesson with the necessary corrections. During the practical laboratory lessons students will be supported by the teacher, by the technical staff and by the tutors, to solve any problem concerning the conduct of the practical test. At the students who are absent for a one practical laboratory lesson, he is given the opportunity to recover the test. Students who are absent for more than three practical laboratory lessons, can no longer complete the practical course to that academic year.
At the end of the 2nd Semester the student must pass the Practical Final Test in order to access Oral Exam.
The Practical Final Test has been valid until the autumn session of the next academic year. After this time the student must retake the Practical Final Test.
To students are given the opportunity, to be able to take the exam in two parts: a partial referring to topics of Pharmaceutical Legislation which will then be completed with the arguments relating to the part of Pharmaceutical Technology. The maximum time that can elapse to complete the exam is 2 years. After this time the part referring to the Pharmaceutical Legislation is no longer valid and the examination and the pratical final test must be given again. The day of the Appeal is drawn up a calendar of dates on which the examinations will be held, in accordance with the needs of students and the teacher.
Verification of learning
The student's assessment includes a Proof Practice Finale that allows you to access the Oral Exam Final. In the 'oral examination is checked the student's knowledge of the concepts of the current pharmaceutical legislation proving to be able to apply to a specific medical prescription. Is checked the student's knowledge of pharmaceutical technology concepts that lead to the transformation of a therapeutically active molecule in a pharmaceutical form which allows the administration and the role and influence of the raw materials used in their formulation on the bioavailability of p.a. .
EVALUATION CRITERIA FOR LEARNING ASSESSMENT
The score of the oral examination shall be awarded by a voting expressed in thirtieths which represents 60% of the acquired knowledge regarding the Pharmaceutical Technology and 40% acquired knowledge regarding the Pharmaceutical Legislation.
In examination assessment to determine the final grade will consider the following elements:
1. Appropriateness, accuracy and consistency of knowledge
2. Expressive skills and appropriate use of the specific language of the discipline
3. Logical and consequential capacity in the fitting of the contents
4. Ability to connect different topics by finding common points and establish a coherent overall design, that is taking care of the structure, organization and logical connections to the exhibition's speech
5. Summary capacity including through the use of its symbolism of matter and the graphic expression of ideas and concepts, for example in the form of formulas, diagrams, equations.
Availability to exchange and interaction with the teacher during the interview.
Critical thinking and ability to self-evaluation.
Consequently, the judgment can be:
a) Enough (18 to 20/30)
The candidate demonstrates little acquisition of theoretical knowledge, superficial level, many gaps. Modest communicative abilities, but still sufficient to support a coherent dialogue, logical capacity and consequentiality in fitting the topics of elementary level; poor capacity of synthesis and rather stunted ability of graphical expression, scanty interaction with the teacher during interview.
b) Moderate (21 to 23)
The candidate demonstrates a moderate acquisition of knowledge but lack of deepening, a few gaps; communicative abilities more than sufficient to support a coherent dialogue; acceptable mastery of the scientific language, logical capacity and consequentiality in fitting the topics of moderate complexity, good enough capacity of synthesis and acceptable ability to graphic expression.
c) Good (24 to 26)
The candidate demonstrates a rather large wealth of knowledge, moderate deepening, with small gaps; satisfactory mastery of the communicative abilities and meaningful scientific language, dialogue capabilities and critical thinking well detectable, good capacity for synthesis and more than acceptable ability to graphic expression.
d) Outstanding (27 to 29)
The candidate demonstrates a very extensive wealth of notions, high in-depth, with marginal gaps; remarkable ability in communicating and high mastery of scientific language; remarkable dialogue capacity, good competence and relevant aptitude for logical synthesis, high capacity of synthesis and graphical expression.
e) Excellent (30)
The candidate demonstrates a wealth of very extensive and in-depth knowledge, irrelevant gaps, high capacity and high mastery in communicating through the scientific language, excellent dialogue capabilities, and marked aptitude to make connections among different topics, excellent ability to synthesize and very familiar with the graphical expression.
The praise is attributed to the candidates clearly above average
Principi di Tecnologia farmaceutica, P Colombo et al., Casa Editrice Ambrosiana,2° Edizione (2015)
Galenica Pratica, E. Ragazzi, Libreria internazionale Cortina-Padova.
P. Minghetti, Legislazione farmaceutica, Nona edizione- Aprile 2018, Ed. Ambrosiana
Italian Pharmacopoeia XII edition and any supplements in force;
European Pharmacopoeia 9th and any supplements in force
Medicamenta, settima ed., Ed. Coop. Farmaceutica, Milano; (available in the library and in the laboratory).
A.T Florence-D. Attwood- Le basi chimico fisiche della Tecnologia Farmaceutica- EdiSES;
A.N. Martin, Physical Pharmacy, Lea & Febiger, Philadelphia;
Remington’s Pharmaceutical science, Mack Ed.;
Slides of the lessons carried out in classroom, during the 1st and 2nd semester, updated electronically delivered to students during the course.