FA/0008 - PHARMACEUTICAL TECHNOLOGY AND LEGISLATION 2 AND INDUSTRIAL MANUFACTURING OF MEDICINES
Academic Year 2021/2022
Free text for the University
CHIARA SINICO (Tit.)
- Teaching style
- Lingua Insegnamento
|[50/21] PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY||[21/00 - Ord. 2014] PERCORSO COMUNE||10||80|
The aim of the course is to provide students with the basic knowledges, supplemented by more recent acquisitions, on the design, preparation and control of modified release dosage forms
In this course, we also develop in parallel the technological and regulatory aspects concerning the industrial production of medicines.
Knowledge: The student must acquire knowledge of the technological and regulatory issues related to the development of a pharmaceutical dosage form. The learning of these aspects will enable him to study, critically and independently, scientific texts in the field of pharmaceutical technology.
Skills: The ability to assess the technological project and the therapeutic efficacy of a medicinal product (through the study of the composition of the raw materials, the application of the basic and modern pharmaceutical technology principles) developed during the course, will find significant application in every field of professional activity.
The specific prior knowledge that the student must possess, concerns basic knowledge of biopharmaceutical and pharmaceutical technologies for the formulation and control of conventional dosage forms. This knowledge is acquired by the student after passing the exam of Pharmaceutical Technology and Legislation I and attending the course of Applied Pharmaceutical Technology.
Controlled release drug delivery systems: introductory description of technological principles.
Oral sustained release. Matrix type drug delivery systems: hydrophobic and hydrophilic matrices (swellable and bioerodible). Reservoir type drug delivery systems. Osmotically controlled drug delivery systems (osmotic pumps). Bioadhesive drug delivery systems.
Oral delayed release: pulsatile drug delivery systems
Parenteral sustained release: macromolecular drug complex, water supensions, oil solutions and suspensions.
Transdermal sustained release: TTS
Drug targeting: general concepts. Physical drug targeting. Passive and active drug targeting.
Polymeric nano/microparticulate drug delivery systems: general concepts, preparation procedures and applications
Vesicular drug delivery systems (liposomes and niosomes): general concepts, preparation procedures and technological applications.
Polymeric prodrugs: general concepts, syntetic schemes, and applications..
Regulatory classification of medicinal products and fixed prices.
Drug manufacturing authorisation and drug marketing authorisation.
Regulatory status of :generics and biosimilars.
Regulation of orphan drugs
Regulation of omeopatic medicinal products.
Regulation of cosmetic products
European regulatory framework for medical and diagnostic devices and biocidal products.
Pharmaceutical company: divisional structure, organisation, management.
Central technical services.
Machinery and packing materials: metals, steels, glass, plastics, elastomers.
Manufacturing and packaging of solid dosage forms
Manufacturing and packaging of liquid dosage forms
Manufacturing and packaging of semisolid dosage forms
Traditional lessons with the help of projections of digital slides on a screen and, possibly, at the blackboard. Each lesson begins with a brief summary of the concepts covered in previous lessons and ends with a discussion aimed to test the acquired knowledge.
If necessary to meet specific educational needs related to the epidemiological situation, lessons will be held in live streaming and recordings of them will be available online.
Verification of learning
"In itinere" written tests and final oral examination.
The final grade takes into account several factors:
Quality of the knowledge, skills, competences and / or manifest:
a) appropriateness, accuracy and consistency of knowledge
b) appropriateness, accuracy and consistency of skills
c) appropriateness, accuracy and consistency of skills
a) Capacity of expression;
b) Proper use of the specific language of the discipline;
c) Capacity logical and consequential in the fitting of the contents;
e) Ability to connect different arguments by finding the common points and establish a consistent overall design, ie taking care of structure, organization and logical connections of speech exhibition;
f) Ability to summarize including through the use of symbolism on the matter, and the graphic expression of ideas and concepts, for example in the form of formulas, tables, equations.
Availability to exchange and interaction with the teacher during the interview.
a) critical spirit;
b) ability to self-evaluation.
Consequently, the judgment can be:
a) Fair (18 to 20/30)
The candidate demonstrates little knowledge acquired, superficial level, many gaps. expressive abilities modest, but still sufficient to support a coherent dialogue, logical and consequential in the fitting of the subjects of the elementary level; poor capacity for synthesis and ability to graphic expression rather stunted, lack of interaction with the teacher durations interview.
b) Moderate (21 to 23)
The applicant demonstrates the discreet acquisition of knowledge but lack of depth, a few gaps; expressive abilities more than sufficient to support a coherent dialogue; acceptable mastery of the language of science, logical and consequential in the fitting of the arguments of moderate complexity, more than enough capacity for synthesis and the ability to graphic expression acceptable.
c) Good (24 to 26)
The candidate demonstrates a wealth of knowledge rather large, moderate depth, with small gaps; satisfactory mastery of the expressive capabilities and significant scientific language; ability dialogical and critical well detectable, good capacity for synthesis and ability to graphic expression more than acceptable.
d) Outstanding (27 to 29)
The candidate demonstrates a wealth of notions very extensive, well depth, with marginal gaps; remarkable powers of expression and high mastery of scientific language; remarkable capacity dialogue, good competence and relevant aptitude for logic synthesis, high capacity for synthesis and graphic expression.
e) Excellent (30)
The candidate demonstrates a wealth of very extensive and in-depth knowledge, gaps irrelevant, high capacity and high mastery of the expressive language of science; excellent ability dialogical aptitude to make connections between different subjects, excellent ability to synthesize and very familiar with the expression graphics.
The praise is attributed to the candidates clearly above average, and whose notional limits, if any, expressive, conceptual, logical, as a whole are completely irrelevant.
P. Colombo et al. “Principi di Tecnologie Farmaceutiche” Casa Editrice Ambrosiana, Milano.
P. Minghetti, M. Marchetti “Legislazione Farmaceutica” Casa Editrice Ambrosiana, Milano.
L. Fabris, A. Rigamonti. “ La fabbricazione industriale dei medicinali” Società Editrice Esculapio
Students will be provided with the digital slides projected in class.