INNOVATIVE PHARMACEUTICAL FORMS
cod. 16727

Academic year 2022/23
4° year of course - First semester
Professor
NICOLI Sara
Academic discipline
Farmaceutico tecnologico applicativo (CHIM/09)
Field
Discipline chimiche, farmaceutiche e tecnologiche
Type of training activity
Characterising
40 hours
of face-to-face activities
5 credits
hub: PARMA
course unit
in ITALIAN

Learning objectives

The purpose of this course is to acquire a deep-rooted knowledge of the fundamental principles of the controlled drug delivery and innovative formulations (both marketed and in-development) and to develop the ability to apply these principles to different kind of formulations and administration route. A further aim of the course is to provide the students the tools for the elaboration of the information given so as to integrate them into their knowledge. In particular at the end of the course the student shall:
-have aquired specific knowledge on mechanisms, materials, processes and formulations
-be able to compare the innovative formulations with the traditional ones
-be able to highlight, for every innovative formulation/administration route, potentialities, limits and impact on patient therapy
-ba able to present (orally or in writing) the topics studied in a clear way and using a correct technical language

Prerequisites

An in-depth knowledge of Pharmaceutical Technology is needed.

Course unit content

The first lecture of the course presents the rationale of the innovative pharmaceutical formulations and highlight the background needed to deal with this course. The program is the following:
General topics
• INTRODUCTION: INNOVATIVE PHARMACEUTICAL FORMULATIONS AND CONTROLLED RELEASE
• BIOAVAILABILITY – ABSORPTION
• POLYMERS FOR CONTROLLED DRUG DELIVERY
• DIFFUSIONE AND DISSOLUTION
Innovative formulations
• RESERVOIR
• MATRICES
• OSMOTIC SYSTEMS
• GASTRORETENTIVE SYSTEMS
• COLON DELIVERY
• MUCOADHESION
• MICROPARTICLES
• NANOPARTICLES
• LIPOSOMES
• HYDROGELS
Alternative administration routes
• TRANSDERMAL DRUG DELIVERY
• BUCCAL DRUG DELIVERY
• OCULAR DRUG DELIVERY
• ORAL ADMINISTRATION OF PEPTIDE AND PROTEINS

Full programme

The first lecture of the course presents the rationale of the innovative pharmaceutical formulations and highlight the background needed to deal with this course. The program is the following:
General topics
• INTRODUCTION: INNOVATIVE PHARMACEUTICAL FORMULATIONS AND CONTROLLED RELEASE
• BIOAVAILABILITY – ABSORPTION
• POLYMERS FOR CONTROLLED DRUG DELIVERY
• DIFFUSIONE AND DISSOLUTION
Innovative formulations
• RESERVOIR. Behavior, drug release kinetic, advantages, limitations, examples of products on the market
• MATRICES. Inert, erodible, swellable matrices. Behavior, drug release kinetic, advantages, limitations, examples of products on the market
• OSMOTIC SYSTEMS Behavior, drug release kinetic, advantages, limitations, examples of products on the market
• GASTRORETENTIVE SYSTEMS Behavior, drug release kinetic, advantages, limitations, examples of products on the market
• COLON DELIVERY Behavior, drug release kinetic, advantages, limitations, examples of products on the market
• MUCOADHESION and MUCUS-PENETRATION. Structure of mucus and characteristics of mucoadhesive and mucus-penetrating polymers. Theories for mucoadhesion. Examples of mucoadhesive formulations for different administration routes.
• MICROPARTICLES. Preparation methods and applications
• NANOPARTICLES Preparation and characterization methods. Applications
• LIPOSOMES Preparation and characterization methods. Applications

• HYDROGELS. Properties, stimuli responsive hydrogels, examples
Alternative administration routes
• TRANSDERMAL DRUG DELIVERY. Advantages and limitations. Transdermal patches: preparation, characterization and marketed products
• NASAL AND PULMONARY DRUG DELIVERY. Advantages and limitations. Examples of formulations
• BUCCAL DRUG DELIVERY. Advantages and limitations. Examples of buccal formulations
• ORAL ADMINISTRATION OF PEPTIDE AND PROTEINS Problems and possible solutions: particulate systems, enzyme inhibitors, absorption enhancers
• OCULAR DRUG DELIVERY (local action). Administration problems in the treatment of anterior and posterior segment eye diseases. Innovative formulations

Bibliography

Textbook: Principi di tecnologie farmaceutiche, P. Colombo, P.L. Catellani, A. Gazzaniga, E. Menegatti, E. Vidale, Casa Editrice Ambrosiana Ed. 2004
Since some topics are not present in the book, specific texts (availabe at the library) will be suggested.
The teacher makes available copies of the slides on Elly portal (in Italian)

Teaching methods

Lessons will be held in the classroom. The first lecture presents the rationale of the innovative pharmaceutical formulations and highlight the background needed to deal with this course. Then, general topics such as bioavailability and bioequivalence, dissolution, diffusion, polymers, controlled release are presented. Finally, the different pharmaceutical formulations and alternative delivery routes are explained in detail. Several examples will be given to train the students to apply the general knowledge to specific formulations. Additionally, 4 hours will be dedicated to exercises and mock examinations.

Assessment methods and criteria

The summative evaluation of the knowledge acquired is made through a written exam, made of two partials relative to the two modules. The student should, after online enrollment:
a) pass a written exam during the official dates established by the Dipartimento di Scienze degli Alimenti e del Farmaco (Module of cosmetic products, weight 50% of the overall grade);
b) pass a written exam during the official dates established by the Dipartimento di Scienze degli Alimenti e del Farmaco (Module of innovative pharmaceutical formulations, weight 50% of the overall grade);

Each written exam, duration 1 hour, consists of 6 open answer questions (score for each question varies from 0 to 3) and 10 multiple choice questions (score for each question varies from 0 to 1). Up to 2 points will be given for the communication skills of the student.
The student should demonstrate to have understood, and to be able to apply, the fundamental concepts of each subject studied. In particular, the evaluation of each module, expressed in thirtieths, will be made on the basis of the following criteria:
-the knowledges of the topic treated during the course
-the ability to understand and elaborate information
-the ability of applying general concepts to specific subjects
-the ability to relate the different topic studied with the knowledge aquired in the previous courses
-the pertinence of the language (in terms of clarity and accuracy)

A fac-simile of the examen is avaiable to the students on the Elly portal.

The results of the exam are published on the portal ESSE3 (https://unipr.esse3.cineca.it/Home.do) within one week of the date of the exam. Students can see the exam, by appointment with the teacher.

Other information

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