INNOVATIVE PHARMACEUTICAL FORMS
Learning outcomes of the course unit
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 contents summary
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
Course contents
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
Recommended readings
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 of the Department of Pharmacy) will be suggested.
Teaching methods
The course is organized with frontal lectures. 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.
Assessment methods and criteria
The final examination is a written test and is organized so as to evaluate:
-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 written language (in terms of clarity and accuracy)
The test is composed of multiple choice questions and open questions. A fac-simile of the examen and the criteria used in the evaluation are avaiable to the students.
