ID:
510707
Duration (hours):
112
CFU:
12
SSD:
FARMACEUTICO TECNOLOGICO APPLICATIVO
Year:
2025
Overview
Date/time interval
Primo Semestre (29/09/2025 - 23/01/2026)
Syllabus
Course Objectives
To study the dosage form influence on the drug bioavailability when administered by oral, transdermal, nasal and
pulmonary route; to give theoretical and methodological knowledge useful for formulating and industrial manufacturing of both conventional and modified release solid oral dosage forms and of transdermal, nasal and
pulmonary dosage forms; marketing authorizations of medicinal products (european and national procedures).
pulmonary route; to give theoretical and methodological knowledge useful for formulating and industrial manufacturing of both conventional and modified release solid oral dosage forms and of transdermal, nasal and
pulmonary dosage forms; marketing authorizations of medicinal products (european and national procedures).
Course Prerequisites
Knowledge of physiology, anatomy, organic chemistry, physics are required to understand the interaction between medicines and the patient and their formulations.
Teaching Methods
Besides theoretical lessons (10 CFU), practical activities (in lab and in classroom, 2 CFU) integrate the course.
For students with specific needs, who cannot attend the teaching activities in person and who have applied for Inclusive Teaching Modes (Modalità Didattiche Inclusive), appropriate teaching material will be available for a profitable independent study. If required, self-learning can be supported by tutoring or integrative teaching activities, or dedicated meetings, including online, with flexibility of time according to needs.
For students with specific needs, who cannot attend the teaching activities in person and who have applied for Inclusive Teaching Modes (Modalità Didattiche Inclusive), appropriate teaching material will be available for a profitable independent study. If required, self-learning can be supported by tutoring or integrative teaching activities, or dedicated meetings, including online, with flexibility of time according to needs.
Assessment Methods
Learning check: 1) “in itinere” written assessement and a complementary final written assessement (multiple choice and open questions) during lessons period or 2) oral examination in one of the official exam dates.
Texts
Principi di Tecnologie Farmaceutiche II Edizione (P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale), Casa editrice Ambrosiana, 2015
La fabbricazione industriale dei medicinali (L. Fabris, A. Rigamonti), Società Editrice Esculapio, 2008.Aulton's Pharmaceutics: the design and manufacture of medicines, 5th Edition (M.E. Aulton, K. Taylor), Elsevier, 2018
La fabbricazione industriale dei medicinali (L. Fabris, A. Rigamonti), Società Editrice Esculapio, 2008.Aulton's Pharmaceutics: the design and manufacture of medicines, 5th Edition (M.E. Aulton, K. Taylor), Elsevier, 2018
Contents
Biopharmaceutical principles
Gastro-intestinal tract: physiology and drug absorption. Bioavailability: physicochemical and dosage form factors.
Solubility and dissolution rate, intestinal permeability and systemic absorption. Biopharmaceutical Classification System
(B.C.S.). Assessment of biopharmaceutical properties (permeability and intestinal absorption. Alternative administration
routes: transdermal and inhaled routes; peculiar biopharmaceutical issues.
Oral Solid Dosage forms
Conventional and modified-release dosage forms.
Powders, granules, hard and soft capsules, tablets. Definitions, features, manufacturing methods. Granulation, pelletization, coating.
Biopharmaceutical and pharmacokinetic rationale for modified-release dosage forms. Delayed- and targeted dosage
forms: gastro-resistant /enteric-coated systems, colon delivery systems and gastric-retentive systems. Prolonged-release
dosage forms: matrices, reservoir systems, osmotic pump systems. Single-unit and multi-unit systems.
Transdermal, nasal and pulmonary drug delivery
Transdermal administration route. Rationale, advantages and limitations, drug choice. Transdermal therapeutic systems,
polymeric excipients and chemical penetration enhancers. Innovative technologies based on physical methods, needlefree
technologies.
Nasal and inhaled drug delivery systems. Pressurized metered-dose inhalers, dry powder inhalers and nebulizers.
Pharmaceutical legislation
Marketing authorization of medicinal products and market exclusivity: EU and international legislation. The procedures for national and European marketing
authorization. Registration dossier. Bioequivalence studies.
Gastro-intestinal tract: physiology and drug absorption. Bioavailability: physicochemical and dosage form factors.
Solubility and dissolution rate, intestinal permeability and systemic absorption. Biopharmaceutical Classification System
(B.C.S.). Assessment of biopharmaceutical properties (permeability and intestinal absorption. Alternative administration
routes: transdermal and inhaled routes; peculiar biopharmaceutical issues.
Oral Solid Dosage forms
Conventional and modified-release dosage forms.
Powders, granules, hard and soft capsules, tablets. Definitions, features, manufacturing methods. Granulation, pelletization, coating.
Biopharmaceutical and pharmacokinetic rationale for modified-release dosage forms. Delayed- and targeted dosage
forms: gastro-resistant /enteric-coated systems, colon delivery systems and gastric-retentive systems. Prolonged-release
dosage forms: matrices, reservoir systems, osmotic pump systems. Single-unit and multi-unit systems.
Transdermal, nasal and pulmonary drug delivery
Transdermal administration route. Rationale, advantages and limitations, drug choice. Transdermal therapeutic systems,
polymeric excipients and chemical penetration enhancers. Innovative technologies based on physical methods, needlefree
technologies.
Nasal and inhaled drug delivery systems. Pressurized metered-dose inhalers, dry powder inhalers and nebulizers.
Pharmaceutical legislation
Marketing authorization of medicinal products and market exclusivity: EU and international legislation. The procedures for national and European marketing
authorization. Registration dossier. Bioequivalence studies.
Course Language
Italian
Degrees
Degrees
PHARMACY
Single-cycle Master’s Degree
5 years
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People
People (2)
Professore Ordinario
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