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 manufacturing of both conventional and modified-release solid oral dosage forms, and for developing transdermal, nasal and pulmonary dosage forms; marketing authorizations of medicinal products (European and National procedures).
Teaching Methods
Besides theoretical lessons (10 CFU) and practical exercises (in lab and in classroom, together with seminars - 2 CFU) integrate the course.
For students with specific needs who are unable to attend educational activities in person and have applied for Inclusive Learning Modes, suitable educational materials will be made available for effective independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, as well as dedicated meetings, including online, with flexible scheduling according to individual needs.
For students with specific needs who are unable to attend educational activities in person and have applied for Inclusive Learning Modes, suitable educational materials will be made available for effective independent study. If requested, self-learning can be supported by tutoring or supplementary teaching activities, as well as dedicated meetings, including online, with flexible scheduling according to individual needs.
Assessment Methods
Two written “in itinere” examinations will be performed (multiple choice and open questions).
Learning check -
Passing the two “in itinere” examinations or passing the first "in itinere" test + a complementary oral exam in one of the official exam dates or passing a complete oral exam in one of the official exam dates.
Tailored examination procedures are implemented for students classified under Specific Learning Disorders (SLD) and Special Educational Needs (SEN), in accordance with applicable regulations and institutional guidelines.
Learning check -
Passing the two “in itinere” examinations or passing the first "in itinere" test + a complementary oral exam in one of the official exam dates or passing a complete oral exam in one of the official exam dates.
Tailored examination procedures are implemented for students classified under Specific Learning Disorders (SLD) and Special Educational Needs (SEN), in accordance with applicable regulations and institutional guidelines.
Texts
Tecnologia farmaceutica (a cura di Paolo Caliceti), Zanichelli Cea Casa Editrice Ambrosiana, 2025.
La fabbricazione industriale dei medicinali (L. Fabris, A. Rigamonti), Società Editrice Esculapio, 2008.
Aulton's Pharmaceutics: the design and manufacturing 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 manufacturing 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, "needle-free" 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, "needle-free" 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
More information
Slides and other materials (English-friendly) useful for the exam preparation will be published on Kiro platform.
Degrees
Degrees
PHARMACY
Single-cycle Master’s Degree
5 years
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People
People
Professore Ordinario
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