ID:
510604
Duration (hours):
80
CFU:
9
SSD:
FARMACEUTICO TECNOLOGICO APPLICATIVO
Year:
2025
Overview
Date/time interval
Secondo Semestre (02/03/2026 - 19/06/2026)
Syllabus
Course Objectives
To provide a complete understanding of the issues related to the development and registration of a pharmaceutical product. To give the theoretical knowledge and methodological skills necessary for the resolution of chemical-physical, technological and biological problems involved in the transformation of an active ingredient into a pharmaceutical dosage form and in the satisfaction of regulatory requests. The student will learn how to use the guidelines of the Regulatory Agencies (EMA, FDA) and ICH to deal with the activities of pharmaceutical development, starting from preformulation studies up to formal stability studies.
Course Prerequisites
The knowledge that comes from the courses of Pharmaceutical Technology and Physical Chemistry is required.
Teaching Methods
Besides the lectures, two credits will be dedicated to exercises. Within these credits, practical laboratory exercises will be carried out (one-two afternoons). A written report resulting from group work will be requested on the practical laboratory activities. There will also be classroom exercises relating to solubility studies, characterization of the solid state and stability, as applications of topics covered in the course. Computer exercises, carried out in small groups, have the aim of making students autonomous in consulting sites of regulatory interest and in searching for the relevant guidelines; also in this case a report for small groups is required. The fundamentals of Experimental Design (DOE) methods will be given, as part of the Quality by Design approach covered in the theoretical part, with examples of applications to pharmaceutical development. Some in-depth seminars on the topics covered are planned, held by colleagues also from the pharmaceutical industry.
To strengthen inclusion of students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study, and if requested, self-learning can be supported by dedicated meetings, including online, with time flexibility depending on needs.
To strengthen inclusion of students with specific needs, who cannot attend teaching activities in person and who have applied for Inclusive Teaching Modality, adequate teaching material will be available for fruitful independent study, and if requested, self-learning can be supported by dedicated meetings, including online, with time flexibility depending on needs.
Assessment Methods
Final total exam (written text) in the fixed dates. An early exam date will be added at the end of the lectures of the semester. The written test is made of:
1) two / three essay questions, to evaluate the ability to recognize and analyze the critical aspects of preformulation and pharmaceutical development steps.
2) thwo/three short questions
3) two/three exercises about the part of the program treated during the practical lessons of the course, to evaluate the ability of application of the acquired knowledge.
For the assay questions, the evaluation will take into account the completeness of the responses and the ability to clearly discuss the subjects covered in relation to the critical aspects of the pharmaceutical development.
1) two / three essay questions, to evaluate the ability to recognize and analyze the critical aspects of preformulation and pharmaceutical development steps.
2) thwo/three short questions
3) two/three exercises about the part of the program treated during the practical lessons of the course, to evaluate the ability of application of the acquired knowledge.
For the assay questions, the evaluation will take into account the completeness of the responses and the ability to clearly discuss the subjects covered in relation to the critical aspects of the pharmaceutical development.
Texts
Martin A., Physical Pharmacy, Ed. Lea & Febiger; Wells, Pharmaceutical Preformulation, Ed. Horwood; Florence-Atwood, Physico-chemical Principles of Pharmacy, Ed. Macmillan;
P. Colombo et al., Principi di Tecnologie Farmaceutiche, Casa Editrice Ambrosiana, 2004.
P. Colombo et al., Principi di Tecnologie Farmaceutiche, Casa Editrice Ambrosiana, 2004.
Contents
The pharmaceutical development of a product from drug substance to drug product: biopharmaceutical, preformulation and formulation aspects. Drug substance: classification according to BCS, characterization of solubility, permeability, physico-chemical properties, pKa, LogP. Polymorphic and pseudo-polymorphic forms.
Methods of characterization of solid state (DSC and X ray diffraction), and of permeability. Methods to obtain new physical forms to improve solubility and stability. Biotechnological drug substances, stability concerns and regulatory aspects. Regulatory aspects of the drug substance.
Drug product: relevance of the dosage form according to the administration route. Excipients and their physico-chemical and technological compatibility. Excipient functionality. Justification of excipient choice and specifications. Formulation approaches to improve solubility, stability and permeability of a drug substance. QbD approach in the pharmaceutical development. Stability assessment: Methods to assess a drug substance and drug product stability. Regulatory aspects of stability studies.
Special attention will be given to the identification of critical process parameters and critical materials attributes.
Methods of characterization of solid state (DSC and X ray diffraction), and of permeability. Methods to obtain new physical forms to improve solubility and stability. Biotechnological drug substances, stability concerns and regulatory aspects. Regulatory aspects of the drug substance.
Drug product: relevance of the dosage form according to the administration route. Excipients and their physico-chemical and technological compatibility. Excipient functionality. Justification of excipient choice and specifications. Formulation approaches to improve solubility, stability and permeability of a drug substance. QbD approach in the pharmaceutical development. Stability assessment: Methods to assess a drug substance and drug product stability. Regulatory aspects of stability studies.
Special attention will be given to the identification of critical process parameters and critical materials attributes.
Course Language
Italian
More information
The frequency of practical exercises in the laboratory and about the consultation of regulatory sites is considered mandatory
Degrees
Degrees
MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY
Single-cycle Master’s Degree
5 years
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People
People
Professore Ordinario
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