Fundamentals of Pharmaceutical Preformulation and Formulation with Laboratory
A.Y. 2024/2025
Learning objectives
To provide the student with theoretical and practical fundamentals regarding solutions, dispersed systems and powders, which represent the main components of liquid, semisolid and solid dosage forms.
Expected learning outcomes
Students will acquire knowledge about powders and relevant properties, dissolution and solubility concepts, issues relevant to physical stability of dispersed systems and principles of rheology.
Lesson period: First semester
Assessment methods: Esame
Assessment result: voto verbalizzato in trentesimi
Single course
This course can be attended as a single course.
Course syllabus and organization
Linea AK
Responsible
Lesson period
First semester
Course syllabus
Lessons
· Principles of dosage forms design and preparation: glossary; routes of administration and types of pharmaceutical dosage forms; notes on biopharmaceutics and delivery of active ingredients; manufacturing unit operations of dosage forms; introduction to essays and technological techniques
· Preformulation : physicochemical properties of substances (solubility, dissolution rate, pKa, logP); solid state properties; drug stability
· Basic principles of diffusion, dissolution and partitioning processes, interfacial phenomena and fluid rheology
· Pharmaceutical powders: introduction to particle size, powders classification, production methods (crystallization, size reduction and separation of particles); particle size analysis; bulk properties.
· Solutions: formulation and properties; methods for increasing the solubility of active ingredients
· Colloidal dispersions: lyophilic and lyophobic colloids, purification of colloids, kinetic properties of colloids, optical and electrical properties of interfaces, physical stability, coacervation, association colloids; gels and their pharmaceutical applications
· Emulsions: formulation and preparation methods; factors determining emulsion type, phase inversion; recognition methods; physical stability; microemulsions
· Suspensions: formulation, flocculated and deflocculated systems, rheological properties
Individual laboratory training
· Characterization of pharmaceutical powders: particle size analysis, bulk density, flowability
· Agglomeration of powders by wet granulation
· Preparation and characterization of simple solutions, suspensions, gels and emulsions
· Evaluation of the release rate of an active ingredient from a pharmaceutical formulation
· Principles of dosage forms design and preparation: glossary; routes of administration and types of pharmaceutical dosage forms; notes on biopharmaceutics and delivery of active ingredients; manufacturing unit operations of dosage forms; introduction to essays and technological techniques
· Preformulation : physicochemical properties of substances (solubility, dissolution rate, pKa, logP); solid state properties; drug stability
· Basic principles of diffusion, dissolution and partitioning processes, interfacial phenomena and fluid rheology
· Pharmaceutical powders: introduction to particle size, powders classification, production methods (crystallization, size reduction and separation of particles); particle size analysis; bulk properties.
· Solutions: formulation and properties; methods for increasing the solubility of active ingredients
· Colloidal dispersions: lyophilic and lyophobic colloids, purification of colloids, kinetic properties of colloids, optical and electrical properties of interfaces, physical stability, coacervation, association colloids; gels and their pharmaceutical applications
· Emulsions: formulation and preparation methods; factors determining emulsion type, phase inversion; recognition methods; physical stability; microemulsions
· Suspensions: formulation, flocculated and deflocculated systems, rheological properties
Individual laboratory training
· Characterization of pharmaceutical powders: particle size analysis, bulk density, flowability
· Agglomeration of powders by wet granulation
· Preparation and characterization of simple solutions, suspensions, gels and emulsions
· Evaluation of the release rate of an active ingredient from a pharmaceutical formulation
Prerequisites for admission
Basic knowledge of chemistry, physics and physiology
Teaching methods
Lectures with slide projection
Individual laboratory training
Individual laboratory training
Teaching Resources
Slides of the lessons and supplementary material selected by the teacher can be downloaded from ARIEL
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006)
L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986).
Aulton's Pharmaceutics 4th ed., Elsevier Ltd (2013). Italian translation by Caviglioli et at.: Tecnologie Farmaceutiche, Edra LSWR, Milano (2015)
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006)
L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986).
Aulton's Pharmaceutics 4th ed., Elsevier Ltd (2013). Italian translation by Caviglioli et at.: Tecnologie Farmaceutiche, Edra LSWR, Milano (2015)
Assessment methods and Criteria
The learning assessment includes a written test and a laboratory evaluation.
The written test, lasting 2 hours, consists of 4 open-ended questions on the topics covered in the lectures and is considered passed if the candidate satisfies all the questions sufficiently. Result of the written test is normally communicated within one week. The learning evaluation will be based on the following criteria:
(a) theoretical and applicative knowledge and understanding of the subjects covered, and (b) ability to link the topics and (c) appropriate use of technical language.
The laboratory unit test consists of 2 calculation exercises the nature of those being addressed during the practical activities and allows the student to achieve 2 points per exercise.
The written test, lasting 2 hours, consists of 4 open-ended questions on the topics covered in the lectures and is considered passed if the candidate satisfies all the questions sufficiently. Result of the written test is normally communicated within one week. The learning evaluation will be based on the following criteria:
(a) theoretical and applicative knowledge and understanding of the subjects covered, and (b) ability to link the topics and (c) appropriate use of technical language.
The laboratory unit test consists of 2 calculation exercises the nature of those being addressed during the practical activities and allows the student to achieve 2 points per exercise.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 32 hours
Lessons: 32 hours
Lessons: 32 hours
Professors:
Cerea Matteo, Foppoli Anastasia Anna
Shifts:
Professor:
Foppoli Anastasia Anna
Turno 1
Professor:
Foppoli Anastasia AnnaTurno 2
Professor:
Cerea MatteoLinea LZ
Responsible
Lesson period
First semester
Course syllabus
Lectures:
- Principles of dosage forms design and preparation: glossary; routes of administration and types of pharmaceutical dosage forms; notes on biopharmaceutics and delivery of active ingredients; manufacturing unit operations of dosage forms; introduction to essays and technological techniques.
- Preformulation : physicochemical properties of substances (solubility, dissolution rate, pKa, logP); solid state properties; drug stability.
- Basic principles of diffusion, dissolution and partitioning processes, interfacial phenomena and fluid rheology.
- Pharmaceutical powders: introduction to particle size, powders classification, production methods (crystallization, size reduction and separation of particles); particle size analysis; bulk properties.
- Solutions: formulation and properties; methods for increasing the solubility of active ingredients.
- Colloidal dispersions: lyophilic and lyophobic colloids, purification of colloids, kinetic properties of colloids, optical and electrical properties of interfaces, physical stability, coacervation, association colloids; gels and their pharmaceutical applications.
- Emulsions: formulation and preparation methods; factors determining emulsion type, phase inversion; recognition methods; physical stability; microemulsions.
- Suspensions: formulation, flocculated and deflocculated systems, rheological properties.
Individual laboratory training:
- Characterization of pharmaceutical powders: particle size analysis, bulk density, flowability.
- Agglomeration of powders by wet granulation.
- Preparation and characterization of simple solutions, suspensions, gels and emulsions.
- Evaluation of the release rate of an active ingredient from a pharmaceutical formulation.
- Principles of dosage forms design and preparation: glossary; routes of administration and types of pharmaceutical dosage forms; notes on biopharmaceutics and delivery of active ingredients; manufacturing unit operations of dosage forms; introduction to essays and technological techniques.
- Preformulation : physicochemical properties of substances (solubility, dissolution rate, pKa, logP); solid state properties; drug stability.
- Basic principles of diffusion, dissolution and partitioning processes, interfacial phenomena and fluid rheology.
- Pharmaceutical powders: introduction to particle size, powders classification, production methods (crystallization, size reduction and separation of particles); particle size analysis; bulk properties.
- Solutions: formulation and properties; methods for increasing the solubility of active ingredients.
- Colloidal dispersions: lyophilic and lyophobic colloids, purification of colloids, kinetic properties of colloids, optical and electrical properties of interfaces, physical stability, coacervation, association colloids; gels and their pharmaceutical applications.
- Emulsions: formulation and preparation methods; factors determining emulsion type, phase inversion; recognition methods; physical stability; microemulsions.
- Suspensions: formulation, flocculated and deflocculated systems, rheological properties.
Individual laboratory training:
- Characterization of pharmaceutical powders: particle size analysis, bulk density, flowability.
- Agglomeration of powders by wet granulation.
- Preparation and characterization of simple solutions, suspensions, gels and emulsions.
- Evaluation of the release rate of an active ingredient from a pharmaceutical formulation.
Prerequisites for admission
Basic knowledge of chemistry, physics and physiology is required.
Teaching methods
Lectures with slide projection.
Individual laboratory training.
Individual laboratory training.
Teaching Resources
Slides of the lessons and supplementary material selected by the teacher, downloadable from ARIEL.
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006)
L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986).
Aulton's Pharmaceutics 4th ed., Elsevier Ltd (2013). Italian translation by Caviglioli et at.: Tecnologie Farmaceutiche, Edra LSWR, Milano (2015)
P. Colombo, P.L. Catellani, A. Gazzaniga et al., Principi e Tecnologie Farmaceutiche, CEA, Milano (2007) A.Martin, Physical Pharmacy, Lippincott Williams & Wilkins, Baltimore (2006)
L.Lachman et al., The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia (1986).
Aulton's Pharmaceutics 4th ed., Elsevier Ltd (2013). Italian translation by Caviglioli et at.: Tecnologie Farmaceutiche, Edra LSWR, Milano (2015)
Assessment methods and Criteria
The learning assessment includes a written test and a laboratory evaluation.
The written test, lasting 2 hours, consists of 4 open-ended questions on the topics covered in the lectures and is considered passed if the candidate suffciently answers all the questions. The result of the written test is normally communicated within one week. The learning evaluation will be based on the following criteria:
(a) theoretical and applicative knowledge and understanding of the topics covered, (b) ability to link the topics and (c) appropriateness in the use of technical language.
The evaluation of the laboratory unit, consists of 2 calculation exercises on the topics covered during the practical exercises and allows to obtain 2 points per test.
The written test, lasting 2 hours, consists of 4 open-ended questions on the topics covered in the lectures and is considered passed if the candidate suffciently answers all the questions. The result of the written test is normally communicated within one week. The learning evaluation will be based on the following criteria:
(a) theoretical and applicative knowledge and understanding of the topics covered, (b) ability to link the topics and (c) appropriateness in the use of technical language.
The evaluation of the laboratory unit, consists of 2 calculation exercises on the topics covered during the practical exercises and allows to obtain 2 points per test.
CHIM/09 - PHARMACEUTICAL AND TECHNOLOGICAL APPLICATIONS OF CHEMISTRY - University credits: 6
Single bench laboratory practical: 32 hours
Lessons: 32 hours
Lessons: 32 hours
Professors:
Gennari Chiara Grazia Milena, Musazzi Umberto Maria
Shifts:
Professor:
Gennari Chiara Grazia Milena
Turno 1
Professor:
Gennari Chiara Grazia MilenaTurno 2
Professor:
Musazzi Umberto MariaEducational website(s)
Professor(s)
Reception:
by appointment
via G. Colombo 71