Descriptif
Different humid and dry processes used in pharmaceutical industries are presented: Pharmaceutical powders compaction, Physics and mechanics of granular media for powder handling.
Objectifs pédagogiques
The objectives are given for each parts:
Pharmaceutical powders compaction
to understand the key concepts of compaction:
-Technology, state of the art in research / industry
-Challenges / advantages & limitation
-Main keys & good practices
-Role of material properties in the development
-Tableting process description
-Role of each ingredient in a given formulation regarding its behaviour
-Behaviour of primary particles and rolled granules regarding Tablet strength
Physics and mechanics of granular media for powder handling,
to understand the key concepts of powder handling
drying
to understand the key concepts of drying
freeze drying
to provide with up-to-date information about all aspects of the freeze-drying process, from formulation & process development to equipment description
milling
- to understand the key concepts of milling Context, concept and generalities
- to study the microscopic approach of milling
- to model milling with various approaches
- Activité sportive : 10
Diplôme(s) concerné(s)
UE de rattachement
- UE-M-ADPH-PhPcsDe : UE 15 Pharmaceutical process design
Pour les élèves du diplômeAdvanced Pharmaceutical Engineering
-Thermodynamics / Phase equilibrium
-Mass and energy balances
-Hydraulics and dispersed systems
-Basical concepts of Chemistry and Physics
-Knowledge of heat and mass transfer phenomena.
-Numerical analysis (less important)
Format des notes
Numérique sur 20Pour les élèves du diplômeAdvanced Pharmaceutical Engineering
Vos modalités d'acquisition :
Test, pactical work reprot, oral presentation with a poster
Le rattrapage est autorisé (Max entre les deux notes écrêté à une note seuil)Le coefficient de l'enseignement est : 4
Programme détaillé
Pharmaceutical powders compaction
Compaction Process and material behaviour - lecture (3h)
-Die-compaction process
-Modelling compaction behavior of powders
Dry granulation : roller compaction & Milling process - lecture (3h)
-Dry granulation: background and theory
-Roll press: design features / operating parameters
-Milling process & granules
-Roll compaction demonstration
Case study distance learning (9h)
-Bilayer tablets (report) - distance learning - 3h
-Practical work to develop bilayer tablet using an instrumented press (1h30)
Compaction of binary mixtures (report) - 3h
Practical work: 1h30 to develop tablet of binary mixtures using an instrumented press
Compaction behaviour of primary and roll compacted powders (granules) - 3h
-Mechanism of rearrangement during densification
-Relative volume variation according to the compressive pressure
-Conclusion
-Practical work : 1h30 to do compaction experiment with primary and granules using an instrumented press
Milling
Description of the used processes (mixing, filling & compaction) by mentioning the main expected problems regarding flowability, homogeneity & de-mixing, tablet strength, disintegration & dissolution
Proposition of main processes to improve the formulation behaviour
Physics and mechanics of granular media for powder handling
-Basics of physics and mechanics of granular media for the understanding of the main issues in industrial powder handling and storage
-Granular friction, Coulomb model, cohesion
-Cohesive powders, Rumpf model, Statics of silos
-Silo design: basics
-Silo design: basics
Practical work (3h): Yield locii obtained using a shear tester
Drying
- Differents steps of drying
- The phenomena of heat transfer
Freeze Drying
-General introduction to freeze-drying technology
-Formulation Characterization and Product Formulation Design
-Cycle Development and Scale-Up aspect that includes Product Freezing, Primary and Secondary Drying
-Product and Process Monitoring
-PAT methods Conventional Cycle Development
-Design (QbD) for freeze-drying
-Product appearance issues
-Container closure integrity
-Modeling & simulation
-Equipment description
Milling
-Context, concept and generalities
-Microscopic approach, breakage mechanisms
-Modelling: various approaches
-How to model grinding phenomena
-Modelling based on energy consumption
-Modelling based on population balance
The way to end-use properties (Ex: particles shape, case of amorphisation...)
-Grinding in practice: some examples
-Talc micronization (Dry way milling)
-Talc, grinding processes, problem approach
-Micronization continuous process (Markov chains modelling)
-Batch micronization (Population Balance, morphology and breakage mechanisms)
-Wet Milling
-Vegetal material: use of grinding as a separation process
-Mechanosynthesis