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Tronc Commun - MOD-M-ADPH-PhMat-SdForm : Solid forms in pharmaceutical material engineering

Descriptif

Many drug substances show suboptimal physicochemical and mechanical properties leading poor manufacturability, stability and bioavailability. This program focuses on improving these properties through engineering materials structure (crystal engineering, cocrystals, amorphous solid dispersions..). It aims to train students in pharmaceutical forms and drug delivery.

Objectifs pédagogiques

Upon completion of this program students will be able to:

-Become familiar with the different solid forms (crystals, amorphous materials) in pharmaceutical materials and the processes for screening and production of them 

-Recognize the role of excipients in creating and stabilizing pharmaceutical solid forms

-Evaluate process technology and processing conditions when formulating pharmaceutical solid forms by encapsulation

48 heures en présentiel
réparties en:
  • Cours Magistraux : 45
  • Travail Autonomie Libre, non programmé l'EDT : 21
  • Evaluation des connaissances et capacités : DS, QCM, présentation orale : 3

21 heures de travail personnel estimé pour l’étudiant.

effectifs minimal / maximal:

4/7

Diplôme(s) concerné(s)

UE de rattachement

Format des notes

Numérique sur 20

Pour les élèves du diplômeAdvanced Pharmaceutical Engineering

Le rattrapage est autorisé (Max entre les deux notes écrêté à une note seuil)

    Le coefficient de l'enseignement est : 3

    Programme détaillé

    Topics included are:

     1. Solid form screening 

    Solid form screening, the activity of generating and analyzing different solid forms of an active pharmaceutical ingredient (API), is an essential part of drug development. The basic principles of solid form screening are introduced, including the methods used in experimental screening (generation, characterization and analysis of solid forms, data mining tools, and high-throughput screening technologies).  

     2.Crystal engineering

    Topics included:

    Liquid-solid equilibrium (solid-liquid equilibrium calculation; influence of particle size on solid-liquid equilibrium; experimental determination of solid-liquid equilibrium; definition of supersaturation).

    Population balance (size distribution, population density definition; demonstration of population balance; application to crystallization (nucleation, growth and agglomeration)).

    The objectives are to estimate the solubility of a solid in a solvent and to know how to use population balance in a simple case.

     

    3. Crystal particle size reduction (micronisation-milling) and 4. Crystalline drug production - nanotechnologies

    In recent years, nano-sized crystalline drugs have been accepted as a valuable drug delivery system for poorly water-soluble drugs. Top-down and bottom-up technologies are the two main approaches for generating nanosuspensions. These courses focuse on the preparation of nanosuspensions by the top-down technologies.

    5. Amorphous state

    This course focuses on fundamentals of amorphous state, techniques for its characterization and physical stabilization.

     6. Particle design by encapsulation  

    Introduction to encapsulation and overview on encapsulation processes.

     

    Mots clés

    pharmaceutical materials engineering, solid screening, crystals, nanocrystals, crystallisation, amorphous, encapsulation, drug design

    Méthodes pédagogiques

    courses, conferences, oral exercises, written work.
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