DRUG Development  in Pharmacuetical
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DRUG Development in Pharmacuetical Pre-clinical Research. Pre-clinical research and development objective :. To obtain a molecule that is active in animals, ready to be tested in humans witn minimum risk and maximum chances of success. Pharmaceutical sciences :. Preformulation

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DRUG Development in Pharmacuetical

Pre-clinical Research

  • Pre-clinical research and development objective :

  • To obtain a molecule that is active in animals,

  • ready to be tested in humans witn minimum risk and

  • maximum chances of success.

  • Pharmaceutical sciences :

  • Preformulation

  • Clinical Development

  • Pharmaceutical Development

  • Regulatory Affairs

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris


Pharmaceutical Sciences – Preformulation

  • Role : establish the physicochemical and biopharmaceutical profile of pharmaceutical compounds to help selection of candidates for clinical administration.

  • Disciplines :

  • Chemical analysis : solubility and chemical stability

  • Physical analysis : solid state profile and stability, polymorphism

  • Biopharmacy : physico-chemistry and formulation for in vivo

  • administration

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris


Purification

Crystallisation

Formulation

Storage

Synthesis

Administration

Storage

Distribution

Physico-chimistry

in the body

Preformulation – Physical analysis

*

* Physical form

of the drug

is

CRUCIAL !

*

*

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris


Physical form of the drug is CRUCIAL !

  • to guarantee a good bioavailability

  • to ensure physical stability during formulation, storage and processing

  • Most stable and appropriate crystalline form wanted

  • Solid state parameters needed :

  • crystallinity *

  • « physical » purity *

  • melting temperature *

  • decomposition temperature *

  • hygroscopicity

  • shape and particle size distribution

  • texture

  • polymorphic form in general *

* Can be obtained by

thermal methods

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris


Thermal info overall needs in a pharmaceutical sciences context

  • Info (any kind) about thermal analysis and microcalorimetry

  • equipment suppliers

  • Basic advices for equipment maintenance and calibration

  • Thermal database for APIs and excipients

  • Basic technical and academic knowledge concerning thermal methods

  • (DSC, MDSC, TGA, Hres TGA, coupling…)

  • Support for complex thermal methods choice of parameters

  • (MDSC, HiRes TGA…)

  • Contacts with experts in the field

  • Items and/or web links for thermal analysis and calorimetry trainings, workshops, conferences, outsourcing, consultancy, jobs, people…

  • Thermal bibliography sorted for specific field of interest

  • (food, pharmaceuticals-polymorphism, cosmetics…)

  • Support for complex data interpretation

Low

priority

High

priority

S. Guinot - First Evitherm Industry Forum Meeting – September the 15th 2003 - Paris


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