PEARLITOL® 200 GT

PEARLITOL® 200 GT
Product Description

PEARLITOL® 200 GT, the only Mannitol allowing to produce and to develop drugs faster, thanks to its tableting properties - enhancing patient compliance without compromising drugs stability.

ROQUETTE FRERES SA

  • FR
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator

ROQUETTE FRERES SA

  • FR
  • 2015
    On CPHI since
  • 5000+
    Employees
Company types
Manufacturer/Innovator

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ROQUETTE FRERES SA resources (16)

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    It’s a hard pill to swallow, but medication adherence is a crucial issue today. For oral formulations in pharma and nutraceuticals, taste, appearance, and aroma directly impact patient compliance and consumer experience.
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    Polysorbates are intensively used in biologics formulation as stabilizer due to their propensity to inhibit aggregation at interfaces but possess low intrinsic stability. In this study, the chemical stability of KLEPTOSE® HPBCDs are compared with polysorbates under various stress conditions.

    When subjected to heat stress and other chemical stressors – autoclave, light and oxidative stresses – HPBCD remains almost stable while polysorbates show more severe degradation. Further, profiling characterization and degradation analysis reveal that HPBCD chemical structure remains intact while polysorbates undergo significant hydrolytic degradation and oxidation.

    Lastly, the physicochemical stability of monoclonal antibody in formulations have been investigated using adalimumab as a model protein. When subjected to light stress, HPBCD-containing formulations show significant decreases in protein aggregation, as well as superior monomer and total protein recovery compared to polysorbate-containing formulations. HPBCD also reduces both agitation and thermal stress-induced protein aggregation and prevents sub-visible particle formation compared to polysorbates.


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