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Related Concept Videos

Colloidal precipitates01:09

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The high insolubility of some precipitates can result in an unfavorable relative supersaturation. This can lead to colloidal particles with a large surface-to-mass ratio, where adsorption is promoted. For instance, in the precipitation of silver chloride, silver ions are adsorbed on the surface of the colloidal particles, forming a primary layer. This layer attracts ions of opposite charge (such as nitrate ions), forming a diffuse secondary layer of adsorbed ions. This electric double layer...
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The long-term stability of drug products is critical to ensuring their quality, safety, and effectiveness over time. Stability directly influences a product's ability to maintain its intended characteristics, ensuring it performs as expected during its intended shelf life. Key attributes such as drug potency, impurities, dissolution, and other physicochemical measures of performance are tested to assess stability. These parameters indicate how well the product retains its quality over time and...
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After filtration, the precipitate is washed to remove coprecipitated impurities and any remaining mother liquor. Colloidal precipitates, such as silver chloride, are washed with an electrolyte (such as dilute nitric acid) to prevent the peptization of the precipitate. In the case of slightly soluble precipitates, the wash solution contains a common ion to reduce solubility. Lead sulfate, which is slightly soluble in water, is washed with dilute sulfuric acid. Similarly, wash solutions may be...
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Protein stability during nebulization: Mind the collection step!

Elsa Bodier-Montagutelli1, Renaud Respaud1, Gérald Perret2

  • 1Université de Tours, UMR 1100, Tours, France; INSERM, Centre d'Etude des Pathologies Respiratoires, UMR 1100, Tours, France; CHRU de Tours, Service de Pharmacie, Tours, France.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|April 15, 2020
PubMed
Summary

Aerosol samplers significantly impact protein stability during respiratory drug development. The choice of sampler affects protein aggregation and activity, necessitating consistent device use throughout the process.

Keywords:
Aerosol collectionAerosolsAggregationNebulizationProtein therapeuticsStability studies

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Aerosol Science

Background:

  • Inhaled protein therapeutics are increasingly important for respiratory diseases.
  • Protein instability (denaturation, aggregation, activity loss) in aerosols is a critical concern.
  • Assessing protein stability requires aerosol collection, but sampler interference is poorly understood.

Purpose of the Study:

  • To compare the impact of six aerosol samplers on the stability of a model monoclonal antibody (Ig1).
  • To evaluate the effect of two samplers on the aggregation and biological activity of three additional proteins.
  • To determine if sampler interference is protein-dependent.

Main Methods:

  • A mesh nebulizer was used to aerosolize a model monoclonal antibody (Ig1).
  • Six different aerosol samplers were employed to collect aerosol droplets.
  • Protein aggregation was measured across size scales, and biological activity was assessed.
  • The impact of two samplers on three other proteins was evaluated.

Main Results:

  • All six samplers produced distinct aggregation profiles for Ig1, with particle counts varying by 100-fold.
  • Ig1 biological activity remained largely unchanged after nebulization across samplers.
  • Sampler impact on aggregation and activity varied significantly between different proteins, sometimes in opposite trends.

Conclusions:

  • Aerosol samplers demonstrably interfere with protein stability.
  • The extent of this interference is dependent on both the specific sampler and the protein characteristics.
  • Consistent use of the same aerosol collection device is crucial during the development of inhaled protein therapeutics.