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Lactose Monohydrate Low Endotoxin plays a crucial role as a bulking agent and stabilizer, particularly in freeze-drying (lyophilization) and spray-drying processes, where its cryoprotective properties help preserve the structural integrity and functionality of temperature-sensitive APIs. Its low bioburden and endotoxin content reduce the risk of adverse immune reactions, making it particularly beneficial for injectable formulations and dry powder inhalers (DPIs). With its high consistency, stability, and safety profile, Lactose LE is a versatile and reliable excipient that enhances pharmaceutical manufacturing efficiency and product quality.

Benefits

  • High purity grade
  • Low bioburden, low endotoxin
  • Q3D statement for parenteral and inhalation applications
  • Conforms to Ph. Eur., USP-NF, JP and ChP
  • Listed in FDA inactive ingredient database for inhalation and parenteral applications
  • Usage for stabilization and protection in temperaturesensitive production processes

Areas of Application

  • DPI formulations
  • Parenteral/Injectables
  • (Thin-film) freeze-drying and spray-drying (high dose formulations and sensitive APIs)

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Precise Particle Size Distribution for Optimal Inhalation Performance

MEGGLE’s InhaLac® product range offers a wide selection of DPI-grade lactose types with precisely specified particle size distributions. These enable targeted formulation adjustments to meet the specific requirements of inhalation devices and active pharmaceutical ingredients.

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