Lacto-Sphere® is lactose for inhalation specifically developed by Micro-Sphere as a carrier for dry powder inhaler (DPI) formulations. The raw material, lactose monohydrate, is produced at the cGMP compliant, FDA-registered drug establishment of Kerry Bioscience in Norwich, NY, USA (Sheffield TM Pharma Ingredients).
Lacto-Sphere meets the requirements of the United States Pharmacopoeia/National Formulary, the European Pharmacopoeia and the Japanese Pharmacopoeia monographs for Lactose monohydrate.
Key benefits of Lacto-Sphere are:
- sourced from a BSE-free country (USA)
- non-rennet
- production under cGMP conditions
- customisable, quick and reliable supply
- available documentation (DMF, MSDS, certificate of origin, statement of compliance with the 'Note of guidance on minimising the risk of transmitting animal spongioform encephalopathy agents' (EMEA/410/01/Rev.2), statement of compliance with the EC decision on 'Laying down rules for the prevention, control and eradication of certain transmissible spongioform encephalopathies' (EC 999/2001), statement of absence of GMO's material in the final product)
Lacto-Sphere is manufactured under controlled environmental conditions. The particle size distribution is routinely determined by laser diffraction. The narrow particle size distribution confers to Lacto-Sphere unique, remarkable characteristics, essential for a full performing lactose for inhalation.
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