LACTO-SPHERE^® is lactose for inhalation specifically developed by Micro-Sphere SA 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, 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 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.