|
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.
|
|