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Applications
Lacto-Sphere® MM3 is added to Dry Powder Inhaler
formulations to prevent the unspecific adhesion of the fine
active ingredient particles to the high-energy site on the
surface of more coarse lactose crystals. Lacto-Sphere® MM3
will occupy these sites leaving the other, less adhesive sites
free for the drug to be delivered. This will enhance the performance
of the formulation leading to a higher emitted dose and lung
deposition of the active ingredient.
Stability
Lacto-Sphere® MM3 has a minimum shelf life of
12 months in unopened, original containers.
Storage
Lacto-Sphere® MM3 should be stored between 15°C and 25°C, below 60% relative humidity, with container closed when not in use.
Packaging
Lacto-Sphere® MM3 standard packaging:
- 15 Kg in 125 L fiber drum, PE bag in alu bag with desiccant,
minimum order 15 kg
| Characteristics |
Specifications |
| Identification |
Complies to all Pharmacopoeia test |
| Appearance of solution |
Complies |
| Acidity or alkalinity |
<0.4mL 0.1 N NaOH/6 g |
| Specific optical rotation |
+54.4 - +55.9 |
| Absorbance |
≤ 0.04 at 400 nm (1g/10mL) |
| Protein/UV absorbing impurities |
≤ 0.25 between 210-220 nm (1g/100mL)
≤ 0.07 between 270-300 nm (1g/100mL) |
| Heavy metals |
≤ 5 ppm |
| Water |
4.5 - 5.5 % |
| Loss on drying |
≤ 0.5% (80°C/2h) |
| Sulphated ash |
≤ 0.1% |
Microbialcontamination
- total aerobic counts
- yeast and moulds
- E. coli
- S. aureus
- P. aeruginosa
- Salmonella
- Enterobacteriaceae |
≤ 10 cfu/g
≤ 5 cfu/g
not detectable in 10 g
not detectable in 10 g
not detectable in 10 g
not detectable in 100 g
not detectable in 10 g |
| Particle size
X90
X50
X10 |
5.0 - 8.0 µm
1.8 - 4.4 µm
0.8 - 1.2 µm
|
| Apparent density
- poured (about)
- tapped (about) |
0.23 g/mL
0.30 g/mL
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