By MEGGLE Excipients…
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MEGGLE InhaLac® 500 micronized DPI grade lactose
InhaLac® 500 is MEGGLE´s first micronized lactose grade that is specifically designed for dry powder inhalation.Developed by MEGGLE’s Wasserburg laboratories in Germany, this inhalation grade lactose exhibits extremely small particles. Combined with high quality and safety, this material will meet individual dry powder inhalation formulation requirements.
Special benefit: Retest after one year!
Design & Features
MEGGLE developed its specialty lactose grade, InhaLac® to meet the challenges associated with dry powder inhalation (DPI). Its highly controlled production process enables different high quality sieved and milled InhaLac® grades to be obtained, providing a range of particle sizes and making them behave as individual particles. Using lactose monohydrate as an excipient not only improves performance efficiency of the inhaler, but also facilitates powder handling during production.
InhaLac® 500 features very small particle size with 90 % of the particles smaller than 10 µm, thus it exhibits a similar size as active pharmaceutical ingredients (APIs). This makes it very versatile across a wide range of applications.
The micronized material features high cohesive properties and enhanced stability (retest after 12 months).
User benefits:
InhaLac® 500 is a micronized ultra fine lactose that is suitable for ternary DPI formulations . The addition of micronized fines improves the drug product performance. This can be related to several known effects, such as hygroscopic buffer effect or the saturation of high-energy active sites. Further, the high cohesiveness of the micronized material helps to alter the fluidization behavior of the powder blend and create agglomerates. The micronized size with an x90 smaller than 10 µm makes InhaLac® 500 perfectly suitable for application in soft spherical pellet formulations.
In summary, InhaLac 500 offers a potent range of overall benefits:
- Improvement of fine particle fractions (FPF) when used in ternary mixtures
- saturation of active sites
- co-agglomeration with drug particles etc.
- x90 less than 10 µm
- Highly Cohesive
- High stability
Quality & Certification
MEGGLE’s InhaLac® alpha-lactose monohydrate grades comply with the current harmonized Ph.Eur., USP-NF and JP monographs. All InhaLac® grades meet additional or stricter specification limits than those specified in current pharmacopoeias in order to meet the special requirements for pulmonary drug delivery. Additionally, MEGGLE is a member of IPEC (International Pharmaceutical Excipients Council.
The pharma-dedicated MEGGLE production facility in Wasserburg, Germany is certified according to DIN ISO 9001:2008 and has implemented GMP according to the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients and USP General Information Chapter <1078>.
MEGGLE invests considerably in raw material resource sustainability, production standards and efficiency and is actively engaged in environmental protection. Lactose meeting pharmaceutical standards is our first priority.
Specifications and regulatory documents can be downloaded from https://www.meggle-pharma.com/.
Technical specifications
InhaLac 500 Microbiology
| Parameter | Specified |
| Total aerobic microbial count (TAMC) | NMT 10 cfu/g |
| Total combined yeasts and molds count (TYMC) | NMT 10 cfu/g |
| Bile tolerant gramnegative bacteria | negative/10g |
| Escherichia coli | negative/10g |
| Pseudomonas aeruginosa | negative/10g |
| Staphylococcus aureus | negative/10g |
| Salmonella spp. | negative/10g |
| Burkholderia cepacia | negative/10g |
| Bacterial endotoxins | < 5 EU/g |
InhaLac® range: Typical powder technological values
| BET surface area (m2/g) | Density bulk (g/ml) | Density tapped (g/ml) | Hausner ratio | Carr’s index (%) | |
| Sieved | |||||
| InhaLac® 70 | 0.13 | 0.60 | 0.71 | 1.18 | 15 |
| InhaLac® 120 | 0.15 | 0.72 | 0.83 | 1.15 | 13 |
| InhaLac® 230 | 0.16 | 0.70 | 0.85 | 1.21 | 18 |
| InhaLac® 251 | 0.33 | 0.64 | 0.88 | 1.38 | 27 |
| Milled | |||||
| InhaLac® 400 | 1.74 | 0.44 | 0.64 | 1.45 | 31 |
| Micronized | |||||
| InhaLac® 500 | 5.30 | 0.24 | 0.37 | 1.54 | 35 |
InhaLac range: Packaging and stability
| Sieved grade | Size | Material | Retest |
| InhaLac® 70 | 25 kg | Carton box with PE-EVOH-PE double inliner | 24 months |
| InhaLac® 120 | |||
| InhaLac® 230 | Carton box with PE-EVOH-PE inliner and OPP+ALU+PE inliner | ||
| InhaLac® 251 | |||
| Milled grade | Size | Material | Retest |
| InhaLac® 400 | 15 kg | Carton box with an aluminum laminated inliner | 24 months |
| Micronized grade | Size | Material | Retest |
| InhaLac® 500 | 10 kg | Carton box with an aluminum laminated inliner | 12 months |
Resources
Click on InhaLac 500 brochure for download.
Click on Technical information to see detailed specifications.
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