By MEGGLE Excipients
NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio
MEGGLE’s newest sieved grade of lactose monohydrate, InhaLac® 160, is ideal for pulmonary and nasal dry powder inhalation applications.
Characterized by a median particle size of approximately 110 μm, the new InhaLac® 160 fills a gap in the InhaLac® range of coarse sieved lactose grades for dry powder inhalation, sitting between the coarser lactose InhaLac® 120 and the finer lactose InhaLac® 230.
This GMP/GDP certified sieved lactose is therefore suitable for pulmonary and nasal drug delivery and offers a range of benefits that include a dedicated production process, highly controlled powder characteristics, highest microbial quality including low endotoxins and retesting after 24 months.
Design & Features
Developed at MEGGLE’s Wasserburg laboratories in Germany, this inhalation grade lactose exhibits a narrowly distributed particle size with a fines content (particles below 15 μm) of 3%. Combined with high quality and safety, this material will meet individual requirements for dry powder inhalation formulations.
InhaLac® 160 features a particle size distribution between the coarser lactose InhaLac® 120 and the finer lactose InhaLac® 230 of:
- x10: 55-85 µm
- x50: 90-120 µm
- x90: 125-165 µm
User benefits
InhaLac® 160 is a sieved lactose monohydrate for inhalation with distinct particle size distribution that extends MEGGLE`s product portfolio of inhalative lactose grades, closing the gap of coarse sieved lactose grades for dry powder inhalation. In summary, InhaLac® 160 offers a potent range of overall benefits:
- Highly controlled powder characteristics
- Highest microbial quality including low endotoxins
- High stability means retest is only required biennially
Quality & Certification
MEGGLE’s InhaLac® alpha-lactose monohydrate grades comply with the current harmonized USP-NF, Ph.Eur., and JP monographs. The strict microbial limits of MEGGLE`s InhaLac® formulations characterizes them as inhaler grades to meet the special requirements for dry powder inhalation. All InhaLac® products are manufactured on product lines that are exclusively dedicated to inhalative lactose.
The pharma-dedicated MEGGLE production facility in Wasserburg, Germany holds an EXCiPACTTM Certificate and has implemented GMP according to the Joint IPEC-PQG Good Manufacturing Practices Guide.
In addition, MEGGLE is certified according to DIN EN ISO 9001:2008 (Quality Management), DIN EN ISO 14001:2004 (Environmental Management) and DIN EN ISO 50000:2014 (Energy Management).
MEGGLE invests considerably in raw material resource sustainability, production standards and efficiency and is actively engaged in environmental protection. Lactose meeting pharmaceutical standards is MEGGLE`s first priority.
Specifications and regulatory documents can be downloaded from https://www.meggle-pharma.com/.
Technical specifications
InhaLac® 160 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 gram-negative bacteria | absence/10g |
Escherichia coli | absence/10g |
Pseudomonas aeruginosa | absence/10g |
Staphylococcus aureus | absence/10g |
Salmonella spp. | absence/10g |
Burkholderia cepacia | absence/10g |
Bacterial endotoxins | NMT 5 EU/g |
InhaLac® sieved range: Typical powder technological values
Particle size distribution (µm) | BET surface area (m2/g) | Density bulk (g/ml) | Density tapped (g/ml) | Hausner ratio | Carr’s index (%) | |
InhaLac® 70 | x10: 135 | 0.13 | 0.60 | 0.71 | 1.18 | 15 |
x50: 215 | ||||||
x90: 301 | ||||||
InhaLac® 120 | x10: 88 | 0.15 | 0.72 | 0.83 | 1.15 | 13 |
x50: 132 | ||||||
x90: 175 | ||||||
InhaLac® 160 | x10: 73 | 0.12 | 0.70 | 0.84 | 1.19 | 16 |
x50: 108 | ||||||
x90: 144 | ||||||
InhaLac® 230 | x10: 45 | 0.16 | 0.70 | 0.85 | 1.21 | 18 |
x50: 97 | ||||||
x90: 144 | ||||||
InhaLac® 251 | x10: 13 | 0.33 | 0.64 | 0.88 | 1.38 | 27 |
x50: 49 | ||||||
x90: 91 |
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® 160 | ||||
InhaLac® 230 | 25 kg | Carton box with an aluminium laminated and PE-EVOH-PE inliner | 24 Months | |
InhaLac® 251 |
Resources
Click on Technical information to see detailed specifications.