NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio
Products & Services | MEGGLE Excipients & Technology
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
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/.
InhaLac® 160 Microbiology
|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|
|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|
|InhaLac® 120||x10: 88||0.15||0.72||0.83||1.15||13|
|InhaLac® 160||x10: 73||0.12||0.70||0.84||1.19||16|
|InhaLac® 230||x10: 45||0.16||0.70||0.85||1.21||18|
|InhaLac® 251||x10: 13||0.33||0.64||0.88||1.38||27|
Packaging and stability
|InhaLac® 70||25 kg||Carton box with PE-EVOH-PE double inliner||24 months|
|InhaLac® 230||25 kg||Carton box with an aluminium laminated and PE-EVOH-PE inliner||24 Months|
MEGGLE Excipients & Technology