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    NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio

    products-servicesMEGGLE Excipients
    November 13th 2018

    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.

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    NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio
    NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio

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