NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio


NEW InhaLac® 160: MEGGLE extends inhalative lactose grade portfolio


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Products & Services | MEGGLE Excipients & Technology

Overview

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

  

Contact

MEGGLE Excipients & Technology
Email: service.pharma@meggle.de

Resources

Click on Meggle InhaLac® 160 for more information
Click on MEGGLE to contact the company directly.
Click on Technical information to see detailed specifications.

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Supplier Information
Supplier: MEGGLE Excipients & Technology
Address: Megglestrasse 6-12, 83512 Wasserburg, Germany
Tel: +49 8071 73-476
Fax: +49 8071 73-320
Website: https://www.meggle-pharma.com/


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