MEGGLE GranuLac® 80 milled alpha-lactose monohydrate grade

MEGGLE has added GranuLac® 80 to its extensive range of milled grade lactose monohydrate excipients designed for wet and dry granulation processes.

Monohydrate GranuLac® 80 extends the MEGGLE milled lactose grade portfolio and offers pharmaceutical companies a wider choice of particle sizes to best meet their formulation needs.

Design & Features

Developed at MEGGLE’s Wasserburg laboratories in Germany, GranuLac® 80 consists of fine, sharp-edged lactose particles, having cohesive powder properties that can be beneficial during granulation processes. Quality is exceptionally fine as a result of MEGGLE’s state-of-the-art production plant and machinery.

Clean unlubricated surfaces created during the compaction process as a result of brittle fracture leads to improved compactibility.

GranuLac® 80 features a median particle size of 50 µm with a particle size distribution (PSD) profile distributed thus:

–             20-42% <53 µm

–             min. 95 % < 212 µm

This PSD, along with bulk density of 670 g/l, perfectly fits between our well-known milled grades GranuLac® 70 and GranuLac® 140.

Applications

MEGGLE’s milled alpha-lactose monohydrate grades have been a favourite choice as filler in dry and wet granulation processes for numerous global and regional pharmaceutical manufacturers, as well as formulation developers for solid oral dosage forms via wet and dry granulation.

GranuLac® 80 is presented as a pure white and highly consistent crystalline, milled lactose monohydrate grade powder that is ideal for tabletting, capsule and sachet filling, and extrusion with spheronization. The small particle size assists tablet hardness.

Quality & Certification

MEGGLE’s GranuLac® milled alpha-lactose monohydrate grades comply with the current harmonized Ph.Eur., USP-NF and JP monographs. 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 www.meggle-pharma.com.

Resources

Click on GranuLac® 80 specifications for full product details.
Click on GranuLac® portfolio for brochure download.