Milled and Sieved Lactose – MEGGLE’s crystalline alpha-lactose monohydrate grades
MEGGLE is a pioneer in co-processing technologies that allow simple, robust formulation development and manufacture. Through co-processing, MEGGLE developed highly functional excipients possessing unique qualities for directly compressible immediate and sustained release pharmaceutical solid dosage forms.
Read the news of MEGGLE´s product Milled and Sieved Lactose in the following article below and/ or download the technical brochure:
Milled and Sieved Lactose
General information
Crystalline alpha-lactose monohydrate grades have a long tradition in pharmaceutical applications due to their chemical and physical stability, in oral, parenteral and inhalative pharmaceutical applications, versatile binder-filler properties, and global availability [1]. Impacting recrystallized alpha-lactose monohydrate particles by either a milling or sieving during production opens multiple opportunities to influence physical characteristics and functional performance.
During the milling process, finer, sharper-edged particles are formed, having cohesive powder properties that can be beneficial during granulation processes. Clean unlubricated surfaces created during the compaction process as a result of brittle fracture lead to improved compactibility [2]. MEGGLE’s milled alpha-lactose monohydrate grades have been historically used as diluents in dry and wet granulation processes by numerous global and regional pharmaceutical manufacturers.
Narrow fractionation of randomly sized lactose crystals results in coarse sieved grades, which show particle size and shapedependent powder flow for increased production speeds. MEGGLE’s sieved alpha-lactose monohydrate grades are mainly monocrystals with some agglomerates, exceptionally suited to permit and optimize applications where powder flow is important.
MEGGLE’s sieved and milled lactose grades are generated by a well-defined manufacturing process resulting in a high degree of crystallinity.
Milled range of product:
GranuLac® 70, GranuLac® 80, GranuLac® 140,
GranuLac® 200, GranuLac® 230, SorboLac® 400Sieved range of product:
PrismaLac® 40, CapsuLac® 60, SacheLac® 80, SpheroLac® 100
Particle size distribution (PSD)
MEGGLE’s crystalline alpha-lactose monohydrate grades are available in various PSDs according to the diversified needs of our customers. Figures 1 and 2 show typical laser diffraction particle size distribution data for MEGGLE’s milled and sieved lactose grades.
Figures 3 and 4 depict the specified PSD range and typical average values by air-jet sieving (milled) and mechanical sieve shaker (sieved). These parameters are constantly monitored through in-process control (IPC) testing and are part of milled and sieved MEGGLE lactose grades’ particle size distribution specification.
Batch-to-batch consistency
Batch-to-batch consistency for all lactose products can beattributed to MEGGLE’s long history and experience in lactosemanufacture, and broad technical expertise. Constant in-processand final product testing ensures consistency and quality.
Isotherms
MEGGLE’s milled and sieved alpha-lactose monohydrateproducts do not adsorb significant amounts of water below 20 °C/ 90 % relative humidity. Figure 5 shows sorption anddesorption isotherm for GranuLac® 200.
See the full technical brochure on “Milled and Sieved Lactose” here
(click the picture to download the brochure)
Benefits Milled and Sieved Lactose
Milled
- Good compactibility
- Narrow particle size distribution
- Good blending properties
- High storage stability
- High batch-to-batch consistency
Sieved
- Excellent flowability
- Narrow particle size distribution
- Good blending properties
- High storage stability
- High batch-to-batch consistency
Source: MEGGLE technical brochure “Milled and Sieved Lactose”
See the overview video of the MEGGLE Dry Powder Inhalation product range here:
Company: MEGGLE is one of the world´s leading manufacturers of pharmaceutical grade lactose and co-processed excipients with expertise of more than 70 years. We encounter lactose in so many areas of our life – reason enough to take a closer look at this multi-functional “white powder”.
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