MEGGLE sieved lactose grades for capsule and sachet filling

Crystalline alpha-lactose monohydrate grades have a long tradition in pharmaceutical applications due to their chemical and physical stability, in oral pharmaceutical applications, versatile binder-filler properties, and global availability.MEGGLE’s expertise in impacting recrystallized alpha-lactose monohydrate particles by sieving during production opens multiple opportunities to influence physical characteristics and functional performance.

Sieved lactose advantages

Powder flow or ‘flowability’, usually expressed by the Hausner Ratio or Carr Index, defines the intrinsic ability of a powder to flow evenly under the action of gravity and other forces.

Flowability is an important functional characteristic in formulation development and product manufacture and is affected by differences in morphology and particle size distribution (PSD). Sieved lactose grades maintain discrete flow performances, exhibiting better flow than milled grades, quantified by methods as the angle of repose, bulk / tapped density derived factors or the volume flow/flowability index.

The excellent flowability of sieved lactose grades make them superior to milled lactose grades for capsule filling on some applications, especially where high speed capsule filling machines are to be used.

Furthermore, the narrow PSD and excellent blending properties make sieved lactose suitable for a range of applications, even in conjunction with very fine or micronized active pharmaceutical ingredients (APIs).

Further advantages of MEGGLE’s sieved lactose grades include high stability in storage, high batch-to-batch consistency, the high quality delivered by ultra-modern production facilities and the in-depth product expertise accumulated over more than 60 years of manufacturing.

Sieved lactose applications

While tablets account for the vast majority of solid oral dosage forms, powder preparations as in capsules and sachets also present viable options to the developer, particularly in early stage developments and clinical trials medication, where final formulation remains undefined.

Furthermore, use of capsule and sachet support patient centric medicines for children and the elderly, who may have problems swallowing tablets. Life cycle management also acknowledges these kinds of dosage forms, which may lead to gaining market share for well-established drugs, which have been around for a while. When developing a powder preparation, processability of the final powder blend as well as content uniformity and little to no powder segregation is imperative to a successful development.

Lactose is highly suitable as filling agent for capsules, based on its limited interaction with gelatin, preserving capsule integrity over time. This is particularly so for Hydroxypropylmethylcellulose (HMPC) hard capsules, which have increasingly become an industry standard.

MEGGLE has decided to contribute to these needs in a meaningful way by providing a range of lactose grades that differ in particle size distribution as well as bulk density. Both parameters are essential to a successful development. Correct choice of grade can overcome content uniformity issues.

To ensure ultimate customer satisfaction, MEGGLE has partnered with leading capsule-filling-machine-manufactures in order to provide expertise from both ends, material and processing. These partnerships allow MEGGLE to tweak and improve its products more precisely for improved off-the-shelf products while also giving customers options to choose tailor-made grades for even better performance.

To provide consistent functionality MEGGLE has implemented a rigorous quality system, which comfortably exceeds current Good Manufacturing Practice (GMP) requirements.

MEGGLE Sieved lactose grades

Narrow classification of randomly sized lactose crystals results in coarse sieved grades, which show particle size and shape-dependent 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, such as capsule and sachet filling, blends, premixes, and triturations.

MEGGLE offers four such sieved lactose grades.

• PrismaLac^® 40: Sieved Monohydrate 40 Mesh Lactose. Flowability is defined as 1.23 on the Hausner Ratio and 18.52% on the Carr Index, based on Bulk Density of 440 g/l and Tapped Density of 540 g/l. Particle size distribution as measured by mechanical sieve shaker is not more than (NMT) 10% at <200 µm and not less than (NLT) 97% at <800 µm.
• CapsuLac^® 60: Sieved Monohydrate 60 Mesh Lactose. Flowability is defined as 1.23 on the Hausner Ratio and 18.57% on the Carr Index, based on Bulk Density of 570 g/l and Tapped Density of 700 g/l. Particle size distribution is NMT 10% <100 µm:, <250 µm: 40-70%, NLT 90% <400 µm and NLT 97% <630 µm.
• SacheLac^® 80: Sieved Monohydrate 80 Mesh Lactose. Flowability is defined as 1.25 on the Hausner Ratio and 19.72% on the Carr Index, based on Bulk Density of 570 g/l and Tapped Density of 710 g/l. Particle size distribution is NMT 20% <100 µm to NLT 98% <400 µm.
• SpheroLac^® 100: Sieved Monohydrate 100 Mesh Lactose. Flowability is defined as 1.26 on the Hausner Ratio and 20.69% on the Carr Index, based on Bulk Density of 690 g/l and Tapped Density of 870 g/l. Particle size distribution is NMT 20% <63 µm to NLT 75%.<200 µm.

All grades have guaranteed shelf life of 36 months before need to retest and are supplied in 20 kg respectively 25 kg paper bags with PE-EVOH-PE inliner.

All MEGGLE sieved grade products conform to the monograph “Lactose Monohydrate” in the European Pharmacopoeia (Ph. Eur.). This monograph is harmonized between Ph. Eur., USP-NF and JP.

The management system of Molkerei MEGGLE Wasserburg has been certified as meeting the requirements of GMP and GDP according to EXCiPACT^™.

To find out more about Meggle’s sieved grade lactose grades please click on the following link: Sieved Lactose from MEGGLE

Resources

Click on PrismaLac® 40 for detailed product specifications.
Click on CapsuLac® 60 for detailed product specifications.
Click on SacheLac® 80 for detailed product specifications.
Click on SpheroLac® 100 for detailed product specifications.
Click on Milled-Sieved Lactose to download brochure.