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MicroceLac® 100

Lactose and microcrystalline cellulose are very well established excipients. Both are naturally derived and used frequently as diluents/binder in oral dosage formulations (ODT).

In a effort to obtain synergistic effects, such as improved tablet hardness and adherence capacity, by combining both excipients, spray-dyring was used in order to bring Lactose and Microcrystalline cellulose together. As a result MicroceLac® 100, a co-processed excipient, was achieved, that provides capability for direct compression, due to given flowability and compactability.

MicroceLac® 100 comprises 75 % alpha-lactose monohydrate and 25 % microcrystalline cellulose (MCC), both maintaining their individual chemical identities.

Shelf life / Retest:
18 months

Standard Packaging:
20 kg - Paper bag with PE-EVOH-PE Inliner

Particle size distribution
[Air jet sieve]

  • <32 µm: NMT 15%
  • <160 µm: 45-70%
  • <250 µm: NLT 90%
Typical Values
  • Bulk Density [g/l]: 460
  • Tapped Density [g/l] : 580
  • Hausner factor: 1.26
  • Carrs index: 20.69 %
MCC Lactose_Tablet hardness_low friability_sticking picking_content uniformity
Benefits
  • Good content uniformity due to low segregation tendency of the active ingredient
  • Smooth surface of the resulting cores for easy and economical coating
  • Compaction of delicate active ingredients due to excellent compactability
  • Consistent tablet hardness due to constant lactose/cellulose ratio
  • High weight consistency at various tabletting speed.
Areas of Application
  • MicroceLac® 100 is primarily designed for direct compression.
  • In comparison with its corresponding physical blend MicroceLac® 100 provides improved tablet hardness, superior flowability and higher adherence capacity, that prevents segregation of a blended API and excipient.
  • Due to its adherence capacity MicroceLac® 100 can be used in low dosage formulation. MicroceLac® 100’s superior hardness yield enables its use in high dosage formulations as well.
Typical particle size distribution (PSD) ofsomething new Batch to batch consistency (B2B) ofsomething new
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