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Business Unit
Excipients
Product Information

CombiLac®

High-functionality excipient CombiLac® is an integrated, lactosebased, co-processed excipient, specifically designed to ease oral solid dosage form development and manufacture. It comprises 70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose (MCC) and 10 % white, native corn starch, each conforming with Ph.Eur., USP-NF, and JP compendial requirements.

The three individual components are integrated into a monoparticulate structure, which is not separable by physical means. CombiLac® shows improved compaction properties compared to an equivalent admixture of individual ingredients, providing robust tablets with minimal friability.

It assures rapid, hardness-independent tablet disintegration for effective API release, and features powder flow characteristics necessary to enhance dosage form weight uniformity and throughput in DC.

Shelf life / Retest:
24 months

Standard Packaging:
20 kg - Carton box with PE-EVOH-PE Inliner
Particle size distribution
[Air jet sieving]

  • < 32 µm: NMT 15%
  • < 160 µm: 35 - 65%
  • < 250 µm: NLT 85%
Typical Values
  • Bulk Density [g/l]: 450
  • Tapped Density [g/l] : 540
  • Angel of repose: 30 °
  • Hausner factor: 1.19
  • Carrs index: 16 %
MCC Starch Lactose_Tablet hardness_low friability_sticking picking_fast disintegration_direct compression
Benefits
  • Excellent compactability
  • Excellent flowability
  • Fast, hardness-independent tablet disintegration for effective API release
  • Low friability
  • Overcoming individual ingredient compacting and handling limitations
Areas of Application
  • Direct compression
  • ODT formulations
  • Dry granulation
Typical particle size distribution (PSD) ofsomething new