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Excipients

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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

EXCiPACT Certificate

Shelf life - Retest Date

Sustainability Statement

Sustainability Whitepaper

14001_eng_2016-2018.pdf

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