CombiLac®
Premium co-processed Excipient
70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose and
15 % native corn starch
Co-processed excipients (CPEs) play a key role in modern pharmaceutical manufacturing by offering significantly improved functionality compared to conventional excipients. Through the physical combination of established substances – multifunctional particle systems are created with enhanced flowability, compactibility, and reduced sensitivity to lubricants. This leads to improved tablet uniformity and mechanical strength while reducing the need for additional formulation steps. Especially in direct compression, CPEs enable more efficient and robust tablet production, even with high drug loads or poorly compressible APIs. Since they are composed of pharmacopoeial-approved components, regulatory requirements are minimal, further increasing their appeal.
The high-functionality excipient, CombiLac® is an integrated, lactose-based, co-processed excipient, specifically designed to ease oral solid dosage form development and manufacture. It is made up of 70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose (MCC) and 10 % white, native corn starch, each conforming with Ph. Eur., USP-NF, JP, ChP 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.
Benefits
- Excellent compactibility
- Excellent flowability
- Fast, hardness-independent tablet disintegration for effective API release
- Low friability
- Overcomes individual ingredient compaction and handling limitations
Areas of Application
- Direct compression
- ODT formulations
- Dry granulation (Roller compaction, slugging)
Order your free sample!
- Dry granulation
- Direct compression
- Roller compaction
- Co-processed Excipients
- Oral Solid Dose
- Orally disintegrating tablet (ODT)
- Placebo tablet
- Low to medium dose DC formulation
- Tablet
20kg – Carton box with PE-EVOH-PE inliner
24 months
Wasserburg am Inn, Germany
Downloads
Typical particle size distribution
Typical Product Data
- x10: 57 µm, x50: 176 µm, x90: 283 µm
- Span [(x90-x10)/x50]: 1.28
- Density bulk: 0.461 g/ml
- Density tapped: 0.545 g/ml
- Hausner Ratio: 1.18
- Carr’s Index: 15 %
Specified Product Data
Particle size distribution
Sieve Method: Air-jet sieving
- <32 µm: NMT 15%
- <160 µm: 35-65%
- <250 µm: NLT 85%
Do you have any questions or need a customised solution?