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CELLACTOSE 80

SEM image Meggle excipient Cellactose 80

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Description

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

In an effort to obtain synergistic effects, such as improved tablet hardness and adherence capacity, by co-processing both excipients, spray-drying was used in order to bring lactose and cellulose together.

As a result Cellactose® 80, a co-processed excipient, was achieved that provides capability for direct compression, due to given flowability and compactability. Cellactose® 80 is made up of 75 % alpha-Lactose-monohydrate and 25 % powdered cellulose.

Shelf life / Retest – Standard Packaging
36 months – 20 kg Paper bag with PE-EVOH-PE Inliner
36 months – 20 kg Carton box with PE-EVOH-PE Inliner

Particle size distribution [Air jet sieve]

  • <32 µm: NMT 20%
  • <160 µm: 35-65%
  • <250 µm: NLT 80%

Typical Values

  • Bulk Density [g/l]: 370
  • Tapped Density [g/l] : 490
  • Hausner factor: 1.32
  • Carrs index: 24.49 %

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 through constant lactose/cellulose ratio
  • High weight consistency at all compaction speeds

Areas of Application

  • Cellactose® 80 is primarily designed for direct compression. In comparison with its corresponding physical blend.
  • Cellactose® 80 provides improved tablet hardness, superior flowability and adherence capacity that prevents segregation of blended API and excipient.
  • Due to its adherence capacity Cellactose® 80 can be used in low dosage formulations. Cellactose® 80’s superior hardness yield enables its use in high dosage formulations,  as well.

 

Cellactose 80_Typical size

Particel size distribution batch-to-batch consistency of Cellactose® 80 by air-jet-sieving.Data obtained from a permanent in-process-controll (IPC) of subsequent batches over a time period of 12 months.

Cellactose 80_Batch

Particel size distribution batch-to-batch consistency of Cellactose® 80 by air-jet-sieving.Data obtained from a permanent in-process-controll (IPC) of subsequent batches over a time period of 12 months.

 

 

Additional information

Manufacturer

Meggle
Quality

Compound of Lactose Monohydrate USP/NF, EP, JP, JP and Powdered Cellulose USP/NF
Composition

Compound of Lactose & Powdered Cellulose
Dosage Form

Capsules;, Tablets
Function

Direct compression, dry granulation and capsule filling. Suitable for use in low as well as high dose formulations. Also, used as cores for coating

Documents and Links

Technical brochure Cellactose 80

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