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MICROCELAC 100

SEM image Meggle excipient Microcelac 100

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Description

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

Typical Values

  • Bulk Density [g/l]: 460
  • Tapped Density [g/l] : 580
  • Hausner factor: 1.26
  • Carrs index: 20.69 %

 

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%

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.

 

Microcelac 100_Typical size Particle size distribution batch-to-batch consistency of MicroceLac® 100 by air-jet-sieving.Data obtained from a permanent in-process-controll (IPC) of subsequent batches over a time period of 12 months.

Microcelac 100_Batch

Particle size distribution batch-to-batch consistency of MicroceLac® 100 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 Microcrystalline Cellulose USP/NF
Composition

Compound of Lactose & MCC
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 MicroceLac

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