DuraLac H

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SKU: PE248 Category:

Description

DuraLac® H is produced by roller-drying a lactose solution at high temperature to form anhydrous beta-lactose and alpha-lactose crystals at levels approximating 80% and 20%, respectively. During beta-lactose crystallization, no water is incorporated in the crystal lattice resulting in lactose´s anhydrous form.

Subsequent to roller-drying, anhydrous lactose is milled and sieved to the desired particle size distribution, optimizing powder flow and compactability. DuraLac® H deforms by brittle fracture during compaction, it is well-suited for directly compressed and dry granulated formulations (roller compaction, slugging).

Shelf life / Retest:
36 months
Particle size distribution
[Air jet sieve]

  • <45 µm: NMT 20%
  • <150 µm: 40-65%
  • <250 µm: NLT 80%

Standard Packaging:
25 kg – Carton box with aluminium laminated inliner

Typical Values

  • Bulk Density [g/l]: 670
  • Tapped Density [g/l] : 880
  • Hausner factor: 1.31
  • Carrs index: 23.86 %
Benefits
  • Excellent compactability
  • Good flowability
  • Relatively low hygroscopicity
  • High storage stability
  • Suitable for formulations requiring low water content

Areas of Application

  • Low dose DC formulations
  • Capsule filling
  • Dry granulation (Roller compaction, slugging)

 

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

Duralac H_Typical sizeParticel size distribution batch-to-batch consistency of DuraLac® H 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

EP, JP, USP/NF

Cas-No

63-42-3

Composition

Anhydrous, DC Lactose

Dosage Form

Tablets

Function

Used in direct compression formulations of moisture sensitive actives. Also used in dry granulation processes and capsule filling

Technical product brochure DuraLac H

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