Meggle Excipients & Technology
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RetaLac®

MEGGLEs co-processed excipient, RetaLac®, appears as a white, or almost white odorless powder, which is freely flowing and partially soluble in cold water. It comprises equal parts of hypromellose (type 2208, a.k.a. “K-type”) with a nominal viscosity of 4000 mPa·s, together with milled ?lpha-lactose monohydrate grade, both of compendial quality. A specialized spray-agglomeration process generates textured, highly structured particles with d50 in the range of many directly-compressible excipients, 100 µm to 200 µm, typically 125 µm.

Lactose identification is performed according to Ph. Eur. lactose monohydrate identification test method C: a red coloration appears. Verification of hypromellose is performed according to the hypromellose monograph, identification test method B, E also Ph. Eur.: a gelation of solution is detectable at >50°C.

Shelf life / Retest:
24 months

Standard Packaging:
12 kg - Plastic Drum with PE-EVOH-PE Inliner
Particle size distribution
[Mechanical sieve shaker]

  • <63 µm: NMT 25%
  • <250 µm: NLT 80%
Typical Values
  • Bulk Density [g/l]: 340
  • Tapped Density [g/l] : 460
  • Hausner factor: 1.35
  • Carrs index: 26.09 %
HPMC Hypromellose Lactose_Sustained Release_modified release_direct compression
Benefits
  • Direct compression of modified release formulations
  • Superior processibility compared to corresponding wet granulated and physical admixture of parent ingredients 
  • Meets compendial requirements
  • Drug release kinetics are predominantly controlled by pure diffusion
  • Unaffected by acidic conditions (between pH 1 and 7)
  • Dissolution can be quit
Areas of Application
  • Tabletting - Direct Compression, also for multi unit and mini tablets
  • Tabletting - Roller Compaction
  • Preparation of aqueous HPMC-formulations
  • Spheronization, Extrusion
Typical particle size distribution (PSD) ofsomething new
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