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

RetaLac®

RetaLac^®