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.
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 %
