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.