RetaLac®, a new Excipient for Direct Compression of Sustained Release Formulations
Ulrich Marcher, Meggle GmbH & Co. KG, BG Excipients and Technology, Germany
In pharmaceutical technology Lactose and Hypromellose (HPMC) are well known excipients and commonly accepted. To overcome limited flow and segregation tendency of HPMC a wet granulation step is traditionally used for obtaining a processable tablet mass.
MEGGLE, as a specialist for Lactose excipients, has developed a new, innovative Lactose-HPMC co-processed material recently, which is commercially available under the brand name RetaLac®. RetaLac® consists of equal parts of α-lactose monohydrate and HPMC and was primarily designed to fulfill the requirements of direct compression: During compaction RetaLac® demonstrates superior functionality compared with the corresponding physical mixture. Co-processing has a significant impact on flowability, RetaLac® is free flowable in contrast to the corresponding physical mixture, which does not flow at all. Moreover segregation during processing is not possible, as the two co-processed excipients cannot be separated by mechanical methods. SEM pictures illustrate that RetaLac® granules show a coarse texture with an highly structured surface, which can be a benefit for your content uniformity results (Fig..).
In comparison to pure HPMC wettability of HPMC in a co-processed form together with Lactose (RetaLac®) is increased drastically, which might facilitate preparation of aqueous dispersions/solutions containing HPMC/Lactose or cleaning of equipment.