Ludipress is a multifunctional vehicle in tablet production. One of the fairly old problems for researcher is the recrystallization of lactoses (primarily the amorphous form) during storage and the impact of this on the parameters of the tablets. Ludipress contains predominantly α-lactose-monohydrate (in both amorphous and crystalline forms), the stability testing of Phenobarbitone and Pyridinolcarbamate tablets (which contain Ludipress) appeared necessary. Different parameters of freshly prepared tablets served as the basis of comparison. Tablets kept in tightly-closed containers under normal conditions (20-23 °C, 40% RH) preserve their quality for as long as 2 years, and no significant change is experienced in their mass or height, breaking hardness, disintegration time or dissolution of the active agent. Results of rapid stability tests on Ludipress kept in an open container at 50 °C and 70% RH revealed that recrystallization of the amorphous α-lactose-monohydrate started after 6 weeks. The physical parameters of Ludipress containing Phenobarbitone and Pyridinolcarbamate tablets exhibited a significant change only if corn starch was also present among the constituents, or if the compositions have a high mass of Ludipress (50%). The changes in the physical parameters, however, did not influence the dissolution of the active agent. These studies suggest the importance of the prescribed conditions of Ludipress storage. Our experience is that processes unfavourably influencing the stability of such tablets can be prevented by appropriate packing.
|Translated title of the contribution||Stability testing of tablets containing Ludipress|
|Number of pages||4|
|Publication status||Published - jan. 1 1995|
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