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Introduction: Raloxifene is a selective estrogen receptor modulator from the benzothiophene family. Several clinical trials have shown that raloxifene reduces bone loss rate in the spinal column and may increase bone mass at certain sites. Objective: to determine the physical and chemical stabilities of raloxifene tablets. Methods. three pilot scale batches of 5 kg each were prepared. In vitro dissolution, chemical stability, photostability and humidity studies were carried out. Samples were collected at 0, 1, 2, 3 and 6 months for the accelerated stability study and at 0, 6, 12, 18 and 24 months for the shelf life stability study. Chemical stability was determined using high performance liquid chromatography analytical method, which was developed and validated prior to the study. Results: in the accelerated stability study, the percentages of dissolved drug were more than 90 % and drug content porcentages were between 90 % and 110 %. Humidity conditions affected the chemical stability of the tablets. Conclusions: All raloxifene tablet batches formulations were stable for 24 months in the studied containers stored at 32 ± 2 ºC and waterproof. In vitro drug release dissolution showed good results for 24 months. |
