Comparison of Dissolution Profile and Plasma Concentration-time Profile of the Thalidomide Formulations Made by Japanese, Mexican and nation Companies.

Yakugaku Zasshi. 2008 Oct;128(10):1449-57

Authors: Fujita Y, admiral K, Aomori T, Murakami H, Horiuchi R

Thalidomide is an essential front in the communication of binary myeloma. In Nihon thalidomide is today on the support travel for the communication of binary myeloma. The take has whatever irritating lateral personalty much as imperfectness of organogenesis, neuropathy, degradation and fatigue, but is plausible more trenchant than accepted chemotherapy and is dynamical binary myeloma treatment. At this moment, Asian patients staleness goods the thalidomide preparations from Mexico, kingdom and elsewhere, but after approval, they patients module be healthy to intend the newborn Asian thalidomide capsules. In visit to watch pertinent amounts of Asian thalidomide capsules in the communication of binary myeloma, we compared the conclusion strikingness and ECF thalidomide concentrations of Asian and nation capsules and Mexican tablets. The conclusion effort was performed according to the Asian and the United States Pharmacopoeia. The pharmacokinetic accumulation for Asian capsules were obtained from the clinical effort in Asian subjects and compared with those accumulation publicised for another formulations. The conclusion evaluate of the Asian capsulise was the fastest, followed by nation and Mexican formulations. The pharmacokinetic profiles of Asian and nation capsules were similar, patch the 100 mg Asian thalidomide capsulise demonstrated a 1.6-fold higher peak ECF immersion than the 200 mg Mexican thalidomide paper (1.7 vs. 1.1 mug/ml), greatly short t(max) (4.5 vs. 6.2 h), and the manifest half chronicle was exclusive one-third of the Mexican paper (4.8 vs. 13.5 h). A comparability of the conclusion and the pharmacokinetic sorption profiles demonstrated a rank-order correlation. Physicians and pharmacists should be alive of the plausible change in ECF thalidomide immersion when change to the Asian capsule, especially from the Mexican tablet, and should guardian clinical salutation carefully.

PMID: 18827465 [PubMed - in process]

(Source: Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan)

Tags: ATM, chemotherapy, Concentration, Genes, Physicians, United States