Raloxifene is a second genaration selective estrogen receptor modulator used to prevent osteoporosis
in postmenopausal women. which is insoluble in water and half life is
27.7 hr. it has estrogen effect on bone and cholesterol metabolism but
behaves as a complete estrogen antagonist on mammary gland and uterine
tissue. raloxifene needs enhancement of solubility and dissolution rate to improve its oral bipavailability and therapeutic efficasy. among the various approaches to enhance solubility
and dissolution rate of poorly soluble drugs complexation with
cyclodextrine is an effective and indutrially accepted technique. In the
present investigation complexation of raloxifene with β-CD was carried
out by using various technique like physical blending method, kneading
method, solvent evaporation method and co-precipitation method. From the
various characterization studies like solubility determination, drug
content determination, production yield & in vitro dissolution
study, it was observed that there was a significant rise in the aqueous solubility
and dissolution rate of the raloxifene from the β-cd incusion complex.
from the result of statistical analysis, batch RLX-6 by kneading method
was found to be optimised batch, because of the maximum enhancement in solubility
and rate of dissolution. Optimised batch was also studied for
compatibility by FTIR studies, and also it was found to be stable for
the period of 90 days as per the ICH guidelines.
SOURCE: PHARMATUTOR.ORG
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