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We prepared the hydrotropic complex of calcium channel blocker using nicotinamide as hydrotrope at pH 4.5. In vitro data showed that there is the improvement of the solubility of drug in hydrotropic complex compare to the plain drugs.
We carried out the in-vivo pk studies in rats. We observed that the drug is not all absorbing at the site of action. We could not able to get the PK profile of drug. All concentration are below quantification limit.
Before carrying out the studies, we did the assay of the drug in complex. According to assay the dose of the drug is calculated as same of plain drug.
Kindly focus on the issues.
Thanking you in advanced.
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Yes; once included in a complex, the complex must be disrupted for the components to be released. This can happen in the presence of lipids and the presence of lipid soluble bile acids is posited to help as well. Amiodarone is a well studied example. Consequently, there should be a marked improvement in absorption in the feed state compared to the unfeed state for oral dosing. (see Siddoway LA (2003), Amiodarone, Guidelines for use and monitoring, American Family Physician 68 (11): 2189-96, for example).
Regards, Frank Bales, Ph.D. mailto: frankbales.-at-.msn.com
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