The Lucknow based Central Drug Research Institute (CDRI) will soon hand over two of its research products to the pharmaceutical industry for further manufacturing and marketing, as part of its business activity.
The two materials, one as an antihyperglycemic and the other as an antidyslipidemic, are on the way of toxicology studies and clinical trials, and are expected to be the next products to come out from the Institute, according to the official sources. Currently, the institute is conducting studies on plant materials for antidyslipidemic activity.
"We have almost finalised certain industrial partners for these products and would transfer the know-how through usual procedure once the trials are in mature situation. But it would not be right to comment on the companies which are on the list at present," a higher official from CDRI told Pharmabiz. However, he declined to comment more on the molecules under development at this stage.
According to a latest document available from the CDRI, the institute is waiting for the ethical approval for initiating phase I multiple dose tolerance study on antihyperglycemic molecule, CDR-134D123, at Seth GS Medical College, Mumbai. The phase I single dose (0.5 to 7.5 g.) double blind tolerance studies on the compound has been completed in 31 healthy human volunteers and the data compilation has also been completed.
As part of its research for natural products, the institute is conducting studies for drugs with antidyslipidemic and antihyperglycemic character. Research on six plants for antihyperglycemic nature and one each for antidyslipidemic and antihyperglycemic nature are at various stages, according to the officials. Five derivatives of plant extracts, for antidyslipidemic product, showed antioxidant activity.
The institute has also carried out general screening of terrestrial plants and marine flora and fauna for antihyperglycemic/antidyslipidemic activities, in which 12 new plant extracts were prepared and submitted for activity testing in the year 2006-07. According to the annual report of the institute, a total of around 36 new plant extracts and 60 new marine extracts were evaluated for antihyperglycemic activity in sucrose-loaded rat model. Out of these, four plant extracts and two marine extracts showed significant improvement on glucose tolerance post sucrose load at 250 mg/kg dose levels in normoglycaemic rats. A pure compound isolated from a plant extract showed significant antihyperglycemic activity in all the three models, namely sucrose loaded rats, streptozotocin-induced diabetic rats and db/db mice.
A novel compound, a rare stigmasterol glycoside derivative, for antihyperglycemic has also been isolated by the institute in the year. The institute screened a total of 51 synthetic compounds for antihyperglycemic activity in sucrose loaded rat model, out of which 13 compounds showed antihyperglycemic activity at 100 mg/kg dose levels, according to the report.