Nothing new. But, this sentence may be problematic:
<<One study entitled "Gastric Absorption of Oral Insulin in Rats" demonstrated that oral insulin could be absorbed through the stomach. >>
So, formulation is degraded in stomach???
Miljenko
Press Release Source: Emisphere Technologies, Inc.
Emisphere Technologies Presents Additional Support for Its Oral Insulin Product Candidate and Other Programs
Tuesday November 12, 8:06 am ET
Presentations Made This Week at American Association of Pharmaceutical Scientists Meeting
TORONTO, Nov. 12 /PRNewswire-FirstCall/-- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced that six abstracts describing various research and development programs using Emisphere's proprietary oral drug delivery technology, which has recently been designated as eligen(TM), are being presented by researchers from Emisphere Technologies at the American Association of Pharmaceutical Scientists Annual Meeting and Exposition (AAPS) in Toronto, Canada, from November 10-14, 2002.
One study entitled "Gastric Absorption of Oral Insulin in Rats" demonstrated that oral insulin could be absorbed through the stomach. This pharmacokinetic study was conducted to determine systemic sites of insulin absorption after oral coadministration of an EMISPHERE® delivery agent. The next research steps for this study include examination of other sites of absorption along the gastrointestinal tract. (Abstract # R6142)
The preclinical data presented in this study support Emisphere's oral insulin clinical program. In September 2001, Emisphere presented data from three studies that demonstrated insulin absorption in the gastrointestinal tract. These studies were able to show a reduction in blood sugar levels corresponding to the serum insulin levels, a quick onset of action and a (dose-dependant) therapeutic response. Delivering insulin to the liver before it reaches the systemic circulation is an important step in providing more physiological insulin delivery to diabetics, something that investigators have been trying to do since the discovery and isolation of insulin.
A second presentation, entitled "Utility of a Novel Oral Delivery Agent in Promoting Heparin Absorption Across Different Sites of Rat Gastrointestinal Tissues" demonstrated that absorption of heparin when dosed orally with an EMISPHERE® delivery agent occurred in all regions of the gastrointestinal tract, but with different levels of absorption. In particular, at the level of EMISPHERE® delivery agent concentration tested, heparin concentration from the stomach and colon were higher than from the upper and lower small intestines. (Abstract # T2169)
A third presentation showed the results of an open label study in healthy subjects that was designed to evaluate the effect of three different oral heparin formulations using an EMISPHERE® delivery agent. After the oral administration of three dosing regimens of heparin and an EMISPHERE® delivery agent, it was determined that all formulations were rapidly absorbed and reached peak concentration within one hour. Rates of absorption among the three formulations were bioequivalent. (Abstract # R6216)
Other data presented at the AAPS meeting this week include:
-- Evaluation of rhGH Bioactivity with a Growth Assay after Oral Dosing of
rhGH in Hypophysectomized Rats (Abstract #W5282)
-- Method Development for the Determination of Water in Heparin Sodium
(Abstract #T3020)
-- In-Vitro Permeation of Cromolyn Across Excised Rat GI Tissues (Abstract
#T2221)
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere, commented, "The data presented this week at AAPS further support clinical results demonstrating that oral drug delivery using our eligen(TM) technology is viable across a number of key therapeutic areas. Further, these data support Emisphere's pipeline of clinical programs currently underway to orally deliver insulin, recombinant human growth hormone (rhGH), heparin, and cromolyn sodium."
About The eligen(TM) Technology
Emisphere has a broad-based technology platform, known as the eligen(TM) technology, to accomplish oral drug delivery, which is based on the application of proprietary, synthetic chemical compounds, known as EMISPHERE® delivery agents, or "carriers" that facilitate the transport of the therapeutic macromolecules and other compounds across biological membranes, such as the small intestine. |
