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Nasal formulations of insulin

A technology for insulin and pharmaceutical preparations, applied in the field of insulin nasal administration, can solve the problems of complex, low bioavailability and the like

Inactive Publication Date: 2011-05-11
CPEX PHARMACEUTICALS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, low bioavailability remains prevalent in intranasal delivery, compounded by high interindividual variability in insulin absorbed by this route

Method used

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  • Nasal formulations of insulin
  • Nasal formulations of insulin
  • Nasal formulations of insulin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] The goals of this study were to determine the optimal method for intranasal administration of insulin and to characterize the dose-response pharmacokinetics and pharmacodynamics. This study was conducted in accordance with the protocol approved by the Institutional Review Board (IRB).

[0051] Preparations and Equipment

[0052] The formulation tested was an intranasal insulin spray comprising conventional short-acting human recombinant insulin dissolved in water with several common excipients including polysorbate 20, sorbitan monolaurate , cottonseed oil and cyclopentadecanolide (CPE-215). The excipient cyclopentadecanolide is a compound that occurs naturally in plants such as Angelia archangelica root and is a common component in many food, cosmetic and personal hygiene products. It is important that the insulin preparation is left at room temperature for 2 to 10 hours before use. Slowly invert it two or three times. Prime the pump when using the spray for the ...

Embodiment 2

[0072]The glucose clamp technique is a well-established measurement method for measuring the direct effect of insulin on glucose uptake. This method of measurement is achieved by clamping or maintaining a predetermined blood glucose level (eg -100 mg / dl) and by using a regulated rate of glucose infusion to offset the effect of the insulin being tested. Thus, the glucose infusion rate (GIR) becomes a direct measure of the amount of glucose "disappearing" from the plasma per unit time.

[0073] Glucose clamp studies are performed according to the following steps:

[0074] a. Subjects fasted from 11:00 PM the night before (except water).

[0075] b. The subjects kept the sitting position and rested for 5 minutes before collecting vital signs.

[0076] c. Both arms are placed on a heating pad to dilate the vein. An IV catheter was placed in the antecubital vein in one arm for infusion of dextrose 20% and insulin through two separate regulator valves. Another IV catheter was in...

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Abstract

The present invention provides a method for achieving a therapeutically effective plasma levels of insulin by admmisteppg at least two doses of pharmaceutical formulation of insulin sequentially into the same nostril The administration of the second dose in the same nostril gives substantially higher plasma levels of insulin when compared with sequential administration in two different nostpls Without being limited to any specific physiological mechanism, it is believed that the first dose of insulin acts as a loading dose This loading dose is required to achieve the subsequent plasma levels of insulin that are observed with subsequent doses The Cmax of plasma insulin achieved by the methods and formulations of the present invention is at least about 7Q microU / ml when plasma insulin is measured from about 0 to about 45 minutes after administration of a second dose The AUC achieved is at least about 1800 microU / (ml* mm).

Description

[0001] Cross References to Related Applications [0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application 61 / 059,225, filed June 5, 2008. technical field [0003] The present invention relates to methods and formulations for nasal administration of insulin. Background technique [0004] Insulin is a hormone that induces the transport of glucose from the blood into cells, where glucose provides the source of energy. Patients with type 1 and type 2 diabetes often require exogenous insulin administration to control blood sugar. Numerous studies have shown that tight blood sugar control is critical to controlling the incidence and severity of many of the major complications of diabetes (Skyler. Clinical Diabetes 22(4):162-166 (2004). A key factor in maintaining glycemic control—especially in type 1 diabetes, where insulin production is limited or non-existent—is the timely delivery of doses of insulin that match the increase in blood g...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K38/28
CPCA61K9/0043A61K38/28A61P5/48A61P3/10
Inventor R·斯多特P·斯特兰奇
Owner CPEX PHARMACEUTICALS INC
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