Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume

a total inhalation and insulin technology, applied in the direction of spray delivery, aerosol delivery, peptide/protein ingredients, etc., can solve the problems of increasing mucosal irritation, no satisfactory method of oral administration of insulin has been developed, and the probability of insulin overdosing is increased, so as to reduce safe maintenance of serum glucose levels. , the effect of reducing the probability of insulin overdosing

Inactive Publication Date: 2006-06-15
ARADIGM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0023] An advantage of the present invention is that the methodology allows the administration of smaller doses of insulin by a convenient and painless route, thus decreasing the probability of insulin overdosing and increasing the probability of safely maintaining desired serum glucose levels.

Problems solved by technology

No satisfactory method of orally administering insulin has been developed.
The lack of such an oral delivery formulation for insulin creates a problem in that the administration of drugs by injection can be both psychologically and physically painful.
In that diabetes is a chronic disease which must be continuously treated by the administration of insulin and in that mucosal irritation tends to increase with repeated exposures to the membrane penetration enhancers, efforts at developing a non-invasive means of administering insulin via nasal administration have not been commercialized.
However, he comments that “the poor reproducibility of the inhaled dose [of insulin] was always the reason for terminating these experiments.” This is an important point in that the lack of precise reproducibility with respect to the administration of insulin is critical.
The problems associated with the inefficient administration of insulin cannot be compensated for by administering excess amounts of the drug in that the accidental administration of too much insulin could be fatal.
Variations in dosing of 10-fold are clearly unacceptable with respect to the administration of most drugs, and in particular, with respect to the administration of insulin.

Method used

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  • Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume
  • Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume
  • Inhaled insulin dosage control delivery enhanced by controlling total inhaled volume

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Embodiment Construction

[0053] Before the present method of delivering aerosolized insulin to treat diabetes mellitus and devices, containers and formulations used in the treatment are described, it is to be understood that this invention is not limited to the particular methodology, containers, devices and formulations described, as such methods, devices and formulations may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention which will be limited only by the appended claims.

[0054] It must be noted that as used herein and in the appended claims, the singular forms “a,”“and,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a formulation” includes mixtures of different formulations, reference to “an analog” refers to one or mixtures of insulin analogs, and reference to “the method of treatm...

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Abstract

Dosages of inhaled insulin are controlled within a narrow range by controlling the total volume of air inhaled by a patient. By repeatedly delivering aerosolized insulin with the same total inhaled volume of air, the amount of insulin delivered to the patient each time is consistent. A device for delivering insulin by inhalation is disclosed which device comprises a means for measuring inhaled volume and for halting inhalation at a pre-determined point. The device also comprises an adjustable means for applying various amounts of force to a container of formulation to expel different amounts of drug from the container based on the force applied.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of application Ser. No. 09 / 950,562, filed Sep. 10, 2001, which is a continuation of earlier filed application Ser. No. 09 / 686,212, filed Oct. 10, 2000 which application is a continuation of earlier filed application Ser. No. 09 / 378,638, filed Aug. 20, 1999, now issued U.S. Pat. No. 6,167,880 which application is a divisional of earlier filed application Serial No. 09 / 160,909, filed Sep. 25, 1998, now issued U.S. Pat. No. 5,941,240 which application is a continuation-in-part of earlier filed application Ser. No. 08 / 846,243, filed Apr. 25, 1997, now issued U.S. Pat. No. 5,884,620 which application is a continuation-in-part of earlier filed application Ser. No. 08 / 754,423, filed Nov. 22, 1996, now issued U.S. Pat. No. 5,743,250 which application is a continuation-in-part of earlier filed application Ser. No. 08 / 549,343, filed Oct. 27, 1995, now issued U.S. Pat. No. 5,915,378 which application is a continu...

Claims

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Application Information

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Patent Type & AuthorityApplications(United States)
IPC IPC(8): A61M11/00A61J7/04A61M11/02A61K9/00A61K38/28A61M15/00A61M16/00A61M16/14
CPCA61J2007/0418A61M16/142A61J2007/0445A61K9/007A61K9/0073A61K38/28A61M15/00A61M15/0045A61M15/0065A61M15/0085A61M15/009A61M2016/0021A61M2016/0036A61M2202/062A61M2202/064A61M2205/50A61M2205/8206Y10S514/866A61M15/0031A61M15/0043A61M15/0051A61M15/008A61J2007/0427A61J7/0418A61J7/0427A61J7/0445A61M11/001A61M15/0066B05B17/0607
InventorGONDA, IGORRUBSAMEN, REID M.FARR, STEPHEN J.
OwnerARADIGM