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Pharmaceutical composition for transmucosal delivery and methods for treating diabetes in a subject in need thereof

A composition, transmucosal technology for use in the field of pharmaceutical compositions for transmucosal delivery and for the treatment of diabetes in a subject in need

Inactive Publication Date: 2017-05-31
EASTGATE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0028] However, despite many attempts, there remains an unmet need to develop a non-invasive delivery system for insulin, and stable and convenient oral insulin dosage forms have to be developed

Method used

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  • Pharmaceutical composition for transmucosal delivery and methods for treating diabetes in a subject in need thereof
  • Pharmaceutical composition for transmucosal delivery and methods for treating diabetes in a subject in need thereof
  • Pharmaceutical composition for transmucosal delivery and methods for treating diabetes in a subject in need thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0182] Embodiment 1: comparative agent

[0183] Sorbitol 20.0g ( P, Cerestar, US or P 150DC, Roquette, France) was carefully mixed with 196 mg of crystalline insulin (insulin USP, water content 9.5%, 27.7 units / mg of dry material). 500 mg of fine powdered PEG-3350NF was added and mixed well, then circular concave tablets (207 mg weight, 8 mm diameter) were compressed using a single punch tablet press. The hardness of the formed tablet was 10-14 kP and the tablet melted in the mouth within 4-7 minutes.

[0184] Placebo tablets were prepared in a similar manner but without insulin. The tablets formed (205 mg weight, 8 mm diameter) had a hardness of 10-13 kP. Tablets dissolve in the mouth within 4-7 minutes. Table 2 shows the composition (in mg) per tablet of the compressed tablets containing insulin but without eutectic mixture.

[0185] Table 2. Insulin Compressed Tablets Without Eutectic Mixture (Composition Per Tablet, mg)

[0186]

Embodiment 2

[0187] Example 2: Sublingual Insulin Tablets Containing Phospholipids

[0188] Using xylitol ( DC, Cerestar), microcrystalline cellulose ( 102), colloidal silicon dioxide and purified soybean lecithin to prepare tablets. After combining with crystalline insulin and sucralose, the blend was mixed carefully, sieved, then blended with PEG-3350 and compressed into round (8 mm) concave tablets (hardness 8-10 kP). The formed tablet dissolves in the mouth within 8-10 minutes.

Embodiment 3

[0189] Example 3: Sublingual Insulin Tablet Containing Soy Lecithin and Nonionic Surfactant

[0190] Tablets prepared as described in Example 2, but containing a combination of lecithin and selected nonionic surfactants.

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Abstract

The present disclosure relates to pharmaceutical compositions of solid dosage form for intraoral administration that provides effective delivery of insulin and insulin analogs via the transmucosal route. Also provided are methods for treating pre-diabetes, diabetes and metabolic syndrome in a subject in need thereof.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of U.S. Provisional Patent Application No. 61 / 947,678, filed March 4, 2014, and U.S. Provisional Patent Application No. 61 / 947,698, filed March 4, 2014, to the fullest extent permitted by law Its entire contents are incorporated herein by reference. technical field [0003] The present invention relates to pharmaceutical compositions in solid dosage form for oral administration, which provide efficient delivery of insulin and insulin analogues via the transmucosal route. Also provided are methods of treating prediabetes, diabetes and metabolic syndrome with the pharmaceutical composition in a subject in need thereof. Background technique [0004] Many drugs cannot be administered orally because the drugs degrade or are not orally bioavailable. For example, many drugs undergo acid-catalyzed hydrolysis in the stomach, undergo degradation in the gastrointestinal tract, or suffer from ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K38/28A61K47/10A61K47/12A61K47/14A61K47/24
CPCA61K9/0056A61K9/006A61K9/1075A61K9/2013A61K9/2018A61K38/26A61K38/28A61K47/10A61K47/24A61K47/26A61K47/28
Inventor J·施瓦兹M·威斯帕皮尔
Owner EASTGATE PHARMA
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