# US 10,307,430 B2 · KATP antagonists (glibenglamid) for use for promoting growth and/or treating hyperglycaemia of a premature infant

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- Number: US 10,307,430 B2
- Document ID: US10307430B2
- Status: Granted
- Kind: B2
- Application number: 14/115,103
- Filed: 2012-05-02
- Published: 2014-02-20
- Granted: 2019-06-04
- Earliest claimed: 2011-05-03
- Assignees: Assistance Publique-Hopitaux de Paris
- Applicants: Michel Polak; Marianne Berdugo Polak
- Inventors: Michel Polak; Marianne Berdugo Polak
- Web page: https://patentgrep.com/patent/US10307430B2

## CPC

- A61K 31/64: Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 31/451: having a carbocyclic group directly attached to the heterocyclic ring, e.g. glutethimide, meperidine, loperamide, phencyclidine, piminodine
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to pharmaceutical compositions comprising an ATP-sensitive potassium (K ATP) channel antagonist (e.g., sulfonylureas, meglitinides) and methods for treating hyperglycaemia and/or promoting growth of a premature and/or small for gestational age infant.

## Claims

### Claim 1

A method for promoting growth in a preterm and/or small-for-gestational-age infant in need of growth promotion, comprising enterally administering a pharmaceutical composition comprising a therapeutically effective amount of a KATP channel antagonist selected from the group consisting of glibenclamide, acetohexamide, carbutamide, glibornuride, chlorpropamide, tolbutamide, tolazamide, glipizide, gliclazide, gliquidone, glyclopyramide, glisoxepide, glimepiride, repaglinide, nateglinide, mitiglinide and combinations thereof to the preterm and/or small-for-gestational-age infant, wherein the pharmaceutical composition is administered to the infant for a period of seven days to six months and the growth of said preterm and/or small-for-gestational-age infant is promoted.

### Claim 2 (depends on 1)

The method of claim 1, wherein the infant weighs less than 2,500 g at birth.

### Claim 3 (depends on 1)

The method of claim 1, wherein the infant weighs less than 1,500 g at birth.

### Claim 4 (depends on 1)

The method of claim 1, wherein the infant is born at less than 32 weeks gestation.

### Claim 5 (depends on 1)

The method of claim 1, wherein the infant is born at less than 28 weeks gestation.

### Claim 6 (depends on 1)

The method of claim 1, wherein the infant is a premature appropriate-for-gestational-age infant with preterm growth restraint.

### Claim 7 (depends on 1)

The method of claim 1, wherein the KATP channel antagonist is selected from the group consisting of glibenclamide, acetohexamide, carbutamide, glibornuride, chlorpropamide, tolbutamide, tolazamide, glipizide, gliclazide, gliquidone, glyclopyramide, glisoxepide, glimepiride, repaglinide, nateglinide and mitiglinide.

### Claim 8 (depends on 1)

The method of claim 1, wherein the KATP channel antagonist is glibenclamide.

### Claim 9 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is in a liquid form.

### Claim 10 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is a suspension of micronized particles of the KATP channel antagonist.

### Claim 11 (depends on 1)

The method of claim 1, wherein the preterm and/or small-for gestational-age infant is younger than 6 months.

### Claim 12 (depends on 1)

The method of claim 1, wherein said pharmaceutical composition comprises a therapeutically effective amount of said KATP channel antagonist and a surfactant.

### Claim 13 (depends on 12)

The method of claim 12, wherein said surfactant is polysorbate 80 or ethoxylated castor oils.

### Claim 14 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to said infant for a period of two weeks to six months.

### Claim 15 (depends on 1)

The method of claim 1, wherein the pharmaceutical composition is administered to said infant for a period of one to six months.
