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A low dose corticosteroid composition

A corticosteroid, composition technology, applied in the field of knowing how to use, can solve the problems of not mentioning pH requirements, not disclosing budesonide and beta-cyclodextrin, not disclosing stable formulations, etc.

Inactive Publication Date: 2006-03-22
SUN PHARMA INDS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent does not disclose the formation of an inclusion complex of budesonide and β-cyclodextrin, nor does it disclose whether it provides a stable formulation
The patent also fails to address issues such as pH requirements for stabilizing budesonide solutions or preventing precipitation of budesonide during storage

Method used

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  • A low dose corticosteroid composition
  • A low dose corticosteroid composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0063] This example illustrates one embodiment of the invention and its preparation, the formulation of which is shown in Table 1 below.

[0064] Element

%w / v

mg / 10ml

budesonide

0.064

6.4

Hydroxypropyl Methyl Cellulose (Methocel E4M)

0.250

25

Hydroxypropyl beta-cyclodextrin

5.5

550

Dextrose (anhydrous)

1.6

16

N-Methylpyrrolidone

1.0

100

Disodium edetate

0.1

10

Potassium sorbate

0.12

12

Hydrochloric acid (1% v / v)

Adjust to pH 4.0-4.5

Adjust to pH 4.0-4.5

Water for Injection

Make up to 100%

Make up to 10ml

[0065] Disperse the hydroxypropyl methylcellulose into about 40% water for injection heated to 80°C, and then add the cooled 25% water for injection after cooling the above solution to 40°C. Hydroxypropyl beta-cyclodextrin dissolved in water for injection was added to the slightly viscous c...

Embodiment 2

[0071] This example illustrates another embodiment of the invention.

[0072] Element

[0073] Disperse the hydroxypropyl methylcellulose into about 40% water for injection heated to 80°C, and then add the cooled 25% water for injection after cooling the above solution to 40°C. Hydroxypropyl beta-cyclodextrin dissolved in water for injection was added to the slightly viscous clear solution formed above under stirring. Under stirring, budesonide dissolved in N-methylpyrrolidone was added dropwise to the above solution. Dissolve edetate disodium and potassium sorbate in 20% water for injection and add to the drug solution. The pH of the resulting solution was adjusted to 4.0-4.5 using hydrochloric acid, and the remaining water for injection was used to make up the volume. The solution was filtered through a 0.22 micron nylon 66 membrane filter using a 2 micron glass fiber pre-filter and bottled.

Embodiment 3

[0075] This example illustrates another embodiment of the invention.

[0076] Element

[0077] The procedure for preparing this solution composition is the same as in Example 2.

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Abstract

The present invention relates to a low-dose composition of budesonide, which is suitable to use the budesonide on the mucous memebane to treat the nasal symptoms which are relevant to the seasonal allergic rhinitis, the perennial allergic rhinitis, perennial non-allergic rhinitis and the rhinopolypus, and prevent the postoperative polypi, chronic sinusitis and recurrent sinusitis, the composition includes the budesonide whose effective dose is below 16 mcg and the liquid carrier that is acceptable at the pharmacy.

Description

[0001] The present invention relates to low dose budesonide corticosteroid compositions suitable for administering budesonide to the mucosa. [0002] In particular, the present invention relates to budesonide low dose compositions suitable for administering budesonide to the mucous membranes for the treatment of nasal allergies associated with seasonal allergic rhinitis, perennial allergic rhinitis, perennial non-allergic rhinitis, nasal polyps Symptoms and prophylaxis of postoperative polyps, chronic sinusitis and recurrent sinusitis, the composition comprising a therapeutically effective dose of budesonide less than 16mcg and a pharmaceutically acceptable liquid carrier, [0003] A preferred low dose composition suitable for administering budesonide to the mucosa is a stable aqueous solution of budesonide. Background of the invention [0004] Budesonide, a synthetic corticosteroid, is an anti-inflammatory drug useful in the prevention and treatment of asthma and in the treat...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/56A61K47/40
Inventor 巴拉拉姆·苏巴斯·鲍米克尼廷·里图·拉得哈贾伊辛格·阿贾伊·科帕德
Owner SUN PHARMA INDS
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