Sustained-release pharmaceutical composition containing acebrophylline and hydrophillic sustained-release agent

A technology of bromoacetphylline and composition, applied in the field of sustained-release pharmaceutical compositions, can solve the problems such as inability to achieve therapeutic effect, patient pain, and irregular administration time.

Inactive Publication Date: 2016-08-31
HYUNDAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Bromacetophylline preparations that have been approved in Korea, for example, a product called surfolase (Modern Drugs) can be taken twice a day and 100 mg each time, when combined with a drug that is taken once a day or a drug that is taken once a day When comparing the medicines of three times (before and after meals), there are the following problems: the patient's medication compliance is lowered because the time point of administration is not clear, and the administration time (interval) is not specified, so the desired ef

Method used

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  • Sustained-release pharmaceutical composition containing acebrophylline and hydrophillic sustained-release agent
  • Sustained-release pharmaceutical composition containing acebrophylline and hydrophillic sustained-release agent
  • Sustained-release pharmaceutical composition containing acebrophylline and hydrophillic sustained-release agent

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] Example 1. Hydrophilic buffer comprising hypromellose with a viscosity of 10,000 cps or less Preparation of Release Formulations

[0051] Components 1 to 5 in Table 1 were mixed and granulated. Components 6 to 8 in Table 1 were added to the granulated granules, mixed, and tabletted. After tableting, coating was performed with the coating agent No. 9 in Table 1.

[0052] The hypromellose with viscosities of METHOCEL K100LV, METHOCEL E4M and METHOCEL E10MCR used in the preparation of Example 1 were 100 cps, 4000 cps and 10000 cps, respectively.

[0053] Table 1

[0054]

[0055]

Embodiment 2

[0056] Example 2. Preparation of Hydrophilic Sustained Release Formulations Comprising Polyethylene Oxide

[0057] Components 1 to 5 in Table 2 were mixed and granulated. Components 6 to 7 in Table 2 were added to the granulated granules, mixed, and tabletted. After tableting, coating was performed with the coating agent No. 8 in Table 2.

[0058] The polyethylene oxide (Polyox WSR N-60K) used in the preparation of Example 2 had a viscosity of 2000cps to 4000cps.

[0059] Table 2

[0060]

[0061]

Embodiment 3

[0062] Example 3. Preparation of Hydrophilic Sustained Release Formulations Comprising Carbomer

[0063] Components 1 to 5 in Table 3 were mixed and granulated. Components 6 to 7 in Table 3 were added to the granulated granules, mixed, and tabletted. After tableting, coating was performed with the coating agent No. 8 in Table 3.

[0064] Carbomer 71G used in the preparation of Example 3 had a viscosity of 4000 cps to 11000 cps.

[0065] table 3

[0066]

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Abstract

The present invention relates to a pharmaceutical composition containing acebrophylline thereby having both immediate and extended release characteristics, and more specifically, to a sustained-release pharmaceutical composition containing the acebrophylline and a hydrophillic sustained-release agent having a viscosity of no more than 13,000 cps.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing acebrophylline and having both fast-acting and sustained-acting properties. The invention relates to a sustained-release pharmaceutical composition comprising bromacetate theophylline and a hydrophilic sustained-release agent with a viscosity of 13000 cps or less. Background technique [0002] As a compound synthesized by salifying ambroxol with 7-theophylline, it is a salt composed of an acid and a base, and when administered orally, it separates into ammonia Broxol and 7-theophylline are metabolized. Bromoacetate theophylline selectively acts on the bronchi and lung tissue to inhibit the activity of phospholipase in the bronchoalveolar and increase the surface activity of the alveoli, thereby exerting an expectorant effect. In addition, by inhibiting the formation of leukotrienes (LTs) and prostaglandins (PGs), it exerts an efficient anti-inflammatory effect, so by reducing br...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/24A61K9/28A61K47/38
CPCA61K9/2054A61K9/2866A61K47/38A61P11/00A61P11/02A61P11/06A61K9/20A61K9/209A61K9/28A61K31/522
Inventor P·S·李C·L·李S·Y·金Y·W·南
Owner HYUNDAI PHARMA
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