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Carbinoxamine maleate oral slow-release suspension and preparation method thereof

A technology for carbinoxamine maleate and sustained-release suspensions, which is applied in pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., to improve taste pleasure and medication compliance , Obvious slow-release effect

Inactive Publication Date: 2018-08-21
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there is no carbinoxamine maleate oral sustained-release suspension on the market, and a kind of carbinoxamine maleate oral sustained-release solution described in the present invention and its preparation method will greatly fill the gap in the domestic market and have a high Clinical application value and market value

Method used

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  • Carbinoxamine maleate oral slow-release suspension and preparation method thereof
  • Carbinoxamine maleate oral slow-release suspension and preparation method thereof
  • Carbinoxamine maleate oral slow-release suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Formula composition

[0063] Drug Resin Complex:

[0064] Carbinoxamine Maleate 24g

[0065] Sodium polystyrene sulfonate 24g

[0066] Deionized water 1 9kg

[0067] Impregnated Drug Resin Compound Granules

[0068] drug resin complex 2 48.2g

[0069] Kollicoat SR 30D 96.4g

[0070] 1,2-propanediol 11.2g

[0071] suspension

[0072]

[0073] Add deionized water to 30L

[0074] Note: 1. Deionized water is finally removed in this step, and its consumption is not included in the preparation.

[0075] 2. The prescription quantity of the drug resin compound is subject to the actual preparation.

[0076] 3. The prescription amount of impregnated drug resin composite particles is subject to the actual preparation.

[0077] Preparation Process:

[0078] 1. Preparation of carbinoxamine maleate-resin complex:

[0079] (1) Weigh 24 g of carbinoxamine maleate, add 3000 ml of deionized water in the prescribed amount, and stir at room temperature for 10 minutes to...

Embodiment 2

[0098] Formula composition

[0099] Drug Resin Complex:

[0100]Carbinoxamine Maleate 24g

[0101] Sodium polystyrene sulfonate 36g

[0102] Deionized water 1 11.3kg

[0103] Impregnated Drug Resin Compound Granules

[0104] drug resin complex 2 62.8g

[0105] Kollicoat SR 30D 157g

[0106] PEG-200 11.2g

[0107] suspension

[0108]

[0109] Add deionized water to 30L

[0110] Note: 1. Deionized water is finally removed in this step, and its consumption is not included in the preparation.

[0111] 2. The prescription quantity of the drug resin compound is subject to the actual preparation.

[0112] 3. The prescription amount of impregnated drug resin composite particles is subject to the actual preparation.

[0113] Preparation Process:

[0114] 1. Preparation of carbinoxamine maleate-resin complex:

[0115] (1) Weigh 24 g of carbinoxamine maleate, add 3000 ml of deionized water in the prescribed amount, and stir at room temperature for 10 minutes to disso...

Embodiment 3

[0134] Formula composition

[0135] Drug Resin Complex:

[0136] Carbinoxamine Maleate 24g

[0137] Sodium polystyrene sulfonate 48g

[0138] Deionized water 1 13.5kg

[0139] Impregnated Drug Resin Compound Granules

[0140] drug resin complex 2 74.8g

[0141] Kollicoat SR 30D 224.4g

[0142] PEG-400 11.2g

[0143] suspension

[0144]

[0145] Add deionized water to 30L

[0146] Note: 1. Deionized water is finally removed in this step, and its consumption is not included in the preparation.

[0147] 2. The prescription quantity of the drug resin compound is subject to the actual preparation

[0148] 3. The prescription amount of impregnated drug resin composite particles is subject to the actual preparation

[0149] Preparation Process:

[0150] 1. Preparation of carbinoxamine maleate-resin complex:

[0151] (1) Weigh 24 g of carbinoxamine maleate, add 3000 ml of deionized water in the prescribed amount, and stir at room temperature for 10 minutes to diss...

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PUM

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Abstract

The invention provides a carbinoxamine maleate oral slow-release suspension which is prepared from impregnated carbinoxamine maleate-resin composite particles and a suspension matrix. The impregnatedcarbinoxamine maleate-resin composite particles are prepared by using an impregnating agent to impregnate a carbinoxamine-maleate-resin compound and performing wet-process granulation, and the impregnating agent comprises a slow-release material and a plasticizer. The invention further provides a preparation method of the suspension. The preparation method is simple; a novel administration systemtaking sodium polystyrene sulfonate as a carrier is adopted, medicine is combined with sodium polystyrene sulfonate, and the objectives of slow release and taste masking are achieved after impregnating through the impregnating agent and wet-process granulation.

Description

technical field [0001] The invention relates to an oral sustained-release suspension, in particular to a carbinoxamine maleate oral sustained-release suspension and a preparation method thereof. Background technique [0002] Carbinoxamine maleate, molecular formula C 16 h 19 ClN 2 O·C 4 h 4 o 4 , is white, odorless, crystalline powder, easily soluble in water. Carbinoxamine is a mildly sedating antihistamine that has been shown to be safe and effective over the past few years. Before 2006, carbinoxamine was widely used, and there were many compound preparations containing carbinoxamine, including solid sustained-release drugs. However, most of these older drugs did not pass the FDA's rigorous approval process. On April 3, 2013, the U.S. Food and Drug Administration (FDA) approved carbinoxamine maleate extended-release (Karbinal ER, Tris Pharma) for seasonal and perennial allergic reactions in children 2 years of age and older Treatment of rhinitis. Karbinal ER is a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K47/32A61K31/4402A61P37/08A61P11/02
CPCA61K9/0095A61K9/10A61K31/4402A61K47/32A61P11/02A61P37/08
Inventor 景亚军何淑旺胡醒解春文陶元景
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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