Salbutamol sulfate film-controlled slow-release pellet capsule

A technology of salbutamol sulfate and sustained-release pellets, which can be used in medical preparations with non-active ingredients, respiratory diseases, organic active ingredients, etc., and can solve problems such as decreased release.

Active Publication Date: 2013-07-24
北京天衡药物研究院有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problem of release decline caused by film aging of salbutamol sulfate film-controlled sustained-release pellets prepared by aqueous dispersion coating, the present invention provides a film-controlled sulfuric acid film capable of maintaining stable release performance throughout the validity period. Salbutamol sustained-release pellet capsules are characterized in that the core of the pellets contains sodium carboxymethyl starch with high water-swellability, and the sustained-release coating film is deformed by water swelling, thereby offsetting the aging of the film

Method used

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  • Salbutamol sulfate film-controlled slow-release pellet capsule
  • Salbutamol sulfate film-controlled slow-release pellet capsule
  • Salbutamol sulfate film-controlled slow-release pellet capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The albuterol sulfate sustained-release pellet capsule of embodiment 1 common ball core

[0031] 1. Prescription

[0032] 1. Pill core prescription (1000 capsules)

[0033]

[0034]

[0035] * Calculated as albuterol is 8g

[0036] 2. Prescription of sustained-release film coating solution

[0037]

[0038] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0039] Second, the preparation process:

[0040] 1. Ball core preparation process:

[0041] (1) Take albuterol sulfate and microcrystalline cellulose PH101 of prescription quantity, put in wet granulator and mix evenly.

[0042] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0043] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0044] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0045] (5) Sieve, and take ball cores between 16 and 30 mesh.

[0046] 2. Prepar...

Embodiment 2

[0069] Example 2 Salbutamol Sulfate Sustained-release Pellet Capsules Containing 5% Sodium Carboxymethyl Starch

[0070] 1. Prescription

[0071] 1. Pill core prescription (1000 capsules)

[0072]

[0073] 2. Prescription of sustained-release film coating solution: same as in Example 1

[0074] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules

[0075] Second, the preparation process:

[0076] 1. Ball core preparation process:

[0077] (1) take by weighing albuterol sulfate, microcrystalline cellulose PH101, sodium carboxymethyl starch of recipe quantity, put in the wet granulator and mix homogeneously;

[0078] (2) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;

[0079] (3) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;

[0080] (4) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;

[0081] (5) Sieve, and take ball cores between 16 and 30 mesh. ...

Embodiment 3

[0097] Example 3 Salbutamol Sulfate Sustained Release Pellet Capsules Containing 10% Sodium Carboxymethyl Starch

[0098] 1. Prescription

[0099] 1. Pill core prescription (1000 capsules)

[0100]

[0101] 2. Prescription of sustained-release film coating solution: same as in Example 1.

[0102] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.

[0103] Second, the preparation process:

[0104] 1. Ball core preparation process: with embodiment 2.

[0105] 2. The preparation process of the slow-release film coating solution: the same as in Example 1.

[0106] 3. Coating (sustained release film):

[0107] The ball core is placed in a fluidized bed for coating, and the weight gain of the coating film is controlled, and the weight gain of the coating is 20.1% and 25.9%.

[0108] 4, heat treatment: with embodiment 1.

[0109] 5. Capsule filling: the coated pellets are filled into capsules.

[0110] 3. Release, content determination and results

[0111] ...

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Abstract

The invention relates to a salbutamol sulfate film-controlled slow-release pellet capsule. A slow-release film of the salbutamol sulfate film-controlled slow-release pellet utilizes Kollicoat SR30D as a film-formation material. A pellet core of the salbutamol sulfate film-controlled slow-release pellet contains sodium carboxymethyl starch having high expansibility, and also contains a pharmaceutically-acceptable common excipient for the slow-release pellet, wherein preferably, the excipient comprises microcrystalline cellulose, and the pellet core comprises 5 to 20wt% of the sodium carboxymethyl starch. The slow-release film comprises Kollicoat SR30D, triethyl citrate as a plasticizer and talcum powder as an antiplastering aid, wherein preferably, a ratio of Kollicoat SR30D to triethyl citrate to talcum powder is 30: 1: 4 and a film weight increasing ratio is in a range of 19 to 38%. The salbutamol sulfate film-controlled slow-release pellet comprises the pellet core containing sodium carboxymethyl starch having high water expansibility and thus after absorbing water, the salbutamol sulfate film-controlled slow-release pellet obviously expands so that the slow-release film is stretched; the thickness of the slow-release film is reduced; the water-permeable micropore size is increased; and permeability is improved and the permeability reduction caused by film aging is counteracted. Therefore, in middle and later stages, the salbutamol sulfate film-controlled slow-release pellet release rate is basically constant; in the last stage, residues are less; and stable release performances can be kept in the period of validity.

Description

technical field [0001] The invention relates to a salbutamol sulfate membrane-controlled sustained-release pellet capsule, in particular to a salbutamol sulfate membrane-controlled sustained-release pellet capsule with a pellet core containing sodium carboxymethyl starch, belonging to the field of pharmaceutical preparations. Background technique [0002] Salbutamol sulfate is a synthetic beta 2 Receptor agonist, can selectively act on bronchial smooth muscle β 2 -receptor, which has a strong bronchodilation effect, and is used for the treatment of bronchial asthma or asthmatic bronchitis and other respiratory diseases accompanied by bronchospasm. [0003] Salbutamol sulfate is dissolved in water. The salbutamol sulfate osmotic pump controlled-release tablets that are administered twice a day by MURO Company can achieve zero-order release and uniform drug release. The disadvantage is that the semipermeable membrane composed of polymer materials is easy to age. The drug res...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/137A61K47/36A61P11/08
Inventor 姜庆伟狄媛吕玉珠唐亚坤刘俊轶
Owner 北京天衡药物研究院有限公司
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