Levalbuterol hydrochloride orally disintegrating tablet and preparation method thereof

A technology of levalbuterol hydrochloride and oral fast disintegrating tablets, which is applied in the directions of pharmaceutical formulations, medical preparations with inactive ingredients, and medical preparations containing active ingredients, etc. Optically active drug failure and other problems, to achieve the effect of low cost, simple process, good disintegration performance

Inactive Publication Date: 2008-01-16
HARBIN UNIV OF COMMERCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The invention patented as 200310107658.4 adopts Eudragit E-100 to coat levosalbutamol hydrochloride and then wet granulate and press the tablet. The preparation process is complex and requires heating in multiple processes. The maximum temperature reaches 60°C, which is easy to destroy hydrochloric acid. The optical activity of levalbuterol makes the drug ineffective; in addition, its disintegrant uses a single low-substituted hydroxypropyl cellulose, although it overcomes the gritty feeling, the effect of the disintegrant is not ideal

Method used

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  • Levalbuterol hydrochloride orally disintegrating tablet and preparation method thereof
  • Levalbuterol hydrochloride orally disintegrating tablet and preparation method thereof

Examples

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Effect test

Embodiment 1

[0069] The prescription of levosalbutamol hydrochloride orally disintegrating tablets in this example is: 1.26 parts of levosalbutamol hydrochloride, 2.52 parts of β-cyclodextrin, 28.51 parts of microcrystalline cellulose, 14.25 parts of low-substituted hydroxypropyl cellulose, cross-linked polyethylene 14.25 parts of pyrrolidone, 28.51 parts of mannitol, 5.35 parts of citric acid, and 5.35 parts of aspartame.

[0070] The preparation method of levosalbutamol hydrochloride oral fast disintegrating tablet is:

[0071] Weigh levosalbutamol hydrochloride, β-cyclodextrin, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, mannitol, citric acid, and aspartame according to the amount, and pass through an 80-mesh sieve , mix and grind levosalbutamol hydrochloride and β-cyclodextrin fully for 20 minutes, mix levosalbutamol hydrochloride β-cyclodextrin inclusion complex with disintegrating agent, filler and flavoring agent evenly acc...

Embodiment 2

[0095] The prescription of levosalbutamol hydrochloride orally disintegrating tablets in this example is: 2.10 parts of levosalbutamol hydrochloride, 6.30 parts of β-cyclodextrin, 37.44 parts of microcrystalline cellulose, 6.18 parts of low-substituted hydroxypropyl cellulose, cross-linked polyethylene 14.54 parts of pyrrolidone, 21.8 parts of lactose, 5.82 parts of citric acid, 5.82 parts of aspartame.

[0096] The preparation method of levosalbutamol hydrochloride oral fast disintegrating tablet is:

[0097] Levosalbutamol hydrochloride, β-cyclodextrin, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, lactose, citric acid, and aspartame were weighed according to the amount, passed through a 80-mesh sieve, Mix levosalbutamol hydrochloride and β-cyclodextrin and grind them thoroughly for 30 minutes, mix levosalbutamol hydrochloride β-cyclodextrin inclusion complex with disintegrant, filler and flavoring agent uniformly acc...

Embodiment 3

[0118] The prescription of levosalbutamol hydrochloride orally disintegrating tablets in this example is: 0.79 parts of levosalbutamol hydrochloride, 3.15 parts of β-cyclodextrin, 35.32 parts of microcrystalline cellulose, 7.06 parts of low-substituted hydroxypropyl cellulose, cross-linked polyethylene 14.13 parts of pyrrolidone, 9.42 parts of mannitol, 18.83 parts of lactose, 5.65 parts of citric acid, and 5.65 parts of aspartame.

[0119] The preparation method of levosalbutamol hydrochloride oral fast disintegrating tablet is:

[0120] Weigh levosalbutamol hydrochloride, β-cyclodextrin, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, mannitol, lactose, citric acid, and aspartame according to the amount, and pass 80 Mesh sieve, mix and grind levosalbutamol hydrochloride and β-cyclodextrin fully for 30 minutes, mix levosalbutamol hydrochloride β-cyclodextrin inclusion complex with disintegrating agent, filler and flavori...

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Abstract

The invention relates to a levalbuterol hydrochloride orally disintegrating tablet and the preparation method; wherein the levalbuterol hydrochloride orally disintegrating tablet comprises an active pharmaceutical ingredient, the levalbuterol hydrochloride, and pharmaceutical necessities. The pharmaceutical necessities include a disintegrant, a filling agent, a masking agent and a corrective. The raw material ingredients calculated by weight ratio are 0.79-2.5 per cent levalbuterol hydrochloride, 50-60 percent disintegrant, 20-40 per cent filling agent, 1.58-10 per cent masking agent and 10-12 per cent corrective, which are made into the orally disintegrating tablets by direct powder compression process. The tablets of the invention is taken easily without water, disintegrated quickly and takes effect quickly, high in bioavailability, less stimulatory function to gastrointestinal tract, and applicable to prevention and cure of bronchial asthma, asthmatic bronchitis, and bronchospasm of an emphysema patient.

Description

(1) Technical field [0001] The invention relates to a levosalbutamol hydrochloride oral pharmaceutical preparation, in particular to a levosalbutamol hydrochloride orally disintegrating tablet that can be disintegrated in the oral cavity without water and a preparation method thereof. (2) Background technology [0002] Bronchial asthma (asthma for short) is a chronic respiratory disease, which is a chronic airway inflammation involving the participation of various inflammatory cells such as eosinophils (Eos), mast cells and T-lymphocytes. This inflammation causes airway hyperresponsiveness, reversible airflow limitation, and respiratory symptoms in susceptible individuals. The onset is rapid, but it disappears quickly. Asthma is a common disease. According to the latest report on the WHO website: In Western Europe, the incidence of asthma has doubled in the past 10 years; at present, there are 100 to 150 million people with asthma in the world, and the incidence is on the ri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/137A61K47/38A61P11/06
Inventor 范玉玲胡淑娟季宇彬
Owner HARBIN UNIV OF COMMERCE
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