Oral liquid formulation comprising salbutamol and guaifenesin

A technology of guaifenesin and liquid preparation, applied in the field of pharmaceutical compositions for treating cough, can solve problems such as accurate methods that do not provide stability of compositions containing salbutamol

Active Publication Date: 2013-12-25
苏鲁・苏布拉马尼・瓦南加穆迪
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0027] It is also a well-known fact that UV methods of chemical elemental analysis do not provide an accurate method for determining the stability of compositions containing salbutamol based on the amount of degraded salbutamol present in the product

Method used

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  • Oral liquid formulation comprising salbutamol and guaifenesin
  • Oral liquid formulation comprising salbutamol and guaifenesin
  • Oral liquid formulation comprising salbutamol and guaifenesin

Examples

Experimental program
Comparison scheme
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Embodiment

[0144] As an example of a preferred embodiment, a formulation is prepared using the following ingredients:

[0145] a) 80% to 98% pure water; preferably 94.7%

[0146] b) 0.001% to 0.05% salbutamol sulfate; preferably 0.025%

[0147] c) 0.1% to 2% guaifenesin; preferably 1%

[0148] d) 0.1% to 2% polymer; preferably 0.45% hydroxypropyl methylcellulose (4000cps)

[0149] e) 0.01% to 0.5% preservative; preferably 0.05% sodium methyl parahydroxybenzoate

[0150] f) 0.001% to 0.5% preservative; preferably 0.005% sodium propyl paraben

[0151] g) 0.001% to 0.1% sweetener; preferably 0.025% neotame

[0152] h) 0.1% to 1% buffer; preferably 0.3% sodium citrate

[0153] i) 0.1% to 1% buffer; preferably 0.225% citric acid

[0154] j) 1% to 5% polymer; preferably 2.5% polyvinylpyrrolidone (PVP K-90)

[0155] k) 0.01% to 1% flavoring agent; preferably 0.5% orange flavoring agent

[0156] l) 0.01% to 1% taste masking agent; preferably 0.2% taste masking agent

[0157] The formulation is prepared using the...

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Abstract

The present invention provides an improved pharmaceutical composition which comprises an aqueous dispersion of one or more cellulose derivatives containing salbutamol and / or one or more of its physiologically acceptable salts and guaiphenesin. The pH of the formulation has been maintained at around 4.5 with citrate buffer for better stability of salbutamol. The liquid formulation of the present invention is found to be stable over its shelf life as confirmed by accelerated studies. The present invention is also directed to an innovative process of formulating an oral liquid dosage form containing Salbutamol sulphate and Guaiphenesin as APIs, and possessing good stability coupled with palatability. The invention is useful as a treatment of Asthma, and used as bronchodilator and expectorant in certain respiratory conditions.

Description

Technical field [0001] The invention relates to a pharmaceutical composition for the treatment of respiratory diseases. The present invention particularly relates to a pharmaceutical composition for treating cough. Background technique [0002] The function of the respiratory system is to exchange gas. In humans and other mammals, the anatomical features of the respiratory system include airways, lungs, and respiratory muscles. Cough in clinical terms refers to a sudden and often repetitive defensive reflex that helps clean up excess secretions, irritants, foreign particles and microorganisms in the large respiratory passages. Since cough is a spontaneous protective reflex, suppressing the cough reflex may have harmful effects, especially when coughing with sputum. However, the cough may still be severe enough (from psychological, physical, and social pressure) to the point where it needs treatment. [0003] Asthma is a chronic inflammation of the lungs in which the airways (br...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/10A61K47/18
CPCA61K47/183A61K9/10
Inventor 苏鲁·苏布拉马尼·瓦南加穆迪德韦纳塞蒂·斯里尼瓦斯拉奥尼拉坎丹·纳拉亚南·许利耶尔库普萨米·森蒂库马尔
Owner 苏鲁・苏布拉马尼・瓦南加穆迪
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