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Vilanterol triphenylacetate inhalation solution and preparation method thereof

A technology of triphenylacetic acid and phenylacetic acid, applied in directions such as pharmaceutical formulation, liquid delivery, dispersion liquid delivery, etc., can solve problems such as inability to achieve drug delivery, and achieve the effects of alleviating liver and kidney damage, simple production process, and reduced drug concentration.

Pending Publication Date: 2022-02-22
INCREASEPHARM TIANJIN INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The vilanterol unilateral powder spray developed by GlaxoSmithKline is in the third phase of clinical trials and has not yet been launched into the market; in addition, the powder spray needs to rely on the patient's large inspiratory flow rate to start the nebulization, and the patient cannot breathe under normal breathing conditions. Enables drug delivery, making it unsuitable for children, the elderly, and other patients with difficult active breathing

Method used

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  • Vilanterol triphenylacetate inhalation solution and preparation method thereof
  • Vilanterol triphenylacetate inhalation solution and preparation method thereof
  • Vilanterol triphenylacetate inhalation solution and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] prescription composition

[0049] name composition vilanterol triphenylacetate 25mg (calculated as vilanterol) Sodium chloride 9g citric acid 0.05g sodium citrate 1g Add water for injection to 1000ml

[0050] Preparation:

[0051] Add 500ml of water for injection into the dispenser, control the water temperature to 75°C, add the raw and auxiliary materials to the above water for injection, stir until it is completely dissolved, add water for injection to the full amount, stir to mix evenly; use a 0.45μm filter membrane Perform primary filtration, 0.22μm filter membrane for fine filtration, all are aseptic filtration, sub-packaged and filled in ampoules.

Embodiment 2

[0053] prescription composition

[0054]

[0055]

[0056] Preparation:

[0057]Add 800ml of water for injection into the dispenser, control the water temperature to 75°C, add the raw and auxiliary materials to the above water for injection, stir until it is completely dissolved, then add water for injection to the full amount, stir to mix evenly; use a 0.45μm filter membrane Perform primary filtration, 0.22μm filter membrane for fine filtration, all are aseptic filtration, sub-packaged and filled in ampoules.

Embodiment 3

[0059] prescription composition

[0060] name composition vilanterol triphenylacetate 30mg (calculated as vilanterol) Sodium chloride 8g citric acid 0.05g sodium citrate 0.85g Add water for injection to 1000ml

[0061] Add 500ml of water for injection into the dispenser, control the water temperature at 80°C, add the raw and auxiliary materials to the above water for injection, stir until it is completely dissolved, add water for injection to the full amount, stir to mix evenly; use a 0.45μm filter membrane Perform primary filtration, 0.22μm filter membrane for fine filtration, all are aseptic filtration, sub-packaged and filled in ampoules.

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Abstract

The invention provides a vilanterol triphenylacetate inhalation solution as well as a preparation method and application thereof. The inhalation solution comprises an active substance, a solvent and an auxiliary material. The single-dose specification of the inhalation solution is 1ml, and the single-dose specification comprises an active substance which is 15-50mu g / mL vilanterol trifenatate and / or a hydrate of vilanterol trifenatate; and the solvent is sterile injection water, the auxiliary material comprises an osmotic pressure regulator and a pH regulator, the concentration of the osmotic pressure regulator is 5-9 mg / ml, and the pH regulator is added to enable the pH value of the inhalation solution preparation to be 5.0-7.0. The solution provided by the invention adopts single-dose packaging, is not added with preservatives, is safe and convenient to use, is used in combination with a liquid atomizer, and can provide a safe, effective and good-stability vilanterol trifenatate pharmaceutical dosage form for inhalation and a drug delivery system.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a vilanterol triphenylacetic acid inhalation solution and a preparation method thereof. Background technique [0002] Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by incompletely reversible airflow limitation, with a large number of patients and a high mortality rate. According to the World Health Organization (WHO), there are currently 600 million people suffering from this disease worldwide, and it will become the third leading cause of death in the world by 2020. There are more than 43 million patients in China, and 1.28 million patients die from this disease every year, with a mortality rate of 17.6%. [0003] According to the "2013 Chinese Medical Association Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease", the treatment drugs include: bronchodilators, glucocorticoids, ...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K47/02A61K47/12A61K31/137A61P11/00A61P11/06
CPCA61K9/0078A61K9/08A61K47/02A61K47/12A61K31/137A61P11/00A61P11/06
Inventor 胡杰王永福洪玉
Owner INCREASEPHARM TIANJIN INST CO LTD
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