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Diphosphonic acid drug for inhalation and preparation method thereof, and application of diphosphonic acid drug in chronic obstructive pulmonary diseases

A bisphosphonic acid and drug technology, applied in the field of bisphosphonic acid drugs for inhalation and their preparation, can solve problems such as undefined safety and problems, achieve good bronchiectasis effect, enhance lung function, and improve lung function

Active Publication Date: 2020-04-24
HANGZHOU DC PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0005] To sum up, the existing published reports of inhalation administration of bisphosphonic acid drugs may not be clear about the dosage used or the dosage is too large, which may cause safety problems

Method used

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  • Diphosphonic acid drug for inhalation and preparation method thereof, and application of diphosphonic acid drug in chronic obstructive pulmonary diseases
  • Diphosphonic acid drug for inhalation and preparation method thereof, and application of diphosphonic acid drug in chronic obstructive pulmonary diseases
  • Diphosphonic acid drug for inhalation and preparation method thereof, and application of diphosphonic acid drug in chronic obstructive pulmonary diseases

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Embodiment Construction

[0036] The present invention will be specifically introduced below in conjunction with the accompanying drawings and specific embodiments.

[0037] A bisphosphonic acid drug for inhalation, comprising: bisphosphonic acid drug, pH regulator, and osmotic pressure regulator; the pH range is 8.2-8.9, and the osmotic pressure is isotonic or hypertonic. As an example, the bisphosphonate drugs include: risedronate sodium, alendronate sodium; the pH regulator and osmotic pressure regulator are bicarbonate, including: sodium bicarbonate, potassium bicarbonate. The mass ratio of bisphosphonic acid drugs to bicarbonate is 1:500-1:1000. Bicarbonate can stabilize the pH value of the bisphosphonate drug solution for inhalation at 8.2-8.5, exert the function of airway absorption enhancer, and temporarily increase the pH of the airway surface to promote the absorption of bisphosphonate drugs into the airway epithelium cell. In terms of bisphosphonic acid drugs, the dosage of the bisphosphon...

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Abstract

The invention discloses a diphosphonic acid drug for inhalation and a preparation method thereof, and application of the diphosphonic acid drug in chronic obstructive pulmonary diseases. A formula ofa drug solution comprises the diphosphonic acid drug, a pH regulator and an osmotic pressure regulator, wherein a pH value is in a range of 8.2-8.9; osmotic pressure is isoosmotic or hyperosmotic pressure; preferably, the pH regulator and the osmotic pressure regulator are bicarbonate; and based on extracellular application concentration, the content of the diphosphonic acid drug is 0.1-100 [mu]M,and the content of the bicarbonate is 1.5% (w / v)-4.0% (w / v). A drug dose researched by the invention is effective and safe, and can meet the clinical medication requirements of diseases such as the chronic obstructive pulmonary diseases.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a bisphosphonic acid drug for inhalation and its preparation method and application. Background technique [0002] Bisphosphonates (bisphosphonates, BPs), also known as bisphosphonates or bisphosphonates, are bisphosphonates used for various bone diseases and calcium metabolism diseases, mainly including risedronate sodium ( risedronate), alendronate (alendronate), ibandronate (ibandronate), and zoledronic acid (zoledronate), etc. Among them, risedronate sodium and alendronate sodium are mainly oral tablets, the dose is 5mg / day (body weight is about 50kg, the same below) or 35mg / week, and they are mainly absorbed through the bypass channel of cells, and the absorption is slow and very Limited, oral bioavailability is very low (about 0.6%), and it is easy to cause digestive tract dysfunction, such as dysphagia, peptic ulcer and so on. The adverse reactions of...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K31/66A61K31/675A61P9/00A61P11/00A61P19/10A61P35/00
CPCA61K31/675A61K31/66A61P11/00A61P19/10A61P9/00A61P35/00A61K9/0078A61K47/02
Inventor 陈燃粟波褚梦思陆泉
Owner HANGZHOU DC PHARM CO LTD
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