A kind of dapagliflozin inhalation powder mist and preparation method thereof

A technology of inhaling powder and carrier, which is applied in the field of medicine, can solve the problems of clinical treatment of type 2 diabetes, affect the efficacy of active drugs, and cannot produce high-quality powder and mist, so as to enrich the variety and improve the hypoglycemic effect , the effect of small density

Inactive Publication Date: 2019-06-28
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Inappropriate excipients not only cannot make better-quality powder aerosols, such as being too hygroscopic and easily adsorbed on the airway wall, too light and easy to exhale, etc., but also affect the efficacy of active drugs. In addition, long-term use will cause damage to the lungs
However, as it is a newly marketed drug, Dapagliflozin currently only has tablet dosage form, and there are no other types of preparations, and there is no relevant preparation process report, which is better for Dapagliflozin's application in type 2 Diabetes clinical treatment presents challenges

Method used

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  • A kind of dapagliflozin inhalation powder mist and preparation method thereof
  • A kind of dapagliflozin inhalation powder mist and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: Dapagliflozin inhalation powder of the present invention

[0029]Dissolve 10g of mannitol and 10g of threonine in 500ml of water respectively, combine and mix to obtain an excipient solution, add 1g of dapagliflozin to the above excipient solution, dissolve, add water to 2400ml, filter with a 0.20μm microporous membrane, Spray dry. The spray-drying control conditions are that the inlet temperature is 110±5°C, the outlet temperature is 65±5°C, the cyclone speed is 90%, and the nozzle air flow rate is 600ml / min to obtain the dapagliflozin powder aerosol.

Embodiment 2

[0030] Embodiment 2: Dapagliflozin inhalation powder of the present invention

[0031] Dissolve 20g of lactose and 30g of leucine in 500ml of water respectively, combine and mix to obtain an excipient solution, add 1g of dapagliflozin to the above excipient solution, dissolve, add water to 2700ml, filter with a 0.20μm microporous membrane, spray dry. The spray-drying control conditions are that the inlet temperature is 110±5°C, the outlet temperature is 65±5°C, the cyclone speed is 90%, and the nozzle air flow rate is 600ml / min to obtain the dapagliflozin powder aerosol.

Embodiment 3

[0032] Embodiment 3: Dapagliflozin inhalation powder of the present invention

[0033] Dissolve 40g of mannitol and 40g of arginine in 500ml of water respectively, combine and mix to obtain an excipient solution, add 1g of dapagliflozin to the above excipient solution, dissolve, add water to 2100ml, filter with a 0.20μm microporous membrane, Spray dry. The spray-drying control conditions are that the inlet temperature is 110±5°C, the outlet temperature is 65±5°C, the cyclone speed is 90%, and the nozzle air flow rate is 600ml / min to obtain the dapagliflozin powder aerosol.

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Abstract

The invention relates to the technical field of medicine, and discloses a dapagliflozin dry powder inhalation. The dry powder inhalation contains dapagliflozin, carriers and amino acids, wherein the carriers are one or more than two materials from lactose, lecithin, phosphatidylchline and mannitol; and the amino acids are one or more than two materials from glutamic acid, aspartic acid, threonine, isoleucine, leucine and arginine. The carriers and the amino acids proper for the dapagliflozin are used and matched; the optimized mixture ratio is selected; and the obtained dapagliflozin dry powder inhalation enriches the types of dapagliflozin preparations and has the advantages of high safety, high bioavailability, high effect taking speed, low dosage, small powder particle diameter, low density, high solubility, high bulk density, good rest angle, high sprayability and moisture absorption difficulty.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a dapagliflozin inhalation powder mist and a preparation method thereof. Background technique [0002] With the change of people's living standards and lifestyles, the prevalence of type 2 diabetes is increasing. It is estimated that since 2007, there are about 246 million diabetic patients in the world, accounting for 5.9% of the world's total population; it is estimated that by 2025, The number of patients will increase to 380 million, or 7.9% of the total adult population, seriously endangering human health. The research and development of new hypoglycemic drugs has already become a hot topic in international medicine. [0003] At present, the treatment of diabetes mainly relies on the injection of exogenous recombinant insulin, improving the sensitivity of tissues to insulin, improving the function of pancreatic beta cells and reducing the absorption of carbohydrates, etc. H...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/72A61K31/351A61K47/26A61K47/18A61K47/24A61P3/10
Inventor 徐春莲陶安进马亚平袁建成
Owner HYBIO PHARMA
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