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Salmeterol xinaiate and fluticasone propionate compound powder inhalation composition

A technology of fluticasone propionate and xinaic acid, which is applied in the field of salmeterol xinafoate fluticasone propionate compound powder inhalation composition and compound powder inhalation composition, and can solve the problem of single carrier

Active Publication Date: 2022-03-18
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In the course of the research, it was found that the lung deposition rate of the active part of the main drug was measured by a new generation of pharmaceutical impactor (NGI). The FPF value continues to decline after 6 months of storage at ±2°C, 75%RH±5%RH relative humidity, and the existing technologies cannot solve this problem well
[0015] Therefore, to overcome the above-mentioned technical problems existing in the existing fluticasone propionate and salmeterol sinafoate compound powder, a more stable, higher lung deposition rate and a single carrier of salmeterol sinafoate are provided. Fluticasone ropropionate compound powder inhalation is urgently needed in clinic

Method used

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  • Salmeterol xinaiate and fluticasone propionate compound powder inhalation composition
  • Salmeterol xinaiate and fluticasone propionate compound powder inhalation composition
  • Salmeterol xinaiate and fluticasone propionate compound powder inhalation composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Invention Example 1 Salmeterol xinaiac and fluticasone propionate compound powder inhalation

[0038] Table 1 Particle size distribution of lactose in Invention Example 1 (μm)

[0039]

[0040] Table 2 Prescription

[0041]

[0042] The active ingredient used in Examples 1-1 to 1-9 is fluticasone propionate d(0.9)=4.8 μm, and the feeding amount is 10 g; salmeterol xinafoate d(0.9)=4.7 μm, and the feeding amount is 2.91 g .

[0043] Preparation process: according to the prescription, the active ingredient and the carrier are premixed by a three-dimensional mixer, and then mixed by a high-speed mixer to obtain a dry powder mixture of the active ingredient and lactose. In the high-speed mixer, two kinds of mixing blades are contained in the mixing cavity, which move in the horizontal and vertical directions respectively. Quantitatively filling the prepared mixture into a multi-dose storage type dry powder administration device. Each product uses the same dry powd...

Embodiment 2

[0044] Invention Example 2 Salmeterol xinaiac and fluticasone propionate compound powder inhalation

[0045] Table 3 Lactose Particle Size Distribution (μm) in Invention Example 2

[0046]

[0047]

[0048] Table 4 Prescription

[0049]

[0050] The active ingredients used in Examples 2-1 to 2-12 are fluticasone propionate d(0.9)=4.8 μm, and the feeding amount is 10 g; salmeterol sinafoate d(0.9)=4.7 μm, and the feeding amount is 2.91 g .

[0051] Preparation process: refer to Invention Example 1.

Embodiment 3

[0052] Invention Example 3 Study on Accelerated Stability of Pulmonary Deposition Rate of Salmeterol Xinanate and Fluticasone Propionate Compound Powder Inhalation

[0053] Take inventive examples 1-1~1-9, 2-1~2-12, commercially available Seretide (Steretide, specification 50 μg / 250 μg) and comparative examples 1~5 samples, at 40°C±2°C, 75 Store at %RH±5%RH relative humidity for 6 months, test at 0 o'clock, 3 months and 6 months during the storage process, use the method to measure the emptying rate, and use the new generation of pharmaceutical impactor (NGI) to measure the main drug Effective site lung deposition rate. The specific test results are shown in the following table. From the results, it can be seen that the samples of Invention Example 1 and Invention Example 2 have better stability than the commercially available products and the comparative example group, and the samples of Invention Example 2 in the process of long-term placement. Stability is the best.

[00...

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Abstract

The invention provides a compound powder inhalation composition of salmeterol xinafoate and fluticasone propionate, which is composed of fluticasone propionate, salmeterol xinafoate and lactose in a certain proportion. Compared with the commercially available Seretide, the compound powder inhalation composition of fluticasone propionate and salmeterol sinafoate has higher lung deposition rate, and shows good stability through accelerated stability test.

Description

Technical field: [0001] The invention relates to a compound powder inhalation composition of a glucocorticoid hormone and a long-acting β2 receptor agonist, in particular to a compound powder inhalation composition of salmeterol xinafoate and fluticasone propionate. It belongs to the field of pharmaceutical technology. Background technique: [0002] Dry powder inhalers (dry powder inhalers, DPI), also known as inhalation powder aerosols, are new dosage forms developed on the basis of quantitative inhalation aerosols and the knowledge of powder engineering. It is a drug delivery system that disperses the micronized drug alone or mixed with a carrier, through a special drug delivery device, and through the active inhalation of the patient, so that the drug is dispersed into a powder mist and enters the respiratory tract to exert local or systemic effects. In recent years, dry powder inhalers have developed rapidly due to their advantages of targeting, high efficiency, quick-a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/56A61K9/72A61K47/26A61P11/00A61K31/137
CPCA61K47/26A61K9/0075A61K31/137A61K31/56A61K2300/00
Inventor 李静王淑丽韩昆颖金玉鑫
Owner TIANJIN JINYAO GRP