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Mometasone furoate suspension nasal spray composition

A technology of mometasone furoate and nasal spray, which is applied in drug combination, steroids, and drug delivery, and can solve the problems of not including mometasone furoate nasal spray

Active Publication Date: 2017-10-20
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, the United States Pharmacopoeia does not include standards for mometasone furoate nasal spray

Method used

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  • Mometasone furoate suspension nasal spray composition
  • Mometasone furoate suspension nasal spray composition
  • Mometasone furoate suspension nasal spray composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Invention Example 1 Preparation of Mometasone Furoate Form M

[0038] Dissolve 1 g of commercially available mometasone furoate in 50 ml of acetonitrile, heat until dissolved, then evaporate the solvent, crystals are precipitated, then filter and dry to obtain crystal form M of mometasone furoate.

[0039] The X-ray powder diffraction is determined for the dried crystal, and its X-ray powder diffraction is measured at 2θ=8.1°, 9.8°, 12.0°, 14.6°, 15.0°, 16.4°, 16.7°, 17.3°, 17.9°, 19.7° , There are characteristic peaks at 24.8°, as detailed in the attached instructions image 3 shown. The TG-DTA spectrogram of the prepared mometasone furoate crystalline form M is as detailed in the attached description. Figure 4 shown.

[0040] Take an appropriate amount of mometasone furoate sample, put it in a weighing bottle, spread it into a thin layer with a thickness of ≤5 mm, and carry out the following experiments. The results are shown in Table 1. The content is detected a...

Embodiment 2

[0051] Invention Example 2 Comparative Study on Stability and Preparation Quality of Mometasone Furoate Suspension Nasal Spray

[0052] Table 2 Prescription of mometasone furoate suspension nasal spray

[0053]

[0054] Refer to commercially available mometasone furoate nasal spray Prescription, prepared mometasone furoate crystal form M suspension nasal spray (group A), mometasone furoate monohydrate suspension nasal spray (group B) and mometasone furoate anhydrous crystal form FORM1 suspension Type nasal spray (Group C), and compared for stability. Group A used micronized mometasone furoate crystal form M, and the particle size was D (0.99) = 3.789 μm when detected by a laser particle size analyzer. Group B used micronized mometasone furoate monohydrate, and the particle size was D(0.99)=3.758 μm when detected by laser particle size analyzer. Group C used micronized mometasone furoate anhydrous FORM1, and the particle size was D(0.99)=3.685 μm when detected by laser p...

Embodiment 3

[0067] Invention Example 3 Preparation and Stability Investigation of Mometasone Furoate Crystal Form M Suspension Nasal Spray

[0068] Table 5 Suspension Nasal Spray Prescription

[0069]

[0070]

[0071] The main ingredient contained in Examples 3-1 to 3-10 is mometasone furoate crystal form M, and the dosage is 0.5 g. The preparation method refers to Example 2.

[0072] 3.1 Stability

[0073] Take 10 bottles for each group, store them for 24 months at 30°C±2°C, 60%RH±5%RH relative humidity, and measure the contents at 0, 12 months and 24 months respectively (using mometasone furoate The measured results are shown in Table 6 below; with reference to the particle size determination method in the USP fluticasone propionate nasal spray standard, the particle size of mometasone furoate was detected at 0 o'clock and at the end of 24 months, and the results of the particle size of mometasone furoate are shown in Table 7 below:

[0074]Table 6 Mometasone furoate content in...

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Abstract

The invention discloses mometasone furoate suspension nasal spray composition containing a mometasone furoate crystal form M and a pharmaceutically acceptable carrier. The X-ray powder diffractionof the mometasone furoate crystal form M has characteristic peaks at the diffraction angles 2 theta equal to8.1+ / -0.1 degrees, 9.8+ / -0.1 degrees, 12.0+ / -0.1 degrees, 14.6+ / -0.1 degrees, 15.0+ / -0.1 degrees, 16.4+ / -0.1 degrees, 16.7+ / -0.1 degrees, 17.3+ / -0.1 degrees, 17.9+ / -0.1 degrees, 19.7+ / -0.1 degrees and 24.8+ / -0.1 degrees.

Description

technical field [0001] The invention relates to a mometasone furoate suspension nasal spray. It belongs to the field of pharmaceutical technology. Background technique [0002] The human nasal cavity is an effective organ for the absorption of pharmacologically active ingredients. Since the 1980s, with the continuous improvement of the level of science and technology, new preparations that exert the local or systemic therapeutic effect of pharmacologically active components through nasal mucosa absorption—collectively referred to as the research and development progress of Nasal Drug Delivery System (Nasal Drug Delivery System) fast. [0003] Nasal Spray (Nasal Spray) is a new formulation for nasal administration developed in recent years. The pharmacologically active components and adjuvant solutions (or suspensions) are filled in a container that can be highly atomized and has a precise quantitative valve, and is administered by manual pressure. Nasal spray has the adv...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/58A61P37/08A61P11/02C07J17/00
CPCA61K9/0043A61K9/12A61K31/58C07B2200/13C07J17/00
Inventor 李秀娟周立飞李静
Owner TIANJIN JINYAO GRP
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