Solid dispersion composition as well as preparation method and application thereof

A technology of solid dispersion and composition, which is applied in the direction of drug combinations, active ingredients of heterocyclic compounds, medical preparations of non-active ingredients, etc., can solve the problems of taste masking of the undisclosed dextromethorphan quinidine composition, and achieve Satisfy the requirements of finished medicine, improve the experience of medication, and the effect of low cost

Active Publication Date: 2022-05-24
BEIJING JITAI PHARM TECH CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above two taste-masking related documents do not disclose the taste-masking of the dextromethorphan quinidine composition.

Method used

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  • Solid dispersion composition as well as preparation method and application thereof
  • Solid dispersion composition as well as preparation method and application thereof
  • Solid dispersion composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Dextromethorphan hydrobromide, quinidine sulfate and polymer carrier dissolved in ethanol to prepare a solution of 5mg / mL, Pipette 0.2 mL of polymer carrier solution into the wells of the high-throughput experimental apparatus, and then aspirate 0.1 mL of dextromethorphan hydrobromide solution and 0.1 mL of quinidine sulfate solution respectively and add them to the wells containing the polymer carrier solution, shake on the high-throughput instrument, place the well plate in a vacuum oven to dry, respectively, to obtain a solid dispersion of dextromethorphan hydrobromide containing a polymer carrier and a solid dispersion of quinidine sulfate containing a polymer carrier.

[0031] The prepared solid dispersion was added to 0.5 mL of water, 100 μL of the solution was aspirated at 60s, diluted after centrifugation, and the detection sample was obtained. The solubility of the sample was measured to obtain a solubility (μg / mL) of a solid dispersion containing different polymer...

Embodiment 2

[0036]Weigh dextromethorphan hydrobromide and quinidine sulfate respectively added utchi L100-55 and an appropriate amount of ethanol, stirred, sonicated until dissolved and clarified, sprayed dry in the spray dryer, after the end of the collection of samples into a glass bottle, placed in a vacuum drying box to dry, respectively to obtain dextromethorphan hydrobromide solid dispersion and quinidine sulfate solid dispersion.

[0037] According to the above method, prepare solid dispersions of different ratios of dextromethorphan or quinidine and utchi L100-55 ratios, and investigate the dissolution of different proportions of solids in pH 1.2 sodium chloride buffer (37 °C), the results are shown in Table 2 below.

[0038]

[0039] The results show that with the increase of the proportion of polymer materials, the dissolution of dextromethorphan and quinidine increased first and then decreased. When the mass ratio of the polymer carrier to dextromethorphan hydrobromide is 1:1, an...

Embodiment 3

[0044]Dextromethorphan hydrobromide, quinidine sulfate, and Utechi L100-55 were dissolved in ethanol, respectively, and prepared into a solution of 20mg / mL, and the pore-causing agent was dissolved in ethanol to prepare a solution of 10mg / mL. Take the same volume of Yutechi L100-55 solution, dextromethorphan hydrobromide solution or quinidine sulfate solution to the wells of the high-throughput experimental device, add different volumes of porosity solutions, oscillate on the high-throughput instrument, and dry the well plates in a vacuum oven to obtain dextromethorphan hydrobromide solid dispersions and quinidine sulfate solid dispersions with different pore-causing agent contents. Using different porous agents, the resulting solid dispersions are shown in Table 4 below.

[0045]

[0046] Using the method of artificial taste in Example 1, each solid dispersion is tasted. The bitterness, numbness, sourness, sweetness, dryness, and grit sensation of solid dispersions are evaluate...

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PUM

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Abstract

The invention discloses a dextromethorphan quinidine solid dispersion composition as well as a preparation method and an application of the dextromethorphan quinidine solid dispersion composition. According to the dextromethorphan and quinidine solid dispersion and the preparation method thereof, the dextromethorphan and quinidine solid dispersion prepared by using the dextromethorphan and quinidine solid dispersion are basically insoluble in an oral cavity and have a good dissolution effect in a gastric juice environment by adding a proper high-molecular carrier and a proper pore-foaming agent, so that the technical effects that the dextromethorphan and quinidine have a good taste modifying effect while the drug dissolution requirement is met are achieved. The dextromethorphan quinidine solid split composition can be easily prepared into various oral preparations easy to swallow, the problem that patients suffering from nervous system diseases are difficult to swallow is solved, and the medication experience can be greatly improved.

Description

Technical field [0001] The present invention relates to the field of pharmaceutical formulations, specifically to a composition comprising a dextromethorphan solid dispersion and a quinidine solid dispersion thereof and a preparation method and application thereof. Background [0002] Dextromethorphan hydrobromide and quinidine sulfate are a combination drug for the treatment of pseudolunar mood (PBA) developed by Avanir Pharmaceuticals Inc. and were first approved for marketing by the FDA in October 2010. The drug was the first and only drug used to treat PBA, also known as emotional incontinence, mainly secondary to neurological diseases such as Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis of the spinal cord, and stroke, characterized by sudden involuntary crying or laughing. [0003] Dextromethorphan and quinidine have a poor taste, bitter and numb, and are currently available in capsules. Patients with neurological disorders are often accompanied by ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/49A61K9/14A61K47/38A61K47/32A61K47/20A61K47/10A61K47/12A61P25/00A61P25/28A61K31/485
CPCA61K31/485A61K31/49A61K9/146A61K9/145A61P25/00A61P25/28
Inventor 裘少君乐涯李海燕赖才达王文首
Owner BEIJING JITAI PHARM TECH CO LTD
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