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Riluzole sustained-release oral-administration suspension

A technology of oral suspension and riluzole, which is applied in the directions of liquid delivery, emulsion delivery, and drug combination, etc., can solve the problems of poor compliance of administration and too frequent administration.

Inactive Publication Date: 2020-07-24
BEIJING VENTUREPHARM BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The marketed dosage forms of riluzole include tablets, capsules, and oral suspensions. Oral solid preparations have poor drug compliance for people who need long-term medication and have dysphagia
However, ordinary oral suspension is administered twice a day, which is too frequent for ALS patients

Method used

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  • Riluzole sustained-release oral-administration suspension
  • Riluzole sustained-release oral-administration suspension
  • Riluzole sustained-release oral-administration suspension

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] prescription composition

[0026]

[0027] Preparation Process:

[0028] (1) Dissolving riluzole in ethyl cellulose aqueous dispersion, wherein the solid content ratio of riluzole to ethyl cellulose aqueous dispersion is 1:3, and spray drying to prepare ethyl cellulose microspheres;

[0029] (2) Weigh the prescription amount of xylitol, acesulfame potassium, citric acid and sodium citrate and dissolve in a certain amount of solvent to obtain a solution containing diluent, flavoring agent and buffer;

[0030] (3) Weigh the prescribed amount of xanthan gum, sodium benzoate and riluzole sustained-release microspheres, and disperse them in a certain amount of solvent to obtain a suspension containing suspending agents, preservatives and active ingredients;

[0031] (4) Mix the above solution with the suspension and stir thoroughly, and dilute to the mark with the remaining solvent.

Embodiment 2

[0033] prescription composition

[0034]

[0035] Preparation Process:

[0036] (1) Dissolving riluzole in ethyl cellulose aqueous dispersion, wherein the solid content ratio of riluzole to ethyl cellulose aqueous dispersion is 1:1, and spray drying to prepare ethyl cellulose microspheres;

[0037] (2) Dissolve the prescription amount of xylitol, sucralose, citric acid and sodium citrate in a certain amount of solvent to obtain a solution containing diluent, flavoring agent and buffer;

[0038] (3) Weigh the prescribed amount of sodium carboxymethylcellulose, sodium benzoate and riluzole sustained-release microspheres, and disperse them in a certain amount of solvent to obtain a suspension containing suspending agents, preservatives and active ingredients;

[0039] (4) Mix the above solution with the suspension and stir thoroughly, and dilute to the mark with the remaining solvent.

Embodiment 3

[0041]

[0042] Preparation Process:

[0043] (1) Dissolving riluzole in ethyl cellulose aqueous dispersion, wherein the solid content ratio of riluzole to ethyl cellulose aqueous dispersion is 1:2, and spray drying to prepare ethyl cellulose microspheres;

[0044] (2) Dissolve the prescription amount of mannitol, aspartame, citric acid and sodium citrate in a certain amount of solvent to obtain a solution containing diluent, flavoring agent and buffer;

[0045] (3) Weigh the prescribed amount of xanthan gum, ethylparaben and riluzole sustained-release microspheres, and disperse them in a certain amount of solvent to obtain a suspension containing suspending agents, preservatives and active ingredients;

[0046] (4) Mix the above solution with the suspension and stir thoroughly, and dilute to the mark with the remaining solvent.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and discloses a Riluzole sustained-release oral-administration suspension. The Riluzole sustained-release oral-administration suspension is used for simultaneously solving problems in smooth release of drugs and compliance of drug administration of people suffering from dysphagia such as the elderly and children. The disclosed sustained-release suspension is prepared through dispersing Riluzole sustained-release microspheres in a solution containing a diluent, a flavoring agent, a suspending agent, a preservative and apH buffering agent, wherein the Riluzole sustained-release microspheres are prepared through dissolving Riluzole in an aqueous dispersion of ethyl cellulose and carrying out spray drying. Compared with common tablets, capsules and oral-administration suspensions on the market at present, the Riluzole sustained-release oral-administration suspension disclosed by the invention has the advantages that drug release is smooth, the number of times of drug administration is reduced, the quality is stable, the mouth feel is good, the compliance of drug administration is high, and the Riluzole sustained-release oral-administration suspension is applicable to the people suffering from the dysphagia such as the elderly and the children.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a sustained-release oral suspension of riluzole with sustained-release effect, which has stable drug release and good taste, and is suitable for administration to people with dysphagia such as the elderly and children. Background technique [0002] Riluzole is a glutamate antagonist, which can inhibit the release of neurotransmitters in the brain, inhibit glutamatergic synaptic transmission, and inhibit the production of γ-aminobutyric acid (GABA), dopamine, and glutamic acid. Reuptake; it can also significantly inhibit the activity of excitatory amino acids; it can stabilize the inactivation state of voltage-dependent sodium channels and has obvious neuroprotective effects. It is mainly used for the treatment of motor neuron diseases and for the treatment of muscular atrophy spinal cord Medicines for lateral sclerosis (ALS, also sometimes called L...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/428A61K47/36A61K47/38A61K9/16A61P25/00A61P21/00
CPCA61K31/428A61K9/0056A61K9/10A61K47/36A61K47/38A61K9/1652A61P25/00A61P21/00
Inventor 赵宇巍王宇杰
Owner BEIJING VENTUREPHARM BIOTECH
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