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Drug composition for treating multiple sclerosis

A technology of gel composition and swollen product, which is applied in drug combination, drug delivery, and pharmaceutical formulation, etc. It can solve problems such as secretion and swallowing affecting the effectiveness of oral mucosal pathways, drug taste stimulation affecting compliance, and poor control of drug doses, etc. , to avoid the first-pass effect of the liver, to facilitate self-medication, and to improve skin and mucous membrane permeability

Active Publication Date: 2017-07-07
HYBIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] discloses taking glatiramer acetate through ingestion or inhalation, but the disadvantage is that it cannot avoid the degradation of the drug by gastrointestinal fluid and the first-pass effect of the liver, enzyme metabolism and enzyme degradation
[0015] The disadvantages of oral administration in are the same as in . Although the inhalation method can avoid the high first-pass effect, long-term inhalation administration requires regular inspection of lung physiological conditions
Moreover, glatiramer acetate is a long-term drug, if it is administered continuously, it will easily cause a certain degree of damage to the lungs, and the dosage of the drug is not easy to control, and the usage is troublesome
[0016] Discloses an oral transmucosal drug delivery method, but the involuntary salivary secretion and swallowing in the oral cavity affect the efficacy of the oral mucosal route; the taste stimulation of the drug affects the compliance of the route
[0017] To overcome the burden of existing parenteral administration that may lead to various adverse reactions, poor compliance, or suspension of treatment, an alternative dosing regimen for glatiramer acetate was developed that would allow glatiramer acetate to effectively treat a form of glatiramer acetate. Multiple Sclerosis Symptoms

Method used

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  • Drug composition for treating multiple sclerosis
  • Drug composition for treating multiple sclerosis
  • Drug composition for treating multiple sclerosis

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Glatiramer Acetate Nasal Gel Composition:

[0050]

[0051] The preparation steps of the gel preparation of every 200 grams are:

[0052] (1) Take the gel matrix carbomer of the prescribed amount, add 3 to 5 times the weight of water, stir to make it fully swell, add dropwise sodium hydroxide to adjust the pH value to 7.0 to 8.0, and stir to obtain a gel;

[0053] (2) Separately take the prescribed amount of glatiramer acetate plus 2 to 5 times the weight of water and dissolve it;

[0054] (3) Stir the dextran, glucose, glycerin and EDTA with 2 to 3 times the weight of water to dissolve them;

[0055] (4) Add the solution of step (2) and step (3) to the gel matrix solution of step (1), then add the absorption enhancer 2-hydroxypropyl-β-cyclodextrin, stir well, and then add water to 200g, and stir evenly to obtain the finished gel.

Embodiment 2

[0057]

[0058] The preparation steps of the gel preparation of every 200 grams are:

[0059] (1) Take the gel matrix polyvinyl alcohol of the prescribed amount, add 4 to 7 times the weight of water, add dropwise acetic acid to adjust the pH value to 5.0 to 6.0, and stir to make it fully swell;

[0060] (2) Separately take the prescribed amount of glatiramer acetate plus 2 to 5 times the weight of water and dissolve it;

[0061] (3) Add mannitol, benzalkonium chloride, propylene glycol, and chitin to 1 to 2 times the weight of water and stir to dissolve them;

[0062] (4) Add the solution of step (2) and step (3) to the gel matrix solution of step (1), then add the absorption-promoting agent lecithin, stir evenly, then add water to 200g, stir evenly, and obtain Finished gel. Example 3:

Embodiment 3

[0063] Glatiramer Acetate Nasal Gel Composition:

[0064]

[0065] The preparation steps of the gel preparation of every 200 grams are:

[0066] (1) Weigh the hypromellose of prescription quantity, add the water of 4~7 times by weight, stir while adding, make it fully swell;

[0067] (2) Separately take the prescribed amount of glatiramer acetate plus 2 to 5 times the weight of water and dissolve it;

[0068] (3) Stir sodium chloride, EDTA, glycerin and starch with 3 to 4 times the weight of water to dissolve them;

[0069] (4) Add the solution of step (2) and step (3) to the gel matrix solution of step (1), then add the absorption-promoting agent sodium glycocholate, stir well, then add water to 200g, stir well, that is A finished gel is produced.

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Abstract

The invention relates to a drug composition for treating multiple sclerosis, in particular to a nasal glatiramer acetate gel composition. The drug composition is prepared from glatiramer acetate, gel substrate and pharmaceutically acceptable auxiliary materials, wherein other acceptable auxiliary materials comprise 0.9%-1.75% of bio-adhesive materials, and the bio-adhesive materials are one or more of starch, chitosan, glucan, and xanthan gum.

Description

technical field [0001] The invention relates to a composition for nasal mucosa administration for treating multiple sclerosis syndrome. Background technique [0002] Multiple sclerosis syndrome (Multiple sclerosis, MS) is clinically an autoimmune disease that can occur in the central nervous system of the human body. It is characterized by inflammation of the brain and spinal cord and changes in nerve demyelination. Its incidence rate is not only high in Europe and the United States, but also in our young and middle-aged people (especially those in their thirties). A common disease, the cause of this type of disease is generally related to the body's own immune regulation disorder. [0003] Currently recognized MS clinical classification: [0004] 1. Relapsing remitting MS (RRMS) [0005] The most common course type of MS, 80% of MS patients are this type at the beginning of the onset, showing an obvious relapse and remission process, each attack basically recovers, leavi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K47/36A61K38/16A61P25/00A61P37/02
CPCA61K9/0043A61K9/06A61K38/16A61K47/36A61K38/02
Inventor 戴荣欢李国弢颜携国陶安进袁建成
Owner HYBIO PHARMA
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