Carglumic acid solid composition and preparation method thereof

A technology of solid composition and carboglutamic acid, which is applied in the direction of drug combination, pill delivery, anti-toxic agent, etc., can solve the poor moisture and heat stability of the raw material drug, easily cause the degradation of the main drug and the production of related substances, and the production process requirements of the preparation Higher problems, to achieve the effect of low environmental requirements, stable and reliable quality, and simple preparation process

Inactive Publication Date: 2015-11-18
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] At present, the marketed product Carboglutamic Acid Tablets adopts the wet granulation tableting method, which has high requirements for the production process of the preparation. Specifically, the raw material drug and auxiliary materials are mixed evenly, and then the binder is added to granulate, sieved and Dry whole granule compression, which involves granulation and drying process, due to the poor moisture and heat stability of the raw material drug, it is easy to cause the degradation of the main drug and the production of related substances

Method used

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  • Carglumic acid solid composition and preparation method thereof
  • Carglumic acid solid composition and preparation method thereof
  • Carglumic acid solid composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0024] Carglutamic acid tablets prescription composition and direct compression method preparation process:

[0025]

[0026] Preparation:

[0027] 1. Pass the carboglutamic acid through a 40-mesh sieve, and set aside;

[0028] 2. Dry the above-mentioned microcrystalline cellulose, croscarmellose sodium, and hypromellose at 60°C for about 2 hours, and pass through a 60-mesh sieve;

[0029] 3. Put carboglutamic acid, dried microcrystalline cellulose, croscarmellose sodium, and hypromellose in a mixer and mix for several minutes until uniform;

[0030] 4. Pass sodium lauryl sulfate and silicon dioxide through a 60-mesh sieve, add to the mixed material in step 3, and continue to mix evenly;

[0031] 5. Sodium stearyl fumarate is passed through a 80-mesh sieve, and added to the mixed material in step 4. After mixing evenly, measure the moisture content; when the moisture content is less than 2%, it is qualified;

[0032] 6. Press the tablet after passing the moisture test, a...

Embodiment 2

[0035] Carglutamic acid tablets prescription composition and direct compression method preparation process:

[0036]

[0037] Preparation:

[0038] 1. Pass the carboglutamic acid through a 40-mesh sieve, and set aside;

[0039] 2. Dry the above-mentioned microcrystalline cellulose, mannitol, sodium carboxymethyl starch, and hydroxypropyl cellulose at 60°C for about 2 hours, and pass through a 60-mesh sieve;

[0040] 3. Put carboglutamic acid and the above-mentioned dried microcrystalline cellulose, mannitol, sodium carboxymethyl starch, and hydroxypropyl cellulose in a mixer and mix for several minutes until uniform;

[0041] 4. Pass sodium lauryl sulfate and poloxamer through a 60-mesh sieve, add to the mixture in step 3, and continue to mix evenly;

[0042] 5. Pass stearic acid through a 80-mesh sieve, add it to the mixed material in step 4, and measure the moisture content after mixing evenly; it is qualified when the moisture content is less than 2%;

[0043] 6. Pres...

Embodiment 3

[0046] Carglutamic acid tablets prescription composition and direct compression method preparation process:

[0047]

[0048]

[0049] Preparation:

[0050] 1. Pass the carboglutamic acid through a 40-mesh sieve, and set aside;

[0051] 2. Dry the above-mentioned microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, and hypromellose at 60°C for about 2 hours, and pass through a 60-mesh sieve;

[0052] 3. Put carboglutamic acid and the above-mentioned dried microcrystalline cellulose, mannitol, cross-linked polyvinylpyrrolidone, and hypromellose in a mixer and mix for several minutes until uniform;

[0053] 4. Pass sodium lauryl sulfate and silicon dioxide through a 60-mesh sieve, add to the mixed material in step 3, and continue to mix evenly;

[0054] 5. Pass the talcum powder through an 80-mesh sieve, add it to the mixed material in step 4, and measure the moisture content after mixing evenly; it is qualified when the moisture content is less than ...

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Abstract

The invention relates to a carglumic acid solid composition for treating hyperammonemia and a preparation method of the composition. The composition includes carglumic acid, one or more of a filling agent, an adhesive, a disintegrating agent, a surfactant, and a lubricant or a flow agent, and is characterized in that microcrystalline cellulose and lauryl sodium sulfate are added to the tablet prescription, so that the problems of tablet disintegration and slow dissolution of the main drug are solved; the tablets are prepared through a direct powder compression method; the preparation method is simple in operating steps, stable in process parameters, and good in repeatability; meanwhile, the impact of damp and hot on the stability of the raw drug materials of carglumic acid is avoided; compared with the original tablets, the tablets provided by the invention are more stable and reliable in product quality, and are suitable for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a carglutamic acid solid composition and a preparation method thereof. Background technique [0002] Carboglutamate is indicated for the treatment of hyperammonemia caused by N-acetylglutamate synthetase (NAGS) deficiency. NAGS deficiency is a very rare genetic disorder that can occur in infants shortly after birth. As a congenital urea cycle disorder, it is likely to cause acute ammonia detoxification loss and eventually death in most cases. In the European Union, the estimated incidence of NAGS deficiency is 0.00125 / 10000. Therefore, as an orphan drug, carboglutamic acid is suitable for the treatment of such diseases. [0003] The urea cycle is the only elimination route for ammonia. In normal mitochondria, N-acetylglutamate (NAG) is an essential conformational activator of carbamyl phosphate synthase (CPS), which can produce the first step substrate o...

Claims

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Application Information

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IPC IPC(8): A61K47/38A61K47/20A61K31/198A61K9/20A61P39/02
Inventor 柯兴发冯小路杨波王彩霞向莹
Owner WUHAN WUYAO SCI & TECH
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