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TPGS micelle oral liquid containing gabapentin compound and preparation method of TPGS micelle oral liquid

The technology of micellar oral liquid and gabapentin is applied in the direction of medical preparations containing active ingredients, medical preparations with inactive ingredients, and pharmaceutical formulas, which can solve the problems of short validity period and achieve the reduction of lactam formation and masking Bitter taste, effect of improving compliance

Pending Publication Date: 2022-04-12
江苏百奥信康医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disclosed stability test results of gabapentin preparations after adding amino acids show that the lactam impurity has increased to 0.3% in 12 months at room temperature, indicating that its validity period is still relatively short

Method used

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  • TPGS micelle oral liquid containing gabapentin compound and preparation method of TPGS micelle oral liquid
  • TPGS micelle oral liquid containing gabapentin compound and preparation method of TPGS micelle oral liquid
  • TPGS micelle oral liquid containing gabapentin compound and preparation method of TPGS micelle oral liquid

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Gaboba Spirit Laurel Subto Micell Oral Liquid

[0029] Step 1 Complex Preparation: 20.0 g (0.1 mol) of lauric acid and 5 g (0.03 mol) gabetry were fully dissolved in 50 ml dimethyl sulfoxide, and the room temperature was allowed to stand for 3 days, i.e., Gabba-biling lauric acid complex solution.

[0030]Step 2 Composite micelle prepares: 50.0 g of polyethylene glycol 1000 vitamin E succinate in the gabbar sputum lauric acid composite solution, after which dimethyl sulfoxide is removed from the dialysis apparatus to obtain a drug micelle solution.

[0031] Step 3 Composite micelle olet oral is prepared: referred to the xylitol 25g, orange fragrance 0.05 g, potassium sorbate 0.1 g, dissolved in purified water 150 ml, and slowly mixed with step 2 under stirring The drug micelle solution is mixed evenly, and the polyethylene glycol 1000 vitamin E succinate gum is obtained by filtration to 200 mL, filtration, and filling.

Embodiment 2

[0032] Example 2: Gabobajikutic Composite Micell Oral Liquid

[0033] Step 1 Complex Preparation: 4.5 g (0.03 mol) of octanoic acid and 5 g (0.03 mol) gabetry is fully dissolved in 100 ml of acetone mixing liquid, and about 40 ° C for 1 day, i.e., gabbar sputum complex solution.

[0034] Step 2 Complex micelle prepares: 50.0 g of polyethylene glycol 1000 vitamin E succinate in the gabbar butty acid composite solution of the above step 1, and the solution is reduced by a solution in a solution in a cylinder bottle to obtain a uniform film. The addition of 100 ml of purified water was added, and the hydration was rotated in a water bath in the 37 ° C to obtain a drug micelle solution.

[0035] Step 3 Complex micelle olet oral hydrolysis: 20g of sorbitol, 0.01 g of banana flavor, 0.1 g of Nepo golden methyl ester, dissolved in 50 ml of purified water, stirred, slowly add the drug obtained in step 2 In the micelle solution, mix evenly, set to 200 mL, filtered, filling, and filling the...

Embodiment 3

[0036] Example 3: Gaboba sputum oleic acid composite micelle oral liquid

[0037] The complex of step 1 was prepared: 45.7 g (0.15 mol) of sodium oleate and 5 g (0.03 mol) gabetry were added to 100 ml of water well, and the solution solution pH to 3 to 6 of hydrochloric acid was transferred with a magnetic stirring of about 20 ° C. The core of the coabetry oleic acid complex solid.

[0038] Step 2 Composite micelle preparation: Step 1 from the elutable oleic acid complex and 50.0 g of polyethylene glycol 1000 vitamin E succinate, add 100 ml of water to 37 ° C ultrasonic hydration, and mixture is obtained Solution.

[0039] Step 3 Composite micelle oral is prepared: 10g of erythritol 10g, strawberry flavor 0.01 g, sodium benzoate 0.1 g to dissolve in 50 ml of purified water, stirred, slowly add the mixture of step 2 to the mixture of step 2 , Mix evenly, set to 200 mL, filtrate, and fill the micelle oral fluid of the Gabobarn-bipped complex.

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Abstract

The invention relates to TPGS micelle oral liquid containing a gabapentin compound. The gabapentin compound is prepared from gabapentin and fatty acid or prepared from gabapentin, fatty acid salt and hydrochloric acid. The prepared TPGS micelle oral liquid containing the gabapentin compound can effectively reduce generation of condensation compound lactam in gabapentin molecules, improves drug stability, masks bitter taste of gabapentin, and improves compliance of patients.

Description

Technical field [0001] The present invention relates to a composition comprising gabobarrow and a method of producing a TPGS micelle oral liquid containing a gabobarn-bipped complex, which is a pharmaceutical preparation. Background technique [0002] Gabobarrow is a gamma-aminobutyric acid (GABA) receptor agonist, earliest successfully developed by Pfizer, clinical mainly used to treat peripheral neuralgia and adjuvant treatment limitations partial epilepsy, can also be used to treat pain (such as belt Brazola after skin pain) and anxiety. The molecular structure formula of the gabapentia is as follows: [0003] [0004] Gaba spun has been launched in several countries and regions, and the listing dosage form mainly has tablets and oral solutions. Baboba sputum is easily soluble in water, but the additional difficulty in the preparation of oral liquid preparations of the Gabba sputum: (1) The mouthfeel in the gabapentium is very bitter; (2) there is a primary amino group and a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K9/08A61K31/196A61K47/54A61K47/22A61P25/02A61P25/10A61P25/00A61P25/22
Inventor 陈再新葛育红滕厚雷朱峰李春艳俞宁浦肖旭华
Owner 江苏百奥信康医药科技有限公司
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