Oral medicament combination of carbamazepine

A carbamazepine and composition technology, applied in the field of hard capsule or soft capsule preparation, can solve the problems of narrow therapeutic window, slow absorption, toxic and side effects, etc., and achieve high bioavailability, reduce toxic and side effects, and good dissolution effect

Inactive Publication Date: 2012-07-04
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Carbamazepine is almost insoluble in water (113μg / ml, 25°C), has polymorphic forms, and different crystalline forms have different dissolution rates in the gastrointestinal tract, so the drug is slowly and irregularly absorbed in the gastrointestinal tract after oral administration , individual differences in blood concentration are large, and the therapeutic window is narrow (4 ~ 12μg / ml), prone to toxic and side effects

Method used

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  • Oral medicament combination of carbamazepine
  • Oral medicament combination of carbamazepine
  • Oral medicament combination of carbamazepine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1. Carbamazepine pharmaceutical composition of the present invention (soft capsule or hard capsule preparation) composition and preparation

[0027] Ingredient amount / grain

[0028] Carbamazepine 50mg

[0029] Caprylic / Capric Glycerides 200mg

[0030] 1,2-Propanediol 150 mg

[0031] Tween 60 200mg

[0032] Hydroxypropyl Methyl Cellulose 10mg

[0033] Preparation:

[0034] The above-mentioned caprylic acid / glyceryl caprate, 1,2-propylene glycol, Tween 60 and hydroxypropyl methylcellulose are mixed uniformly to obtain a mixed solution, and the above-mentioned carbamazepine is added to the mixed solution, The pharmaceutical composition of the present invention is obtained, and then the obtained pharmaceutical composition is divided into soft capsules or hard capsules to obtain the soft capsule or hard capsule preparation containing the self-microemulsion of the present invention.

Embodiment 2

[0035] Embodiment 2. Carbamazepine pharmaceutical composition of the present invention (soft capsule or hard capsule preparation) composition and preparation

[0036] Ingredient amount / grain

[0037] Carbamazepine 30mg

[0038] soybean oil 250mg

[0039] Macrogol 400 200mg

[0040] Tween 80 250mg

[0041] Methylcellulose 30mg

[0042] Preparation:

[0043] The above-mentioned soybean oil, polyethylene glycol 400, Tween 80 and methylcellulose are mixed uniformly to obtain a mixed solution, and the above-mentioned carbamazepine is added to the mixed solution to obtain the pharmaceutical composition of the present invention , and then the obtained pharmaceutical composition is divided into soft capsules or hard capsules to obtain the soft capsule or hard capsule preparation containing the self-microemulsion of the present invention.

Embodiment 3

[0044] Embodiment 3. carbamazepine pharmaceutical composition of the present invention (soft capsule or hard capsule preparation) composition and preparation

[0045] Ingredient amount / grain

[0046] Carbamazepine 50 mg

[0047] Oleic and Caprylic / Capric Glycerides 200 mg

[0048] (1:2, w / w) mixture

[0049] Macrogol 400 150mg

[0050] Polyoxyethylene castor oil 200mg

[0051] Polyvinylpyrrolidone 10mg

[0052] Preparation:

[0053] Mix the above-mentioned oleic acid and caprylic acid / capric glyceride (1:2, w / w), polyethylene glycol 400, polyoxyethylene castor oil, and polyvinylpyrrolidone to obtain a mixed solution, and pour the mixed solution Add the above-mentioned carbamazepine to obtain the pharmaceutical composition of the present invention, then the gained pharmaceutical composition is divided into soft capsules or hard capsules to obtain soft capsules or hard capsules containing the self-microemulsion of the present invention.

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Abstract

The invention relates to an oral medicament combination of carbamazepine, containing at most 10% of carbamazepine, and a proper amount of oil, surface active agents, assistant surface active agents and supersaturated matter. The invention also provides a preparation containing the medicament combination, in particular to a soft capsule or a hard capsule. The oral medicament combination of carbamazepine in the invention has high bioavailability so that the oral dosage of the carbamazepine is reduced, and the toxic and side effects are reduced to a certain degree.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a carbamazepine oral pharmaceutical composition, a method for preparing the pharmaceutical composition and a preparation containing the carbamazepine oral pharmaceutical composition, especially a hard capsule or soft capsule preparation. Background technique [0002] Carbamazepine is a clinically commonly used drug with definite curative effect. It is the drug of choice for the treatment of epilepsy, and it is also used for the treatment of trigeminal neuralgia, manic depression and arrhythmia. The existing oral preparations of carbamazepine have tablets and capsules. Carbamazepine is almost insoluble in water (113μg / ml, 25°C), has polymorphic forms, and different crystalline forms have different dissolution rates in the gastrointestinal tract, so the drug is slowly and irregularly absorbed in the gastrointestinal tract after oral administration , large individual diff...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/107A61K9/66A61K31/55A61P25/08
Inventor 全东琴张楠
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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