Amhexenoic acid preparation liquid composition
A vigabatrin and liquid technology, which is applied in the direction of drug combination, drug delivery, medical preparations of non-active ingredients, etc., can solve the problems that powders are prone to bacteria, cannot be stored for a long time, and are inconvenient for children to use for a long time
Pending Publication Date: 2022-06-21
SHANGHAI AUCTA PHARMA CO LTD
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- Abstract
- Description
- Claims
- Application Information
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Problems solved by technology
[0004] The present invention solves the problem that the solid powder in the prior art is inconvenient for children to use for a long time after being prepared. The powder is easy to grow bacteria after adding water, is unstable under acidic conditions, and cannot be stored for a long time. Technical problems such as being degraded provide a liquid preparation that is stable in nature, is not prone to bacteria, and is convenient for taking medicine according to children's weight
Method used
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Examples
Experimental program
Comparison scheme
Effect test
Embodiment 1
[0059] Example 1: Accurately weigh 500 mg of vigabatrin, 1 g of sucrose, 1 mg of orange essence, 10 mg of methylparaben, 50 mg of Tween 80, and 30 mg of proanthocyanidin, add the above components to 5 mL of water, and then add 0.2M pH Phosphate buffer = 6.8 was made up to 10 mL.
Embodiment 2-8
[0060] Other Examples 2-8: In a similar manner to Example 1, other configurations except API and buffer are shown in Table 1 below:
[0061] Table 1 Solution compositions of different groups*
[0062]
[0063]
[0064] (*The above examples all contain 5000 mg of vigabatrin acid, which was made up to 100 mL with 0.2M phosphate buffer at pH=6.8)
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The invention discloses an amhexenoic acid preparation liquid composition and also discloses an oral solution prepared from the composition and a diluent, and the solution is suitable for treating CNS diseases, such as patients with resistant epilepsy, complex partial epileptic seizure, secondary systemic epileptic seizure, refractory complex partial seizure and infant spasm. The dosage form capable of being used for multiple times is good in stability, convenience is provided for medical staff, patient compliance is improved, human errors during dosage are reduced, and the medication safety of children and babies is also improved.
Description
technical field [0001] The invention relates to new dosage forms of vigabatrin and its pharmaceutically acceptable salts, isomers, complexes, polymorphs, hydrates and lipids, which are suitable for long-term storage and multiple use. Background technique [0002] vigabatrin is a marketed product in the United States, the generic name is Vigabatrin, and the trade name is Vigabatrin. Developed by Lundbeck Pharma for the treatment of intractable complex partial-onset epilepsy and infantile spasms. There are currently only two dosage forms on the market, oral tablet and powder. Due to the characteristics of the patient population of children and infants, the dosage needs to be adjusted, but it is not convenient to divide the oral tablet, and only the powder can be used for this group of patients. However Before taking the powder, it needs to be prepared into a solution with water, and the liquid is for one-time use. This can result in administration errors, wasted doses, ...
Claims
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Patent Timeline
Login to View More IPC IPC(8): A61K9/08A61K31/198A61K47/02A61K47/06A61K47/10A61K47/12A61K47/22A61K47/26A61K47/32A61K47/36A61K47/38A61P25/00A61P25/08
CPCA61K31/198A61K9/08A61K47/36A61K47/38A61K47/32A61K47/26A61K47/10A61K47/12A61K47/22A61K47/02A61K47/06A61P25/08A61P25/00
Inventor 王众勤李守峰高梦华李博莉段宁宁
Owner SHANGHAI AUCTA PHARMA CO LTD
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