Freeze-dried preparation containing methylcobalamin and process for producing the same

A technology for methyl vitamins and freeze-dried preparations, which is applied in the directions of medical preparations containing active ingredients, medical preparations without active ingredients, and freeze-dried delivery, etc. Storage stability and other issues, to achieve the effect of excellent stability over time

Active Publication Date: 2006-06-07
EISIA R&D MANAGEMENT CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, since the water injection needs to be dissolved in ethanol, physiological saline or buffer solution, 15-50ml / ampule of methyl vitamin B 12 solution, so it is pointed out that the aqueous injection has the problems of ensuring light stability and storage stability, as well as sterility

Method used

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  • Freeze-dried preparation containing methylcobalamin and process for producing the same
  • Freeze-dried preparation containing methylcobalamin and process for producing the same
  • Freeze-dried preparation containing methylcobalamin and process for producing the same

Examples

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manufacture example 1

[0091] As one embodiment of the preparation method of the freeze-dried preparation of the present invention, based on the mixing ratio described later, an excipient composed of a mixture of sucrose and mannitol and vitamin B methyl 12 A raw material solution was prepared together, and it was prepared by the following freeze-drying method.

[0092] 0.5% (w / v) methyl vitamin B 12 (trade name Methycobal: manufactured by Eisai Co., Ltd.) and 2.5% (w / v) excipient mixture were mixed to prepare a raw material solution, which was sterile-filtered and aseptically dispensed into each vial in an accurate amount for lyophilization. . After freeze-drying, stopper completely, make the vitamin B containing methyl of the present invention 12 freeze-dried preparations.

[0093] Specifically, put the amount according to the mixing ratio of sucrose and mannitol shown in Figure 1 into a 100ml beaker, add 80ml of distilled water for injection, and stir it with a magnetic stirrer to dissolve it....

manufacture example 2

[0097] 0.5% (w / v) methyl vitamin B 12 (trade name Methycobal: manufactured by Eisai Co., Ltd.) and 5.0% (w / v) excipient mixture were mixed to prepare a raw material solution, which was subjected to sterile filtration and aseptically dispensed into vials in exact amounts for lyophilization. . After freeze-drying, stopper completely, make the vitamin B containing methyl of the present invention 12 freeze-dried preparations.

[0098] Specifically, put the amount according to the mixing ratio of sucrose and mannitol shown in Figure 2 into a 100ml beaker, add 80ml of distilled water for injection, and stir it with a magnetic stirrer to dissolve it. After confirming that the above excipients are fully dissolved, add 500 mg of methyl vitamin B 12 , Stir, after confirming that it is fully dissolved, use a 100ml volumetric flask to make up to volume, add distilled water to make the total solution volume 100ml.

[0099] Then, the above solution was divided into 18ml vials, 5ml per b...

manufacture example 3

[0102] Next, the mixture of lactose and mannitol as an excipient was based on the mixing ratio shown in Fig. 12 Raw material solutions were prepared together, and lyophilized preparations (Examples 11 and 12) were prepared under the same conditions as in Production Example 1.

[0103] In addition, as Comparative Example 3, a lyophilized preparation containing only mannitol shown in FIG. 3 as an excipient was prepared by the same method.

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Abstract

The present invention provides a freeze-dried preparation containing a high content of methylcobalamin which is highly stable over time and can be used in high-concentration methylcobalamin therapy. Disclosed is the freeze-dried preparation containing methylcobalamin or a pharmacologically acceptable salt thereof and an excipient wherein the excipient is at least in an amorphous state. The freeze-dried preparation according to the present invention is characterized in that when the excipient comprises a sugar and a sugar alcohol, the excipient in the amorphous state is contained in an amount of at least 20% by weight, based on the total weight of the sugar and the sugar alcohol.

Description

technical field [0001] The present invention relates to vitamin B containing methyl as a therapeutic agent for amyotrophic lateral sclerosis 12 High-concentration freeze-dried preparation for injection and preparation method thereof. Background technique [0002] Amyotrophic lateral sclerosis is a disease mainly caused by lesions of the brainstem, spinal cord, and motor neurons, leading to progressive bulbar syndrome, upper motor neuron disorders, and lower motor neuron disorders, also known as ALS (amyotrophic lateralsclerosis), "due to the degeneration and disappearance of motor nerve cells in the spinal cord and brain, clinically leads to generalized muscle atrophy and convulsions, usually after 2 to 3 years, and death due to paralysis of the respiratory muscles", is the so-called difficult A kind of disease. [0003] The cause of amyotrophic lateral sclerosis is still unclear. At present, no fundamental treatment method for the disease has been found, not only can not ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/714A61K9/00A61K9/19A61K47/02A61K47/10A61K47/26A61P25/00
CPCA61K9/0019A61K9/19A61K31/714A61K47/02A61K47/10A61K47/26A61P21/00A61P25/00
Inventor 加藤晃良野村晃子
Owner EISIA R&D MANAGEMENT CO LTD
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