Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1997-03-13
1999-11-30
Lee, Howard C.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 23, 514 53, 514 58, 514474, 514738, A61K 31715, A61K 3134, A61K 31045
Patent
active
059943246
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to a water-soluble vitamin composition and a process for production thereof.
BACKGROUND OF THE INVENTION
For producing tablets containing water-soluble vitamins such as L-ascorbic acid as an active component, a large amount of a binder is required, which limits a L-ascorbic acid content. Many activities have been attempted to produce tablets having a high L-ascorbic acid content and tablets having high mechanical strength (hardness).
For example, in U.S. Pat. No. 3,453,368, 85 to 95% by weight of L-ascorbic acid is mixed with 5 to 15% by weight of modified starch and the mixture is subjected to wet kneading. Then, the resultant mixture is granulated and dried to obtain granules containing L-ascorbic acid, mixed with a lubricant and compressed to obtain tablets containing L-ascorbic acid.
However, according to this method, it is difficult to obtain homogenous granules and fluidity of the granules is not satisfactory. Moreover, tablets prepared using the granules have insufficient mechanical strength (hardness).
In general, tablets need certain mechanical strength (hardness) to prevent breakage and wear during production and marketing steps and use. Then, activities have been attempted to investigate production processes, various excipients, binders, disintegrators and lubricants.
JP-B 58-403 discloses a process for production of L-ascorbic acid granules having excellent compressibility which comprises fluidizing L-ascorbic acid powder which can pass through a 200 mesh sieve in a fluidized bed granulator, while spray-coating the granules with a solution containing about 1 to about 10% by weight of a binder such as a water-soluble, organic solvent-soluble cellulose material to obtain granules containing about 2 to about 4% by weight of the binder. This patent also discloses a process for producing a pharmaceutical preparation which comprises mixing a lubricant with the above-obtained L-ascorbic acid granules and compressing the resultant mixture into a tablet.
JP-B 61-21526 discloses granules for tablets having a specific distribution of particle size comprising about 98:5 to 99.5% by weight (dry matter) of sodium L-ascorbate and a binder such as a water-soluble, organic solvent-soluble as cellulose material, and a tablet using the granules.
JP-B 5-66928 discloses granules for tablets having a specific distribution of particle size, wherein soluble polyvinyl pyrrolidone and ascorbic acid are used, and there is disclosed that a tablet having a high disintegration rate is obtained.
OBJECTS OF THE INVENTION
Strength of tablets can be improved to some extent according to the above conventional techniques for improving mechanical strength (hardness) of tablets. However, it is yet insufficient. Moreover, tablets having relatively higher mechanical strength (hardness) tend to have longer disintegration time.
Then, an object of the present invention is to provide a water-soluble vitamin composition having an excellent tablet properties from which a tablet having higher mechanical strength (hardness) in comparison with conventional tablets and having excellent disintegration properties, i.e. having a high disintegration rate can be obtained. The present invention also provides a process for production of the composition.
SUMMARY OF THE INVENTION
In view of the above circumstances, the present inventors have studies intensively. As a result, the present inventors have found that compression molding properties can be improved by using a certain additive without increasing the amount of a binder and that, although a concentration of a spray solution for granulation becomes higher, its viscosity does not increase, thereby granulation can be done in a period almost same as that prior to addition of the additive. The present inventors have further studied and have completed the present invention.
That is, the present invention provides a water-soluble vitamin composition which comprises about 90 to 99.8% by weight of a water-soluble vitamin, a polymer binder, an
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Ashida Hiroshi
Izutsu Daisuke
Yamashita Akio
Lee Howard C.
Takeda Chemical Industries Ltd.
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