Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1995-11-28
1999-03-23
Woodward, Michael P.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424489, 424 942, A61K 920, A61K 3854
Patent
active
058856188
DESCRIPTION:
BRIEF SUMMARY
This application claims priority of DK 0719/93 filed 18 Jun., 1993 under 35 U.S.C. 119 and priority of PCT/DK94/00237 under 35 U.S.C. 120.
FIELD OF INVENTION
This invention relates to a directly compressible enzyme powder useful for producing enzyme-containing tablets. It also relates to a process for the preparation of such a powder and to a tablet prepared from such a powder.
BACKGROUND OF THE INVENTION
In the art of tablet technology tablets are often made from a spray-dried powder containing an active component which after spray-drying and prior to tabletting is mixed with one or more components (for example flow-aids) needed for tabletting to take place. Flow-aids are added in order to make the powder for tabletting free-flowing. Free-flowing means that the powder may be poured through a hopper without caking or sticking to the side walls. An example of a typical flow-aid is fumed silicon dioxide.
By using this traditional method the spray-dried powder is normally very dusty and difficult to handle, so there are safety problems by handling them if the active component has an allergy potential. Often this very dusty powder also has to be handled in more than one operation: First the spray-dried powder is mixed with flow-aids as described above, and then a granulation may be needed in order to give the powder the right strength for tabletting.
To overcome these difficulties much effort has been put into developing directly compressible powders which are non-dusting and free-flowing, for instance by spray-drying an emulsion containing a vitamin, a carbohydrate and a gelatin (see U.S. Pat. No. 4,892,889).
Tablets containing enzymes such as amylases, proteases, lipases, invertases, papain, trypsin, pepsin, pancreatin, etc. have been described long ago (see for instance U.S. Pat. No. 3,515,642). They are made by the conventional methods of converting a freeze-dried or spray-dried powder into tablets.
SUMMARY OF THE INVENTION
In accordance with this invention, it has surprisingly been found that a directly compressible enzyme powder may be produced by mixing a liquid enzyme preparation with a suitable carrier, using the principle of wet granulation, whereby the step of freeze-drying and spray-drying is avoided. The resulting enzyme powder has extraordinary good compression qualities and may directly be tabletted.
Accordingly, in a first aspect the present invention relates to a directly compressible powder, which comprises a carbohydrate and an enzyme. In a second aspect the invention relates to a process for the preparation of such a powder and to a tablet prepared from such a powder.
DETAILED DISCLOSURE OF THE INVENTION
According to this invention the directly compressible powder comprises a carrier of carbohydrate(s) and one or more enzymes.
In the present context a directly compressible powder is a powder which may be directly tabletted without adding any excipients except possibly a lubricant. This means that no flow-aids and binders are added before tabletting, but a lubricant such as stearic acid, hydrogenated vegetable oil or Mg stearate may be added, if necessary.
In order to make the powder directly compressible the demands made on the carrier are quite large: It has to be a material with plastic properties (so that the resulting tablet does not fall apart before use), on the other hand, when the tablet is used the carrier must be able to absorb liquid and make the tablet disintegrate. Moreover, as the powder is directly compressible, the powder should be free-flowing, which means that no flow-aids need to be added before tabletting. Lastly, as the resulting tablet may be ingested by humans, the carrier should preferably be non-toxic.
In order to make the powder directly compressible the water content of the powder may be of at the most 10% (w/w), preferably in the range of 3-5% (w/w), and the particles of the powder may be in the range from 50 to 1500 .mu.m, preferably in the range from 125 to 1000 .mu.m, more preferably in the range from 150 to 700 .mu.m.
Some carbohydrates or mixture
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patent: 4551177 (1985-11-01), Trubiano et al.
Johnson, K., "Beano-Reducing the Flatulence Factor", East West Natural Health, vol. 22, No. 1, p. 143(3), Feb. 1992.
Abstract JP 4008288, Jan. 13, 1992.
Abstract DE 2140747, Aug. 13, 1971.
Abstract SU 1024087, Jun. 23, 1983.
JP 62-269685, Nov. 24, 1987.
Knap Inge Helmer
Knudsen Breian
Agris, Esq. Cheryl H.
Brumback Brenda G.
Novo Nordisk A S
Woodward Michael P.
Zelson Esq. Steve T.
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