Claims
- 1. A direct tableting auxiliary consisting essentially of an intimate mixture of
- (A) from 88 to 96% by weight of a pulverulent carrier pharmaceutically acceptable for use in the preparation of tablets, said carrier consisting of lactose, or an amount of lactose together with not more than the same amount of mannitol or calcium phosphate as another carrier,
- (B) from 2 to 6% by weight of a binder selected from the group consisting of polyvinylpyrrolidone having a K value of from 20 to 40, hydroxypropylmethylcellulose, hydroxypropylcellulose and gelatine and
- (C) from 2 to 10% by weight of tablet disintegrating agent selected from the group consisting of crosslinked, insoluble polyvinylpyrrolidone, crosslinked carboxymethylcellulose, crosslinked carboxylmethyl starch and formaldehyde casein, all percentages being based on the direct tableting auxiliary,
- said auxiliary having a particle size distribution of from about 50 to 500 .mu.m.
- 2. The direct tableting auxiliary of claim 1, wherein the binder B is polyvinylpyrrolidone having a K value of from 20 to 40.
- 3. The direct tableting auxiliary of claim 1, wherein the tablet disintegrating agent C is crosslinked insoluble polyvinylpyrrolidone.
- 4. The direct tableting auxiliary of claim 1 which contains from 2 to 5% of polyvinylpyrrolidone having a K value of 20 to 40 as the binder B and from 3 to 6% of crosslinked insoluble polyvinylpyrrolidone as the tablet disintegreting agent C.
- 5. A direct tableting auxiliary consisting essentially of an intimate mixture of
- (A) from 88 to 96% by weight of a pulverulent carrier pharmaceutically acceptable for use in the preparation of tablets, said carrier consisting of lactose, or an amount of lactose together with not more than the same amount of mannitol or calcium phosphate as another carrier,
- (B) from 2 to 6% by weight of a binder selected from the group consisting of polyvinylpyrrolidone having a K value of 20 to 40, hydroxypropylmethylcellulose, hydroxypropylcellulose and gelatine and
- (C) from 2 10% by weight of tablet distinge-disintegrating agent selected from the group consisting of crosslinked insoluble polyvinylpyrrolidone, crosslinked carboxymethylcellulose, crosslinked carboxymethyl starch and formaldehyde casein, all percentages being based on the direct tableting auxiliary,
- said direct tableting auxiliary being prepared by spray granulation, wet granulation or spray drying a mixture of components A, B and C.
- 6. The direct tableting auxiliary of claim 5, wherein the binder B is polyvinylpyrrolidone having a K value of from 20 to 40.
- 7. The direct tableting auxiliary of claim 5, wherein the tablet disintegrating agent C is crosslinked insoluble polyvinyl pyrrolidone.
- 8. The direct tableting auxiliary of claim 5, which has a particle size distribution of from 50 .mu.m to 500 .mu.m.
- 9. The direct tableting auxiliary of claim 5, prepared by spray granulation wherein a dry mixture of component A and component C is spray granulated with a solution of component B in a fluidized bed.
- 10. The direct tableting auxiliary of claim 5, prepared by wet granulation wherein a dry mixture of component A and component C is mixed with a solution of component B and the resulting wet mixture of components A, B and C are passed through at least one sieve and then dried.
- 11. The direct tableting auxiliary of claim 5, prepared by spray drying wherein components A and B are dissolved and suspended in an aqueous solution, component C is added to the suspension of components A and B and the resulting suspension or components A, B and C are spray dried.
- 12. A pharmaceutical tablet comprising a pharmaceutically active ingredient and the direct tableting auxiliary of claim 5.
- 13. A process for preparing a direct tableting auxiliary comprising spray drying, spray granulation or wet granulation of an intimate mixture consisting essentially of
- (A) from 88 to 96% by weight of a pulverulent carrier pharmaceutically acceptable for use in the preparation of tablets, said carrier consisting of lactose, or an amount of lactose together with not more than the same amount of mannitol or calcium phosphate as another carrier,
- (B) from 2 6% by weight of a binder selected from the group consisting of polyvinylpyrrolidone having a K value of 20 to 40, hydroxypropylmethylcellulose, hydroxypropylcellulose and gelatine and
- (C) from 2 to 10% by weight of tablet distintegrating agent selected from the group consisting of crosslinked insoluble polyvinylpyrrolidone, crosslinked carboxymethylcellulose, crosslinked carboxymethyl starch and formaldehyde casein, all percentages being based on the direct tableting auxiliary.
- 14. The process of claim 13, wherein a dry mixture of component A and component C is spray granulated with a solution of component B in a fluidized bed.
- 15. The process of claim 13, wherein a dry mixture of component A and component C is mixed with a solution of component B and the resulting wet mixture of components A, B and C are passed through at least one sieve and then dried.
- 16. The process of claim 13, wherein components A and B are dissolved and suspended in an aqueous solution, component C is added to the suspension of components A and B and the resulting suspension of components A, B and C are spray dried.
Priority Claims (1)
Number |
Date |
Country |
Kind |
3505433 |
Feb 1985 |
DEX |
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Parent Case Info
This application is a continuation of application Ser. No. 826,094, filed on Feb. 6, 1986 now abandoned.
US Referenced Citations (2)
Number |
Name |
Date |
Kind |
4353887 |
Hess et al. |
Oct 1982 |
|
4681755 |
Colombo et al. |
Jul 1987 |
|
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Country |
2126810 |
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DEX |
3012136 |
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DEX |
908016 |
Oct 1962 |
GBX |
1391554 |
Apr 1975 |
GBX |
Non-Patent Literature Citations (4)
Entry |
Kornblum et al. (1973) Journal of Pharmaceutical Sciences 62 (1):43-49. |
Kamp et al. (1983) Pharmaceutisch Weekblad Scientific Edition 5:165-171. |
Voight (1975) Lehrbuch der pharmazutischen Technologie, p. 188, Section 8.5.9. |
Pharmacopoea Danica (1948) 9th Edition, p. 82. |
Continuations (1)
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Number |
Date |
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Parent |
826094 |
Feb 1986 |
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