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Details for Patent: 5,516,531

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Details for Patent: 5,516,531

Title: Spherical granules having core and their production
Abstract:The spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose, because of their excellent hardness, can be coated further evenly, (e.g. sustained release coating, gastric coating, enteric coating), and at the time the granules are excellent in disintegration.
Inventor(s): Makino; Tadashi (Osaka, JP), Tabata; Tetsuro (Osaka, JP), Hirai; Shin-ichiro (Kyoto, JP)
Assignee: Takeda Chemical Industries, Ltd. (Osaka, JP)
Filing Date:Jun 28, 1994
Application Number:08/266,615
Claims:1. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said low substituted hydroxypropylcellulose, wherein the drug is a drug for the central nervous system, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

2. The spherical granules having a core according to claim wherein the mean particles of the hydroxypropylcellulose diameter is not more than 100 .mu.m.

3. The spherical granules having a core according to claim 1, wherein the drug for the central nervous system is selected from the group consisting of diazepam, idebenone, aspirin, ibuprofen, paracetamol, naproxen, piroxicam, diclofenac, indomethacin, sulindac, lorazepam, nitrazepam, phenytoin, acetaminophen, ethenzamide and ketoprofen.

4. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said low substituted hydroxypropylcellulose, wherein the drug is a drug for the circulatory system, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

5. The spherical granules having a core according to claim 4, wherein the drug for the circulatory system is selected from the group consisting of molsidomine, vinpocetine, propanolol, methyldopa, dipyridamole, furosemide, triamterene, nifedipine, atenolol,spironolactone, metoprolol, pindolol, captopril and isosorbide nitrate.

6. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said low substituted hydroxypropylcellulose, wherein the drug is a drug for the respiratory system, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

7. The spherical granules having a core according to claim 6, wherein the drug for the respiratory system is selected from the group consisting of amlexanox, dextromethorphan, theophylline, pseudoephedrine, salbutamol and guaifenesin.

8. The spherical granules having a core according to claim 1, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 30 .mu.m.

9. The spherial granules having a core according to claim 4, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 100 .mu.m.

10. The spherical granules having a core according to claim 4, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 30 .mu.m.

11. The spherical granules having a core according to claim 6, wherein the mean particle diameter of the hydroxypropylcellulose is more than 100 .mu.m.

12. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said low substituted hydroxypropylcellulose, wherein the drug is an antibiotic or chemotherapeutic agent, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

13. The spherical granules having a core according to claim 12, wherein the antibiotic or chemotherapeutic agent is selected from the group consisting of cephalexin, cefaclor, cefradine, amoxicillin, pivampicillin, bacampicillin, dicloxacillin, erythromycin, erythromycin stearate, lincomycin, doxycycline, trimethoprim and sulfamethoxazole.

14. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said low substituted hydroxypropylcellulose, wherein the drug is a drug for the metabolic system, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

15. The spherical granules having a core according to claim 14, wherein the drug for the metabolic system is selected from the group consisting of serrapeptase, glibenclamide and potassium chloride.

16. Spherical granules having a core coated with spraying powder containing a drug and low substituted hydroxypropylcellulose having an hydroxypropoxy content of about 4-20% and a mean particle diameter of not more than 200 .mu.m, wherein said spraying powder comprises about 20% to about 35% (w/w) of said Low substituted hydroxypropylcellulose, wherein the drug is a vitamin drug, and wherein the spherical granules pass through 12 mesh sieve but do not pass through 32 mesh sieve.

17. The spherical granules having a core according to claim 16, wherein the vitamin drug is selected from the group consisting of vitamin B.sub.1, vitamin B.sub.2, vitamin B.sub.6, vitamin C and fursultiamine.

18. The spherical granules having a core according to claim 6, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 30 .mu.m.

19. The spherical granules having a core according to claim 12, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 100 .mu.m.

20. The spherical granules having a core according to claim 12, wherein the mean particle diameter of the hydroxypropylcellulose is not more than 30 .mu.m.

21. The spherical granules having a core according to claim 14, wherein the mean particle diameter of the hydropropylcellulose is not more than 100 .mu.m.

22. The spherical granules having a core according to claim 14, wherein the mean particle diameter of the hydropropylcellulose is not more than 30 .mu.m.

23. The spherical granules having a core according to claim 16, wherein the mean particle diameter of the hydropropylcellulose is not more than 100 .mu.m.

24. The spherical granules having a core according to claim 16, wherein the mean particle diameter of the hydropropylcellulose is not more than 30 .mu.m.
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