Claims
- 1. A composition useful for making oral dosage forms capable of dissolving in the mouth in less than 40 seconds without the need for conventional super disintegrant and having a friability of less than 1%; wherein the composition comprises drug-containing liquiflash particles and an excipient mass.
- 2. The composition of claim 1, wherein the excipient mass comprises a directly a compressible inorganic salt; a cellulose derivative; or a mixture of a directly compressible inorganic salt and a cellulose derivative.
- 3. The composition of claim 1, wherein the liquiflash particles contain at least one bioaffecting agent and a combination of at least one solubilizer and at least one spheronization aid.
- 4. The composition of claim 2, wherein the mass is formed of about 50% directly compressible inorganic salt and about 50% cellulose derivative.
- 5. The composition of claim 2 wherein the directly compressible inorganic salt is selected from the group consisting of directly compressible dibasic calcium phosphate dihydrate and magnesium aluminum silicate NF.
- 6. The composition of claim 1, wherein the excipient mass comprises a linear polyol.
- 7. The composition of claim 1, wherein the excipient mass comprises a directly compressible polyol.
- 8. The composition of claim 1, wherein the excipient mass comprises manitol; xylitol or a mixture thereof..
- 9. The composition of claim 1, wherein the excipient mass comprises lactose, maltose, sucrose or a mixture thereof.
- 10. The composition of claim 1, wherein the liquiflash particles and the excipient mass are combined in proportions selected such that the active ingredient remains substantially within the microspheres when the composition is compressed to obtain a dosage form having a hardness of 20 to about 50.
- 11. The composition of claim 1, wherein the liquiflash particles are coated.
- 12. The composition of claim 11, wherein the liquiflash particles are coated with at least one taste-masking coating.
- 13. The composition of claim 12, wherein the coating contains at least one cellulosic, acrylic vinylic polymer.
- 14. The composition of claim 12, wherein the coating a polymethacrylate polymer.
- 15. A composition useful for making oral dosage forms capable of dissolving in the mouth in less than 30 seconds and having a friability of less than 1%; wherein the composition comprises drug-containing liquiflash particles and an excipient mass comprising less than 2.5% by weight of a super disintegrant.
- 16. The composition of claim 15, wherein the excipient mass comprises a directly compressible inorganic salt; a cellulose derivative; or a mixture of a directly compressible inorganic salt and a cellulose derivative.
- 17. The composition of claim 15, wherein the liquiflash particles contain at least one bioaffecting agent and a combination of at least one solubilizer and at least one spheronization aid.
- 18. The composition of claim 16, wherein the mass is formed of about 50% directly compressible inorganic salt and about 50% cellulose derivative.
- 19. The composition of claim 15, wherein the directly compressible inorganic salt is selected from the group consisting of directly compressible dibasic calcium phosphate dihydrate and magnesium aluminum silicate NF.
- 20. The composition of claim 15, wherein the excipient mass comprises a linear polyol.
- 21. The composition of claim 15, wherein the excipient mass comprises a directly compressible polyol.
- 22. The composition of claim 15, wherein the excipient mass comprises manitol; xylitol or a mixture thereof..
- 23. The composition of claim 15, wherein the excipient mass comprises lactose, maltose, sucrose or a mixture thereof.
- 24. The composition of claim 15, wherein the liquiflash particles and the excipient mass are combined in proportions selected such that the active ingredient remains substantially within the microspheres when the composition is compressed to obtain a dosage form having a hardness of 20 to 50 N.
- 25. The composition of claim 15, wherein the liquiflash particles are coated.
- 26. The composition of claim 25, wherein the liquiflash particles are coated with at least one taste-masking coating.
- 27. The composition of claim 26, wherein the coating contains at least one cellulosic polymer.
- 28. A composition useful for making oral dosage forms capable of dissolving in the mouth in less than 30 seconds and having a friability of less than 1%; wherein the composition comprises between 5 and 45% by weight of drug-containing liquiflash; between 25.0 and 85.0% of an excipient mass comprising less than 2.5% by weight of a super disintegrant.
- 29. The composition of claim 28, wherein the excipient mass comprises a directly compressible inorganic salt; a cellulose derivative; or a mixture of a directly compressible inorganic salt and a cellulose derivative.
- 30. The composition of claim 28, wherein the liquiflash particles contain at least one bioaffecting agent and a combination of at least one solubilizer and at least one spheronization aid.
- 31. The composition of claim 28, wherein the mass is formed of about 50% directly compressible inorganic salt and about 50% cellulose derivative.
- 32. The composition of claim 31, wherein the directly compressible inorganic salt is selected from the group consisting of directly compressible dibasic calcium phosphate dihydrate and magnesium aluminum silicate NF.
- 33. The composition of claim 28, wherein the excipient mass comprises a linear polyol.
- 34. The composition of claim 28, wherein the excipient mass comprise s a directly compressible polyol.
- 35. The composition of claim 28, wherein the excipient mass comprises lactose, maltose, sucrose or a mixture thereof.
- 36. The composition of claim 28, wherein the liquiflash particles and the excipient mass are combined in proportions selected such that the active ingredient remains substantially within the microspheres when the composition is compressed to obtain a dosage form having a hardness of 20 to about 50.
- 37. The composition of claim 28, wherein the liquiflash particles are coated.
- 38. The composition of claim 37, wherein the liquiflash particles are coated with at least one taste-masking coating.
- 39. The composition of claim 38, wherein the coating contains at least one cellulosic polymer.
- 40. The composition of claim 28, wherein the composition comprises between 5 and 20% by weight of microcrystalline cellulose.
- 41. The composition of claim 40, wherein the composition comprises between 15 and 18% by weight of microcrystalline cellulose.
- 42. The composition of claim 28, wherein the excipient mass comprises manitol; xylitol or a mixture thereof.
- 43. The composition of claim 42, wherein manitol is present at a proportion of between 27.1 and 83.6% by weight of the composition.
- 44. The composition of claim 28, wherein the super disintegrant is present at a proportion of less than 2.2% by weight.
- 45. The composition of claim 28, wherein the super disintegrant is present at a proportion of less than 2.0% by weight.
- 46. The composition of claim 28, wherein the super disintegrant is present at a proportion of less than 1.5% by weight.
- 47. The composition of claim 1, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least three months.
- 48. The composition of claim 15, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least three months.
- 49. The composition of claim 28, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least three months.
- 50. The composition of claim 1, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least six months.
- 51. The composition of claim 15, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least six months.
- 52. The composition of claim 28, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least six months.
- 53. The composition of claim 1, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least one year.
- 54. The composition of claim 15, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least one year.
- 55. The composition of claim 28, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition has a shelf life in a bottle of at least one year.
- 56. The composition of claim 1, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition is capable of packaging employing conventional blister technology.
- 57. The composition of claim 15, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition is capable of packaging employing conventional blister technology.
- 58. The composition of claim 28, wherein the liquiflash particles and the excipient mass are combined in proportions such that the dosage form obtained by compressing the composition is capable of packaging employing conventional blister technology.
zolpidem; tevenen; Cox-2 inhibitor; Ace inhibitor; and a calcium channel blocker.
- 59. The composition of claim 1, wherein the liquiflash particles contain an active ingredient selected from the group consisting of fluoxetine; paroxetine; zolpidem; tevenen; Cox-2 inhibitor; Ace inhibitor; and a calcium channel blocker.
- 60. The composition of claim 15, wherein the liquiflash particles contain an active ingredient selected from the group consisting of fluoxetine; paroxetine; zolpidem; tevenen; Cox-2 inhibitor; Ace inhibitor; and a calcium channel blocker.
- 61. The composition of claim 28, wherein the liquiflash particles contain an active ingredient selected from the group consisting of fluoxetine; paroxetine; zolpidem; tevenen; Cox-2 inhibitor; Ace inhibitor; and a calcium channel blocker.
- 62. The composition of claim 1, wherein the liquiflash particles contain an active selected from the group of active agents consisting of antitussives, antihistamines, decongestants, alkaloids, mineral supplements, laxatives, vitamins, antacids, ion exchange resins, anti-cholesterolemics, anti-lipid agents, antiarrhythmics, antipyretics, analgesics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, anti-infectives, psycho-tropics, antimanics, stimulants, gastrointestinal agents, sedatives, antidiarrheal preparations, anti-anginal drugs, vasodialators, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, antitumor drugs, anticoagulants, antithromobotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypoglycemic agents, thyroid and antithyroid preparations, diuretics, antispasmodics, uterine relaxants, mineral and nutritional additives, antiobesity drugs, anabolic drugs, erythropoietic drugs, antiasthmatics, cough suppressants, mucolytics, H2-antagonists, anti-uricemic drugs and mixtures thereof.
- 63. A dosage form comprising a composition according to claim 1.
- 64. A dosage form comprising a composition according to claim 15.
- 65. A dosage form comprising a composition according to claim 28.
- 66. A method of for preparing an oral dosage form capable of dissolving in the mouth in less than 40 seconds without the need for conventional super disintegrant and having a friability of less than 1%; wherein the method comprises directly compressing a composition comprising liquiflash particles containing at least one bioaffecting agent and an excipient mass.
- 67. The method of claim 66, wherein the liquiflash particles and the excipient mass are combined in proportions such that the active ingredient remains substantially within the microspheres when the composition is compressed to obtain a dosage form having a hardness of 20 to about 50 or greater.
- 68. The method of claim 66, wherein the excipient mass comprises a directly compressible inorganic salt; a cellulose derivative; or a mixture of a directly compressible inorganic salt and a cellulose derivative.
RELATED APPLICATIONS
[0001] The present application is a continuation in part of U.S. application Ser. No. 09/179,926 filed Oct. 27, 1998, the content of which are hereby incorporated by reference in their entirety.
Continuation in Parts (1)
|
Number |
Date |
Country |
Parent |
09179926 |
Oct 1998 |
US |
Child |
10176135 |
Jun 2002 |
US |