Patent
Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms
| العنوان: | Co-processed carbohydrate system as a quick-dissolve matrix for solid dosage forms |
|---|---|
| Patent Number: | 8,545,889 |
| تاريخ النشر: | October 01, 2013 |
| Appl. No: | 11/448523 |
| Application Filed: | June 06, 2006 |
| مستخلص: | The present invention comprises a co-processed carbohydrate system, and formulations produced therefrom, which formulations are directly compressible into solid dosage forms, some of which rapidly and completely dissolve or disintegrate in the oral cavity within 60 seconds. The invention also comprises the solid dosage forms produced by directly compressing the co-processed carbohydrate system, some of which, when placed in the oral cavity, shall dissolve or disintegrate, preferably within about 60 seconds. |
| Inventors: | Norman, Gary T. (Middletown, DE, US); Nuguru, Kalyan S. (Mantua, NJ, US); Amin, Arun F. (Wilmington, DE, US); Chandar, Sarath (Moorestown, NJ, US) |
| Assignees: | SPI Pharma, Inc. (Wilmington, DE, US) |
| Claim: | 1. A non0filamentous particle consisting essentially of at least two co-spray-dried polyols, wherein the at least two co-spray-dried polyols comprises from about 60% to about 99.5% mannitol, and wherein the at least two co-spray-dried polyols comprises mannitol and a second polyol in a ratio of about 99.5:0.5 to about 60:40. |
| Claim: | 2. The particle of claim 1 , wherein said at least two co-spray dried polyols further comprises a polyol selected from the group consisting of sorbitol, maltitol, lactitol, xylitol, erythritol, isomalt, and mixtures thereof. |
| Claim: | 3. The particle of claim 1 , wherein said particle is directly compressible. |
| Claim: | 4. A composition comprising the non-filamentous particle according to claim 1 . |
| Claim: | 5. The composition of claim 4 , wherein said at least two co-spray dried polyols further comprises a polyol selected from the group consisting of sorbitol, maltitol, lactitol, xylitol, erythritol, isomalt, and mixtures thereof. |
| Claim: | 6. The composition of claim 4 , further comprising a disintegrant. |
| Claim: | 7. The composition of claim 6 , wherein said disintegrant is selected from the group consisting of crospovidone, croscarmellose, sodium starch glycolate, and combinations thereof. |
| Claim: | 8. The composition of claim 4 , further comprising a glidant. |
| Claim: | 9. The composition of claim 8 , wherein said glidant is selected from the group consisting of colloidal silica, silica gel, precipitated silica, and combinations thereof. |
| Claim: | 10. The composition of claim 4 , further comprising an active ingredient. |
| Claim: | 11. The composition of claim 10 , wherein said active ingredient is coated. |
| Claim: | 12. The composition of claim 4 , wherein said composition is directly compressible. |
| Claim: | 13. The composition of claim 6 , wherein said composition dissolves in the oral cavity in less than 60 seconds. |
| Claim: | 14. The composition of claim 6 , wherein said composition is directly compressible. |
| Claim: | 15. The composition of claim 6 , wherein said composition has a friability in the range of about 0.0 percent to about 5.0 percent. |
| Claim: | 16. A composition according to claim 4 , wherein said at least two co-spray-dried polyols are mannitol and sorbitol. |
| Claim: | 17. A composition according to claim 4 , wherein said at least two co-spray-dried polyols are mannitol and xylitol. |
| Claim: | 18. The particle of claim 1 , wherein said at least two co-spray-dried polyols are mannitol and xylitol. |
| Claim: | 19. The particle of claim 1 , wherein said at least two co-spray-dried polyols are mannitol and sorbitol. |
| Claim: | 20. The particle of claim 19 , wherein the ratio of mannitol to sorbitol ranges from about 99.5:0.5 to about 60:40. |
| Claim: | 21. The particle of claim 1 , wherein the at least two co-spray-dried polyols comprises from about 70% to about 95% mannitol. |
| Claim: | 22. The particle of claim 1 , wherein the at least two co-spray-dried polyols comprises from about 80% to about 90% mannitol. |
| Current U.S. Class: | 424/489 |
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| Primary Examiner: | Tran, Susan |
| Attorney, Agent or Firm: | Morgan, Lewis & Bockius LLP |
| رقم الانضمام: | edspgr.08545889 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |