Serving 500+ biopharmaceutical companies globally:
Generated: September 19, 2017
|Title:||Film forming compositions comprising modified starches and iota-carrageenan and methods for manufacturing soft capsules using same|
|Abstract:||Disclosed herein are composition comprising a modified starch and a carrageenan, especially iota-carrageenan, where the compositions are suitable for use in manufacturing soft capsules.|
|Inventor(s):||Tanner; Keith Edward (Safety Harbor, FL), Getz; John J. (Delray Beach, FL), Burnett; Stephen W. (Clearwater, FL), Youngblood; Elizabeth (Valrico, FL), Draper; Peter Robert (LaSalle, CA)|
|Assignee:||R. P. Scherer Technologies, Inc. (Paradise Valley, NV)|
1. A dried film composition suitable for soft capsules the composition consisting essentially of from 42-84% by weight gel formers comprising a mixture of iota-carrageenan and modified
starch; water; a plasticizer, aid a buffer, wherein said iota-carrageenan and said modified starch are at a weight ratio of at least 1.5:1.
2. A composition suitable for forming a soft capsule, the composition comprising iota-carrageenan and at least one modified starch selected from the group consisting of hydroxypropylated tapioca starch, hydroxypropylated maize starch, acid thinned hydroxypropylated corn starch, potato starch, pregelatinized modified corn starches, and wherein said starch has a hydration temperature below about 90.degree. C. and wherein the weight ratio of modified starch to iota-carrageenan ranges from 1.5:1 to 4.0:1.
3. A composition according to claim 1 wherein the plasticizer is glycerin.
4. A composition according to claim 3 wherein said buffer is a sodium or potassium salt.
5. A composition according to claim 3 further comprising a preservative.
6. A capsule comprising a shell and a fill material, the shell consisting essentially of a film according to claim 1.
7. A composition suitable for forming a wet film for encapsulating materials, the composition comprising a modified starch selected from the group consisting of native potato starch, pre-gelatinized modified corn starch, pre-gelatinized acid thinned modified corn starch, acid modified hydroxypropylated corn starch, flash dried acid modified native corn dent starch, hydroxypropylated acid modified tapioca starch, maltins, modified corn starch and modified high amylose corn starch, and iota-catrageenan in a ratio by weight of at least 1:5:1; said film capable of fusion under apressure of at least about 207 kPa (30 psi).
8. A composition according to claim 7 wherein said weight ratio is in the range of 1.5:1 to 4:1.
9. A composition according to claim 7 wherein said weight ratio is in the range of 2:1 to 3:1.
10. A composition according to claim 7 additionally comprising a buffer system and wherein said film is capable of fusion under pressure in the range of 207 kPa to 2070 kPa and at fusion temperatures in the range of 25-80.degree. C.
11. A composition according to claim 10 having a melt temperature of from 4-20.degree. C. above said fusion temperature.
12. A composition according to claim 8 wherein said modified starch comprises 12-30% by weight of the film composition.
13. A composition according to claim 12 wherein said modified starch comprises 20-30% by weight of said composition.
14. A composition according to claim 9 wherein said modified starch is acid modified hydroxypropylated corn starch.
15. A composition according to claim 7 wherein said iota-carrageenan comprises 6-12% by weight of the composition.
16. A composition according to claim 15 wherein the carrageenan comprises 8-10% by weight of the composition.
17. A composition according to claim 16 wherein the carrageenan comprises about 10% by weight of the composition.
18. A composition according to claim 7 wherein the carrageenan is standardized iota-carrageenan.
19. A composition according to claim 7 wherein said modified starch and said iota-carrageenan comprise at least 20% by weight of the composition.
20. A composition according to claim 7 wherein the composition additionally comprises a plasticizer and a buffer.
21. A composition according to claim 20 wherein said plasticizer is selected from the group consisting of glycerin, sorbitol, propylene glycol, polyethylene glycol.
22. A composition according to claim 21 wherein the plasticizer comprises no more than 50% by weight of the composition.
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