IPC분류정보
국가/구분 |
United States(US) Patent
공개
|
국제특허분류(IPC7판) |
|
출원번호 |
16976250
(2019-03-15)
|
공개번호 |
20210046013
(2021-02-18)
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국제출원번호 |
PCT/US19/22477
(2019-03-15)
|
발명자
/ 주소 |
- Ahmad, Humera
- Do, Jonathan
- Lin, Jing
|
출원인 / 주소 |
|
인용정보 |
피인용 횟수 :
0 인용 특허 :
0 |
초록
Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.
대표청구항
▼
1. An enteric softgel capsule comprising: (a) a fill material; and(b) an enteric shell composition, wherein the fill material comprises at least one pharmaceutically active ingredient,wherein the enteric shell composition comprises about 2% w/w to about 10% w/w of a carrageenan, about 10% w/w to abo
1. An enteric softgel capsule comprising: (a) a fill material; and(b) an enteric shell composition, wherein the fill material comprises at least one pharmaceutically active ingredient,wherein the enteric shell composition comprises about 2% w/w to about 10% w/w of a carrageenan, about 10% w/w to about 30% w/w of a gelatin, about 10% w/w to about 35% w/w of a plasticizer, and about 20% w/w to about 50% why of a solvent, andwherein the enteric softgel capsule is free of conventional enteric polymers. 2. An enteric softgel capsule comprising: (a) a fill material; and(b) an enteric shell composition, wherein the fill material comprises at least one pharmaceutically active ingredient,wherein the enteric shell composition comprises about 2% w/w to about 10% w/w of a carrageenan, about 10% w/w to about 30% w/w of a gelatin, about 10% w/w to about 35% w/w of a plasticizer, about 20% w/w to about 50% w/w of a solvent, and about 0.1% w/w to about 3% w/w of a buffer and/or alkalizing agent, andwherein the n ric softgel capsule is free of conventional enteric polymers. 3. The enteric softgel capsule of claim 1 or 2, wherein the carrageenan comprises at least one of iota-carrageenan, kappa-carrageenan and mixtures thereof. 4. The enteric saftgel capsule of claim 3, wherein the carrageenan is iota-carrageenan. 5. The enteric softgel capsule of claim 1 or 2, wherein the gelatin comprises at least one of Type A gelatin, Type B gelatin and mixtures thereof. 6. The enteric softgel capsule of claim 1 or 2, wherein the gelatin comprises at least one of fish gelatin, hide gelatin, bone gelatin and mixtures thereof. 7. The enteric softgel capsule of claim 5, wherein the gelatin is Type B high bloom gelatin. 8. The enteric softgel capsule of claim 5, wherein the gelatin is Type A high bloom gelatin. 9. The enteric saftgel capsule of claim 1 or 2, wherein the plasticizer comprises at least one of glycerol, glycerin, sorbitol and mixtures thereof. 10. The enteric softgel capsule of claim 9, wherein the plasticizer is glycerol, 11. The enteric softgel capsule of claim 1 or 2, wherein the solvent is water. 12. The enteric softgel capsule of claim 2, wherein the buffer is disodium phosphate. 13. The enteric softgel capsule of claim 1 further comprising a buffer. 14. The enteric softgel capsule of any one of claims 1-13, wherein the capsule disintegrates in about one hour, about two hours, about three hours, about four hours, or about five hours in an acidic medium. 15. The enteric softgel capsule of any one of claims 1-14 therein the fill material has a pH of about 2.5 to about 6.5, or about 3.0 to about 6.0, or about 3.5 to about 5.5. 16. A process of preparing an enteric softgel capsule according to claim 1 or 2 comprising the steps of: (a) preparing a fill material; and(b) encapsulating the fill material with the enteric shell composition. 17. The process of claim 16, further comprising preparing the enteric shell composition by adding the solvent, the glycerin and the gelatin to a melter to form a mixture. 18. The process of claim 17, comprising mixing the mixture at a temperature of about 70° C. to about 80° C. under vacuum. 19. The process of claim 18, further comprising heating the mixture to a temperature of about 82° C. to about 85° C. 20. The process of any one of claims 17 to 19, further comprising combining the mixture with a premix of the carrageenan and the plasticizer.
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