Enteric softgel capsules
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.
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, and
wherein the shell composition comprises about 40 wt % to about 80 wt % of a gelatin, about 2.0 wt % to about 20 wt % of a pectin, about 0.15 wt % to about 4.0 wt % of a cellulose derivative, and about 15 wt % to about 40 wt % of a plasticizer, wherein the pectin has a degree of esterification lower than about 50%, and
wherein the capsule does not include an enteric coating.
2. The enteric softgel capsule of claim 1 , wherein the gelatin is selected from the group consisting of type A gelatin, type B gelatin and mixtures thereof.
3. The enteric softgel capsule of claim 1 , wherein the gelatin is selected from the group consisting of fish gelatin, hide gelatin, bone gelatin and mixtures thereof.
4. The enteric softgel capsule of claim 1 , wherein the plasticizer is selected from the group consisting of glycerol, sorbitol and combinations thereof.
5. The enteric softgel capsule of claim 4 , wherein the plasticizer is glycerol.
6. The enteric softgel capsule of claim 1 , wherein the cellulose derivative is selected from the group consisting of hydroxypropyl methylcellulose, methyl cellulose, hydroxypropyl cellulose, and combinations thereof.
7. The enteric softgel capsule of claim 6 , wherein the cellulose derivative is hydroxypropyl methylcellulose.
8. The enteric softgel capsule of claim 1 , wherein the enteric shell composition comprises from about 45 wt % to about 75 wt % of the gelatin.
9. The enteric softgel capsule of claim 8 , wherein the enteric shell composition comprises from about 50 wt % to about 70 wt % of the gelatin.
10. The enteric softgel capsule of claim 1 , wherein the enteric shell composition comprises from about 3 wt % to about 15 wt % of the pectin.
11. The enteric softgel capsule of claim 10 , wherein the enteric shell composition comprises from about 3 wt % to about 5.5 wt % of the pectin.
12. The enteric softgel capsule of claim 1 , wherein the enteric shell composition comprises from about 20 wt % to about 35 wt % of the plasticizer.
13. The enteric softgel capsule of claim 12 , wherein the enteric shell composition comprises from about 25 wt % to about 30 wt % of the plasticizer.
14. The enteric softgel capsule of claim 1 , wherein the enteric shell composition comprises from about 0.20 wt % to about 2.0 wt % of the cellulose derivative.
15. The enteric softgel capsule of claim 14 , wherein the enteric shell composition comprises from about 0.25 wt % to about 1.4 wt % of the cellulose derivative.
16. The enteric softgel capsule of claim 1 , wherein the capsule disintegrates in less than about 30 minutes in an intestinal environment based on a disintegration test performed in a basket-rack assembly NT-40H model apparatus in a 1000 mL beaker at about 37° C.±2° C.
17. The enteric softgel capsule of claim 1 , wherein the capsule disintegrates in about one hour in an acidic medium based on a disintegration test performed in a basket-rack assembly NT-40H model apparatus in a 1000 mL beaker at about 37° C.±2° C.
18. A process of preparing an enteric softgel capsule according to claim 1 comprising the steps of:
(a) preparing the fill material; and
(b) encapsulating the fill material with the enteric shell composition.
19. The process according to claim 18 further comprising preparing the enteric shell composition by admixing the gelatin, hydroxypropyl methylcellulose, the pectin and the plasticizer, wherein the enteric shell composition is free of enteric polymers.