Coated enteric softgel capsules
Disclosed herein is a softgel capsule including a fill material, shell composition and a coating having an enteric polymer, wherein the coating provides about 1% to about 10% weight gain of the capsule. The coating improves the robustness of enteric property and minimized the moisture absorption during dissolution of the softgel capsule.
1 . A delayed release softgel capsule comprising:
a fill material, wherein the fill material comprises an active agent;
a shell composition, wherein the shell composition comprises pectin in an amount of about 2.5 wt % to about 20 wt %, based on total weight of the shell composition; and
a coating comprising an enteric polymer comprising a combination of methyl acrylate, methyl methacrylate and methacrylic acid, wherein the coating provides a weight gain of 0.5 wt % to 3 wt % of the capsule,
wherein the shell composition does not rupture at a pH of 1.2 at 15 minutes, when measured with a USP Apparatus II with paddles at 50 RPM, 750 ml 0.1N HCL acidic media adjusted to pH with phosphate buffer.
2 . The delayed release softgel capsule of claim 1 , wherein the shell composition further comprises a plasticizer.
3 . The delayed release softgel capsule of claim 2 , wherein the plasticizer comprises glycerol, glycerin, sorbitol, sorbitol sorbitan solution, triacetin, polysorbate, or combinations thereof.
4 . The delayed release softgel capsule of claim 3 , wherein the plasticizer comprises glycerin and sorbitol sorbitan solution.
5 . The delayed release softgel capsule of claim 3 , wherein the polysorbate comprises polysorbate 20, polysorbate 80 or combinations thereof.
6 . The delayed release softgel capsule of claim 1 , wherein the shell composition further comprises gelatin.
7 . The delayed release softgel capsule of claim 6 , wherein the gelatin is selected from the group consisting of Type A gelatin, Type B gelatin, and mixtures thereof.
8 . The delayed release softgel capsule of claim 6 , wherein the gelatin is selected from the group consisting of fish gelatin, hide gelatin, bone gelatin and mixtures thereof.
9 . The delayed release softgel capsule of claim 1 , wherein the shell composition further comprises gellan gum.
10 . The delayed release softgel capsule of claim 1 , wherein the shell composition further comprises dextrose.
11 . The delayed release softgel capsule of claim 1 , wherein the shell composition further comprises water.
12 . The delayed release softgel capsule of claim 1 , wherein the pectin is a low methoxy pectin.
13 . The delayed release softgel capsule of claim 1 , wherein the enteric polymer further comprises an acrylic polymer, cellulose acetate succinate, cellulose acetate phthalate, cellulose acetate butyrate, hydroxypropyl methyl cellulose phthalate, hydroxy propyl methyl cellulose acetate succinate (hypermellose acetate succinate), polyvinyl acetate phthalate (PVAP), algenic acid salt, stearic acid, shellac or a combination thereof.
14 . The delayed release softgel capsule of claim 13 , wherein the algenic acid salt is sodium alginate, potassium alginate, or a combination thereof.
15 . The delay release softgel capsule of claim 13 , wherein the enteric polymer is an acrylic polymer, a methacrylic polymer, or a combination thereof.
16 . The delayed release softgel capsule of claim 1 , wherein the coating further comprises a plasticizer.
17 . The delayed release softgel capsule of claim 16 , wherein the plasticizer comprises glyceride, triethyl citrate, or a combination thereof.
18 . The delayed release softgel capsule of claim 6 , wherein the gelatin is in an amount of about 15 wt % to about 60 wt %, based on total weight of the shell composition.
19 . The delayed release softgel capsule of claim 10 , wherein the dextrose is in an amount of about 0.001 wt % to about 5 wt %, based on total weight of the shell composition.
20 . The delayed release softgel capsule of claim 3 , wherein the plasticizer is in an amount of about 5 wt % to about 60 wt %, based on total weight of the shell composition.
21 . The delayed release softgel capsule of claim 1 , wherein the shell composition does not rupture at a pH of between 6 and 7 at 15 minutes, when measured with a USP Apparatus II with paddles at 50 RPM, 750 ml 0.1N HCL acidic media adjusted to pH with phosphate buffer.