Enteric coating composition and method of making and using the same
A dosage form coating composition is disclosed. The composition includes an alginate, a pectin, a plasticizer, and optionally an emulsifying agent. The alginate is present in an amount by weight of at least 40.0% and at most 80.0% and the pectin is present in an amount by weight of at least 16.0% and at most 40.0%—and/or—the alginate and the pectin are present in a weight ratio of at least 1:1 and at most 5:1. The dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating. The coated dosage form has at least two sequentially observed properties exhibiting enteric coating behavior.
1 . A dosage form coating composition comprising:
an alginate in an amount by weight of at least 40.0% and at most 80.0%;
a pectin in an amount by weight of at least 16.0% and at most 40.0%; and
a plasticizer in an amount by weight of at least 0.5% and at most 30.0%;
wherein the dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating and at least the following two sequentially observed properties:
(i) the enteric coating does not exhibit visible signs of dissolution after being immersed in a 0.1 M solution of hydrochloric acid or simulated gastric fluid at a predetermined temperature and for a first predetermined length of time, wherein the predetermined temperature is between 30° C. and 45° C., wherein the first predetermined length of time is between 15 minutes and 3 hours; and
(ii) after the being immersed in the 0.1 M solution of hydrochloric acid or simulated gastric fluid, the enteric coating is at least partially dissolved after being immersed in a phosphate buffer having a pH between 6.5 and 7.0 or simulated intestinal fluid at the predetermined temperature for a second predetermined length of time, wherein the second predetermined length of time is between 60 minutes and 6 hours.
2 . The dosage form coating composition of claim 1 , wherein the alginate and the pectin are present in a weight ratio of between 1:1 and 5:1.
3 . The dosage form coating composition of claim 1 , the dosage form coating composition comprising an emulsifying agent.
4 . The dosage form coating composition of claim 3 , wherein the emulsifying agent is a lecithin.
5 . The dosage form coating composition of claim 4 , wherein the lecithin is a sunflower lecithin.
6 . The dosage form coating composition of claim 3 , wherein the emulsifying agent is present in an amount by weight of between 0.1% and 10.0%.
7 . The dosage form coating composition of claim 1 , wherein the alginate is present in an amount by weight of between 45.0% and 80%.
8 . The dosage form coating composition of claim 1 , wherein the alginate is sodium alginate.
9 . The dosage form coating composition of claim 1 , wherein the alginate has a viscosity as measured at 10% solids of between 1 cP and 500 cP.
10 . The dosage form coating composition of claim 1 , wherein the pectin is present in an amount by weight of between 17.0% and 40.0%.
11 . The dosage form coating composition of claim 1 , wherein the pectin has a degree of esterification of between 40% and 55%.
12 . The dosage form coating composition of claim 1 , wherein the pectin is non-amidated.
13 . The dosage form coating composition of claim 1 , wherein the plasticizer is present in an amount by weight of between 2.5% and 30.0%.
14 . The dosage form coating composition of claim 1 , wherein the plasticizer is at least one of glycerine or coconut oil.
15 . The dosage form coating composition of claim 1 , wherein the predetermined temperature is between 35° C. and 39° C.
16 . The dosage form coating composition of claim 1 , the dosage form coating composition further comprising at least one of an opacifying agent, a sweetening agent, a flavor masking agent, a colorant, a spray dried flavorant, a dried crystal flavorant, a liquid flavorant, a granule flavorant, a spray dried sensate, a dried crystal sensate, a granule sensate, or a liquid sensate.
17 . The dosage form coating composition of claim 1 , wherein the composition is substantially free of cellulosic film formers.
18 . The dosage form coating composition of claim 1 , wherein the composition is substantially free of shellac.
19 . The dosage form coating composition of claim 1 , wherein the composition is substantially free of modified food starch.
20 . A dosage form coating composition comprising:
an alginate in an amount by weight of at least 40.0% and at most 80.0%;
a pectin; and
a plasticizer;
wherein the alginate and the pectin are present in a weight ratio of at least 1:1 and at most 5:1, wherein the dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating and at least the following two sequentially observed properties:
(i) the enteric coating does not exhibit visible signs of dissolution after being immersed in a 0.1 M solution of hydrochloric acid or simulated gastric fluid at a predetermined temperature and for a first predetermined length of time, wherein the predetermined temperature is between 30° C. and 45° C., wherein the first predetermined length of time is between 15 minutes and 3 hours; and
(ii) after the being immersed in the 0.1 M solution of hydrochloric acid or simulated gastric fluid, the enteric coating is at least partially dissolved after being immersed in a phosphate buffer having a pH between 6.5 and 7.0 or simulated intestinal fluid at the predetermined temperature for a second predetermined length of time, wherein the second predetermined length of time is between 60 minutes and 6 hours.