Enteric Coated Particles Containing An Active Ingredient
Enterically coated particles and chewable tablets made therefrom are disclosed. The enterically coated particles are comprised of a core containing an active ingredient, a first coating layer comprised of polymeric composition having a Tg less than about 40° C. that substantially covers the core; and a second coating layer, which substantially covers the first coating layer, comprised of a high temperature film forming polymer. The particles may be produced into a tablet form, such as a chewable tablet form, that provides for the immediate release of the active ingredient.
1 - 34 . (canceled)
35 . A tablet comprising enterically coated particles, wherein said particles comprise:
a) a particle core containing an active ingredient;
b) a first layer that substantially covers the core and has a surface; and
c) a second layer on the surface of the first layer, wherein the first layer comprises an enteric polymer and has a Tg less than about 40° C. and the second layer comprises an enteric polymer and has a Tg greater than about 56° C., wherein the average diameter of the particle core is from about 30 to about 600 microns.
36 . The tablet of claim 35 , wherein the second layer substantially covers the first layer.
37 . The tablet of claim 35 , wherein the first layer is present in an amount, based upon the total weight of the coated particle, from about 5% to about 50% and the second layer is present in an amount, based upon the total weight of the coated particle, from about 3% to about 20%.
38 . The tablet of claim 35 , wherein the first layer is comprised of methacrylic acid-methacrylic acid ester copolymers; cellulose acetate phthalate; polyvinyl acetate phthalate; shellac; hypromellose phthalate; or derivatives, copolymers or mixtures thereof.
39 . The tablet of claim 35 , wherein the first layer is comprised of a methacrylic acid-methylacrylic acid ester copolymer having a mean molecular weight of about 800,000.
40 . The tablet of claim 35 , wherein the second layer is comprised of copolymers of acrylic acid esters.
41 . The tablet of claim 35 , wherein the second layer is comprised of a film forming copolymer comprising a reaction product of polymethacrylic acid and at least one member of the group consisting of acrylic acid ester and polymethacrylic acid ester.
42 . The tablet of claim 38 , wherein the second layer is comprised of a film forming copolymer comprising a reaction product of polymethacrylic acid and at least one member of the group consisting of acrylic acid ester and polymethacrylic acid ester.
43 . The tablet of claim 39 , wherein the second layer is comprised of a film forming copolymer comprising a reaction product of polymethacrylic acid and at least one member of the group consisting of acrylic acid ester and polymethacrylic acid ester.
44 . The tablet of claim 35 , wherein the first layer is comprised of, based upon the total dry weight of the first layer:
a) from about 60 percent to about 80 percent of a film forming material having a Tg greater than about 70° C.; and
b) from about 20 percent to about 40 percent of a plasticizer.
45 . The tablet of claim 35 , wherein the first layer is comprised of, based upon the total dry weight of the first layer:
a) from about 60 percent to about 80 percent of a film forming material selected from the group consisting of methyacrylic acid-methyacrylic acid ester copolymer, cellulose acetate phthalate, polyvinylacetate phthalate, shellac, hypromellose phthalate, and derivatives, copolymers and mixtures thereof; and
b) from about 20 percent to about 40 percent of a plasticizer.
46 . The tablet of claim 35 , wherein the first layer is comprised of, based upon the total dry weight of the first layer:
a) from about 60 percent to about 80 percent of methacrylic acid-methyl methacrylate copolymer having a Tg greater than about 70° C.; and
b) from about 20 percent to about 40 percent of a plasticizer.
47 . The tablet of claim 35 wherein the second layer is comprised of, based upon the total dry weight of the second layer:
a) from about 80 percent to about 95 percent of a film forming material having a Tg greater than about 70° C.; and
b) from about 5 percent to about 20 percent of a plasticizer.
48 . The tablet of claim 44 , wherein the second layer is comprised of, based upon the total dry weight of the second layer:
a) from about 80 percent to about 95 percent of a film forming material having a Tg greater than about 70° C.; and
c) from about 5 percent to about 20 percent of a plasticizer.
49 . The tablet of claim 45 , wherein the second layer is comprised of, based upon the total dry weight of the second layer:
a) from about 80 percent to about 95 percent of a film forming material having a Tg greater than about 70° C.; and
d) from about 5 percent to about 20 percent of a plasticizer.
50 . The tablet of claim 46 , wherein the second layer is comprised of, based upon the total dry weight of the second layer:
a) from about 80 percent to about 95 percent of a film forming material having a Tg greater than about 70° C.; and
e) from about 5 percent to about 20 percent of a plasticizer.
51 . The tablet of claim 50 , wherein the second layer substantially covers the first layer.
52 . The tablet of claim 50 , wherein the first layer is present in an amount, based upon the total weight of the coated particle, from about 5% to about 50% and the second layer is present in an amount, based upon the total weight of the coated particle, from about 3% to about 20%.
53 . The tablet of claim 51 , wherein the first layer is present in an amount, based upon the total weight of the coated particle, from about 5% to about 50% and the second layer is present in an amount, based upon the total weight of the coated particle, from about 3% to about 20%.
54 . A method of administering an active ingredient, said method comprising chewing a tablet of claim 35 .