CUSTOMIZABLE DOSAGE FORMS CONTAINING SIMETHICONE
An improved customizable dosage form comprising a substrate, such as a tablet core, that has one or more distinct, discreet cavities on its exterior surface, wherein simethicone is deposited into at least one of the cavities.
1 . A dosage form comprising a substrate with at least one cavity, wherein the at least one cavity comprises simethicone and at least one material to immobilize the simethicone.
2 . The dosage form of claim 1 , wherein the substrate is a tablet core.
3 . The dosage form of claim 1 wherein the dosage form comprises at least two cavities.
4 . The dosage form of claim 1 wherein the dosage form comprises at least two cavities, and wherein at least one cavity is on an opposing surface.
5 . The dosage form of claim 1 , wherein the dosage form comprises four cavities on each of the opposing surfaces.
6 . The dosage form of claim 3 , wherein the at least two cavities are separated by at least a 1 mm portion of the surface of the substrate.
7 . The dosage form of claim 1 , wherein the substrate is elongated.
8 . The dosage form of claim 1 , wherein the dosage form comprises loperamide.
9 . The dosage form of claim 1 ,wherein the dosage form comprises calcium carbonate, aluminum hydroxide, magnesium stearate, magnesium hydroxide or combinations thereof.
10 . The dosage form of claim 3 , wherein the at least two cavities are elongated along the same axis as the elongated substrate.
11 . The dosage form of claim 3 , wherein the at least two cavities are equal in size.
12 . The dosage form of claim 1 , wherein the substrate is coated.
13 . The dosage form of claim 1 , wherein the material to immobilize the simethicone is a polymer, monomer, polyol, or gelling material.
14 . A method of making a dosage form, comprising:
(a) preparing a substrate with two opposing surfaces and at least one cavity;
(b) depositing a flowable material comprising simethicone into at least one cavity on one side of the substrate; and
(c) adding a second material to immobilize the simethicone.
15 . The method of claim 14 , wherein the second material is deposited on the surface of the simethicone.
16 . The method of claim 14 , wherein the second material is photocurable.
17 . The method of claim 14 , wherein the second material is capable of ionic gelation.
18 . The method of claim 14 ,wherein the second material melts at less than 120° C.
19 . The method of claim 14 , further comprising an additional drying step.
20 . The method of claim 14 , wherein the substrate comprises loperamide.
21 . The method of claim 14 , wherein loperamide is deposited into a second cavity.
22 . The method of claim 14 , wherein the substrate comprises calcium carbonate, aluminum hydroxide, magnesium stearate, magnesium hydroxide or combinations thereof.
23 . A method of making a dosage form, comprising:
(a) preparing a substrate with two opposing surfaces and at least one cavity;
(b) depositing a flowable material comprising a mixture of simethicone and a second material into at least one cavity on one side of the substrate; and
(c) immobilizing the mixture of simethicone and second material through ionic gelation, photocuring, solution evaporation, drying or cooling.