Rapidly disintegrating gelatinous coated tablets
View Patent ↗The present invention relates to an improved gelatinous coated dosage form having two end regions coated with gelatinous materials and an exposed circumferential band. Openings are provided in at least the exposed band to reveal the core material. The invention also relates to methods for manufacturing such gelatinous coated dosage forms.
1. A dosage form comprising:
a) a core having an exterior surface and first and second ends;
b) a subcoating over portions of the exterior surface of the core;
c) a first gelatinous coating over at least part of the subcoating; and
d) a second gelatinous coating over at least part of the subcoating;
wherein the first and second gelatinous coatings are provided on said first and second ends of the core;
wherein said first and second gelatinous coatings form a gap between which the subcoating is exposed;
wherein at least one opening is provided through the subcoating to expose the exterior surface of the core, and
wherein the one or more openings are provided only through the subcoating.
2. A dosage form according to claim 1 , wherein the subcoating comprises a polymeric material and does not contain a gelatin.
3. A dosage form according to claim 1 , wherein a plurality of openings in the form of holes is provided only through the subcoating.
4. A dosage form according to claim 3 , wherein the plurality of holes is provided through the subcoating only within the exposed gap between said first and second gelatinous coatings.
5. A dosage form according to claim 1 , wherein the core is a compressed tablet.
6. A dosage form according to claim 5 , wherein the compressed tablet has an elongated shape.
7. A dosage form according to claim 1 , wherein the first gelatinous coating and second gelatinous coating contain colorants or coloring agents other than white.
8. A dosage form according to claim 1 , wherein printed matter is provided on the exterior surface of at least one of the first and second gelatinous coatings.
9. A dosage form according to claim 1 that allows for dissolution of an active ingredient that conforms to USP specifications for immediate release tablets containing that particular active ingredient.
10. A dosage form according to claim 1 wherein the core contains an active ingredient and at least about 40%, preferably about 60%, of the active ingredient dissolves within 3 minutes when tested according to any USP dissolution method for that active ingredient.
11. A method for producing a dosage form comprising:
a) coating a compressed tablet having two opposing ends with a subcoating material;
b) providing one end of the coated compressed tablet in a gelatinous material;
c) providing a second end of the coated compressed tablet in a gelatinous material; and
d) providing one or more openings in the dosage form that expose the compressed tablet;
wherein the gelatinous coatings resulting from steps b) and c) form a gap that exposes the coating of step a) and wherein the one or more openings are provided only through the subcoating.
12. A method according to claim 11 wherein a compressed tablet is in the form of a elongated tablet having an axis of symmetry that does not pass through the two opposing ends and the gap is provided around a circumference that is in the same plane as said axis of symmetry.
13. A method according to claim 12 wherein subcoating is not transparent and is a color other than white.
14. A method according to claim 12 wherein at least one gelatinous material is not transparent and contains a colorant other than white.