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 comprising 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 a first part of the subcoating; and
d) a second gelatinous coating over at least a second 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 through which a portion of the subcoating is exposed, and wherein said first and second gelatinous coatings do not touch or overlap one another;
wherein a plurality of openings is provided only through the exposed portion of the subcoating; and
wherein the subcoating weight gain is less than or equal to about 3%.
2. A dosage form according to claim 1 , wherein subcoating comprises a polymeric material and does not contain a gelatin.
3. A dosage form according to claim 2 , wherein subcoating layer weight gain is less than or equal to about 2.75%.
4. A dosage form according to claim 1 , wherein the core is a compressed tablet.
5. A dosage form according to claim 4 , wherein the core has an elongated shape.
6. A dosage form comprising:
a) a core comprising an exterior surface, a subcoating over at least a portion of the exterior surface, first and second ends, and one or more active ingredients;
b) a first gelatinous coating over at least a first part of the core; and
c) a second gelatinous coating over at least a second part of the core;
wherein the first and second gelatinous coatings are provided on said first and second ends of the core, and wherein a portion of the subcoating is not coated with said first or second coatings thereby forming a gap through which the subcoating is exposed;
wherein a total amount of said first and second gelatinous coatings is from about 3 to about 10 weight percent based on a weight of the core;
wherein a plurality of openings is provided only through the exposed portion of the subcoating; and
wherein the time for release of at least about 80% of the one or more active ingredients, using USP Apparatus II (paddle method) at 50 rpm with any dissolution media appropriate for the particular active ingredient and dosage form, is not more than 50 percent of the time specified in the applicable USP or NDA specifications for immediate release solid dosage forms containing such active ingredient.
7. The dosage form of claim 6 , wherein the core comprises acetaminophen and from which at least about 80% of the acetaminophen is released after 6 minutes in 37° C. water using USP Apparatus II (paddle method) at 50 rpm.
8. The dosage form of claim 6 , wherein said first and second gelatinous coatings comprise a gelatin.
9. The dosage form of claim 6 , wherein the width of the gap is from about 3% to about 21% of the overall length of the uncoated core.
10. A dosage form comprising:
a) a core comprising an exterior surface, a subcoating, and first and second ends;
b) a first gelatinous coating over at least a first part of the core; and
c) a second gelatinous coating over at least a second part of the core;
wherein the first and second gelatinous coatings are provided on said first and second ends of the core, and wherein a portion of the subcoating is not coated with said first or second coatings thereby forming a gap through which the subcoating is exposed;
wherein total level of said subcoating is not more than about 3 weight percent based on a weight of the uncoated core;
wherein a plurality of openings is provided only through the exposed portion of the subcoating; and
wherein said first and second gelatinous coatings are substantially free of visible bubble defects.
11. The dosage form of claim 10 , wherein the width of gap is at least about 5% of the overall length of the uncoated core.
12. The dosage form according to claim 1 wherein the subcoating contains a coloring agent.
13. The dosage form according to claim 12 wherein the coloring agent is a color other than the color of the core.
14. The dosage form according to claim 6 wherein the subcoating contains a coloring agent.
15. The dosage form according to claim 14 wherein the coloring agent is a color other than the color of the core.
16. The dosage form according to claim 10 wherein the subcoating contains a coloring agent.
17. The dosage form according to claim 16 wherein the coloring agent is a color other than the color of the core.
18. A dosage form according to claim 2 , wherein subcoating layer weight gain is less than or equal to about 2%.