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 and comprising one or more active ingredients;
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 through which the subcoating is exposed, wherein the first and second gelatinous coatings do not touch or overlap one another, and wherein a width of said gap is equal to or greater than 7% to about 25% of an overall length of the core; and
wherein the subcoating provides a weight gain that is less than or equal to about 2%.
2. The dosage form according to claim 1 , wherein the subcoating is a polymeric material that does not contain gelatin.
3. The dosage form according to claim 1 , wherein the core is a compressed tablet.
4. The dosage form according to claim 3 , wherein the core has an elongated shape.
5. The dosage form of claim 1 , wherein the first gelatinous coating and the second gelatinous coating are from about 3 weight percent to about 10 weight percent based on the weight of the core; and wherein the dissolution of the one or more active ingredients reaches the USP specifications for amount dissolved immediate release tablets containing the particular one or more active ingredients in not more than half the time specified in the USP method.
6. The dosage form of claim 5 , wherein the core comprises acetaminophen, and wherein at least about 90% of the acetaminophen is released after 6 minutes in USP pH 5.8 phosphate buffer in USP Apparatus II (paddle method) at 50 rpm.
7. The dosage form of claim 5 , wherein said first gelatinous coating and said second gelatinous coating comprise gelatin.
8. The dosage form of claim 1 , wherein said first gelatinous coating and said second gelatinous coating are substantially free of visible bubble defects.
9. A method for producing a dosage form comprising:
a) making a compressed tablet having two opposing ends;
b) coating the compressed tablet having two opposing ends with a subcoating material provided over at least part of its exterior surface;
c) providing one end of the subcoated compressed tablet with a gelatinous material; and
d) providing a second end of the subcoated compressed tablet with a gelatinous material;
wherein the gelatinous coatings resulting from steps c) and d) form a gap that exposes an exterior surface of the subcoated compressed tablet from step b), wherein a width of said gap is equal to or greater than 7% to about 25% of an overall length of the core; and
wherein the subcoating layer weight gain is less than or equal to about 2%.
10. The method according to claim 9 wherein a compressed tablet is in the form of 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.
11. The dosage form of claim 1 , wherein the width of gap is at least 10% to about 15% of the overall length of the core.
12. The method of claim 10 , wherein the width of gap is at least 10% to about 15% of the overall length of the core.
13. The dosage form of claim 1 , wherein the one or more active ingredients is selected from the group consisting of acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.
14. The dosage form of claim 1 , wherein the one or more active ingredients is selected from the group consisting of pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, mixtures thereof, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof.