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 first gelatinous coating over at least part of the core; and
c) a second gelatinous coating over at least part of the core;
wherein the first and second gelatinous coatings are provided on said first and second ends of the core;
wherein the total level of said first and second gelatinous coatings is from about 3 to about 10 weight percent based on the weight of the core;
wherein said first and second gelatinous coatings form a gap through which the core is exposed;
wherein the width of gap is from more than 7% to about 25% of the overall length of the uncoated core; and
wherein the time for release of at least about 80% of one or more active ingredients contained in the dosage form, 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.
2. The dosage form of claim 1 , 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.
3. The dosage form of claim 1 , wherein said first and second gelatinous coatings comprise a gelatin.
4. The dosage form of claim 1 , wherein the width of gap is from more than 10% to about 15% of the overall length of the uncoated core.
5. The dosage form according to claim 1 , wherein the core is a compressed tablet.
6. The dosage form according to claim 5 , wherein the compressed tablet has an elongated shape.
7. The dosage form according to claim 1 , wherein said dosage form allows for dissolution of an active ingredient following an immediate release profile for tablets containing that particular active ingredient.
8. The dosage form according to claim 1 , wherein at least about 40% of said one or more active ingredients dissolve within 3 minutes in 900 mLs of water when tested using USP dissolution apparatus II with a paddle speed of 50 rpm.
9. The dosage form according to claim 1 , wherein said one or more active ingredients are selected from the group consisting of acetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, pseudoephedrine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, astemizole, terfenadine, fexofenadine, loratadine, desloratadine, cetirizine, and pharmaceutically acceptable salts, esters, and isomers thereof.
10. The dosage form according to claim 8 , wherein at least about 60% of said one or more active ingredients dissolve within 3 minutes in 900 mLs of water when tested using USP dissolution apparatus II with a paddle speed of 50 rpm.