# US 11,298,324 B2 · Rapidly disintegrating gelatinous coated tablets

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- Number: US 11,298,324 B2
- Document ID: US11298324B2
- Status: Granted
- Kind: B2
- Application number: 16/823,058
- Filed: 2020-03-18
- Published: 2020-07-09
- Granted: 2022-04-12
- Earliest claimed: 2004-01-13
- Assignees: Johnson & Johnson Consumer Inc.
- Applicants: Johnson & Johnson Consumer inc.
- Inventors: Roger A Rinker; Nicholas J. Casale; James H. Comly; Brenda Pollock; Johan Geerke; Martin Costello; Dennis Wieand; Kishor Parekh
- Web page: https://patentgrep.com/patent/US11298324B2

## CPC

- A61K 9/2886: {having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer (of the type active core-drug layer-inactive layer A61K9/209)}
- A61K 9/2072: {characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms (A61K9/0004, A61K9/0056, A61K9/0065 take precedence)}
- A61K 9/282: {Organic compounds, e.g. fats}
- A61K 9/286: {Polysaccharides, e.g. gums; Cyclodextrin}
- A61K 9/2866: {Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose}
- A61K 9/2873: {Proteins, e.g. gelatin}
- A61K 9/2893: {Tablet coating processes (mechanical aspects A61J3/06)}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)

## Abstract

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.

## Claims

### Claim 1

A dosage form, comprising:
a core, wherein the core comprises at least one active ingredient;
a subcoating, wherein the subcoating is applied to an exterior surface of the core;
a first gelatinous coating applied to a first end of the core;
a second gelatinous coating applied to a second end of the core;
wherein the first gelatinous coating and the second gelatinous coating are applied to the first end of the core and the second end of the core, respectively, after the subcoating is applied to the exterior surface of the core;
wherein the first gelatinous coating and the second gelatinous coating are separated from one another and form a gap through which the subcoating is exposed, wherein the gap has a width of equal to or greater than 7% to about 25% of an overall length of the core.

### Claim 2 (depends on 1)

The dosage form according to claim 1, wherein the subcoating is applied to the entire exterior surface of the core.

### Claim 3 (depends on 1)

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.

### Claim 4 (depends on 3)

The dosage form of claim 3, wherein the one or more active ingredients is selected from fexofenadine and pharmaceutically acceptable salts thereof.

### Claim 5

A method for producing a dosage form comprising:
a) coating an exterior surface of a compressed tablet having two opposing ends with a subcoating to form a subcoated compressed tablet;
b) providing one end of the subcoated compressed tablet with a gelatinous material; and
c) providing a second end of the subcoated compressed tablet with a gelatinous material;
wherein the gelatinous coatings resulting from steps b) and c) form a gap that exposes an exterior surface of the subcoated compressed tablet from step a), wherein a width of said gap is equal to or greater than 7% to about 25% of an overall length of the core.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the subcoating is applied to the entire exterior surface of the compressed tablet.

### Claim 7 (depends on 5)

The method of claim 5, 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.

### Claim 8 (depends on 7)

The method of claim 7, wherein the one or more active ingredients is selected from fexofenadine and pharmaceutically acceptable salts thereof.

### Claim 9

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, wherein the subcoating is applied to the exterior surface of the core to form a subcoated core;
c) a first gelatinous coating over at least part of the subcoated core; and
d) a second gelatinous coating over at least part of the subcoated core;
wherein the first and second gelatinous coatings are provided on said first and second ends of the subcoated 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 subcoated core is exposed; wherein the width of gap is from more than 7% to about 25% of the overall length of the subcoated core.

### Claim 10

A method of treatment, comprising administering a dosage form, wherein said dosage form comprises:
a) a core having an exterior surface and first and second ends, wherein the core comprises one or more pharmaceutically active ingredients, cellulose or a derivative of cellulose, pregelatinized starch, and magnesium stearate;
b) a subcoating, wherein the subcoating is applied to the exterior surface of the core to form a subcoated core;
c) a first gelatinous coating over at least part of the subcoated core; and
d) a second gelatinous coating over at least part of the subcoated core;
wherein the first and second gelatinous coatings are provided on the first and second ends of the subcoated core; wherein the first and second gelatinous coatings form a gap through which the subcoated core is exposed, wherein the gap has a width of greater than 7% to about 25% of the length of the subcoated core, wherein the gap does not affect swallowability of the dosage form; and wherein the first and second gelatinous coatings each comprise gelatin.