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Last Updated: September 21, 2021

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Claims for Patent: 9,504,655


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Summary for Patent: 9,504,655
Title:Capsule dosage form of metoprolol succinate
Abstract: The present invention provides an extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units and processes for their preparation.
Inventor(s): Vats; Sandeep Kumar (Sonipat, IN), Mondal; Balaram (East Midnapore, IN), Ramaraju; Kalaiselvan (Tiruchirappalli, IN), Singh; Romi Barat (Varanasi, IN)
Assignee: SUN PHARMACEUTICAL INDUSTRIES LIMITED (Mumbai, IN)
Application Number:15/012,775
Patent Claims: 1. An extended-release capsule dosage form of metoprolol succinate in the form of coated discrete units, wherein the capsule dosage form comprises metoprolol succinate in an amount of about 30% to about 70% by the total weight of the dosage form and is bioequivalent to the marketed extended release tablet of metoprolol succinate.

2. The extended-release capsule dosage form according to claim 1, wherein the capsule is in the form of a sprinkle capsule.

3. The extended-release capsule dosage form according to claim 1, wherein the coated discrete units have a particle size from about 0.2 mm to 2.5 mm.

4. The extended-release capsule dosage form according to claim 1, wherein the coated discrete units are coated inert core in the form of plurality of pellets, granules, minitablets, or beads.

5. The extended-release capsule dosage form according to claim 1, wherein the coated discrete units comprise a) inert cores; b) a drug layer over the inert cores comprising metoprolol succinate; and c) an extended release layer over the drug layer coated cores.

6. The extended-release capsule dosage form according to claim 5, wherein the inert cores are water-soluble or water-swellable.

7. The extended-release capsule dosage form according to claim 6, wherein the water-soluble or water-swellable inert cores are made up of sugar, microcrystalline cellulose, cellulose, starch, modified starch, or mixtures thereof.

8. The extended-release capsule dosage form according to claim 7, wherein the sugar is selected from the group consisting of glucose, mannitol, lactose, xylitol, dextrose, and sucrose.

9. The extended-release capsule dosage form according to claim 5, wherein the extended-release layer comprises an extended-release polymer in an amount of about 5% to about 20% based on the weight of drug layer coated cores.

10. The extended-release capsule dosage form according to claim 9, wherein the extended-release polymer is selected from the group consisting of water-soluble/swellable polymers, water-insoluble polymers, and mixtures thereof.

11. The extended-release capsule dosage form according to claim 10, wherein the water-soluble polymer is selected from the group consisting of hydroxypropyl methyl cellulose, hydroxyethyl cellulose, polyethylene glycol, poly(ethylene oxide), hydroxypropyl cellulose, carboxymethyl cellulose, xanthan gum, starch, and mixtures thereof.

12. The extended-release capsule dosage form according to claim 10, wherein the water-insoluble polymer is selected from the group consisting of cellulose ethers, cellulose esters, polymethacrylic acid esters copolymers, aminoalkyl methacrylate copolymers, copolymers of polyvinyl acetate and polyvinyl pyrrolidone, and mixtures thereof.

13. The extended-release capsule dosage form according to claim 12, wherein the cellulose ether is ethyl cellulose.

14. The extended-release capsule dosage form according to claim 12, wherein the water-insoluble polymer further comprises a pore-former.

15. The extended-release capsule dosage form according to claim 14, wherein the pore-former is selected from the group consisting of low viscosity grade hydroxypropyl methylcellulose, sodium alginate, sugars and sugar alcohols, low molecular weight polyethylene glycol, polyvinyl alcohol, and mixtures thereof.

16. An extended-release sprinkle capsule dosage form of metoprolol succinate comprising coated discrete units, having a particle size from about 0.2 mm to 2.5 mm, wherein the capsule dosage form releases not less than 15% of metoprolol succinate after 4 hours, when measured in a United States Pharmacopeia (USP) type 2 dissolution apparatus, paddle at 50 rpm, at a temperature of 37.degree. C..+-.0.5.degree. C. in 500 mL of pH 7.5 phosphate buffer.

17. The extended-release sprinkle capsule dosage form according to claim 16, wherein the capsule dosage form releases about 15% to about 45% of metoprolol succinate after 4 hours, when measured in a United States Pharmacopeia (USP) type 2 dissolution apparatus, paddle at 50 rpm, at a temperature of 37.degree. C..+-.0.5.degree. C. in 500 mL of pH 7.5 phosphate buffer.

18. An extended-release sprinkle capsule dosage form of metoprolol succinate comprising coated discrete units, having a particle size from about 0.2 mm to 2.5 mm, wherein the capsule dosage form exhibits the following in-vitro dissolution profile, when measured in a United States Pharmacopeia (USP) type 2 dissolution apparatus, paddle at 50 rpm, at a temperature of 37.degree. C..+-.0.5.degree. C. in 500 mL of pH 7.5 phosphate buffer: a) not less than 15% of metoprolol succinate is released after 4 hours; and b) not less than 60% of metoprolol succinate is released after 12 hours.

19. The extended-release sprinkle capsule dosage form according to claim 16 wherein the capsule dosage form comprises metoprolol succinate in an amount of about 30% to about 70% by the total weight of the dosage form.

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