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Details for Patent: 7,510,727

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Details for Patent: 7,510,727

Title:Melt-extrusion multiparticulates
Abstract: A unit dose sustained-release oral dosage form containing a plurality of melt-extruded particles, each consisting essentially of a therapeutically active agent, one or more retardants, and an optional water-insoluble binder is disclosed. The particles have a length of from about 0.1 to about 12 mm and can be of varying diameters and each unit dose provides a release of therapeutically active agents over at least about 8 hours. Methods of preparing the unit doses as well as extrusion processes and methods of treatment are also disclosed.
Inventor(s): Oshlack; Benjamin (New York, NY), Chasin; Mark (Manalapan, NJ), Huang; Hua-Pin (Englewood Cliffs, NJ)
Assignee: Purdue Pharma L.P. (Stamford, CT)
Filing Date:Dec 23, 2003
Application Number:10/745,950
Claims:1. A unit dose sustained-release oral dosage form comprising a non-coated plurality of extruded particles, each of said particles consisting essentially of hydromorphone hydrochloride dispersed in a matrix comprising one or more hydrophobic retardants and one or more hydrophilic retardants; and a water insoluble binder; said particles being non-spheroidal and having a length from about 0.1 mm to about 12 mm and a diameter from about 0.1 mm to about 5 mm, said unit dose providing a release of said hydromorphone hydrochloride over at least about 6 hours.

2. A sustained-release formulation comprising a non-coated plurality of extruded particles, each of said particles comprising hydromorphone hydrochloride dispersed in a matrix comprising one or more hydrophobic retardants selected from the group consisting of ethylcellulose and acrylic polymers and one or more hydrophilic retardants comprising hydroxyalkylcellulose; and a water insoluble binder selected from the group consisting of fatty alcohols, hydrogenated fats, fatty acid glycerides, hydrocarbons, waxes, hydrophobic and hydrophilic polymers having hydrocarbon backbones, fatty acid esters and mixtures thereof: said particles being non-spheroidal and having a length from about 0.1 mm to about 12 mm and a diameter from about 0.1 mm to about 5 mm and providing sustained release of hydromorphone hydrochloride over at least about 6 hours.

3. The unit dose of claim 1, wherein said hydrophobic retardant is selected from the group consisting of ethylcellulose and acrylic polymers, and said hydrophilic retardant comprises hydroxyalkylcellulose.

4. The unit dose of claim 3, wherein said acrylic polymer is comprised of monomers selected from the group consisting of an ester of acrylic acid, an ester of methacrylic acid, an alkyl ester of acrylic acid, an alkyl ester of methacrylic acid, and mixtures of any of the foregoing.

5. The unit dose of claim 1, wherein said water insoluble binder is selected from the group consisting of fatty alcohols, hydrogenated fats, fatty acid esters, fatty acid glycerides, hydrocarbons, waxes, stearic acid, stearyl alcohol, and hydrophobic and hydrophilic polymers having hydrocarbon backbones, and mixtures thereof.

6. The unit dose of claim 1, wherein said water insoluble binder is selected from the group consisting of stearyl alcohol, stearic acid, water-insoluble waxes, and mixtures thereof.

7. The unit dose of claim 1, wherein said hydromorphone hydrochloride is present in an amount from about 2 mg to about 64 mg.

8. A unit dose sustained-release oral dosage form comprising a non-coated plurality of extruded particles, each of said particles comprising: hydromorphone hydrochloride dispersed in a matrix comprising one or more hydrophobic retardants selected from the group consisting of acrylic polymers and alkylcelluloses and one or more hydrophilic retardants comprising hydroxyalkylcellulose; said particles being non-spheroidal and having a size from about 0.1 mm to about 12 mm and a diameter from about 0.1 mm to about 5 mm, said unit dose providing a release of said hydromorphone hydrochloride over at least about 6 hours.

9. The unit dose of claim 8, wherein said acrylic polymer is comprised of monomers selected from the group consisting of an ester of acrylic acid, an ester of methacrylic acid, an alkyl ester of acrylic acid, an alkyl ester of methacrylic acid, and mixtures of any of the foregoing.

10. The unit dose of claim 8, further comprising a water insoluble binder.

11. The unit dose of claim 10, wherein said binder is selected from the group consisting of stearyl alcohol, stearic acid water insoluble waxes, fatty alcohols, hydrogenated fats, fatty acid esters, fatty acid glyercides, hydrocarbons, waxes, and hydrophobic and hydrophilic polymers having hydrocarbon backbones, and mixtures thereof.

12. The unit dose of claim 8, wherein each of said particles comprise from about 1% to about 99% of said one or more retardants.

13. The unit dose of claim 8, wherein each of said particles comprise from about 5% to about 95% of said one or more retardants.

14. The unit dose of claim 8, wherein the diameter of said particles is from about 0.1 mm to about 3 cm.

15. A unit dose sustained-release oral dosage form comprising a non-coated plurality of melt extruded particles, each of said particles comprising: (a) hydromorphone hydrochloride; (b) one or more hydrophobic retardants and one or more hydrophilic retardants; and (c) an optional water insoluble binder, said particles having a (length) size from about 0.1 mm to about 12 mm, said unit dose providing a release of said hydromorphone hydrochloride over at least about 6 hours.

16. The dosage form of claim 15, wherein said hydrophobic retardant is an acrylic polymer, and said acrylic polymer is comprised of monomers selected from the group consisting of an ester of acrylic acid, an ester of methacrylic acid, an alkyl ester of acrylic acid, an alkyl ester of methacrylic acid, and mixtures of any of the foregoing.

17. The dosage form of claim 15, wherein said water insoluble binder is selected from the group consisting of hydrogenated vegetable or castor oil, paraffin. higher aliphatic alcohols, higher aliphatic acids, long chain fatty acids, fatty acid esters, and mixtures thereof.

18. The dosage form of claim 15, wherein said binder is selected from the group consisting of higher aliphatic alcohols and water-insoluble waxes.

19. The dosage form of claim 15, wherein said particles have a diameter from about 0.1 to about 5 mm.

20. The dosage form of claim 15, wherein each of said particles comprise from about 1% to about 99% of said retardant.

21. The dosage form of claim 15, wherein each of said particles comprise from about 5% to about 95% of said retardant.

22. The unit dose of claim 8, wherein said hydromorphone hydrochloride is present in an amount from about 2 mg to about 64 mg.

23. The dosage form of claim 1, wherein each of said particles comprise from about 1% to about 99% of said retardant.

24. The dosage form of claim 1, wherein each of said particles comprise from about 5% to about 95% of said retardant.

25. The formulation of claim 2, wherein each of said particles comprise from about 1% to about 99% of said retardant.

26. The formulation of claim 2, wherein each of said particles comprise from about 5% to about 95% of said retardant.

27. The formulation of claim 2, wherein said hydromorphone hydrochloride is present in an amount from about 2 mg to about 64 mg.

28. The unit does of claim 15, wherein said hydrophilic retardant comprises hydroxyalkylcellulose.

29. The unit dose of claim 15, wherein said hydromorphone hydrochloride is present in an amount from about 2 mg to about 64 mg.
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