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Claims for Patent: 7,820,199

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Claims for Patent: 7,820,199

Title:Stable extended release oral dosage composition
Abstract:A film-coated extended release solid oral dosage composition containing a nasal decongestant, pseudoephedrine or salt thereof, e.g., pseudoephedrine sulfate in a core effective to provide a geometric maximum plasma concentration of pseudoephedrine of about 345 ng/mL to about 365 ng/mL at a time of about 7.60 hrs to about 8.40 hrs and having two or three film-coatings on the core, the second one containing an amount of the non-sedating antihistamine, desloratadine, effective to provide a geometric maximum plasma concentration of desloratadine of about 2.15 ng/mL to about 2.45 ng/mL at a time of about 4.0 hours to about 4.5 hours, and use of the composition for treating patients showing the signs and symptoms associated with allergic and/or inflammatory conditions of the skin and airway passages are disclosed.
Inventor(s): Kou; Jim H. (Basking Ridge, NJ)
Assignee: Schering Corporation (Kenilworth, NJ)
Application Number:11/244,743
Patent Claims: 1. A pharmaceutical tablet comprising: (a) a sustained release core comprising about 240 mg of pseudoephedrine or a pharmaceutically acceptable salt thereof; (b) a first film coating covering the core that is free from destabilizing amounts of stearic acid, povidone, crospovidone, lactose, ethyl cellulose and hydroxypropylmethyl cellulose 2208 and (c) a second film coating, comprising about 5 mg of desloratadine, covering the first coating, wherein the tablet is formulated to produce total desloratadine degradation products in the tablet of not more than 2.0% by weight after actual or simulated storage at about 25.degree. C. and about 60% relative humidity for at least 24 months.

2. The pharmaceutical tablet of claim 1, formulated for once daily administration.

3. The pharmaceutical tablet of claim 1, further comprising hydroxypropylmethyl cellulose 2910 in a third film coating.

4. The pharmaceutical tablet of claim 1, further comprising polyethylene glycol.

5. The pharmaceutical tablet of claim 1, further comprising simethicone.

6. The pharmaceutical tablet of claim 1, further comprising talc.

7. The pharmaceutical tablet of claim 1, wherein at least 80% of the desloratadine in the tablet dissolves into a stirred 0.1N HCl solution at about 37.degree. C. in less than 45 minutes.

8. The pharmaceutical tablet of claim 1, wherein at least 80% of the pseudoephedrine or pharmaceutically acceptable salt thereof in the tablet dissolves into a stirred 0.1N HCl solution at about 37.degree. C. (1st hour) and thereafter in a stirred phosphate buffer having a pH of about 7.5 at about 37.degree. C. in less than 16 hours.

9. The pharmaceutical tablet of claim 1, formulated to produce total desloratadine degradation products in the tablet of about 1.4% to about 1.6% by weight of N-formyldesloratadine, after actual or simulated storage at about 25.degree. C. and about 60% relatively humidity for at least 24 months.

10. The pharmaceutical tablet of claim 1, wherein, after administration of a single dose of the tablet to a human, the mean time to maximum plasma concentration (Tmax) of desloratadine occurs at about 6-7 hours post dose.

11. The pharmaceutical tablet of claim 1, wherein administration of a single dose of the tablet to a human produces a peak plasma concentration (Cmax) of desloratadine of about 1.79 ng/mL.

12. The pharmaceutical tablet of claim 1, wherein, after administration of a single dose of the tablet to a human, the mean time to maximum plasma concentration (Tmax) of pseudoephedrine occurs at about 8-9 hours post dose.

13. The pharmaceutical tablet of claim 1, wherein administration of a single dose of the tablet to a human produces a peak plasma concentration (Cmax) of pseudoephedrine of about 328 ng/mL.

14. The pharmaceutical tablet of claim 1, wherein daily administration of the tablet to a human produces a mean steady state area under the concentration time curve (AUC(0-24 hrs)) of pseudoephedrine of about 6438 nghr/mL.

15. A pharmaceutical tablet comprising a sustained release core comprising about 240 mg of pseudoephedrine or a pharmaceutically acceptable salt thereof, and an immediate release coating comprising about 5 mg of desloratadine, wherein the tablet is formulated for once daily administration; the tablet comprises a water-swellable film-forming neutral or cationic copolymeric ester in a coating between the core and the immediate release coating; and the tablet is formulated to produce total desloratadine degradation products in the tablet of not more than 2.0% by weight, after actual or simulated storage at about 25.degree. C. and about 60% relative humidity for at least 24 months.

16. The pharmaceutical tablet of claim 1, comprising polyethylene glycol, talc and simethicone.
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