ORAL CONTROLLED RELEASE DOSAGE FORM
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Abstract
A dosage form that provides a controlled release solid dosage form for the oral administration of a central nervous system stimulant, preferably methylphenidate hydrochloride.
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Citations
41 Claims
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1-29. -29. (canceled)
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30. A controlled release methylphenidate tablet comprising:
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(A) a controlled release methylphenidate core tablet comprising; (a) a compressed mixture comprising; (i) methylphenidate or a pharmaceutically acceptable salt or isomer thereof; (ii) a hydrogel polymer; (iii) a diluent; and (iv) optionally a lubricant; and (b) an enteric coating surrounding the compressed mixture; (B) an immediate release methylphenidate coating applied to the enteric coating of the controlled release methylphenidate core tablet wherein the immediate release methylphenidate coating comprises; (a) methylphenidate or a pharmaceutically acceptable salt or isomer thereof; and (b) a binder; and wherein the controlled release methylphenidate tablet exhibits the following dissolution profile when tested in a United States Pharmacopeia type 2 (paddle) apparatus at 50 rpms in 900 ml of phosphate buffer with a pH of 7.5 and at 37°
C.;1-35% of the methylphenidate is released after 1 hour; 5-40% of the methylphenidate is released after 2 hours; and not less than 70% of the methylphenidate is release after 10 hours; and when administered to humans exhibits a plasma peak for the immediate release methylphenidate coating (Tmax1) between 1 and 5 hours, a plasma peak for the controlled release methylphenidate core (Tmax2) between 4 and 12 hours, and a plasma trough (Tmin) between 2 and 7 hours in between the two peak plasma levels. - View Dependent Claims (31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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Specification