Oral controlled release dosage form
First Claim
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1. A controlled release central nervous system stimulant formulation comprising:
- (a) a core comprising of;
(i) a central nervous system stimulant;
(ii) a binder;
(iii) a diluent; and
(b) a controlled release coating comprising;
(i) at least one enteric polymer;
(ii) a plasticizer; and
(iii) optionally a anti-sticking agent; and
(c) an immediate release drug layer comprising;
(i) a central nervous system stimulant;
(ii) a binder; and
(iii) optionally a stabilizer;
(d) optionally an overcoat comprising;
(a) a coating agent.
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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
29 Claims
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1. A controlled release central nervous system stimulant formulation comprising:
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(a) a core comprising of;
(i) a central nervous system stimulant;
(ii) a binder;
(iii) a diluent; and
(b) a controlled release coating comprising;
(i) at least one enteric polymer;
(ii) a plasticizer; and
(iii) optionally a anti-sticking agent; and
(c) an immediate release drug layer comprising;
(i) a central nervous system stimulant;
(ii) a binder; and
(iii) optionally a stabilizer;
(d) optionally an overcoat comprising;
(a) a coating agent. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A controlled release pharmaceutical dosage formulation for oral administration comprising a core with a central nervous system stimulant, an enteric coating surrounding the core and an immediate release layer comprising a central nervous system stimulant and a stabilizer, wherein the formulation when administered to humans exhibits (a) a maximum plasma concentration up to about 20 ng/ml;
- (b) an AUC0-24 up to about 200 ng/ml;
(c) a Tmax2 of about 3 to about 12 hours. - View Dependent Claims (20)
- (b) an AUC0-24 up to about 200 ng/ml;
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21. A controlled release formulation consisting essentially of:
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(a) a core consisting essentially of;
(i) 540 weight percent of a central nervous stimulant;
(ii) 3-40 weight percent of a binder; and
(iii) 25-90 weight percent of a diluent; and
(iv) 0.1-10 weight percent anti-sticking agent; and
(b) a controlled release coating consisting essentially of;
(i) 10-85 weight percent based upon the total weight of the controlled release coating of an enteric polymer;
(ii) 0.5-15 weight percent based upon the total weight of the controlled release coating of a plasticizer; and
(iii) 10-70 weight percent based upon the total weight of the controlled release coating of an anti-sticking agent; and
(c) an immediate release drug layer consisting essentially of;
(a) 30-60 weight percent based upon the total weight of the immediate release coating of a central nervous system stimulant; and
(b) 40-70 weight percent based upon the total weight of the immediate release layer of a binder; and
(c) 0.005-5 weight percent based upon the total weight of the immediate release layer of a stabilizer. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29)
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Specification