Dosage forms and compositions for osmotic delivery of variable dosages of oxycodone
First Claim
1. A controlled release oral dosage form for once-a-day administration of oxycodone comprising:
- (a) a drug core which comprises;
(i) an osmotic agent; and
(ii) a low dose of oxycodone, or one or more pharmaceutically-acceptable salts thereof;
(b) a semipermeable membrane at least partially surrounding the drug core; and
(c) an exit orifice through the semipermeable membrane which communicates with the drug core so as to allow release of the oxycodone to the environment;
wherein the drug core upon hydration in the environment exhibits a viscosity of about 50 cps to 100 cps.
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Accused Products
Abstract
Dosage forms, compositions and methods for the controlled release of oxycodone over a prolonged period of time are described. The present invention discloses a novel means for delivering varying doses of oxycodone using a drug composition having only oxycodone, a polymer carrier and varying amounts of salt to provide a particular viscosity of the hydrated drug core for delivery of the drug at the desired release rate. The present invention functions by modulating the viscosity of the hydrated drug layer in operation by the addition or reduction of salts in the drug composition. The system is independent of solubility enhancers or pH modifiers. The sustained release dosage forms provide therapeutically effective average steady-state plasma oxycodone concentrations when administered once per day.
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Citations
16 Claims
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1. A controlled release oral dosage form for once-a-day administration of oxycodone comprising:
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(a) a drug core which comprises;
(i) an osmotic agent; and
(ii) a low dose of oxycodone, or one or more pharmaceutically-acceptable salts thereof;
(b) a semipermeable membrane at least partially surrounding the drug core; and
(c) an exit orifice through the semipermeable membrane which communicates with the drug core so as to allow release of the oxycodone to the environment;
wherein the drug core upon hydration in the environment exhibits a viscosity of about 50 cps to 100 cps. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. A controlled release oral dosage form for once-a-day administration of oxycodone comprising:
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(a) a drug core which comprises;
(i) a high dose of oxycodone, or one or more pharmaceutically-acceptable salts thereof; and
(ii) does not comprise an osmotic agent;
(b) a semipermeable membrane at least partially surrounding the drug core; and
(c) an exit orifice through the semipermeable membrane which communicates with the drug core so as to allow release of the oxycodone to the environment;
wherein the drug core upon hydration in the environment exhibits a viscosity of about 50 cps to about 100 cps. - View Dependent Claims (10, 11, 12, 13)
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14. A controlled release oral dosage form for once-a-day administration of oxycodone comprising:
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(a) a drug core which comprises;
(i) an osmotic agent; and
(ii) a low dose of oxycodone, or one or more pharmaceutically-acceptable salts thereof;
(b) a semipermeable membrane at least partially surrounding the drug core; and
(c) an exit orifice through the semipermeable membrane which communicates with the drug core so as to allow release of the oxycodone to the environment;
wherein the release index is about 20% to 100%.
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15. A controlled release oral dosage form for once-a-day administration of oxycodone comprising:
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(a) a drug core which comprises;
(i) a high dose of oxycodone, or one or more pharmaceutically-acceptable salts thereof; and
(ii) does not comprise an osmotic agent;
(b) a semipermeable membrane at least partially surrounding the drug core; and
(c) an exit orifice through the semipermeable membrane which communicates with the drug core so as to allow release of the oxycodone to the environment;
wherein the release index is about 20% to 100%.
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16. An osmotic drug composition comprising a high dose of oxycodone and a polymer carrier and not comprising an osmotic agent.
Specification