Methods and dosage forms for controlled delivery of oxycodone
First Claim
1. A sustained release oral dosage form for once-a-day controlled delivery of oxycodone comprising:
- (a) a core which comprises;
(i) an osmotic agent; and
(ii) oxycodone and/or one or more pharmaceutically-acceptable acid addition salts thereof (the compound);
(b) a semipermeable membrane enveloping the core; and
(c) an exit orifice through the semipermeable membrane which communicates with the core so as to allow release of the compound to the environment;
wherein the dosage form releases the compound over a prolonged period of time at a uniform rate of release such that the average hourly release rate from the core varies positively or negatively by no more than about 30% from either the preceding or the subsequent average hourly release rate during a period of time Δ
Tuniform which begins with the time when the cumulative release of the compound from the core reaches about 25% and which ends with the time when the cumulative release of the compound from the core reaches 75%.
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Abstract
Dosage forms and methods for the controlled release of oxycodone over a prolonged period of time are described. The sustained release dosage forms provide therapeutically effective average steady-state plasma oxycodone concentrations when administered once per day. This once-a-day dosing regimen results in only one peak plasma oxycodone concentration occurrence in each 24 hour period that occurs at a later time after administration and exhibits a lesser magnitude than the peak plasma oxycodone concentration that occurs following administration of oxycodone in an immediate-release dosage form and other prior art extended release dosage forms.
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Citations
21 Claims
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1. A sustained release oral dosage form for once-a-day controlled delivery of oxycodone comprising:
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(a) a core which comprises;
(i) an osmotic agent; and
(ii) oxycodone and/or one or more pharmaceutically-acceptable acid addition salts thereof (the compound);
(b) a semipermeable membrane enveloping the core; and
(c) an exit orifice through the semipermeable membrane which communicates with the core so as to allow release of the compound to the environment;
wherein the dosage form releases the compound over a prolonged period of time at a uniform rate of release such that the average hourly release rate from the core varies positively or negatively by no more than about 30% from either the preceding or the subsequent average hourly release rate during a period of time Δ
Tuniform which begins with the time when the cumulative release of the compound from the core reaches about 25% and which ends with the time when the cumulative release of the compound from the core reaches 75%. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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Specification