Methods and dosage forms for controlled delivery of oxycodone

• Main Authors: AYER, ATUL, JOHNSON, DEBORAH J, MODI, NISHIT B, DESJARDIN, MICHAEL A, PORS, LINDA H, ALLPHIN, CLARK P, FINK, TRACY A, SEROFF, SONYA, SHIVANAND, PADMAJA
• Format: Patent
• Language: English
• Published: 29.06.2007
• Edition: 7
• Subjects: HUMAN NECESSITIES; HYGIENE; MEDICAL OR VETERINARY SCIENCE; PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES; SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS

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: (i) 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 Delta-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%; and (ii) administration of the dosage form on a once-a-day basis provides a mean, steady state, plasma concentration profile which for a 24 hour period commencing with an administration of said dosage form has a maximum value Cmax and a 24-hour value C24 which satisfy the relationship: Cmax <2·C24. 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.