Encased tamper resistant controlled release dosage forms
AssigneePurdue Pharma L.P.
InventorHaiyong Hugh Huang
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Abstract
In certain embodiments, the present invention is directed to a solid controlled release dosage form comprising: a core comprising a first portion of an opioid analgesic dispersed in a first matrix material; and a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material; wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37 C.
Claims20
A solid controlled release dosage form comprising:
- a core comprising a first portion of an opioid analgesic dispersed in a first matrix material, wherein the opioid analgesic comprises oxycodone or a pharmaceutically acceptable salt thereof;
- and
- a shell encasing the core and comprising a second portion of the opioid analgesic dispersed in a second matrix material,
- wherein the dosage form further comprises acetaminophen;
- wherein the amount of opioid analgesic released from the dosage form is proportional within 20% to elapsed time from 8 to 24 hours, as measured by an in-vitro dissolution in a USP Apparatus 1 (basket) at 100 rpm in 900 ml simulated gastric fluid without enzymes (SGF) at 37° C.
Dependencies are inferred from the claim text.