Use of binders for manufacturing storage stable formulations

Pharmaceutical composition according to 34 or 35, wherein the prolonged release pharmaceutical composition comprises oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof in a ratio of 2:1 by weight.

Use of a binder for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions has less than 4% of total substances related to oxycodone or a pharmaceutically acceptable salt or derivative thereof and/or related to naloxone or a pharmaceutically acceptable salt or derivative thereof.

Use of a binder for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions pharmaceutical composition has less than 0.5% of known oxycodone or a pharmaceutically acceptable salt or derivative thereof related substances or known naloxone or a pharmaceutically acceptable salt or derivative thereof related substances.

Use of a binder for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition after storage under stressed conditions releases the pharmaceutically active agents with substantially the same release rate as before subjecting the pharmaceutical composition to stressed conditions.

Use of a hydroxypropyl cellulose for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions has less than 4% of total substances related to oxycodone or a pharmaceutically acceptable salt or derivative thereof and/or related to naloxone or a pharmaceutically acceptable salt or derivative thereof.

Use of a hydroxypropyl cellulose for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions has less than 0.5% of known oxycodone or a pharmaceutically acceptable salt or derivative thereof related substances or known naloxone or a pharmaceutically acceptable salt or derivative thereof related substances.

Use of hydroxypropyl cellulose for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition after storage under stressed conditions releases the pharmaceutically active agents with substantially the same release rate as before subjecting the pharmaceutical composition to stressed conditions.

Use of povidone for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions has less than 4% of total substances related to oxycodone or a pharmaceutically acceptable salt or derivative thereof and/or related to naloxone or a pharmaceutically acceptable salt or derivative thereof.

Use of povidone for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition after storage under stressed conditions has less than 0.5% of known oxycodone or a pharmaceutically acceptable salt or derivative thereof related substances or known naloxone or a pharmaceutically acceptable salt or derivative thereof related substances.

Use of povidone for manufacturing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical composition after storage under stressed conditions releases the pharmaceutically active agents with substantially the same release rate as before subjecting the pharmaceutical composition to stressed conditions.

Use of HPC for stabilizing a prolonged release pharmaceutical composition comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof.

Use of HPC as a binder to produce a prolonged release formulation in accordance with any of claims 124 to 138.