USE OF BINDERS FOR MANUFACTURING STORAGE STABLE FORMULATIONS
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0 Petitions
Accused Products
Abstract
The present invention relates to storage stable prolonged release pharmaceutical dosage forms comprising oxycodone or a pharmaceutically acceptable salt thereof and naloxone or a pharmaceutically acceptable salt thereof, the manufacture thereof as well as their use for administration to human beings.
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Citations
181 Claims
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1-138. -138. (canceled)
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139. An oral prolonged release pharmaceutical composition comprising:
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at least one prolonged release material; oxycodone or a pharmaceutically acceptable salt thereof in an amount equivalent to 1 to 15 mg of oxycodone HCl; naloxone or a pharmaceutically acceptable salt thereof in an amount equivalent to 0.5 to 7.5 mg of naloxone HCl; and a binder selected from hydroxypropyl cellulose, co-povidone, hydroxypropylmethyl cellulose, polyvinyl pyrrolidone vinyl alcohol (PVPVA), microcrystalline cellulose, polyethylene glycols (PEGs), gelatin, starch, glycerol esters of fatty acids, and combinations thereof. - View Dependent Claims (140, 141, 142, 143, 144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175, 176, 177)
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178. An oral prolonged release pharmaceutical composition comprising:
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at least one prolonged release material; oxycodone or a pharmaceutically acceptable salt thereof in an amount equivalent to 1 to 15 mg of oxycodone HCl; and naloxone or a pharmaceutically acceptable salt thereof in an amount equivalent to 0.5 to 7.5 mg of naloxone HCl; wherein the composition does not include povidone.
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179. An oral prolonged release pharmaceutical composition comprising:
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at least one prolonged release material; oxycodone or a pharmaceutically acceptable salt thereof in an amount equivalent to 1 to 15 mg of oxycodone HCl; and naloxone or a pharmaceutically acceptable salt thereof in an amount equivalent to 0.5 to 7.5 mg of naloxone HCl; wherein the composition after storage under stressed conditions has less than 4% of total substances related to oxycodone or a pharmaceutically acceptable salt thereof and related to naloxone or a pharmaceutically acceptable salt thereof; wherein the stressed conditions are at least 3 months at 25°
C. and 60% relative humidity.
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180. An oral prolonged release pharmaceutical composition comprising:
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at least one prolonged release material; oxycodone or a pharmaceutically acceptable salt thereof in an amount equivalent to 1 to 15 mg of oxycodone HCl; and naloxone or a pharmaceutically acceptable salt thereof in an amount equivalent to 0.5 to 7.5 mg of naloxone HCl; wherein the composition after storage under stressed conditions has less than 0.5% of known substances related to oxycodone or a pharmaceutically acceptable salt thereof or related to naloxone or a pharmaceutically acceptable salt thereof; wherein known substances related to oxycodone or a pharmaceutically acceptable salt thereof include 6-α
-oxycodol, noroxycodone, 14-hydroxycodeinone, oxycodone-N-oxide, and hydrocodone base;wherein known substances related to naloxone or a pharmaceutically acceptable salt thereof include noroxymorphone, 10a-hydroxynaloxone, 7,8-didehydronaloxone, pseudonaloxone, and 3-O-allylnaloxone; wherein the stressed conditions are at least 3 months at 25°
C. and 60% relative humidity.
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181. An oral prolonged release pharmaceutical composition comprising:
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at least one prolonged release material; oxycodone or a pharmaceutically acceptable salt thereof in an amount equivalent to 1 to 15 mg of oxycodone HCl; and naloxone or a pharmaceutically acceptable salt thereof in an amount equivalent to 0.5 to 7.5 mg of naloxone HCl; wherein the composition after storage under stressed conditions releases the oxycodone or the pharmaceutically acceptable salt thereof and the naloxone or the pharmaceutically acceptable salt thereof (the pharmaceutically active agents) with substantially the same release rate as an identical reference pharmaceutical composition that has not been subjected to stressed conditions; wherein the stressed conditions are at least 3 months at 25°
C. and 60% relative humidity.
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Specification