Compositions containing opiate analgesics

• US 5,948,787 A
• Filed: 02/28/1997
• Issued: 09/07/1999
• Est. Priority Date: 02/28/1997
• Status: Expired due to Term

• Current Assignee: Encinal Pharmaceutical Investments, LLC
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Hwang, Paul M., Ayer, Atul D., Kuczynski, Anthony L., Merrill, Sonya, Johnson, Deborah J., Ahlgren, Nils W.
• Primary Examiner(s): Jarvis, William R. A.
• Application Number:
  US08/808,147
• Time in Patent Office: 921 Days
• Field of Search: 514/282
• US Class Current: 514/282
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/2009 Inorganic compounds
• CPC Class Codes: A61K 9/2027 obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
• CPC Class Codes: A61K 9/2031 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
• CPC Class Codes: A61K 9/2054 Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Abstract

An opiate analgesic composition and a non-opiate analgesic composition are disclosed for delivering an analgesic in either embodiment to a patient in need of relief from pain. The analgesics are present optionally with a nonionic surfactant and with an osmotic composition comprising a carbonate or bicarbonate for delivering the opiate analgesic and non-opiate analgesic from a dosage form.

Claims

1. An analgesic composition comprising 40 wt % morphine sulfate, pentahydrate, 53 wt % poly(ethylene oxide) of 200,000 molecular weight, 6 wt % poly(vinyl pyrrolidone) of 40,000 molecular weight, 0.95 wt % of magnesium stearate, and 0.05% butylated hydroxytoluene.

2. An analgesic composition comprising 40% morphine sulfate pentahydrate, 53 wt % poly(ethylene oxide) of 300,000 molecular weight, 6 wt % poly(vinyl pyrrolidone) of 40,000 molecular weight, 0.95 wt % of magnesium stearate, and 0.05% butylated hydroxytoluene.

3. An analgesic composition comprising 35 wt % opiate analgesic, 57 wt % poly(ethylene oxide) of 200,000 molecular weight, 6 wt % poly(vinyl pyrrolidone) of 40,000 molecular weight, 1 wt % polysorbate, 0.95 wt % magnesium stearate, and 0.05 wt % butylated hydroxytoluene.

4. An analgesic composition comprising 35 wt % opiate analgesic, 57 wt % poly(ethylene oxide) of 300,000 molecular weight, 6 wt % poly(vinyl pyrrolidone) of 40,000 molecular weight, 1 wt % polysorbate, 0.95 wt % magnesium stearate, and 0.05 wt % butylated hydroxytoluene.

5. An analgesic composition comprising 50 ng to 1000 mg of an opiate analgesic selected from the group consisting of morphine, hydrocodone, leyorphanol, oxymorphone, and levallorphan, 35 to 275 mg of a poly(alkylene oxide) of 100,000 to 350,000 molecular weight, 0.5 to 50 mg of poly(vinyl pyrrolidone) of 7,500 to 225,000 molecular weight, 0 to 10 mg of a nonionic surfactant selected from the group consisting of polyoxyethylene fatty alcohol ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan monopalmitate, and polyoxyethylene sorbitan monolaurylsulphate, 0.1 to 10 mg of a lubricant selected from the group consisting of magnesium stearate, calcium stearate, potassium oleate, stearic acid and sodium stearate, and 0.01 to 0.5 mg of an antioxidant selected from the group consisting of butylated hydroxytoluene, alpha tocopherol, tocopherol acetate, ascorbyl palmitate, butylated hydroxyanisole, and propyl gallate.

6. An analgesic composition comprising 50 ng to 1000 mg of an opiate analgesic selected from the group consisting of morphine, hydrocodone, hydromorphone, levorphanol, oxymorphone, and levallorphan, 35 to 275 mg of a poly(alkylene oxide) of 100,000 to 350,000 molecular weight, 0.5 to 50 mg of poly(vinyl pyrrolidone) of 7,500 to 225,000 molecular weight, 0 to 10 mg of a nonionic surfactant selected from the group consisting of polyoxyethylene fatty alcohol ester, sorbitan fatty acid ester, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene sorbitan monolaurate, polyoxyethylene sorbitan monostearate, polyoxyethylene sorbitan monooleate, polyoxyethylene sorbitan monopalmitate, and polyoxyethylene sorbitan monolaurylsulphate, and 0.1 to 10 mg of a lubricant selected from the group consisting of magnesium stearate, calcium stearate, potassium oleate, stearic acid, and sodium stearate.