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Hydromorphone therapy

a technology of hydromorphone and hydromorphone, which is applied in the field of hydromorphone therapy, can solve the problems of changing the release rate of hydromorphone from polyalkylene oxide, conventional dosage forms, and a lack of pharmaceutical and medical arts, so as to suppress anxiety and apprehension, relieve pain, and lessen pain for patients

Inactive Publication Date: 2004-11-25
MERRILL SONYA +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides a new dosage form and therapeutic composition for delivering hydromorphone for pain relief. The new dosage form delivers hydromorphone in a sustained-release program over time, allowing for controlled and continuous dosage. The therapeutic composition is made of hydromorphone and its pharmaceutically acceptable salts, and can be administered as an oral solid or from an osmotic dosage form. The invention also provides a method for reducing pain in a patient and a dosage form that minimizes the impact of the gastrointestinal environment on hydromorphone delivery. Overall, the invention provides a more effective and reliable treatment for pain relief."

Problems solved by technology

A pharmaceutically-acceptable dosage form for oral administering hydromorphone to provide analgesic therapy beyond its short half-life at a controlled-rate over an extended period of time appears to be lacking in the pharmaceutical and medical arts.
For example, the hydromorphone could become immobile and trapped in the polyalkylene oxide, also, the polyalkylene oxide could exhibit unacceptable swelling in the presence of aqueous including biological fluid and thereby change the rate of release of the hydromorphone from the polyalkylene oxide.
The concentration differences in dosing patterns are related to the presence and absence of administered drug, which is a major disadvantage associated with conventional dosage forms.
These conventional dosage forms and their accompanying peaks and valleys do not provide for dose-regulated drug therapy over an extended period of time.
The hydromorphone as delivered by the prior art is often dosed two or more times a day, which does not lend itself to controlled and sustained therapy.

Method used

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Examples

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example 1

[0053] A novel therapeutic composition comprising hydromorphone, wherein the hydromorphone is a member selected from the group consisting of hydromorphone pharmaceutically acceptable base and hydromorphone pharmaceutically acceptable salt, is prepared as follows: First, 175 g of hydromorphone hydrochloride, 647.5 g of poly(ethylene oxide) possessing a 200,000 molecular weight, and 43.75 g of poly(vinyl pyrrolidone) having an average-molecular weight of 40,000 are added to planetary mixing bowl and the ingredients dry mixed for ten minutes. Then, 331 g of denatured anhydrous alcohol is slowly added to the blended ingredients, with continuous blending for approximately ten minutes. Next, the freshly prepared wet granulation is passed through a 20-mesh screen, allowed to dry at 25.degree. C. for about 20 hours, and then passed through a 16-mesh screen. Next, the granulation is transferred to the planetary mixer and lubricated with 8.75 g of magnesium stearate to produce a therapeutic h...

example 2

[0054] The therapeutic compositions manufactured by following the above example provide compositions comprising 1 to 500 mg of a member selected from the group consisting of hydromorphone, hydromorphone base, hydromorphone salt and hydromorphone derivative; at least one polymeric carrier for the hydromorphone selected from 20 to 375 mg of poly(alkylene oxide) comprising a 50,000 to 750,000 molecular weight represented by poly(methylene oxide), poly(ethylene oxide), poly(propylene oxide), poly(isopropylene oxide) and poly(butylene oxide)., or a polymeric carrier for the hydromorphone consisting of 20 to 375 mg of carboxymethylcellulose having a 10,000 to 175,000 molecular weight represented by a member selected from the group consisting of alkali carboxymethylcellulose, sodium carboxymethylcellulose and postassium carboxymethylcellulose; 0.01 to 25 mg of poly(vinyl) polymer possessing a 5,000 to 350,000 molecular weight represented by poly(vinyl pyrrolidone), copolymer of poly(vinyl ...

example 3

[0055] The therapeutic composition provided by the invention can be dry compressed into an orally administrable dosage form. For example, a mixture of dry-powder ingredients comprising a hydromorphone pharmaceutically acceptable base or a hydromorphone pharmaceutically acceptable salt as represented by: hydrochloride, hydrobromide, sulfate, bisulfate, acetate, valerate, oxalate, oleate, laureate, borate, benzoate, lactate, phosphate, tosylate, citrate, maleate, fumarate, succinate, tartrate and napsylate; a tablet excipient represented by 0 to 200 mg of microcrystalline cellulose; 20 to 375 mg of sodium carboxymethylcellulose of 10,000 to 175,000 molecular weight; 0.01 to 25 mg of a binder agent represented by poly(vinyl pyrrolidone) of 5,000 to 350,000 molecular weight, a hydroxypropylmethylcellulose of 9,200 to 75,000 molecular weight, and gelatin; and 0 to 10 mg of a lubricant, such as stearic acid, calcium stearate or magnesium stearate; are dried, sieved and mixed with other op...

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Abstract

A hydromorphone composition, a hydromorphone dosage form and a method for administering hydromorphone are disclosed, indicated for the management of pain.

Description

[0001] This application is application is a division of U.S. application Ser. No. 08 / 935,223 filed on Sep. 22, 1997, which application Ser. No. 08 / 935,223 is a continuation-in-part of U.S. application Ser. No. 08 / 611,294 filed on Mar. 5, 1996 now U.S. Pat. No. 5,702,725 issued Dec. 30, 1997, which application Ser. No. 08 / 935,223 is a continuation of U.S. application Ser. No. 08 / 271,593 filed Jul. 7, 1994 and now U.S. Pat. No. 5,529,787 issued on Jun. 25, 1996.[0002] This invention pertains to a novel dosage form comprising hydromorphone for the management of pain. The invention concerns also a novel therapeutic composition comprising hydromorphone indicated for treating pain. The invention relates additionally to a method for the management of pain by administering continuously release-rate controlled doses of hydromorphone over an extended time to produce analgesic therapy.[0003] Hydromorphone is an analgesic with its principal therapeutic effect, the relief of pain. The precise me...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/20A61K9/22A61K31/485
CPCA61K9/0004A61K9/2027A61K9/2031A61K9/2054A61K31/485A61P25/00
Inventor MERRILL, SONYAAYER, ATUL D.CHADHA, NAVJOTKUCZYNSKI, ANTHONY L.
Owner MERRILL SONYA
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