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ANALGESIC COMPOSITION OF TOPICALLY APPLIED NSAIDs AND OPIOIDS

[Category : - HEALTH]
[Viewed 1207 times]

The present invention relates to pharmaceutical formulations comprising at least two compounds, one effecting opioid analgesia and one effecting cyclooxygenase 1 and 2 activity, in amounts sufficient to potentiate an antino-ciceptive response when both compounds are topically administered in a physiologically acceptable topical excipient. The pharmaceutical formulations of the present invention are used to prevent or relieve acute pain and chronic peripheral neuropathy and/or neuropathic inflammation in a patient in need of such treatment. Topical ad- ministration of a topical NSAID/opioid synergistic drug formulation provides a superior method for the clinical treatment of peripheral pain. It has now been found that topical administration of a composition comprising certain relative amounts of opioids and NSAID results in the synergistic potentiation of peripheral antinociceptive responses. Use of topically administered compositions comprising the proportions of opioids and topical NSAID described and claimed herein provides an important new approach to management of the peripheral pain


The topical gel formulation of the present invention can be prepared by dissolving a mixture comprising a nonster- oidal antiinflammatory drug of a propionic acid derivative such as ketoprofen, flurbiprofen, ibuprofen, naproxen, fenoprofen, benoxaprofen, indoprofen, pirpro- fen, carprofen, oxaproztn, pranoprofen, suprofen, almino- profen, butibufen, diclofenac, ketorolac, aspirin, bex- tra, celebrex, vioxx and acetominophen in conjunction with opioids such as morphine, methadone, meperidine, tramadol, buprenorphine, pentasozine, hydromorphone, hy- drocodone, oxycodone, fentanyl, sufentanyl, loperamide, naloxone and naltrexone. To improve skin penetration of selected synergistic combination of the NSAIDs and opioids we have used poloxamer; and one or more agents selected from lower alcohol, glycerin, propylene glycol and polyethylene glycol; one or more agent enhancers se- lected from fatty acids, fatty alcohols and menthol. More specifically, the lower alcohol used in the present invention may be ethanol and isopropyl alcohol, and poloxamer derivatives may be poloxamer 407 and poloxamer 338, poloxamer 237 and others. The concentrated aqueous solution of poloxamer, used as a gel forming agent of this invention, is a low viscous transparent liquid at refrigerator temperature or lower, but turns to a clear semisolid gel on heating to room or body temperature.


Financial information

Our analgesic formulation is designed to treat peripheral postoperative and neuropathic pain. We have received patent in EU and Australia, in Canada and India application is pending as well. So we are looking for the sale our patent and detailed methods of the gel preparation. This is our main goal, but we are open to discuss orther possibilities as well.


It has been estimated that over hundreds million patients suffer from either postoperative acute or chronic pain annually in the whole world. Global pain and inflammation markets are growing at an average of 30% per year and are estimated to reach the $40 billion level by 2016. Existing pain medications, including opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs) and selective cyclo-oxygenase inhibitors (COX inhibitors), are frequently limited by numerous adverse effects. Consequently, the pain and inflammation market represents a therapeutic area where substantial unmet patient need will drive significant market share for innovative products with reduced side effects. Neuropathic pain is a hyperalgesic pain condition resulting from dysfunction of the peripheral or central nervous system. Neuropathic pain is associated with a variety of etiologies, including trauma, infection, diabetes, immune deficiencies, ischemic disorders, and toxic neuropathies. It is estimated that 3.4 million people per year in the US are diagnosed with diabetic neuropathy, trigeminal neuralgia, or post-herpetic neuralgia. Other causes include multiple sclerosis, post-stroke pain, HIV-associated pain, herpes virus infection, and cancer. Approximately 46 million patients are affected worldwide and the lifestyle of these patients can be severely impeded, a problem compounded by the lack of efficacy and frequent incidence of side effects associated with current treatment options. Opioids are frequently ineffective in treating neuropathic pain. Current treatments, such as gabapentin (Neurontin TM ), involve non-selective regulation of neurotransmitter systems or ion channels and generally result in significant dose-limiting CNS side effects. In this area where no current single drug treatment is effective in more than 50% of patients, novel therapeutic approaches are an urgent priority. The world market for neuropathic pain management is projected to reach approximately $8.5 billion by 2016.









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