FIELD: chemistry.
SUBSTANCE: invention relates to novel co-crystalline form of tramadol in form of free base and naproxen, or co-crystalline form of solvate methanol containing tramadol and naproxen, wherein molecular ratio of tramadol to naproxen makes 1:2. Co-crystalline form can be applied to pain treatment, preferably, acute pain, chronic pain, neuropathic pain, heavy or moderate pain, allodynia, hyperalgesia, or cancer pain, including diabetic neuropathy or diabetic peripheral neuropathy and osteoarthritis, fibromyalgia; rheumatoid arthritis, ankylosing spondylitis, scapulohumeral periarthritis, or ischialgia. Co-crystalline form mainly contains enantiomeric forms of naproxen and tramadol, in particular (S)-naproxen or (R)-naproxen and (-)-tramadol or (+)-tramadol. Proposed co-crystalline forms are characterised by X-ray powder diffraction data, as well as by indices of monoclinic elementary cell and indices of endometric acute peak, corresponding to melting point, which has start at 82-84°C.
EFFECT: invention also relates to method for producing co-crystalline form and pharmaceutical composition based thereon.
12 cl, 11 dwg, 5 tbl, 4 ex
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Authors
Dates
2016-10-10—Published
2009-10-16—Filed