Nucynta ER

DRUG DESCRIPTION

NUCYNTA® ER (tapentadol) is a mu-opioid receptor agonist, supplied in extended-release film-coated tablets for oral administration, containing 58.24, 116.48, 174.72, 232.96, and 291.20 mg of tapentadol hydrochloride in each tablet strength, corresponding to 50, 100, 150, 200, and 250 mg of tapentadol free-base, respectively. The chemical name is 3-[(1R,2R)-3-(dimethylamino)-1ethyl-2-methylpropyl]phenol monohydrochloride. The structural formula is:

NUCYNTA® ER (tapentadol)  Structural Formula Illustration

The molecular weight of tapentadol HCl is 257.80, and the molecular formula is C14H23NO•HCl. The n-octanol: water partition coefficient log P value is 2.87. The pKa values are 9.34 and 10.45. In addition to the active ingredient tapentadol HCl, tablets also contain the following inactive ingredients: polyethylene oxide, hypromellose, polyethylene glycol and alpha-tocopherol (vitamin E). The film coating is comprised of polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Blue #2 aluminum lake is used for 100-, 150-, 200-, and 250-mg strengths; and additionally, yellow iron oxide is used in 150-mg tablets. Printing inks contain shellac glaze and propylene glycol for all strengths, and black iron oxide (50-, 100-, 150and 200-mg tablet) or titanium dioxide (250-mg tablet).



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