SPL Set ID: 3e0ccb95-3e8e-477c-b4d2-6060ee05f930
1 drug(s) with this SPL Set ID
Tramadol hydrochloride extended-release (tramadol hydrochloride) tablet is a centrally acting synthetic analgesic in an extended-release formulation. The chemical name is (±) cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. Its structural formula is: Figure 1 The molecular weight of tramadol HCl is 299.84. It is a white, bitter, crystalline and odorless powder that is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride extended-release tablets, for oral administration, contain 100, 200 or 300 mg of tramadol HCl in an extended-release formulation. The tablets are white to off-white in color and contain the inactive ingredients colloidal silicon dioxide, dibutyl sebacate, ethyl cellulose, microcrystalline cellulose, povidone, and sodium stearyl fumarate. The imprinting ink contains shellac, iron oxide black and propylene glycol. Drug Substance