Tramadol hydrochloride (C16H25NO2.HCl, MW 299.84, Ultram®) is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The partition coefficient is 1.35 at pH 7. Tramadol is commercially available as 50 mg film-coated tablets and in combination with acetaminophen. The tablets also contain corn starch, hydroxypropyl methylcellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax. The suspensions were prepared by counting out six 50 mg Ultram tablets. The tablets were pulverized in a glass mortar to a fine powder. Thirty mL of Ora-Plus was mixed with 30 mL of either strawberry syrup or
Ora-Sweet SF and vigorously stirred. The mortar was rinsed with about 15 mL of the vehicle and mixed well. The contents were transferred to a 60 mL calibrated amber plastic prescription bottle. The mortar was rinsed with about 15 mL of the vehicle mixture and transfer and the contents added to the bottle. This was repeated as necessary with sufficient vehicle to final volume and mixed well. The study results showed that all formulations were stable for up to 90 days. The initial and final pH values at both temperatures ranged from 4.30 to 4.34.
PERCENT TRAMADOL HYDROCHLORIDE REMAINING AFTER STORAGE FOR UP TO 90