SPL Set ID: c4312b7b-7a42-45f1-b6e6-e20ea76020c4
1 drug(s) with this SPL Set ID
Venlafaxine hydrochloride extended-release capsule, USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI. Venlafaxine is designated 1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl] Cyclohexanol Hydrochloride salt or (±)-1-[α- [(dimethylamino)methyl]-pmethoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows: Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: ethyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol and talc. The capsule shell contains gelatin, purified water, sodium lauryl sulfate and titanium dioxide. Additionally each 37.5 mg capsule shell contains iron oxide black and each 75 mg and 150 mg capsule shell contains iron oxide red. The capsule is imprinted with black pharmaceutical ink and contains following inactive ingredients: black iron oxide, potassium hydroxide, propylene glycol, purified water and shellac. FDA approved dissolution test specifications differ from USP. Image