SPL Set ID: b1b0f2ff-d9df-42ab-b471-226ecf97e075
1 drug(s) with this SPL Set ID
Methylphenidate Hydrochloride Extended-Release Tablets USP are a central nervous system (CNS) stimulant. Methylphenidate hydrochloride extended-release tablets are available in four tablet strengths. Each extended-release tablet for once-a-day oral administration contains 27, 36, or 54 mg of methylphenidate HCl USP and is designed to have a 12-hour duration of effect. Chemically, methylphenidate HCl is d,l (racemic) methyl α-phenyl-2-piperidineacetate hydrochloride. Its structural formula is: Methylphenidate HCl USP is a white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Methylphenidate hydrochloride extended-release tablets also contain the following inert ingredients: silicified microcrystalline cellulose, ethylcellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, medium-chain triglycerides, oleic acid, polyethylene glycol, polyvinyl alcohol, propylene glycol, talc, titanium dioxide, triacetin, shellac. Each tablet also contains the following additional inert ingredients: 27 mg : yellow iron oxide, red iron oxide, black iron oxide; 36 mg : red iron oxide, black iron oxide; 54 mg : red iron oxide, black iron oxide. Chemical Structure 11.1 System Components and Performance Methylphenidate hydrochloride extended-release tablets use a precisely designed diffusion process to deliver methylphenidate hydrochloride at a controlled rate. The system comprises a polymeric core surrounded by a diffusion controlling membrane with an immediate release drug overcoat. In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water enters the tablet core through the diffusion controlling membrane, and methylphenidate is released in a controlled fashion resulting in C max at 6 to 7 hours. The non-absorbed components of the tablet pass through the gastrointestinal tract and are eliminated in the stool. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized. Meets USP Dissolution Test 4.