Invega

Invega Description

paliperidone

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Description
Each extended-release tablet contains 3, 6, or 9 mg of paliperidone.
The chemical name is (±)-3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4H-pyrido[1,2 a]pyrimidin-4-one.
INVEGA utilizes osmotic drug-release technology, whereby osmotic pressure delivers paliperidone from the dosage form at a controlled rate. The system, which resembles a capsule-shaped tablet in appearance, comprises an osmotically active trilayer core surrounded by a subcoat and semipermeable membrane. The trilayer core is composed of two drug layers containing the drug and excipients, and a push layer containing osmotically active components. There are two precision laser-drilled orifices on the drug-layer dome of the tablet. Each strength is identified by a unique color overcoat and print markings. In an aqueous environment, such as the gastrointestinal tract, the water-dispersible color overcoat erodes quickly. Water is then imbibed through the semipermeable, rate-controlling membrane. The membrane controls the rate at which water enters the tablet core, which, in turn, controls drug delivery. The hydrophilic polymers of the core hydrate and swell, creating a gel containing paliperidone that is then pushed out through the tablet orifices. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell, along with insoluble core components.
Excipients/Inactive Ingredients: Inactive ingredients of INVEGA are acetone, butylated hydroxytoluene, carnauba wax, cellulose acetate, hydroxyethyl cellulose, ink water-based black, iron oxides, polyethylene glycol, polyethylene oxides, purified water, sodium chloride and stearic acid. The 9 mg tablets also contain color overcoating material pink and povidone. The 6 mg tablets also contain color overcoating material beige and povidone. The 3 mg tablets also contain color overcoating material white.
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