AVINZA (morphine sulfate extended-release capsules) 30, 60, 90, and 120 mg contain both immediate release and extended release beads of morphine sulfate for once daily oral administration.

Chemically, morphine sulfate is 7,8-didehydro-4,5 alpha-epoxy-17-methyl-morphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate with a molecular weight of 758. Morphine sulfate occurs as white, feathery, silky crystals; cubical masses of crystal; or white crystalline powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pK_a is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).

Each AVINZA Capsule contains either 30, 60, 90, or 120 mg of morphine sulfate, USP and the following inactive ingredients: ammonio-methacrylate copolymers, NF, fumaric acid, NF, povidone, USP, sodium lauryl sulfate, NF, sugar starch spheres, NF, and talc, USP. The capsule shell contains black ink, gelatin, titanium dioxide, D&C yellow No. 10 (30 mg), FD&C green No. 3 (60 mg), FD&C red No. 40 (90 mg), FD&C red No. 3 (120 mg), and FD&C blue No. 1 (120 mg).

Structure:

AVINZA uses the proprietary SODAS™ (Spheroidal Oral Drug Absorption System) technology to produce the extended release component of AVINZA, which combined with an immediate release component achieves the desired release profile characteristics of AVINZA capsules. Within the gastrointestinal tract, due to the permeability of the ammonio-methacrylate copolymers of the beads, fluid enters the beads and solubilizes the drug. This is mediated by fumaric acid, which acts as an osmotic agent and a local pH modifier. The resultant solution then diffuses out in a predetermined manner which prolongs the in vivo dissolution and absorption phases. (see Pharmacokinetics)

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