|Title:|| Sustained release indomethacin|
|Abstract:||A sustained release indomethacin pharmaceutical product is provided that utilizes a pellet formulation encapsulated in a hard gelatin capsule. A portion of the pellets is uncoated for immediate and rapid release of indomethacin for elevating the plasma level. The remainder of the pellets are coated with a polymer to sustain the plasma level. The uncoated and coated pellets may be mixed with non-medicated pellets as a capsule filler.|
|Inventor(s):|| Dempski; Robert E. (Dresher, PA), Mehta; Gunvant N. (Lansdale, PA), Saboe; Joseph C. (Norristown, PA) |
|Assignee:|| Merck & Co., Inc. (Rahway, NJ) |
1. A sustained release pharmaceutical formulation in capsule unit dosage form that provides prolonged plasma levels of indomethacin and is clinically effective, containing 25
to 150 mg of 500 to 1500 micron size pellets of indomethacin, in the form of:
(A) Uncoated pellets comprising pharmaceutical carriers and 5-50 mg of indomethacin for immediate release of about 35% of the total indomethacin, and rapid elevation of plasma levels; and
(B) Coated pellets comprising pharmaceutical carriers and 15-145 mg of indomethacin as a sustaining dose of about 65% of the total indomethacin wherein the coating consists of polyvinyl acetate as a slow dissolving material.
2. The pharmaceutical formulation of claim 1, wherein the unit dosage form also includes non-medicated pellets to achieve the correct adjusted fill volume for the capsule.
3. The pharmaceutical formulation of claim 1, wherein component (A) is pellets comprising 10-35% by weight indomethacin; 20-40% by weight confectioner's sugar; 3-15% by weight of hydroxypropylmethylcellulose; 3-15% by weight corn starch; and
15-25% by weight microcrystalline cellulose; and component (B) is component (A) pellets coated with said slow dissolving material.