Uniform delivery of topiramate over prolonged period of time with enhanced dispersion formulation

Topiramate Capsule Shaped Bilayer 100 mg System

[0121] A dosage form adapted, designed and shaped as an osmotic drug delivery device is manufactured as follows as illustrated in FIG. 1A:

[0122] Preparation of the Drug Layer Granulation

[0123] 60.0 g of topiramate, 25.45 g of polyethylene oxide with average molecular weight of 200,000, 5.0 g of cross-linked povidone with average molecular weight of more than 1,000,000(PVP XL or PVP XL-10) and 4.0 g of of polyvinylpyrrolidone (Povidone K29-32) are added to a glass jar. Next, the dry materials are mixed for 30 seconds. Then, 20 ml of denatured anhydrous alcohol is slowly added to the blended materials with continuous mixing for approximately 2 minutes. Next, the freshly prepared wet granulation is allowed to dry at room temperature for approximately 18 hours, and passed through a 16-mesh screen. Next, the granulation is transferred to an appropriate container, 0.05 g of butylated hydroxytoluene is added as an antioxidant and the result...

Topiramate Capsule Shaped Bilayer 100 mg System

[0140] A dosage form adapted, designed and shaped as an osmotic drug delivery device is manufactured as follows as illustrated in FIG. 1A:

[0141] First, 900.0 g of topiramate, 441.8 g of polyethylene oxide with average molecular weight of 200,000, 75.0 g of cross-linked povidone with average molecular weight of more than 1,000,000 (PVP XL or PVP XL-10) and 60 g of of polyvinylpyrrolidone identified as K29-32 having an average molecular weight of 40,000 are added into a bowl of the Kitchen Aid mixer. Next, the dry materials are mixed for 30 seconds. Then, 200 to 1000 ml of denatured anhydrous alcohol is slowly added to the blended materials with continuous mixing. Next, the freshly prepared wet granulation is allowed to dry at room temperature for approximately 18 hours to final moisture content of 0.5 to 1.5%, and passed through a 16-mesh screen. Next, the granulation is transferred to an appropriate container, 0.8 g of butylated hydro...

Topiramate Capsule Shaped Bilayer 100 mg System with Solubilizing Surfactant

[0150] A dosage form was manufactured as follows. First, 2880 g of topiramate, 958 g of polyethylene oxide with average molecular weight of 200,000 and 4980 g of poloxamer 407 (Lutrol F127) having an average molecular weight of 12,000 were added to a fluid bed granulator bowl. Next two separate binder solutions, a poloxamer 407 binder solution and a polyvinylpyrrolidone identified as K29-32 having an average molecular weight of 40,000 binder solution were prepared by dissolving 500 g of the same poloxamer 407 (Lutrol F127) in 4500 g of water and 750 g of the same polyvinylpyrrolidone in 4250 of water, respectively. The dry materials were fluid bed granulated by first spraying with 3780 g of the poloxamer binder solution and followed by spraying 3333 g of the polyvinylpyrrolidone binder solution. Next, the wet granulation was dried in the granulator to final moisture content of 0.2 to 0.8%, and sized using b...