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Claims for Patent: 7,785,627

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Claims for Patent: 7,785,627

Title:Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative
Abstract:A pharmaceutical dosage form comprising a controlled release component comprising an antihyperglycemic drug in combination with a second component comprising a thiazolidinedione derivative is herein disclosed and described.
Inventor(s): Kositprapa; Unchalee (Davie, FL), Goldfarb; Robert I. (Golden Beach, FL), Cardinal; John (Tamarac, FL), Nangia; Avinash (Weston, FL)
Assignee: Watson Pharmaceuticals, Inc. (Corona, CA)
Application Number:10/664,803
Patent Claims: 1. A once a day oral pharmaceutical tablet consisting of (a) a core; (b) a primary seal coat; (c) an immediate release pioglitazone coating; and (d) optionally an aesthetic coating wherein: the core (a) consists of: (i) a compressed mixture of: (I) 50-98% of metformin hydrochloride; (II) 0.1-40% of a binding agent; (III) 0-20% of an absorption enhancer; and (IV) 0-5% of a lubricant; (ii) optionally a secondary seal coat surrounding the compressed mixture; and (iii) a semipermeable membrane consisting essentially of: (I) 50-99% of a polymer selected from the group consisting of ethylcellulose, cellulose esters, cellulose diesters, cellulose triesters, cellulose ethers, cellulose ester-ether, cellulose acylate, cellulose diacylate, cellulose triacylate, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose acetate propionate and cellulose acetate butyrate; (II) 0-40% of a flux enhancer; and (III) 0-25% of a plasticizer, said membrane having at least one passageway formed therein for release of the metformin; the primary seal coat (b) is applied to the semipermeable membrane (iii), does not contain an active pharmaceutical ingredient and rapidly disperses or dissolves in water; the immediate release pioglitazone coating (c) consists of: (i) 0.1-20% based upon the total weight of the tablet of pioglitazone hydrochloride; (ii) 0.1-30% based upon the total weight of the tablet of a binder; (iii) 0-25% based upon the total weight of the tablet of a pore former; and (iv) 0-20% based upon the total weight of the tablet of a surfactant; wherein the immediate release pioglitazone coating (c) is applied to the primary seal coat (b) that is applied to the semipermeable membrane (a)(iii) of the core (a); the tablet provides a Tmax of 8-12 hours for the metformin and a Tmax of 1-4 hours for the pioglitazone: the tablet exhibits the following metformin dissolution profile when tested in a USP Type 2 apparatus at 75 rpms in 900 ml of simulated intestinal fluid and 37.degree. C.: 0-15% of the metformin is released after two hours; 20-40% of the metformin is released after four hours; 45-90% of metformin is released after eight hours; and not less than 60% of the metformin is released after twelve hours; and the tablet exhibits the following pioglitazone dissolution profile when tested in a USP apparatus Type 1 apparatus at 100 rpm in a pH 2.0 HCl-0.3M KCl buffer solution: at least 79% of the pioglitazone is released after 20 minutes and at least 95% of the pioglitazone is release after 30 minutes.

2. The tablet of claim 1 wherein the immediate release pioglitazone coating is applied to the primary seal coating using a solvent mixture of water and an organic solvent.

3. The tablet of claim 1 wherein the compressed mixture of the core consists of: (I) 75-95% of metformin hydrochloride; (II) 3-15% of a binding agent; (III) 2-10% of an absorption enhancer; and (IV) 0.5-1% of a lubricant.

4. The tablet of claim 1 wherein the polymer of the semipermeable membrane is cellulose acetate.

5. The tablet of claim 1 wherein the polymer of the semipermeable membrane is cellulose acetate.
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