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(12) United States Patent (10) Patent No.: US 7,588,779 B2 Hahn (45) Date of Patent: Sep

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(12) United States Patent (10) Patent No.: US 7,588,779 B2 Hahn (45) Date of Patent: Sep US007588779B2 (12) United States Patent (10) Patent No.: US 7,588,779 B2 Hahn (45) Date of Patent: Sep. 15, 2009 (54) PHARMACEUTICAL FORMULATION (56) References Cited CONTAINING A BIGUANDE AND AN U.S. PATENT DOCUMENTS ANGOTENSIN ANTAGONST 5,196,444 A 3, 1993 Naka et al. (75) Inventor: Elliot F. Hahn, North Miami Beach, FL 5,534,534 A T/1996 Makino et al. US) 5,650,170 A 7/1997 Wright et al. ( 5,705,517 A 1/1998 Naka et al. 6,099,859 A * 8/2000 Cheng et al. ................ 424/464 (73) Assignee: Andrx Labs, LLC, Davie, FL (US) 6,099,862 A 8, 2000 Chen et al. - 6,682,759 B2 1/2004 Lim et al. (*) Notice: Subject to any disclaimer, the term of this 2001 OO24659 A1 9, 2001 Chen et al. patent is extended or adjusted under 35 2004/0034.065 A1 2/2004 Allison et al. ............... 514,342 U.S.C. 154(b) by 0 days. 2004/0106660 A1 6/2004 Kositprapa et al. 2004O161462 A1 8/2004 Kositprapa et al. (21) Appl. No.: 11/628,066 2004/0219209 A1 11/2004 Chen et al. 2005/0226928 A1 10, 2005 LOdin et al. (22) PCT Filed: May 27, 2005 (86). PCT No.: PCT/US2005/O18939 FOREIGN PATENT DOCUMENTS WO WO99/471.25 9, 1999 S371 (c)(1), WO WO O2, 15933 2, 2002 (2), (4) Date: Nov. 28, 2006 (87) PCT Pub. No.: WO2005/117591 OTHER PUBLICATIONS PCT Pub. Date: Dec. 15, 2005 http://en.wikipedia.org/wiki/Biguanide (2007).* * cited by examiner (65) Prior Publication Data Primary Examiner Kevin Weddington US 2007/O231386 A1 Oct. 4, 2007 (74) Attorney, Agent, or Firm Hedman & Costigan, P.C. (51) Int. Cl. (57) ABSTRACT A6 IK 9/20 (2006.01) A6 IK 3/44 (2006.01) A pharmaceutical dosage form comprising a controlled A6 IK3I/55 (2006.01) release component comprising an antihyperglycemic drug in (52) U.S. Cl. ........................ 424/464: 514/342: 514/635 combination with a second component comprising a angio (58) Field of Classification Search ................. 514/342, tensin antagonist is herein disclosed and described. 514/635; 424/464 See application file for complete search history. 34 Claims, No Drawings US 7,588,779 B2 1. 2 PHARMACEUTICAL FORMULATION However, none of these patents, or the publication describe a CONTAINING A BIGUANDE AND AN dosage form having the advantages of the Subject invention. ANGOTENSIN ANTAGONST Angiotensin antagonists are compounds functioning to control the renin-angiotensin System as well as being clini BACKGROUND OF THE INVENTION cally useful for the treatment of circulatory diseases Such as hypertensive diseases, heart diseases (e.g. hypercardia, heart The present invention relates to a pharmaceutical dosage failure, cardiac infarction, etc.), strokes, cerebral apoplexy, form comprising an antihyperglycemic drug, in combination etc. These compounds are required to have potent angiotensin with a second drug. More specifically, the present invention II receptor antagonistic activity and to exert strong oral and relates to an oral dosage form comprising a biguanide, e.g., 10 long-lasting angiotensin II antagonist action. Several 2-sub metformin or buformin or a pharmaceutically acceptable salt stituted benzimidazole derivatives possessing highly angio thereof e.g., metformin hydrochloride or the metformin salts tensin II receptor antagonistic activity as well as exerting described in U.S. Pat. Nos. 3,957,853 and 4,080,472, which strong oral and long-lasting angiotensin II antagonistic and are incorporated herein by reference in combination with an anti-hypertensive action have been developed. These com angiotensin antagonist as described in U.S. Pat. Nos. 5,196, 15 pounds are potent angiotensin II antagonists that are of value 444; 5,534,534; 5,703,110; and 5,705,517 also incorporated in the treatment of circulatory system diseases such as hyper herein by reference. tensive diseases, heart diseases, strokes, nephritis, etc. Many techniques have been used to provide controlled and Also known in the art is WO 99/471.25 and U.S. Pat. No. extended-release pharmaceutical dosage forms in order to 6,099,862 that disclose a metformin osmotic tablet coated maintain therapeutic serum levels of medicaments and to with an immediate release coating containing an antihyperg minimize the effects of missed doses of drugs caused by a lycemic or a hypoglycemic drug. lack of patient compliance. Although the prior art teaches pharmaceutical dosage for For example, extended release tablets have been described mulations that contain both an antihyperglycemic compound which have an osmotically active drug core surrounded by a and an angiotensin antagonist, the present invention provides semi-permeable membrane. These tablets function by allow 25 numerous benefits over the prior art teachings as will be ing the aqueous components of a fluid Such as gastric or described below. intestinal fluid to permeate the coating membrane and dis Solve the active ingredient so the resultant drug solution can be released through a passageway in the coating membrane. SUMMARY OF THE INVENTION Alternatively, if the active ingredient is insoluble in the per 30 meating fluid, it can be pushed through the passageway by an The present invention relates to a pharmaceutical dosage expanding agent such as a hydrogel. Some representative form comprising a first active drug, preferably an antihyper examples of these osmotic tablet systems can be found in U.S. glycemic drug, in combination with a second active drug. The Pat. Nos. 3,845,770; 3,916,899; 4,034,758; 4,077,407 and second active drug may be any drug useful in combination 4,783,337. U.S. Pat. No. 3,952,741 teaches an osmotic device 35 therapy with the first active drug. In one embodiment, the first wherein the active agent is released from a core Surrounded active drug is a biguanide and the second active drug is an by a semipermeable membrane only after sufficient pressure angiotensin antagonist. has developed within the membrane to burst or rupture the In certain embodiments, the second active drug may be membrane at a weak portion of the membrane. selected from antidiabetic agents, cardiovascular agents, anti The basic osmotic device described in the above cited 40 lipemic agents, or antiplatelet agents. patents have been refined over time in an effort to provide The termantidiabetic agent may include, but would not be greater control of the release of the active ingredient. For limited to biguanides (i.e., Metformin, Buformin, Phen example, U.S. Pat. Nos. 4,777,049 and 4,851,229 describe formin), Sulfonylureas (i.e., Acetohexamide, Carbutamide, osmotic dosage forms comprising a semipermeable wall Sur Chlorpropamide, Glibornuride, Gliclazide, Glimepiride, rounding a core. The core contains an active ingredient and a 45 Glipizide, Gliquidone, Glisoxepid, Glyburide, Glybuthiaz modulating agent wherein the modulating agent causes the ole, Glybuzole, Glyhexamide, Glymidine, Glypinamide, active ingredient to be released through a passageway in the Phenbutamide, Tolazamide, Tolbutamide, Tolcyclomide) semipermeable membrane in a pulsed manner. Further refine thiazolidinediones (i.e., PiogliataZone, RosiglitaZone, Trogli ments have included modifications to the semipermeable taZone), beta andrenergic blockers, and other antidiabetics membrane Surrounding the active core such as varying the 50 Such as acarbose, calcium mesoxalate, miglitol, nateglinide, proportions of the components that form the membrane, e.g. repaglinide, Voglibose. U.S. Pat. Nos. 5,178,867, 4,587,117 and 4,522,625, or The term cardiovascular agent may include, but would not increasing the number of coatings Surrounding the active be limited to, alpha andrenergic agonists that include, but are core, e.g., U.S. Pat. Nos. 5,650,170 and 4,892,739. not limited to, Adrafinil, Adrenalone, Amidephrine, Apra Certain controlled or sustained release formulations that 55 clonidine, Budralazine, Clonidine, Cyclopentamine, Dexme employ antihyperglycemic drugs such as metformin hydro detomidine, Dimetofrine, Dipivefrin, Ecabapide, Ephedrine, chloride have been limited to the use of an expanding or Epinephrine, Fenoxazoline, Guanabenz, Guanfacine, gelling agent to control the release of the drug from the Hydroxyamphetamine, Ibopamine, Indanazoline, dosage form. This limited research is exemplified by the Isometheptene, Mephentermine, Metaraminol, Methoxam teachings of WO 96/08243 and by the product insert for 60 ine, Methylhexaneamine, Midodrine, MivaZerol, Modafinil, GLUCOPHAGETM XR, which is a controlled release met Moxonidine, Naphazoline, Norepinephrine, Norfenefrine, formin HCl product commercially available from Bristol Octodrine, Octopamine, Oxymetazoline, Phenylephrine Myers Squibb Co. Hydrochloride, Phenylpropanolamine, Phenylpropylmethy Angiotensin antagonists have been described in U.S. Pat. lamine, Pholedrine, Propylhexedrine, Pseudoephedrine, Ril Nos. 5,196,444; 5,534,534 and 5,705,517. The therapeutic 65 menidine, Synephrine, Talipexole, Tetrahydrozoline, Tia value of these compounds in combination therapy has further menidine, TramaZoline, Tuaminoheptane, TymaZoline, been described in published PCT application WO 0215933. Tyramine, and Xylometazoline. US 7,588,779 B2 3 4 Beta andrenergic agonists include but are not limited to Vasopressors include but are not limited to Antihypoten Albuterol, Bambuterol, Bitolterol, Carbuterol, Clenbuterol, sive: Amezinium Methyl Sulfate, Angiotensin Amide, Clorprenaline, Denopamine, Dixoethedrine, Dopexamine, Dopamine, Dimetofrine, Etifelmin, Etilefrin, Gepefrine, Ephedrine, Epinephrine, Etafedrine, Ethylnorepinephrine, Metaraminol, Methoxamine, Midodrine, Norepinephrine, Fenoterol, Formoterol, Hexoprenaline, Ibopamine, Isoet
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