Source: http://www.google.com/patents/US7759359?dq=6272333
Timestamp: 2016-06-29 13:38:22
Document Index: 794405152

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 2', 'Application No. 2', 'Application No. 04', 'Application No. 2', 'Application No. 04', 'Application No. 2', 'Application No. 04']

Patent US7759359 - Method of treating bladder dysfunction with once-a-day trospium salt formulation - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA pharmaceutical composition of a pharmaceutically acceptable trospium salt, with upon administration to a human patient generates an average steady state blood levels of trospium with a minimum (Cmin) and maximum (Cmax) blood levels of about 0.5-2.5 ng/ml and about 2.0-6.0 ng/ml, respectively....http://www.google.com/patents/US7759359?utm_source=gb-gplus-sharePatent US7759359 - Method of treating bladder dysfunction with once-a-day trospium salt formulationAdvanced Patent SearchPublication numberUS7759359 B2Publication typeGrantApplication numberUS 11/889,964Publication dateJul 20, 2010Priority dateNov 4, 2003Fee statusPaidAlso published asCA2537103A1, CA2537103C, DE602004030931D1, EP1680110A1, EP1680110A4, EP1680110B1, EP2210605A1, US7410978, US7763635, US7781448, US7781449, US20050191351, US20080207661, US20080207662, US20080207663, US20080207664, US20100221352, US20100221353, US20100221354, US20100221355, US20100221356, US20100222375, US20130089607, WO2005046684A1Publication number11889964, 889964, US 7759359 B2, US 7759359B2, US-B2-7759359, US7759359 B2, US7759359B2InventorsArgaw Kidane, Henry H. Flanner, Padmanabh Bhatt, Arash RaoufiniaOriginal AssigneeSupernus Pharmaceuticals, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (91), Non-Patent Citations (60), Referenced by (6), Classifications (35), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetMethod of treating bladder dysfunction with once-a-day trospium salt formulation
US 7759359 B2Abstract
This application is a Continuation of U.S. application Ser. No. 10/980,818 filed Nov. 4, 2004 now U.S. Pat. No. 7,410,978, which claims the benefit under 35 U.S.C. �119(e) of U.S. Provisional Application No. 60/517,198 filed Nov. 4, 2003, and U.S. Provisional Application No. 60/523,968 filed Nov. 21, 2003, which are hereby incorporated by reference in their entirety.
The present invention is primarily directed to once-daily, orally administrable forms of trospium, which due to its charged nature is usually found in the form of a salt, typically trospium chloride. Such formulations have not been previously known, most likely because trospium chloride presents challenges due to its high solubility and limited absorption window. Moreover, previous researchers have noted that due to the limited region of absorption, conventional modified release dosage forms were not thought practical. See, e.g., Schr�der, S. et al. (Institute for Pharmacology, Clinical Pharmacology, University of K In and Madaus AG, K�ln, Germany). However, the present inventors have discovered oral dosage forms, which can be given once a day yet meet the steady state blood levels required for the treatment or prevention of diseases or conditions that would benefit from its spasmolytic activity.
The delayed-release component has a coat applied to the surface of the active pellet that delays the release of the drug from the pellet after administration for a certain period of time. This delayed release is accomplished by applying a coating of enteric materials. “Enteric materials” are polymers that are substantially insoluble in the acidic environment of the stomach, but are predominantly soluble in intestinal fluids at various specific pHs. The enteric materials are non-toxic, pharmaceutically acceptable polymers, and include, for example, cellulose acetate phthalate (CAP), hydroxypropyl methylcellulose phthalate (HPMCP), polyvinyl acetate phthalate (PVAP), hydroxypropyl methylcellulose acetate succinate (HPMCAS), cellulose acetate trimellitate, hydroxypropyl methylcellulose succinate, cellulose acetate succinate, cellulose acetate hexahydrophthalate, cellulose propionate phthalate, copolymer of methylmethacrylic acid and methyl methacrylate, copolymer of methyl acrylate, methylmethacrylate and methacrylic acid, copolymer of methylvinyl ether and maleic anhydride (Gantrez ES series), ethyl methyacrylate-methylmethacrylate-chlorotrimethylammonium ethyl acrylate copolymer, natural resins such as zein, shellac and copal collophorium, carboxymethyl ethylcellulose, co-polymerized methacrylic acid/methacrylic acid methyl esters such as, for instance, materials known under the trade name EUDRAGIT�L12.5, L100, or EUDRAGIT�S12.5, S100, and several commercially available enteric dispersion systems (e.g., EUDRAGIT� L30D55, EUDRAGIT� FS30D, EUDRAGIT� L100-55, EUDRAGIT� S100 (Rohm Pharma), KOLLICOAT� MAE30D and 30DP (BASF), ESTACRYL� 30D (Eastman Chemical), AQUATERIC� and AQUACOAT� CPD30 (FMC)). The foregoing is a list of possible materials, but one of skill in the art would appreciate that there are other such materials that would meet the objectives of the present invention of providing for a delayed release profile including tailoring release based on the ambient pH environment, temporal considerations and other factors.
Trospium chloride immediate release (IR) pellets were manufactured by coating 30/35-mesh sugar spheres with trospium chloride from a coating dispersion consisting of trospium chloride, hydroxypropylmethylcellulose (HPMC E5, a binder), talc (an anti-tacking agent), and water in a Glatt's� GPCG-1 fluid bed coater. Table 1 provides the formula composition of trospium chloride IR capsules, as well as modified release compositions, and Table 2 sets forth the composition of the pellets. The drug layering dispersion is prepared by dissolving the HPMC E5 in water, dissolving the trospium chloride therein, then dispersing the talc, and stirring for 20 minutes. The resulting dispersion was stirred throughout the coating process to prevent settling of coating components. Coating parameters for Glatt's� GPCG-1 are given in Table 3. The pellets generated contained about 20% w/w of trospium chloride.
The composition of trospium chloride XR pellet filled capsules is provided in Table 1. Trospium chloride XR pellets were manufactured by coating trospium chloride immediate release pellets with a Surelease� Clear coating dispersion using a Glatt� fluid bed coater. Surelease� Clear is a 25% w/w aqueous dispersion supplied by Colorcon (West Point, Pa.). The Surelease� Clear coating dispersion was prepared by adding water to Surelease� Clear and mixing for 20 minutes to achieve a 20% w/w dispersion of Surelease� Clear. This 20% w/w Surelease� Clear dispersion was used for coating. The resulting dispersion was stirred throughout the coating process to prevent settling of coating components. Various coating levels of Surelease� Clear were examined with the objective of achieving extended release pellets with different extents of delay in coating dissolution, which are shown in Table 4. FIG. 2 shows the dissolution profiles for ethylcellulose coated trospium pellets.
The composition of trospium chloride DR pellet filled capsules is provided in Table 1. Table 2 provides the composition of delayed release pellets. Trospium chloride immediate release pellets were coated with Eudragit� L30D55 from a coating dispersion consisting of Eudragit� L30D55, triethylcitrate (a plasticizer), talc (an anti-tacking agent), and water using a Glatt� fluid bed coater. Eudragit� L30D55 is a 30% w/w aqueous dispersion supplied by Rohm America (Piscataway, N.J.). The Eudragit� L30D55 coating dispersion was prepared by dispersing talc in water and mixing for at least 20 minutes. Eudragit� L30D55 dispersion was sieved through an 80-mesh sieve. Triethylcitrate was added to the Eudragit�L30D55 dispersion and mixed for at least 30 minutes. The talc dispersion was then slowly poured into the Eudragit� L30D55/TEC dispersion and mixed for at least 30 minutes. The resulting dispersion (an 11.7% w/w Eudragit� L30D55 aqueous dispersion) was filtered through an 80-mesh sieve and stirred throughout the coating process to prevent settling of coating components. Various coating levels of Eudragit�L30D55 were examined with the objective of achieving an acid resistant coating. FIG. 3 shows the dissolution profiles for trospium chloride delayed release pellets.
Extended release pellets were prepared as in Example 2, with a 15% w/w coating of SURELEASE�. Delayed release pellets were manufactured by coating immediate release pellets with Eudragit FS30D, in a manner similar to Example 3. Eudragit�FS30D is a 30% aqueous dispersion supplied by Rohm America (Piscataway, N.J.). The Eudragit�FS30D coating dispersion is 18% w/w Eudragit�FS30D. The enteric coated pellets are combined with extended release pellets in the XR pellets to DR pellets ratio of 1:1, to achieve a total trospium chloride dose of 60 mg.
Delayed release pellets manufactured by coating immediate release pellets with Eudragit� L30D55 as described in Example 3 were filled into capsules at a fill weight that provides 35 mg trospium chloride in the capsule dosage unit.
A human trial of four controlled release formulations was conducted. The study compared four controlled release dosage units described in the previous examples (DR1 40 mg, DR2 40 mg, XR 40 mg and a mixture of 20 mg IR:120 mg DR2) with a 40 mg IR capsule given as once daily single dose and the 20 mg IR tablet (Spasmo-Lyt�, Madaus), which was given twice a day at 12 hour intervals.
A second human trial was conducted comparing four controlled release formulations described in Table 1b with 20 mg IR tablet (Spasmo-Lyt�, Madaus), which was given twice a day at 12 hour intervals.
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Bul., 18 (10) 1409-1416 (1995).Referenced byCiting PatentFiling datePublication dateApplicantTitleUS20100221352 *Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical composition for the once-a-day oral administration of trospium chlorideUS20100221353 *Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical Composition For Once-A-Day Administration of Trospium ChlorideUS20100221354 *May 12, 2010Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical composition for once-a-day oral administration of trospium chlorideUS20100221355 *Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical composition for once-a-day oral administration of trospium chlorideUS20100221356 *May 12, 2010Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical composition for once a day administration of trospium chlorideUS20100222375 *Sep 2, 2010Supernus Pharmaceuticals, Inc.Pharmaceutical Composition Comprising Trospium Chloride for Once-A-Day Administration* Cited by examinerClassifications U.S. Classification514/299, 514/410, 424/468, 514/413, 514/409, 514/278, 514/414, 514/279International ClassificationA61K9/50, A61K9/48, A61K9/28, A61K31/44, A61K31/4747, A61K9/20, A61K9/22, A61K31/40Cooperative ClassificationA61K9/2086, A61K9/2846, A61K9/5026, A61K9/2866, A61K9/16, A61K9/5078, A61K31/46, A61K9/20, A61K9/5047, A61K9/4808, A61K9/1652European ClassificationA61K9/28H6F2, A61K9/50H6F2B, A61K9/48A, A61K31/44, A61K9/50H6B, A61K9/20K4, A61K9/28H6B2, A61K9/50K2Legal EventsDateCodeEventDescriptionMay 12, 2008ASAssignmentOwner name: SUPERNUS PHARMACEUTICALS, INC.,MARYLANDFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KIDANE, ARGAW;FLANNER, HENRY H.;BHATT, PADMANABH;AND OTHERS;SIGNING DATES FROM 20080227 TO 20080328;REEL/FRAME:020935/0023Owner name: SUPERNUS PHARMACEUTICALS, INC., MARYLANDFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:KIDANE, ARGAW;FLANNER, HENRY H.;BHATT, PADMANABH;AND OTHERS;SIGNING DATES FROM 20080227 TO 20080328;REEL/FRAME:020935/0023Jan 20, 2014FPAYFee paymentYear of fee payment: 4Apr 14, 2015ASAssignmentOwner name: TCD ROYALTY SUB, LLC, NEW YORKFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SUPERNUS PHARMACEUTICALS, INC.;REEL/FRAME:035407/0299Effective date: 20150402RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services