Discrete Particles In Supporting Matrix Patents (Class 424/469)
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Patent number: 6630162Abstract: The invention relates to a pharmaceutical formulation containing tolterodine or a tolterodine-related compound, or a pharmacologically acceptable salt thereof, as active ingredient, in which the formulation exhibits a controlled in vitro release of the active ingredient in phosphate buffer at pH 6.8 of not less than about 80% after 18 hours, and after oral administration to a patient is capable of maintaining a substantially constant serum level of the active moiety or moieties for 24 hours. The invention also relates to the use of the pharmaceutical formulation for treating overactive bladder and gastrointestinal disorders.Type: GrantFiled: November 9, 2000Date of Patent: October 7, 2003Assignee: Pharmacia ABInventors: Lisbeth Nilvebrant, Bengt Hallen, Birgitta Olsson, Jan Strombom, Torkek Gren, Anders Ringberg, Martin Wikberg
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Patent number: 6627222Abstract: An antibiotic product for delivering at least Amoxicillin or dicloxacillin that is comprised of three dosage forms with different release profiles with each of Amoxicillin and dicloxacillin being present in at least one of the dosage forms.Type: GrantFiled: March 7, 2002Date of Patent: September 30, 2003Assignee: Advancis Pharmaceutical Corp.Inventors: Edward M. Rudnic, James D. Isbiter, Donald J. Treacy, Jr., Sandra E. Wassink
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Patent number: 6627214Abstract: Fumaric acid is added in amounts sufficient to reduce the burn sensation commonly associated with propionic acid derivatives.Type: GrantFiled: May 4, 1999Date of Patent: September 30, 2003Assignee: McNeil-PPC, Inc.Inventors: Frank J. Bunick, Feng Lin
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Patent number: 6627223Abstract: A pharmaceutical dosage form such as a capsule capable of delivering therapeutic agents into the body in a time-controlled or position-controlled pulsatile release fashion, is composed of a multitude of multicoated particulates (beads, pellets, granules, etc.) made of one or more populations of beads. Each of these beads except an immediate release bead has at least two coated membrane barriers. One of the membrane barriers is composed of an enteric polymer while the second membrane barrier is composed of a mixture of water insoluble polymer and an enteric polymer. The composition and the thickness of the polymeric membrane barriers determine the lag time and duration of drug release from each of the bead populations. Optionally, an organic acid containing intermediate membrane may be applied for further modifying the lag time and/or the duration of drug release.Type: GrantFiled: February 7, 2001Date of Patent: September 30, 2003Assignee: Eurand Pharmaceuticals Ltd.Inventors: Phillip Percel, Krishna S. Vishnupad, Gopi M. Venkatesh
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Publication number: 20030180361Abstract: Sustained release oral solid dosage forms of opioid analgesics are provided as multiparticulate systems which are bioavailable and which provide effective blood levels of the opioid analgesic for at least about 24 hours. A unit dose of the opioid analgesic contains a plurality of substrates including the opioid analgesic in sustained release form. The substrates have a diameter from about 0.1 mm to about 3 mm.Type: ApplicationFiled: March 20, 2003Publication date: September 25, 2003Inventors: Benjamin Oshlack, Mark Chasin
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Publication number: 20030181414Abstract: Formulations for the oral administration of NADH in multiparticulate enteric coated form and/or dosed either into gelatine capsules or sachets or dispensersType: ApplicationFiled: March 12, 2003Publication date: September 25, 2003Applicant: VALPHARMA S.A.Inventors: Roberto Valducci, Tiziano Alighieri, Serozh Avanessian
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Patent number: 6623756Abstract: Solid dosage articles such as pharmaceutical tablets for the controlled release of a desired compound such as an active ingredient are directly compressed from a flowable, compressible mixture of the active ingredient, a slightly cross-linked rheology modifying polymer or copolymer, and one or more excipients. The rheology modifying polymer or copolymer is a granulated powder of suitable particle size and is generally made from one or more unsaturated (di)carboxylic acids, half ester thereof, and other optional monomers.Type: GrantFiled: April 27, 2000Date of Patent: September 23, 2003Assignee: Noveon IP Holdings Corp.Inventors: William R. Wilber, Jian-Hwa Guo, Edward S. Greenberg
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Patent number: 6620432Abstract: A pharmaceutical composition is provided containing an admixture of phenytoin sodium and an erodible matrix which extends the release of the phenytoin sodium over about a two hour period. The erodible matrix comprises binder(s) and diluent(s) which control the release of drug from the pharmaceutical composition. The erodible matrix can further comprise an alkaline pH modifier.Type: GrantFiled: May 11, 2001Date of Patent: September 16, 2003Assignee: Mylan Pharmaceuticals Inc.Inventors: William J. Addicks, Joseph P. Duda, Daniel A. Snider, Kerry R. Benson
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Publication number: 20030170304Abstract: The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component comprising a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition.Type: ApplicationFiled: January 30, 2003Publication date: September 11, 2003Inventors: John G. Devane, Paul Stark, Niall M. M. Fanning
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Patent number: 6610323Abstract: An enteric coated pharmaceutical dosage form comprising an H+,K+-ATPase inhibitor is disclosed. The dosage form comprises at least two portions of the H+,K+- ATPase inhibitor to be released in at least two consecutive pulses. The dosage form has at least one fraction with a pulsed delayed release and another fraction with instant release of the H+,K+-ATPase inhibitor. The portions are released in time by from 0.5 and up to 12 hours interval, preferably by from 0.5 and up to 8 hours, and more preferably by from 0.5 and up to 4 hours interval. The dosage form is intended for once daily administration.Type: GrantFiled: January 15, 1999Date of Patent: August 26, 2003Assignee: AstraZeneca ABInventors: Per Johan Lundberg, Brita Sjöblom
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Patent number: 6610328Abstract: An antibiotic product for delivering at least Amoxicillin or Clarithromycin that is comprised of three dosage forms with different release profiles with each of Amoxicillin and Clarithromycin being present in at least one of the dosage forms.Type: GrantFiled: March 7, 2002Date of Patent: August 26, 2003Assignee: Advancis Pharmaceutical Corp.Inventors: Edward M. Rudnic, James D. Isbister, Donald J. Treacy, Jr., Sandra E. Wassink
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Publication number: 20030157172Abstract: A pharmaceutical composition suitable for oral administration is provided, the composition comprising an aqueous medium having suspended therein a solid substance of low water solubility in particulate form, and further comprising a suspending agent and at least one pharmaceutically acceptable water-soluble or swellable nonsurfactant polymer, the total amount of all such polymers present being ineffective to (a) increase viscosity of the composition to a degree that significantly impairs pourability, or (b) significantly increase rate of sedimentation or phase separation, of the composition. The composition has improved mouth feel.Type: ApplicationFiled: December 9, 2002Publication date: August 21, 2003Inventors: Guang Wei Lu, Po-Chang Chiang
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Patent number: 6605303Abstract: An enteric coated pharmaceutical extended release dosage form of a H+, K+-ATPase inhibitor giving an extended plasma concentration profile of a H+, K+-ATPase inhibitor. The extended plasma profile is obtained by a pharmaceutical composition which comprises a core material of a hydrophilic or hydrophobic matrix, and the H+, K+-ATPase inhibitor and optionally pharmaceutically acceptable excipients. The dosage form may be administered once daily.Type: GrantFiled: January 15, 2000Date of Patent: August 12, 2003Assignee: AstraZeneca ABInventors: Per-Gunnar Karehill, Per Johan Lundberg
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Patent number: 6605300Abstract: A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.Type: GrantFiled: July 19, 2001Date of Patent: August 12, 2003Assignee: Shire Laboratories, Inc.Inventors: Beth A. Burnside, Xiaodi Guo, Kimberly Fiske, Richard A. Couch, Donald J. Treacy, Rong-Kun Chang, Charlotte M. McGuinness, Edward M. Rudnic
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Publication number: 20030147955Abstract: Pharmaceutical tablets containing low amounts of a tamsulosin active material are made by a dry process. The tablets, which contain 0.1 to 1.5% tamsulosin active material, can be formed reliably with low variations without the aid of a liquid.Type: ApplicationFiled: November 7, 2002Publication date: August 7, 2003Inventors: Johannes J. Platteeuw, Frans van Dalen, Jacobus M. Lemmens
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Patent number: 6599931Abstract: A test system for characterizing the compatibility of bioactive substances with polyvinylpyrrolidones in a solid dispersion consisting of one or more bioactive substances and 1,3-bis(1-pyrrolidonyl)butane.Type: GrantFiled: September 18, 1999Date of Patent: July 29, 2003Assignee: Abbott GmbH & Co. KGInventors: Jörg Breitenbach, Robert Heger, Dirk Simon, Bernd Liepold
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Patent number: 6599529Abstract: An oral pharmaceutical modified release multiple-units composition for the administration of a therapeutically and/or prophylactically effective amount of a non-steroid anti-inflammatory drug substance to obtain both a relatively fast onset of the therapeutic effect and the maintenance of a therapeutically active plasma concentration for a relatively long period of time is disclosed.Type: GrantFiled: July 17, 2000Date of Patent: July 29, 2003Assignee: Nycomed Danmark A/SInventors: Annette Skinhøj, Poul Bertelsen
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Patent number: 6596311Abstract: This invention provides a formulation for preparing a fast disintegrating tablet comprising a drug in multiparticulate form, one or more water insoluble inorganic excipients, one or more disintegrants, and optionally one or more substantially water soluble excipients, the amounts of said ingredients being such as to provide a disintegration time for the tablet in the order of 75 seconds or less, typically 30 seconds or less.Type: GrantFiled: September 6, 2000Date of Patent: July 22, 2003Assignee: Eurand International S.p.A.Inventor: Luca Dobetti
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Patent number: 6596844Abstract: The present invention pertains to a method for forming poly-acrylic acid granules and granules formed therefrom wherein the granules are flowable, have an increased bulk density relative to the as polymerized polyacrylic acids, and a low amount of dust which is generally characterized herein as particles which pass through a 325 mesh screen. The granules formed by the method of the present invention can be used to prepare controlled release tablets, especially controlled release pharmaceutical tablets. The controlled release properties of the tablets formed from granules prepared according to the present invention are unexpectedly better than tablets prepared from granules formed by other known granulation methods.Type: GrantFiled: December 20, 2001Date of Patent: July 22, 2003Assignee: Noveon IP Holdings Corp.Inventors: Daniel James Adams, David William Weaver
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Publication number: 20030133982Abstract: The present invention relates to zero-order sustained release solid dosage forms suitable for administration of a wide range of therapeutically active medicaments, especially those that are water-soluble, and to a process of making same. The solid dosage form comprises (a) a matrix core comprising ethylcellulose and the active agent and (b) a hydrophobic polymer coating encasing the entire matrix core.Type: ApplicationFiled: December 19, 2002Publication date: July 17, 2003Inventors: John M. Heimlich, Loksidh D. Ganorkar, Ernest J. Lee, Robert M. Noack, Ronald R. VerHage
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Patent number: 6592902Abstract: The invention relates to oral pharmaceutical compositions useful as aldosterone receptor blockers comprising the active agent micronized eplerenone in an amount of about 10 mg to about 1000 mg and one or more carrier materials.Type: GrantFiled: January 31, 2002Date of Patent: July 15, 2003Inventors: Shilpa S. Thosar, Rajeev D. Gokhale, Dwain S. Tolbert
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Patent number: 6592897Abstract: The invention relates to a controlled release tablet which in part or as a whole contains water-insoluble linear polysaccharides, preferably the polysaccharide poly(1,4-&agr;-D-glucan), in the form of microparticles, as retardation material. The tablet is also capable of controllably releasing an active agent.Type: GrantFiled: January 25, 2001Date of Patent: July 15, 2003Assignee: Axiva GmbHInventors: Holger Bengs, Silke Schuth, Jürgen Grande, Gitte Böhm, Arnold Schneller
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Publication number: 20030124187Abstract: Novel coamoxiclav formulations are described, having reduced weight compared to existing formulations, as well as formulations comprising amoxycillin and potassium clavulanate in a ratio of 8:1 and formulations prepared from granulates of amoxycillin and granulates of amoxycillin and clavulanate.Type: ApplicationFiled: November 22, 2002Publication date: July 3, 2003Applicants: SmithKline Beecham Laboratoires Pharmaceutiques,, SmithKline Beecham s.a., SmithKline Beecham CorporationInventors: Jacky Andre Gustave Mention, Jose Luis Sanroma Bordallo, Kevin Huntley Storm
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Patent number: 6576260Abstract: Disclosed herein is sustained-release formulations of tramadol comprising tramadol saccharinate coated with at least one sustained-release coating. The sustained release formulations may also contain tramadol in non-sustained release form, and other pharmaceutically acceptable excipients. Also disclosed are methods of preparation of and methods of treatment using the inventive formulations.Type: GrantFiled: February 28, 2002Date of Patent: June 10, 2003Assignee: Gruenenthal GmbHInventors: Johannes Bartholomaeus, Heinrich Kugelmann, Iris Ziegler
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Publication number: 20030104060Abstract: The invention provides fenofibrate tablets comprising granulates, wherein the granulates can comprise carrier particles, micronized fenofibrate, and at least one hydrophilic polymer.Type: ApplicationFiled: November 8, 2002Publication date: June 5, 2003Inventors: Andre Stamm, Pawan Seth
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Patent number: 6572889Abstract: A polymer or copolymer composition derived from one or more unsaturated carboxylic acids that is cross-linked and carbamazepine in conjunction with conventional materials such as fillers, excipients, and surface active agents is disclosed. Solid dosage forms of immediate and sustained release tablets containing the polymer or copolymer composition can be formed by wet granulation or wet granulation followed by blending with direct compression ingredients. The polymer or copolymer, as a controlled release agent, can enhance controlled-release properties while meeting acceptable release rates as specified by the USP.Type: GrantFiled: March 7, 2002Date of Patent: June 3, 2003Assignee: Noveon IP Holdings Corp.Inventor: Jian-Hwa Guo
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Publication number: 20030099709Abstract: The present invention relates generally to the development of pharmaceutical compositions which provide for sustained release of biologically active polypeptides. More specifically, the invention relates to the use of pH/thermosensitive, biodegradable hydrogels, consisting of a A-B di block or A-B-A tri block copolymer of poly(d,l- or l-lactic acid) (PLA) or poly(lactide-co-glycolide) (PLGA) (block A) and polyethylene glycol (PEG) (block B), with ionizable functional groups on one or both ends of the polymer chains, for the sustained delivery of biologically active agents.Type: ApplicationFiled: July 8, 2002Publication date: May 29, 2003Applicant: Amgen Inc.Inventors: Subodh Shah, Weiguo Dai
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Publication number: 20030099708Abstract: The invention includes dispensing a suspension containing solid particles for use in manufacturing a dosage form or other biomedical article by 3DP. The suspension contains solid particles suspended in a liquid. The solid particles may be one or more Active Pharmaceutical Ingredients. The solid particles may be particles of material that are insoluble in the liquid, or they may be particles of a substance that have already dissolved in the liquid up to the saturation level and are present in a concentration beyond what can be dissolved. In addition to solid particles, the liquid may also contain other substances dissolved in it, either substances containing Active Pharmaceutical Ingredients (API) or substances without API. One aspect of the invention includes prevention of agglomeration by adding one or more of several categories of additives to the suspending liquid.Type: ApplicationFiled: November 21, 2001Publication date: May 29, 2003Applicant: Therics, IncInventors: Charles William Rowe, Wendy E. Pryce Lewis, Michael J. Cima, Esteban R.N. Bornancini, Jill K. Sherwood, Chen-Chao Wang, Christopher M. Gaylo, James A. Fairweather
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Patent number: 6569455Abstract: The present invention relates to stable quick-release extrudates that contain low-viscosity hydroxypropylcellulose and at least one active ingredient. This invention also relates to a method for preparing said extrudates without the use of solvents as well as to the use of said extrudates in the production of quick-release preparations.Type: GrantFiled: January 9, 2002Date of Patent: May 27, 2003Assignee: Bayer AktiengesellschaftInventors: Venkata-Rangarao Kanikanti, Jürgen Sdebik
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Patent number: 6565883Abstract: Pharmaceutical composition capable of releasing a therapeutically effective dose of active agent, e.g., rivastigamine, in a time-controlled manner.Type: GrantFiled: April 8, 2002Date of Patent: May 20, 2003Assignee: Novartis AGInventors: Jörg Ogorka, Oskar Kalb, Rajen Shah, Satish Chandra Khanna
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Patent number: 6558703Abstract: A drug delivery system for oral administration in solid dry form of a greasy/oily/sticky substance and a pharmaceutically active substance or a pharmaceutically active substance which itself is greasy/oily/sticky characterized by having a plurality of porous inorganic particles of small size incorporated with considerable amounts of greasy/oily/sticky substances and having fast release characteristics and a process for the preparation of such porous inorganic particles containing greasy/oily/sticky substances.Type: GrantFiled: January 4, 1999Date of Patent: May 6, 2003Assignee: AstraZeneca ABInventors: Christer Karlsson, Per Johan Lundberg, Adam Rosinski, Malin Söderbom
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Patent number: 6558699Abstract: This invention relates to high drug load granulation of (E)-&agr;-[2-n-butyl-1-[(4-carboxyphenyl)methyl]-1H-imidazol-5-yl]methylene-2-thiophenepropionic acid in the anhydrous form, a process for its production, compositions containing the compound and methods of using the compound to block angiotensin II receptors and to treat hypertension, congestive heart failure and renal failure.Type: GrantFiled: December 12, 2001Date of Patent: May 6, 2003Assignee: SmithKline Beecham CorporationInventor: Gopadi M. Venkatesh
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Patent number: 6558701Abstract: A multilayer tablet for oral administration containing at least one Tramadol layer including Tramadol or a physiologically acceptable salt thereof; at least one diclofenac layer including diclofenac or a physiologically acceptable salt thereof, and at least one separating layer which separates the tramadol layer(s) and the diclofenac layer(s) from each other.Type: GrantFiled: December 17, 2001Date of Patent: May 6, 2003Assignee: Gruenenthal GmbHInventors: Johannes Bartholomaeus, Iris Ziegler
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Patent number: 6558700Abstract: A multiple-unit sustained release tablet characterized by consisiting of a granular part and a powdery part, each granule comprising a matrix composed of a water-insoluble polymer and an active ingredient. Another tablet characterized in that each granule is coated with a release-controlling film. The object of the present invention is to provide a multiple-unit sustained release tablet showing little change in dissolution speed caused by the compression in the tableting step.Type: GrantFiled: October 17, 2000Date of Patent: May 6, 2003Assignee: Taisho Pharmaceutical Co., Ltd.Inventors: Kazutaka Tsuchida, Shinji Aoki
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Patent number: 6555136Abstract: Novel pharmaceutical dosage forms provide for pulsatile delivery of methylphenidate, i.e., release encapsulated drug in spaced apart “pulses.” The dosage forms are comprised of first, second and optionally third dosage units, with each dosage unit having a different drug release profile. The dosage forms may comprise capsules housing compressed tablets or drug-containing beads or particles, or may comprise a single tablet with the first, second and optionally third dosage units each representing an integral and discrete segment thereof. Methods of treatment using the pharmaceutical dosage forms are provided as well.Type: GrantFiled: November 13, 2001Date of Patent: April 29, 2003Assignee: PharmaQuest, Ltd.Inventor: Kamal K. Midha
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Patent number: 6555137Abstract: A coated antacid comprising sucralfate and an antacid inhibits decline in the adhesion characteristics of sucralfate whereby the drug ingested can reliably show its effect in the stomach. This coated antacid not only shows the mucosa repairing effect of sucralfate itself, but also shows the antacid effect and the gastric mucosa protective effect of the coated antacid, thereby synergistically producing an excellent antiulcer effect and an excellent ulcer inhibiting/healing effect.Type: GrantFiled: December 29, 1999Date of Patent: April 29, 2003Assignees: Chugai Seiyaku Kabushiki Kaisha, Fuji Chemical Industry Co., Ltd.Inventors: Tamotsu Yamazaki, Heiji Ikushima, Tetsuo Shirai
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Patent number: 6551620Abstract: An orally adminsterable pharmaceutical pellet formulation for the treatment of the intestinal tract is disclosed, which comprises a core and an enteric coating, the core including, as a pharmaceutical active compound, aminosalicylic acid or a pharmaceutically tolerable salt or a derivative thereof.Type: GrantFiled: July 16, 2001Date of Patent: April 22, 2003Assignee: Dr. Falk Pharma GmbHInventor: Norbert Otterbeck
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Patent number: 6551618Abstract: Devices useful in the delivery of DNA encoding neurotrophic agents, anti-fibrotic agents, and related compositions are disclosed herein for use in the treatment of central and/or peripheral nervous system injury. Methods of making and using the disclosed devices and DNA are also described. In various embodiments, the invention also discloses compositions and devices that may further include a targeting agent, such as a polypeptide that is reactive with an FGF receptor (e.g., bFGF), or another ligand that binds to cell surface receptors on neuronal cells, or a support cell. The invention also discloses methods of promoting neuronal survival and regeneration via transfection of an axon as it grows through a device or composition of the present invention, or via transfection of a repair cell.Type: GrantFiled: October 23, 1998Date of Patent: April 22, 2003Assignees: University of Birmingham, King's College, Selective Genetics, Inc.Inventors: Andrew Baird, Ana Maria Gonzalez, Ann Logan, Martin Berry
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Patent number: 6551617Abstract: There is provided a coating composition that masks the undesirable taste of a pharmaceutically active ingredient, i.e. drug or medicine, that is consumed orally. The coating composition has polyvinyl acetate, and a dimethylaminoethyl methacrylate and neutral methacrylic acid ester. Optionally, an alkaline modifier may be included in the coating composition to enhance release of the active ingredient.Type: GrantFiled: April 20, 2000Date of Patent: April 22, 2003Assignee: Bristol-Myers Squibb CompanyInventors: Michael Corbo, Jatin Desai, Mahesh Patell, Ronald Warrick
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Patent number: 6548083Abstract: The present invention is directed to an active agent dosage form which is adapted for retention in the stomach and useful for the prolonged delivery of an active agent formulation to a fluid environment of use. The active agent dosage form is a polymer matrix that swells upon contact with the fluids of the stomach. A portion of the polymer matrix is surrounded by a band of insoluble material that prevents the covered portion of the polymer matrix from swelling and provides a segment of the dosage form that is of sufficient rigidity to withstand the contractions of the stomach and delay expulsion of the dosage form from the stomach until substantially all of the active agent has been dispensed.Type: GrantFiled: July 13, 2000Date of Patent: April 15, 2003Assignee: Alza CorporationInventors: Patrick S.-L. Wong, Liang-Chang Dong, David E. Edgren, Felix Theeuwes, Phyllis I. Gardner, Francisco Jao, Jason J. Wan
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Patent number: 6544553Abstract: Provided is an oral dosage form suitable to deliver a combined dosage of progesterone and which upon delivery through the gastrointestinal tract provides a blood concentration of from about 0.1 ng/ml to about 400 ng/ml progesterone; said dosage form comprising a combination that includes (a) a first solid form comprising from about 25 mg to about 500 mg micronized progesterone in a solid polyethylene glycol carrier having an average molecular weight of from about 1000 to 10,000 and constituting at least about 30% of said first solid form; and (b) a second solid form comprising an estrogen.Type: GrantFiled: December 28, 1999Date of Patent: April 8, 2003Assignee: Watson Pharmaceuticals, Inc.Inventors: David Chung Hsia, Thomas Chun Ho, Domingo Yap Tan, Fredric B. Weihmuller
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Patent number: 6544556Abstract: An oral solid dosage form includes a therapeutically effective amount of an NSAID and a proton pump inhibitor in an amount effective to inhibit or prevent gastrointestinal side effects normally associated with the NSAID. Also disclosed is a method of treating a human patient in need of antiinflammatory, analgesic and/or antipyretic therapy, comprising orally administering to the patient an oral pharmaceutical dosage form which includes a therapeutically effective amount of an NSAID and an amount of a proton pump inhibitor effective to substantially inhibit gastrointestinal side effects of the NSAID. The invention is further related to a method of prophylactically treating a human patient who is on a therapy known to have significant gastrointestinal side effects or is about to begin such a therapy, via concurrent administration of an NSAID and a proton pump inhibitor in a combination (single) oral dosage form.Type: GrantFiled: September 11, 2000Date of Patent: April 8, 2003Assignee: Andrx CorporationInventors: Chih-Ming Chen, Unchalee Kositprapa
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Patent number: 6537580Abstract: The present invention provides storage stable, shaped particles of allotropic organic compounds. The particles of the present invention can be shaped according to the desired application. Preferred shapes of such particles are microspheres, particularly those having diameters of about 1 to about 1,000 microns. The stable shaped particles of the present invention are particularly well-suited to the fabrication of pharmaceutical formulations, particularly where sustained release and uniform bioavailability are desired. The storage stable particles are formed by a solid state crystallization of allotropic organic compounds. The solid state crystallization process of the present invention affords a means for achieving a storage stable crystalline form of said allotropic compound without loss or deterioration of the original particle dimensions.Type: GrantFiled: July 12, 2000Date of Patent: March 25, 2003Inventors: John-Claude Savoir, Juan Angeles, Aurelio De Gyves, Abraham Gomez
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Patent number: 6534090Abstract: The present invention is for an oral osmotic controlled drug delivery system for a sparingly soluble drug comprising: a. a core comprising (i) finely particulate anhydrous carbamazepine (ii) a polymeric swelling agent consisting of one or more swellable hydrophilic polymers selected such that the polymeric swelling agent exhibits controlled swelling and the wall does not rupture or burst, (iii) a crystal habit modifier in whose presence, upon contact with an aqueous medium, the anhydrous carbamazepine being transformed into cuboidal or rod-shaped crystals of the dihydrate of carbamazepine, or mixtures thereof, and (iv) water-soluble compounds for inducing osmosis, b. a wall made of acylated cellulose which is impermeable to the components of the core, but permeable to water, and c. a passageway through the wall for releasing the components present in the core to the surrounding environment.Type: GrantFiled: June 26, 2001Date of Patent: March 18, 2003Assignee: Sun Pharmaceutical Advanced Research Centre LimitedInventors: Shivanand P. Puthli, Suma G. Menon, Jayant S. Karajgi, Nitin B. Dharmadhikari, Ratnesh H. Shrivastava, Pratibha S. Pilgaonkar
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Patent number: 6534089Abstract: The invention disclosed pertains to a novel delivery system comprising an agent formulation and means for dispensing the agent formulation from the delivery system.Type: GrantFiled: June 23, 2000Date of Patent: March 18, 2003Assignee: Alza CorporationInventors: Atul D. Ayer, Andrew Lam, Judy A. Magruder, Lawrence G. Hamel, Patrick S. L. Wong
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Patent number: 6534088Abstract: This invention discloses an orally administered pharmaceutical composition for the treatment of elevated levels of cholesterol and related conditions comprising a statin and fenofibrate in the form of microparticles of solid fenofibrate that are stabilized by phospholipid as a surface active substance, wherein a therapeutically effective amount of the composition provides the statin and a quantity of fenofibrate to a fasted human patient that is greater than 80% of the quantity of fenofibrate provided by the same amount of the composition when administered to the same patient who has been fed a high fat meal.Type: GrantFiled: April 20, 2001Date of Patent: March 18, 2003Assignee: SkyePharma Canada Inc.Inventors: Pol-Henri W. Guivarc'h, Indu Parikh, Robert A. Snow
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Publication number: 20030049319Abstract: A controlled release pharmaceutical formulation for the administration of an antihistamine and decongestant to a patient wherein the formulation employs a compressed matrix core for the controlled release of a decongestant and an immediate release coating for the immediate release of the antihistamine.Type: ApplicationFiled: September 16, 2002Publication date: March 13, 2003Inventors: Mongkol Sriwongjanya, Timothy Weng, David Barman, Unchalee Kositprapa
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Patent number: 6531158Abstract: The present invention provides a drug delivery system for the oral administration of a hydrophobic active ingredient. The active ingredient's post-ingestion dissolution rate and its corresponding bioavailability can be optimized by intimately mixing a micronized hydrophobic drug with suitably sized inert particles to a dispersion that will facilitate desired bioavailability. In a particular embodiment, the hydrophobic active ingredient is fenofibrate. Suitably sized inert particles include microcrystalline cellulose and lactose. Dispersion may be monitored by microscopic visualization.Type: GrantFiled: August 9, 2000Date of Patent: March 11, 2003Assignee: Impax Laboratories, Inc.Inventors: Ching-Ling Teng, Charles Hsiao, Joshua Gatts
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Publication number: 20030044466Abstract: Drugs intended for absorption in the stomach or upper intestinal tract are administered in oral drug delivery systems in conjunction with any of various substances that have been discovered to function as potent agents for inducing the fed mode. By inducing the onset of the fed mode, these agents cause the stomach to prolong its retention of the drug delivery system, which is either large enough to be retained in the stomach during the fed mode or swells or expands to such a size upon ingestion. The fed mode inducing agents include the following compounds and their salts: glycine and glycylglycine, xylitol and related sugar alcohols, sodium and other metal docusates, &bgr;-casomorphins, &agr;-lipoic acid and similarly structured acids, 2,2-diaryl-4-(4′-aryl-4′-hydroxypipendino)butyramides, arginine, Trp-Trp, alkylpyridinium halides, dihydroxybenzoic acids, and potent sweeteners such as aspartame, aspartic acid, acesulfame, and stevioside.Type: ApplicationFiled: September 4, 2002Publication date: March 6, 2003Applicant: DEPOMED, INC.Inventors: Micheline Markey, John W. Shell, Bret Berner
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Patent number: 6528094Abstract: The present invention provides storage stable, shaped particles of allotropic organic compounds. The particles of the present invention can be shaped according to the desired application. Preferred shapes of such particles are microspheres, particularly those having diameters of about 1 to about 1,000 microns. The stable shaped particles of the present invention are particularly well-suited to the fabrication of pharmaceutical formulations, particularly where sustained release and uniform bioavailability are desired. The storage stable particles are formed by a solid state crystallization of allotropic organic compounds. The solid state crystallization process of the present invention affords a means for achieving a storage stable crystalline form of said allotropic compound without loss or deterioration of the original particle dimensions.Type: GrantFiled: May 23, 2001Date of Patent: March 4, 2003Inventors: John-Claude Savoir, Juan Angeles, Aurelio De Gyves, Abraham Gomez