Retarded Or Controlled-release Layer Produced (e.g., Enteric) Patents (Class 427/2.16)
  • Patent number: 11896719
    Abstract: The present invention provides for a method of treatment of IgA nephropathy, which method comprises: (i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711>/Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test; (a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.
    Type: Grant
    Filed: January 23, 2023
    Date of Patent: February 13, 2024
    Assignee: CALLIDITAS THERAPEUTICS AB
    Inventors: Eva Kristina Riesel, Lena Margareta Pereswetoff-Morath, Kari Sandvold, Christian Olle Andreas Pedersen
  • Patent number: 9259507
    Abstract: The invention relates to a bioactive settable hydrogel matrix having a pore creating material, which may also carry a therapeutic agent, and methods of using the same, for example, use in promoting internal wound healing, tissue repair, tissue regeneration.
    Type: Grant
    Filed: April 21, 2009
    Date of Patent: February 16, 2016
    Assignee: Warsaw Orthopedic, Inc.
    Inventors: Thomas Andrew Simonton, Jeffrey L. Scifert
  • Publication number: 20150132396
    Abstract: The present invention relates to a formulation comprising a pharmaceutically active ingredient and a coating. The invention also relates to the use of the formulation in the treatment and prevention of disorders of the gastrointestinal tract. Also disclosed are methods for preparing the formulations.
    Type: Application
    Filed: November 7, 2014
    Publication date: May 14, 2015
    Applicant: SIGMOID PHARMA LIMITED
    Inventors: Ivan Coulter, Vincenzo Aversa, Mónica Rosa, Bernard Francis McDonald
  • Publication number: 20150099003
    Abstract: A sustained-release pharmaceutical composition of topiramate, which is free of binding agent. The sustained-release pharmaceutical composition of topiramate is a sustained-release pellet, comprising a blank pellet core, a drug layer, and a sustained-release coating layer.
    Type: Application
    Filed: March 7, 2013
    Publication date: April 9, 2015
    Applicant: Institute of Pharmacology and Toxicology Academy of Military Medical Sciences P.L.A. China
    Inventors: Song Li, Chunsheng Gao, Wu Zhong, Yuli Wang, Meiyan Yang, Li Shan, Xinbo Zhou, Zhibing Zheng, Xiaokui Wang
  • Publication number: 20150064264
    Abstract: A dosage form comprises a low-solubility drug, and a precipitation-inhibiting polymer. The drug is in a solubility-improved form and in the form of particles at least partially coated with the precipitation-inhibiting polymer.
    Type: Application
    Filed: November 7, 2014
    Publication date: March 5, 2015
    Applicant: Bend Research, Inc.
    Inventors: Leah E. Appel, Walter C. Babcock, Dwayne T. Friesen, Roderick J. Ray, Daniel T. Smithey, Sheri L. Shamblin, Ravi M. Shanker
  • Patent number: 8945616
    Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, and an extended release polymer. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.
    Type: Grant
    Filed: February 17, 2009
    Date of Patent: February 3, 2015
    Assignee: Mylan Pharmaceuticals Inc.
    Inventors: Mummini Aruna Murty, Boyong Li
  • Patent number: 8945615
    Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, an extended release polymer, and an acid. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.
    Type: Grant
    Filed: February 17, 2009
    Date of Patent: February 3, 2015
    Assignee: Mylan Pharmaceuticals Inc.
    Inventors: Mummini Aruna Murty, Boyong Li
  • Publication number: 20130295190
    Abstract: The present disclosure provides improved systems and methods utilizing colloidal/ultrafine superdisintegrant-based composite particles for dispersion and/or dissolution of active pharmaceutical agents. In general, the present disclosure utilizes a surfactant-free or near surfactant-free formulation by incorporating a wet milled SDI as a dispersant in the formulation. As such, the present disclosure provides for the preparation of surfactant-free or substantially surfactant-free formulations (e.g., nano-composite micro-particle formulations) by incorporating a wet-milled superdisintegrant (SDI) as the dispersant in the formulations. The advantageous SDI particles (e.g., colloidal/ultrafine SDI particles) of the present disclosure can be used to break-up the aggregates (e.g., nanoparticle aggregates) of the active agents (e.g. poorly water-soluble drugs) in the formulations (e.g.
    Type: Application
    Filed: March 14, 2013
    Publication date: November 7, 2013
    Applicant: New Jersey Institute of Technology
    Inventors: Ecevit Bilgili, Rajesh Dave, Anagha Bhakay, Mohammad Azad
  • Publication number: 20130289055
    Abstract: A powder of cold-soluble polysaccharide and polyol, which is highly viscous in water and suitable for direct compression, and a method for preparing the powder and uses thereof are described, the powder being notably intended for preparing solid forms with controlled release of an active principle.
    Type: Application
    Filed: November 2, 2011
    Publication date: October 31, 2013
    Applicant: ROQUETTE FRERES
    Inventors: Baptiste Boit, Fabrice Buquet, Gregory Le Bihan, Philippe Lefevre
  • Publication number: 20130142880
    Abstract: The present invention refers to pharmaceutical beclomethasone dipropionate compositions in modified-release gastro-resistant microspheres and to their oral use in the treatment of inflammatory pathologies of the intestinal tract. Said compositions in microspheres comprise: a) a core consisting of a microsphere of inert material; b) a first intermediate coating comprising beclomethasone dipropionate and at least one physiologically acceptable excipient; c) a second modified-release gastro-resistant coating. The present invention also refers to a process for obtaining said compositions.
    Type: Application
    Filed: August 2, 2011
    Publication date: June 6, 2013
    Applicant: SOFAR SPA
    Inventor: Carla Labruzzo
  • Publication number: 20130059010
    Abstract: A sustained release oral pharmaceutical form suitable for single daily dose administration has a neutral microgranule coated with a mounting layer of active ingredient and pharmaceutically acceptable binder; and a coating layer of a hydrophobic coating polymer of a non-water soluble cellulose derivative, and at least 20% of inert load in relation to dry weight of hydrophobic coating polymer. The pharmaceutical form has improved resistance to rapid release of active ingredient, particularly in the presence of alcohol.
    Type: Application
    Filed: May 14, 2010
    Publication date: March 7, 2013
    Applicant: ETHYPHARM
    Inventors: Catherine Herry, Laury Trichard
  • Publication number: 20120141592
    Abstract: The present invention refers to controlled release granular compositions of mesalazine and their use in the treatment of inflammatory pathologies of the intestinal tract. The aforesaid granular compositions comprise: a) a central core comprising an inert substrate; b) an intermediate layer comprising mesalazine and one or more physiologically acceptable excipients; c) a gastro-resistant coating. The present invention then refers to a process for obtaining the aforesaid granular compositions.
    Type: Application
    Filed: July 21, 2010
    Publication date: June 7, 2012
    Applicant: SOFAR SPA
    Inventors: Antonio Mannello, Carla Labzzuo
  • Patent number: 8137734
    Abstract: The present invention is directed to a method of preparing an extended release pharmaceutical composition comprising cyclobenzaprine, comprising coating inert particles with a cyclobenzaprine-containing a drug layering composition to form IR beads, then coating the IR beads with an extended-release coating to form ER beads.
    Type: Grant
    Filed: June 18, 2009
    Date of Patent: March 20, 2012
    Assignee: Aptalis Pharmatech, Inc.
    Inventors: Gopi M. Venkatesh, James M. Clevenger, Timothy Grinstead
  • Publication number: 20120045506
    Abstract: The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol, whereby the ethanol resistance conferring coating layer comprises at least 70% by weight of a mixture of a polymeric portion a) and an excipients portion b), with the polymeric portion a) is consisting of a water insoluble essentially neutral vinyl polymer or vinyl copolymer and the excipients portion b) is consisting of the excipients b1) 100 to 250% by weight of a non-porous inert lubricant, b2) 1 to 35% by weight of a cellulosic compound, b3) 0.1 to 25% by weight of an emulsifier and additionally or alternatively to b3), b4) 0.
    Type: Application
    Filed: March 18, 2009
    Publication date: February 23, 2012
    Applicant: EVONIK ROEHM GmbH
    Inventors: Hans Baer, Thomas Fuerst, Gerhard Renner, Michael Gottschalk
  • Publication number: 20110311631
    Abstract: The invention relates to a controlled release pharmaceutical composition, comprising a core, comprising a pharmaceutical active ingredient, whereby the core is coated by an ethanol resistance conferring coating layer which has the effect of conferring the release profile of the pharmaceutical active ingredient to be resistant against the influence of ethanol. The coating layer comprises a polymeric portion consisting of a water-insoluble neutral vinyl polymer or vinyl copolymer and an amino methacrylate copolymer and an excipients portion consisting of a lubricant, an emulsifier, a plasticizer and optionally a cellulosic compound.
    Type: Application
    Filed: March 18, 2009
    Publication date: December 22, 2011
    Applicant: EVONIK RÖHM GMBH
    Inventors: Hans Baer, Thomas Fuerst, Thomas Rupp, Gerhard Renner, Michael Gottschalk
  • Publication number: 20110217289
    Abstract: Formulations of sparingly water-soluble active ingredientscomprising carrier particles provided with active ingredient-containing coatings, the sparingly soluble active ingredients being embedded in coatings composed of amphiphilic copolymers, and the coatings being applied in the form of a solvent-free melt.
    Type: Application
    Filed: March 4, 2011
    Publication date: September 8, 2011
    Applicant: BASF SE
    Inventors: Karl Kolter, Dejan Djuric
  • Publication number: 20110135722
    Abstract: The present invention deals with a multiparticulate tablet, which disintegrates in the mouth containing: i) a proton pomp inhibiting agent, in particular of the benzimidazole type, in the form of enteric coated microgranules, which enteric coated granules are overcoated with at least one barrier coating, such as for instance a methacrylic copolymer-based protective film; ii) at least one antacid in the form of granules, for instance based on CaCO3 and/or Mg(OH)2 and/or Al(OH)3; and, iii) a mixture of excipients comprising at least one disintegrating agent, one diluent agent, a lubricant, and optionally a swelling agent, a permeabilising agent, sweeteners, flavourings and colours. Furthermore, the present invention is directed to processes for the manufacture of the tablet and its use in the treatment of gastrointestinal disorders.
    Type: Application
    Filed: June 10, 2010
    Publication date: June 9, 2011
    Inventors: Bruno Criere, Nourredine Nouri, Ake Pilbrant, Pascal Suplie, Jean-Marc Zuccarelli
  • Publication number: 20110104266
    Abstract: The object of the present invention is to minimize the risks of dose dumping associated with the concomitant consumption of alcohol and certain modified-release pharmaceutical or dietetic forms. The invention relates to an oral form comprising microparticles of the reservoir type for the modified release of at least one active principle (AP), characterized in that it is resistant to immediate dumping of the dose of AP in the presence of alcohol. In particular, the oral form according to the invention is characterized in that the time taken to release 50% of the AP in an alcoholic solution is not reduced more than 3-fold relative to the time taken to release 50% of the AP in an alcohol-free aqueous medium. The form comprises an agent 13, which is a pharmaceutically acceptable compound whose hydration or solvation rate or capacity is greater in an alcohol-free aqueous medium than in alcoholic solution.
    Type: Application
    Filed: January 11, 2011
    Publication date: May 5, 2011
    Applicant: Flamel Technologies
    Inventors: Florence Guimberteau, Frédéric Dargelas
  • Patent number: 7871643
    Abstract: A pharmaceutical form, contains an active compound-containing core, which is covered with a coating layer of a gastric juice-resistant, intestinal juice-soluble (meth)acrylate copolymer, a separating layer situated between said core and said coating layer, the separating layer containing a film-forming water-soluble polymer, wherein the separating layer contains at least two layers: an inner layer containing a water-repellent substance, and thereon a layer comprising the film-forming water-soluble polymer.
    Type: Grant
    Filed: July 20, 2007
    Date of Patent: January 18, 2011
    Assignee: Evonik Roehm GmbH
    Inventors: Rosario Lizio, Erna Roth, Hans-Ulrich Petereit
  • Publication number: 20100330183
    Abstract: The invention disclosed herein relate to an oral vaccine in which the vaccine composition and adjuvant(s) are carried on a solid fast-dispersing dosage form. The vaccines are targeted toward mucosal tissue and the adjuvant serves to ensure sufficient residence time for the vaccine composition on the mucosal tissue to facilitate its absorption thereby. The fast-dispersing oral solid vaccine dosage form of the invention is particularly useful to administer the vaccine to patients that have difficulty swallowing medications. In one embodiment, the invention provides a fast disintegrating oral solid vaccine dosage form comprising: an immunogenic amount of an antigenic preparation, the antigenic preparation comprising a microsphere-antigen complex; an adjuvant, wherein the adjuvant enhances the absorption of the antigen or potentiates the immunogenic response; a mucoadhesive substance; and a low density dosage form matrix.
    Type: Application
    Filed: March 1, 2010
    Publication date: December 30, 2010
    Inventor: HARRY SEAGER
  • Patent number: 7785650
    Abstract: Water soluble, gelatin-free dip coatings for pharmaceutical solid dosage forms such as tablets comprising HPMC and xanthan gum, carrageenan, and mixtures thereof, or HPMC and castor oil or maltodextrin.
    Type: Grant
    Filed: June 27, 2007
    Date of Patent: August 31, 2010
    Assignee: McNeil-PPC, Inc.
    Inventors: Cynthia Gulian, Walter G. Gowan, Jr., Kishor B. Parekh, Joseph M. Morris, Thomas J. Markley, Dennis C. Wieand, Gerard P. McNally, Christopher Szymczak
  • Publication number: 20100209501
    Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, and an extended release polymer. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.
    Type: Application
    Filed: February 17, 2009
    Publication date: August 19, 2010
    Inventors: Mummini Aruna Murty, Boyong Li
  • Publication number: 20100209500
    Abstract: Embodiments of a controlled release minitablet comprise an extended release core and an optional pH dependent delayed release coating thereon, wherein the extended release core comprises budesonide, a carrier, an extended release polymer, and an acid. The budesonide may be embedded in the extended release polymer to facilitate extended release of the budesonide upon administration.
    Type: Application
    Filed: February 17, 2009
    Publication date: August 19, 2010
    Inventors: Mummini Aruna Murty, Boyong Li
  • Publication number: 20080026051
    Abstract: A pharmaceutical form, contains an active compound-containing core, which is covered with a coating layer of a gastric juice-resistant, intestinal juice-soluble (meth)acrylate copolymer, a separating layer situated between said core and said coating layer, the separating layer containing a film-forming water-soluble polymer, wherein the separating layer contains at least two layers: an inner layer containing a water-repellent substance, and thereon a layer comprising the film-forming water-soluble polymer.
    Type: Application
    Filed: July 20, 2007
    Publication date: January 31, 2008
    Applicant: ROEHM GMBH
    Inventors: Rosario LIZIO, Erna ROTH, Hans-Ulrich PETEREIT
  • Patent number: 7022663
    Abstract: Pharmaceutical compositions useful for treating autoimmune diseases in a mammal comprising as an active ingredient a therapeutically effective amount of Copolymer 1, and microcrystalline cellulose are disclosed. Processes for the manufacture of such compositions are also disclosed.
    Type: Grant
    Filed: February 16, 2001
    Date of Patent: April 4, 2006
    Assignee: Yeda Research and Development Co., Ltd.
    Inventors: Adrian Gilbert, Rivka Riven-Kreitman, Milka Linenberg, Sharon Cohen-Vered, Ramon F. Joubran
  • Patent number: 6872336
    Abstract: Among the conventional processes for producing solid dispersion, the solid dispersion obtained by a solvent method is excellent in terms of solubility and bioavailability of a poorly soluble drug. However, due to frequent uses of organic solvents in the solvent method, problems have arisen such as organic solvent residue in products, environmental pollution and operational safety as well as corporate problems such as capital investment and the like required to avoid such events. The present invention provides a process for preparing pharmaceutical solid preparations without use of organic solvents frequently used in conventional solvent methods.
    Type: Grant
    Filed: August 30, 2002
    Date of Patent: March 29, 2005
    Assignee: Shin-Etsu Chemical Co., Ltd.
    Inventors: Fumie Tanno, Yuichi Nishiyama
  • Patent number: 6723372
    Abstract: A process for the production of encased, spherical granular grains comprising spraying grains which consist of a prostane derivative and a cyclodextrin vehicle, forming together a prostane-cyclodextrine-clathrate, with an aqueous polymer dispersion of ethyl cellulose and/or poly(methyl)acrylic acid ester in a fluidized or boiling bed is disclosed. The polymer dispersion is applied in a thickness equivalent to 1-5% (w/w) of the total mass of the encased grains. The coated grains are cured for at least 24 hours. Grains produced according to this method have a pharmaceutical active ingredient release profile which remains unchanged over the storage time.
    Type: Grant
    Filed: August 23, 2000
    Date of Patent: April 20, 2004
    Assignee: Schering Aktiengesellschaft
    Inventor: Torsten Wagner
  • Publication number: 20030211155
    Abstract: The pharmaceutical composition of the invention, which comprises a benzimidazole compound of the formula 1
    Type: Application
    Filed: January 3, 2003
    Publication date: November 13, 2003
    Applicant: TAKEDA CHEMICAL INDUSTRIES, LTD.
    Inventors: Tadashi Makino, Tetsuro Tabata, Shin-Ichiro Hirai