Plural Concentric Cores Patents (Class 424/471)
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Publication number: 20040176465Abstract: The invention provides a solid composition comprising fluoxetine, exhibiting a dissolution profile, as determined in a basket at 100 rpm and a buffer pH 7.5, such that after 15 minutes, from 30 to 70% of the fluoxetine is released, after 30 minutes, from 70 to 98% of the fluoxetine is released, after 45 minutes, more than 90% of the fluoxetine is released.Type: ApplicationFiled: March 7, 2003Publication date: September 9, 2004Inventor: Pawan Seth
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Publication number: 20040175426Abstract: The invention provides for sustained release formulations for systemic delivery of drugs or other therapeutic agents that are highly soluble in water. Methods of administration of the agents and devices useful for administration are also disclosed. In particular, sustained release formulations are disclosed for the treatment of glaucoma, including methods and devices suitable for the administration of the formulations.Type: ApplicationFiled: January 23, 2004Publication date: September 9, 2004Applicant: Control Delivery Systems, Inc.Inventor: Paul Ashton
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Publication number: 20040175427Abstract: A stable pharmaceutical composition of omeprazole for oral administration which consists essentially of: (a) a core of Omeprazole or a pharmaceutically equivalent salt, a filler and an alkaline material selected from the group consisting of lysing and arginine; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent which is applied from an organic solvent based system.Type: ApplicationFiled: March 19, 2004Publication date: September 9, 2004Inventors: Chih-Ming Chen, Joseph Chou, Unchalee Kositprapa
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Publication number: 20040170688Abstract: An industrially advantageous enteric formulation of Fluoxetin without the use of hydroxypropylmethylcellulose acetate succinate and sucrose is covered by this invention. The present invention also covers said enteric formulations of Fluoxetin in the form of tablets or capsules with an optional separating layer. When in the form of capsules, the separating layer is capsule shell itself thus reducing processing step of said enteric formulations. The formulation of the present invention along with Fluoxetin or its pharmaceutically accepted salts, solvates, enantiomers or mixtures thereof including racemic mixture is also contemplated to be within the scope of present invention.Type: ApplicationFiled: February 6, 2004Publication date: September 2, 2004Inventors: Abhijit Mukund Deshmukh, Ujwal Damu Kolhe, Vipin Tatyasaheb Dhanorkar, Mailatur Sivaraman Mohan
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Publication number: 20040170687Abstract: Ingredients in pharmaceutical compositions are provided with a coating material for improving stability thereof. The coating material prevents reactive contact between otherwise incompatible ingredients in the composition. Without contact, incompatible ingredients will not degrade thereby prolonging the stability and shelf life of the composition.Type: ApplicationFiled: February 27, 2003Publication date: September 2, 2004Applicant: Integrity Pharmaceutical CorporationInventors: William R. Hurd, Michael J. Dempsey, William C. Williams
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Publication number: 20040170689Abstract: This invention relates to new stable oral pharmaceutical formulations prepared by covering an nucleus formed by a core with a first hydrophobic polymer layer, a second layer coating the first layer, wherein said second layer comprises one or more labile pharmaceutical compounds in one or more acceptable hydrophobic excipients, and an optional third enteric polymer layer.Type: ApplicationFiled: March 11, 2004Publication date: September 2, 2004Inventors: Debra Alida Odink, I-Lan Sue, Gary Conard Visor
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Patent number: 6783772Abstract: An oral composition in tablet form containing therapeutic amounts of alendronate sodium for release of the alendronate sodium in the stomach and by passing the oesophagus, comprising a compacted granulated core with the alendronate sodium embedded in an inert fiber matrix, lined with a moisture barrier film and enclosed in a sugar based inert fiber matrix shell.Type: GrantFiled: December 12, 2003Date of Patent: August 31, 2004Inventors: Sanjeev Khandelwal, Pratibha Omray
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Publication number: 20040166160Abstract: Dosage forms and methods for providing a modulated release of cyclobenzaprine are provided. The sustained release dosage forms provide therapeutically effective average steady-state plasma cyclobenzaprine concentrations when administered once per day. The composition of the delay layer and the composition of the drug layer are characterized by the viscosity of the hydrated delay layer remaining higher than the viscosity of the hydrated drug layer during operation in one embodiment. The result is greater uniformity in the release rate from the core providing a more optimal ascending release rate. In other embodiments, the hydrated delay layer has a viscosity that is lower than the viscosity of the hydrated drug layer as well as a hydrated delay layer that is substantially similar to the hydrated drug layer.Type: ApplicationFiled: January 9, 2004Publication date: August 26, 2004Inventors: Ramkumar Subramanian, Brian L. Barclay, Zahedeh Hatamkhany, Yuxiang Zhang, Fernando Gumucio
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Publication number: 20040162263Abstract: Oral formulations of pharmaceuticals are provided with enhanced bioavailability by targeting specific regions of the gastrointestinal tract. Particularly, water soluble and acid-labile drugs such as cytidine analogs (e.g., decitabine) and 2′-deoxyadenosine analogs (e.g., pentostatin) are formulated with pH-sensitive polymers so that these drugs are preferably absorbed in the upper regions of the small intestine, such as the jejunum. In addition, drugs with poor oral bioavailability such as camptothecin compounds (e.g., 9-nitro-camptothecin) can also be formulated using similar strategies in order to significantly improve their oral bioavailability. These formulations can be used to treat a wide variety of diseases or conditions, such hematological disorders, benign tumors, cancer, restenosis, inflammatory diseases, and autoimmune diseases.Type: ApplicationFiled: October 31, 2003Publication date: August 19, 2004Applicant: SuperGen, Inc., a Delaware CorporationInventors: Howard Sands, Sanjeev Redkar, Harish Ravivarapu
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Publication number: 20040161460Abstract: Pharmaceutical compositions and methods of using the composition are provided. The pharmaceutical composition comprises an inert core surrounded by an active coating containing one or more bisphosphonic acids or salts thereof, a seal coating surrounding the active coating and an enteric coating surrounding the seal coating. Alendronic acid and alendronate sodium trihydrate are the preferred active ingredients. The composition may be provided in the form of pellets in a capsule or Peltabs. The invention further provides methods for the treatment of disorders caused by the abnormal dissolution or deposition of calcium salts using the inventive compositions.Type: ApplicationFiled: October 16, 2003Publication date: August 19, 2004Applicant: U & I PHARMACEUTICALS LTD.Inventors: Amar Lulla, Geena Malhotra
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Publication number: 20040161461Abstract: The invention provides an extended release pharmaceutical tablet containing: (i) a core comprising by weight, based on the core weight, about 70% to about 99% metformin and pharmaceutically acceptable excipients; and (ii) a coating surrounding said core, wherein said coating is permeable to metformin. The extended release tablets of the invention exhibit a dissolution profile such that after about 2 hours, from about 7% to about 60% of the metformin is released; after about 4 hours, from about 15% to about 90% of the metformin is released; after about 8 hours, from about 50% to about 100% of the metformin is released; after about 12 hours, more than about 75% of the metformin is released.Type: ApplicationFiled: February 4, 2004Publication date: August 19, 2004Inventors: Pawan Seth, Benoit Schmitt
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Publication number: 20040161462Abstract: 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.Type: ApplicationFiled: February 12, 2004Publication date: August 19, 2004Inventors: Unchalee Kositprapa, Robert I. Goldfarb, John R. Cardinal, Avinash Nangia
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Publication number: 20040156900Abstract: The present invention provides a timed pulse release composition comprising: a. a core composition comprising a therapeutically active agent, a swelling agent, and optionally water soluble compound(s) for inducing osmosis, and b. a coat composition comprising one or more film forming polymers, wherein upon imbibing fluid from the surrounding the core swells, and the coat ruptures to release in a pulse, the therapeutically active agent in a reliable manner at about a predetermined time wherein the reliable manner of rupture comprises rupturing of 36 tablets out of a total of 36 tablets at about the predetermined time when tested by subjecting the tablets to USP dissolution test using an aqueous media at 37±0.5oC, in a USP Type I or Type II apparatus at an rpm selected from the range of about 50 rpm to about 100 rpm.Type: ApplicationFiled: October 9, 2003Publication date: August 12, 2004Inventors: Dilip Shantilal Shanghvi, Nitin Bhalachandra Dharmadhikari, Yashoraj Rupsinh Zala, Satish C. Khanna
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Publication number: 20040156901Abstract: The invention is directed to a pharmaceutical composition of topiramate, an anticonvulsant which is useful for treating epilepsy. More specifically, the present invention provides a solid dosage formulation of topiramate intended primarily for use by pediatric patients, or for patients who have difficulty swallowing tablets. Processes for preparing the pharmaceutical composition are also described.Type: ApplicationFiled: December 30, 2003Publication date: August 12, 2004Inventors: Madhav S. Thakur, Pramod M. Kotwal, Irwin S. Gibbs
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Publication number: 20040151748Abstract: The present invention relates to hormone coating layers having desirable hormone delivery characteristics and product lifetime. In one embodiment, the invention is a hormone composition including a substrate having an external surface, and a coating layer disposed on the external surface. The coating layer preferably includes a polymer web, a UV protectant material, and from about 1 wppm to about 100,000 wppm of a hormone dispersed throughout the polymer web. The invention also relates to methods for making hormone coating materials of the present invention. The coating compositions of the present invention preferably are implemented in human and animal food packaging materials in order to safely and efficiently protect the foodstuffs contained therein from insect infestation.Type: ApplicationFiled: February 3, 2003Publication date: August 5, 2004Inventors: Timothy Jon Leeper, Joy Michelle Thomas, Amy Marie Nichols
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Publication number: 20040151773Abstract: Disclosed are an enteric coated formulation of a benzimidazole derivative comprising a core and a film of an enteric coating agent on the surface thereof, the core containing a complex of the benzimidazole derivative and an ion-exchange resin, and the enteric coating agent having the degree of substitution by an acidic group of less than 30%, and a method for preparation thereof.Type: ApplicationFiled: January 23, 2004Publication date: August 5, 2004Inventor: Jong Soo Woo
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Patent number: 6770297Abstract: This invention relates to a controlled release delivery system of solid dosage form with a plurality of controls on the release of the active ingredient or ingredients.Type: GrantFiled: May 26, 2000Date of Patent: August 3, 2004Assignee: Unitech Pharmaceuticals, Inc.Inventor: Jiajiu Shaw
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Publication number: 20040146558Abstract: An oral enteric-coated preparation of the present invention comprises a core containing an active ingredient unstable to acid, an intermediate film enveloping the core, and an enteric film further enveloping the intermediate film, and the intermediate film comprises a matrix sparsely soluble in water and water-soluble fine particles dispersed therein. The presence of the intermediate film consisting of the matrix sparsely soluble in water and the water-soluble fine particles between the outer enteric film and the core uniformizes the disintegration time of the intermediate film and thus suppresses a variation in the time to start releasing the active ingredient in the core.Type: ApplicationFiled: January 28, 2003Publication date: July 29, 2004Applicant: KYOWA PHARMACEUTICAL CO., LTD.Inventors: Kenji Hirata, Masaki Mori
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Publication number: 20040146559Abstract: A dosage form comprises an active ingredient, a core having an outer surface and a first shape and a shell having outer and inner surfaces and a second shape, in which the shell surrounds at least a portion of the core, and the first and second shapes are substantially different. In one embodiment the shell comprises at least about 80% of a flowable material selected from the group consisting of film formers, gelling polymers, thermoplastic materials, low melting hydrophobic materials, non-crystallizable sugars, non-crystallizable sugar-alcohols, and mixtures thereof. In another embodiment the shell is substantially free of pores having a diameter of 0.5 to 5.0 microns. In another embodiment, the core and shell each having a different number of planes of symmetry with respect to the same reference axis.Type: ApplicationFiled: December 4, 2003Publication date: July 29, 2004Inventors: Harry S. Sowden, Frank J. Bunick, Gerard P. McNally, Der-Yang Lee, Martin Thomas
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Publication number: 20040142035Abstract: Disclosed are pharmaceutical compositions, particularly oral dosage forms, which comprise two or more enteric coating materials, either as a coating or as part of a matrix dosage form, and methods of making and using the same. The compositions are characterized by having a sustained release profile at lower pH and an accelerated dissolution profile at higher pH.Type: ApplicationFiled: January 5, 2004Publication date: July 22, 2004Inventors: Rong-Kun Chang, Niraj Shah
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Publication number: 20040131683Abstract: Oral conjugated estrogen formulations are disclosed and described. In one aspect, the oral formulation may be a tablet having a core and one or more coatings thereon. In addition to conjugated estrogen ingredients, the core may include one or more organic excipients and one or more inorganic excipients. In one aspect, the organic excipients may include less than about 20% w/w of a cellulose ingredient, and less than about 50% w/w of a sugar ingredient. In another aspect, the inorganic excipients may include less than about 10% w/w of a calcium phosphate tribasic ingredient. In yet another aspect, the formulation does not crack when stored at about 40° C. and about 75% relative humidity for about 2 months.Type: ApplicationFiled: September 22, 2003Publication date: July 8, 2004Applicant: Watson Pharmaceuticals, Inc.Inventor: Thomas Ho
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Publication number: 20040131677Abstract: Process for the preparation of programmed liberation compositions with venlafaxinee and the resulting product, from which the resulting product allows a better absorption of the active principle and a drastic decrease of the adverse effects, due to the preparation methodology. The formulation comprises a first phase, in which the non-active cores are elaborated as spherical micro granules, from sugar and starch. In the second phase, it is added to them the active drug, as impalpable powder, utilizing as binding, a povidone alcoholic solution. In the third phase, it is applied the coating on the micro granules that contain the active drug. At last, in the fourth phase, it is made the encapsulation of the recoated micro granule.Type: ApplicationFiled: November 4, 2003Publication date: July 8, 2004Inventor: Fernando Rafael De Souza
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Publication number: 20040131684Abstract: A stable pharmaceutical composition of omeprazole for oral administration which consists essentially of: (a) a core of Omeprazole or a pharmaceutically equivalent salt, a filler and an alkaline material selected from the group consisting of lysing and arginine; and (b) a single layer of coating on said core which comprises a layer of an enteric coating agent which is applied from an organic solvent based system.Type: ApplicationFiled: November 13, 2003Publication date: July 8, 2004Inventors: Chih-Ming Chen, Joseph Chou, Unchalee Kositprapa
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Publication number: 20040126428Abstract: The present invention provides a pharmaceutical that includes, in combination, a core, and a coating surrounding the core comprising a resinate of an opiate. The pharmaceutical oral dosage form is failsafe, and not subject to abuse.Type: ApplicationFiled: November 14, 2003Publication date: July 1, 2004Inventors: Lyn Hughes, Simon Andrew Bellamy
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Publication number: 20040127413Abstract: The invention relates to enteric compounds comprising a keto acid, and methods of making and using these compounds in order to treat malnourishment, conditions resulting from malnourishment, and various pathological conditions.Type: ApplicationFiled: September 26, 2003Publication date: July 1, 2004Inventors: Thierry Plouvier, Thierry Bouyssou, Serge Biosa, Christian Jeanpetit, Daniel Kilhoffer, Eliane Le Peillet-Feuillet, Francoise Tubery
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Publication number: 20040121014Abstract: The present invention relates to a method for administering a corticosteroid to a posterior segment of an eye. In the method, a sustained release device is implanted to deliver the corticosteroid to the eye. The aqueous corticosteroid concentration remains less than vitreous corticosteroid concentration during release of the corticosteroid from the device.Type: ApplicationFiled: November 14, 2003Publication date: June 24, 2004Applicant: Control Delivery Systems, Inc.Inventors: Hong Guo, Paul Ashton
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Publication number: 20040121015Abstract: A controlled release delivery composition which can be administered to a high fat use environment such as the human gastrointestinal tract following a high fat meal. The delivery composition is embodied as a core surrounded by an asymmetric polymeric membrane. In a preferred embodiment, the asymmetric polymeric membrane is cellulose acetate.Type: ApplicationFiled: December 3, 2003Publication date: June 24, 2004Applicant: Pfizer IncInventors: Mark B. Chidlaw, Dwayne T. Friesen, Scott M. Herbig, James A.S. Nightingale, Cynthia A. Oksanen, James B. West
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Publication number: 20040115265Abstract: A multilayered tablet having three or more layers is provided which is useful for cholesterol lowering and reducing the risk of a myocardial infarction, which includes a first layer containing aspirin, another layer containing pravastatin, and a middle barrier layer, which preferably contains a buffering agent, which separates the first layer containing aspirin from the other layer containing pravastatin, and prevents or minimizes interaction of aspirin with pravastatin. A method for lowering cholesterol and reducing risk of a myocardial infarction employing such composition is also provided.Type: ApplicationFiled: December 11, 2002Publication date: June 17, 2004Inventors: Loutfy Benkerrour, Olivier Galley, Francoise Quinet, Admassu Abebe, Peter Timmins
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Publication number: 20040115266Abstract: A method of manufacturing an itraconazole oral dosage from that is substantially free of residual methylene chloride comprises the steps of: (a) providing a working solution comprising an alcohol, a strong acid (preferably an inorganic acid or organic sulphonic acid), itraconazole, a water-soluble polymer, and water, with the itraconazole and the strong acid preferably present in the working solution in a ratio of 1 Mole itraconazole to 1-3 Moles acid; (b) providing particles formed from a pharmaceutically acceptable core material; (c) combining the working solution with the particles to produce itraconazole-coated particles; (d) drying the itraconazole-coated particles; and(e) forming the dried itraconazole-coated particles into an itraconazole oral dosage form that is substantially free of residual methylene chloride. The products of such methods and methods of use thereof are also disclosed.Type: ApplicationFiled: February 5, 2004Publication date: June 17, 2004Inventors: Ranga Raju Namburi, John Elgin Kerr
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Publication number: 20040105835Abstract: The invention concerns compositions from modified starches, such as starch ethers or oxidized starch, more particularly hydroxpropylated starch (HPS) or hydroxylethylated starch (HES) for the use in pharmaceutical, veterinary, food, cosmetic or other products like films for wrapping food, aspics or jellies, preferably for predosed formulations like soft or hard capsules. The hard capsules obtained by the present invention with a conventional dipping molding process are similar to hard gelatine capsules (HGC).Type: ApplicationFiled: November 25, 2003Publication date: June 3, 2004Inventors: Robert A. Scott, Dominique Cade, Xiongwei He
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Publication number: 20040101556Abstract: Stabilized controlled release pharmaceutical preparations are disclosed in which active ingredient degradation is prevented without the use of a stabilizer. The active ingredient is sealed away from excipients that can adversely affect stability by sealing the excipients rather than the active ingredient. The preparations are substantially unaffected by exposure to storage conditions of elevated temperature and/or elevated relative humidity.Type: ApplicationFiled: November 21, 2002Publication date: May 27, 2004Inventors: Boyong Li, Xiu Xiu Cheng
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Publication number: 20040102522Abstract: A non effervescent tablet of ibuprofen, comprising a tablet core and, if desired, a sugar or film coat, wherein the tablet core, based on the weight of the tablet core, consists of 50 to 100% by weight sodium ibuprofen hydrate and 50 to 0% by weight auxiliary material component and contains no lubricant and no disintegrant, and wherein the sodium ibuprofen hydrate has a water content of 8 to 16% by weight, preferably 11 to 16% by weight, possesses a sufficient hardness, is comparably small and leads to a particularly rapid increase in blood level and thereby to an accelerated onset of analgesic effect. Contrary to the current doctrine sodium ibuprofen hydrate having a suitable water content is sufficiently compressible.Type: ApplicationFiled: October 14, 2003Publication date: May 27, 2004Inventors: Peter Gruber, Markus Reher
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Publication number: 20040096503Abstract: An edible dry-powder formulation of a film coating for pharmaceuticals and confectioneries using gum acacia as a low-cost film former is provided. A cellulosic polymer such as hydroxypropyl methylcellulose is used in addition to the gum acacia. A plasticizer such as propylene glycol is also added. The resulting formulation is a dry, free flowing powder that can be put into solution and applied to a tablet or other substrate without an extended waiting period. The resulting film coating is clear, shiny, durable and extremely economical. Because the formulation is a dry powder, it has along shelf life and low shipping costs.Type: ApplicationFiled: November 12, 2003Publication date: May 20, 2004Applicant: Chr. Hansen, Inc.Inventors: Charles W. Gayser, Jean-Paul Goyette
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Publication number: 20040096502Abstract: Tamsulosin pellets having an advantageous release profile are formed. The pellets have an enteric coating and release less than 10% of the tamsulosin in two hours in SGF.Type: ApplicationFiled: November 14, 2002Publication date: May 20, 2004Inventor: Johannes J. Platteeuw
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Publication number: 20040096504Abstract: The present invention includes a drug delivery coating. The drug delivery coating comprises a matrix comprising one or more co-polymers of ethylene comprising carboxylic acid containing unsaturated monomers. The drug delivery coating also comprises a drug contacting the matrix.Type: ApplicationFiled: November 12, 2003Publication date: May 20, 2004Inventor: Gene Michal
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Publication number: 20040091535Abstract: Disclosed is a pharmaceutically acceptable oral dosage form comprising fenofibrate, phospholipid, a buffer salt, a water-soluble bulking agent selected from maltodextrin, mannitol, and combinations thereof, a cellulosic additive, beads or crystals of a pharmaceutically acceptable water-soluble excipient support material, a polyvinylpyrrolidone or crospovidone, croscarmellose sodium, granular mannitol, sodium dodecyl sulfate, silicon dioxide, and a stearate, wherein the fenofibrate is in the form of microparticles, and wherein at least a portion of the phospholipid is coated on the surfaces of the fenofibrate microparticles, the phospholipid coated microparticles are embedded in a matrix comprising the water-soluble bulking agent, phospholipid that is not coated on the microparticles, the buffer salt and the cellulosic additive, and the matrix is coated on up to 100% of the surfaces of the beads or crystals of the excipient support material.Type: ApplicationFiled: May 2, 2003Publication date: May 13, 2004Applicant: SKYEPHARMA CANADA INC.Inventors: Michael Vachon, Awadhesh K. Mishra, Robert A. Snow, Pol-Henri Guivarc'H
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Publication number: 20040091536Abstract: A dry, reconstitutable telitiromycin suspension characterized in that it contains granules or granules comprising a core containing telithromycin which is optionally associated with at least one waxlike compound and optionally with at least one polymer and/or binding agent, and at least three successive layers of coating from the core outwards, said granules being associated with excipients including at least one thickening agent, at least one preservative agent and at least one pH modulator agent.Type: ApplicationFiled: September 9, 2003Publication date: May 13, 2004Inventors: Julien Meisonnier, Christophe Lebon, Sandrine Salle
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Publication number: 20040091533Abstract: The present invention relates to an oral pharmaceutical formulation that employs: (1) a compressed core containing a decongestant or pharmaceutically acceptable salt thereof; (2) a delayed release coating on the compressed core and (3) immediate release therapeutic amounts of a decongestant and an antihistamine.Type: ApplicationFiled: November 8, 2002Publication date: May 13, 2004Inventors: Unchalee Kositprapa, Mongkol Sriwongjanya
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Publication number: 20040091534Abstract: Isosorbide mononitrate formulations and methods of treatment are disclosed. The formulations and treatments provide for subtherapeutic levels of the mononitrate in a washout period to prevent nitrate tolerance.Type: ApplicationFiled: April 23, 2003Publication date: May 13, 2004Applicant: Athpharma LimitedInventors: Edward James Geoghegan, Seamus Mulligan, Mary Margaret Foynes
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Publication number: 20040091537Abstract: A method and composition are provided for coating a component to achieve colon-targeted delivery. A component is coated with a fructose-based non-digestible carbohydrate such as a inulin, fructo-oligosaccharide or neosugar. The coated component is orally administered to a monogastric animal. The non-digestible coating causes the composition to pass through the stomach and small intestine without being degraded, and delivers the component to the colon where the coating is digested by microbial fermentation and the component is released.Type: ApplicationFiled: October 14, 2003Publication date: May 13, 2004Inventor: Guy W. Miller
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Publication number: 20040086566Abstract: In a preferred embodiment of the invention, a solid dosage form is provided comprising a matrix, wherein the matrix comprises (a) a pharmaceutically effective amount of metformin or a pharmaceutically acceptable salt thereof and (b) a waxy matrix material. The invention also provides a method of making a solid dosage form, the method comprising: (a) hot melting a waxy material to form a melt, (b) granulating metformin or a pharmaceutically acceptable salt thereof with the melt to form a granulate; (c) milling the granulate; and (d) compressing granulate to form a matrix.Type: ApplicationFiled: November 4, 2002Publication date: May 6, 2004Applicant: ALPHARMA, INC.Inventor: Xiaoying Zhang
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Publication number: 20040086565Abstract: A dosage formulation for once daily administration prior to sleeping is described that provides an initial delay in pharmaceutical release followed by controlled release of the pharmaceutical. There is also provided a method for preparing a time specific delayed, controlled release formulation of dosage, which method includes coating a single pellet with at least one dosage layer, which is coated by at least one seal coat and at least one outer rate controlling layer of a water soluble polymer coat. The dosage formulation of this invention provides a substantially drug free interval of about 0 to 5 hours followed by a drug delivery interval at a rate permitting bioavailability thereof for up to about 24 hours following oral administration. A method of using the formulations of the present invention for the treatment of early morning pathologies, including atrial fibrillation, is also described.Type: ApplicationFiled: April 10, 2003Publication date: May 6, 2004Inventor: Atul M. Mehta
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Patent number: 6730321Abstract: A press-coated tablet suitable for oral administration, comprising an immediate-release compartment comprising a compressed blend of an active agent. The immediate-release compartment has a dissolution profile in which 10-75% of the active agent is dissolved within one hour and not less than 90% of the active agent is dissolved within 6 hours. The tablet further comprises an extended-release compartment with a dissolution profile in which 5-40% of the active agent is dissolved within one hour, 20-75% within three hours, 40-95% of the active agent within 6 hours, and not less than 60% of the active agent is dissolved within 8 hours. Additionally, the press-coated extended-release compartment substantially envelops the immediate-release compartment, and comprises a compressed blend of the active agent, a hydrophilic polymer and hydrophobic material. The tablet exhibits a first order release of the active agent interrupted by a pulsed delivery of the active agent.Type: GrantFiled: April 16, 2002Date of Patent: May 4, 2004Assignee: Impax Pharmaceuticals, Inc.Inventors: Richard Ting, Charles Hsiao
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Patent number: 6730320Abstract: An antibiotic product, in particular a tetracycline, such as doxycycline, is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more delayed release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cmax at different times.Type: GrantFiled: December 20, 2001Date of Patent: May 4, 2004Assignee: Advancis Pharmaceutical Corp.Inventors: Edward M. Rudnic, James D. Isbister, Donald J. Treacy, Jr., Sandra E. Wassink
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Publication number: 20040081695Abstract: An immediate release tablet is provided. The tablet comprises at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90° C. The tablet may advantageously be produced by direct compression. Although the wax is hydrophobic, the tablet has excellent disintegration.Type: ApplicationFiled: November 5, 2003Publication date: April 29, 2004Inventors: Harry S Sowden, Frank J Bunick, John Burke, Der-Yang Lee, Martin Thomas
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Publication number: 20040081696Abstract: The present invention is concerned with pellets comprising a 710-1180 &mgr;m (16-25 mesh) sugar core, a coating film of a water-soluble polymer and an antifungal agent, and a seal coating layer wherein the residual concentration of dichloromethane is below 600 ppm; pharmaceutical dosage forms comprising said pellets and a method of preparing said pellets.Type: ApplicationFiled: October 15, 2003Publication date: April 29, 2004Applicant: Janssen Pharmaceutica N.V.Inventors: Paul Marie Victor Gilis, Valentin Florent Victor De Conde, Roger Petrus Gerebern Vandecruys
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Publication number: 20040081697Abstract: A pharmaceutical composition, which composition comprises: an insulin sensitiser and another antidiabetic agent and a pharmaceutically acceptable carrier therefor, wherein the composition is arranged to provide a modified release of at least one of the insulin sensitiser and the other antidiabetes agent, and the use of such composition in medicine.Type: ApplicationFiled: October 21, 2003Publication date: April 29, 2004Applicant: SmithKline Beecham p.l.c.Inventors: Karen Lewis, Nicola Jayne Lilliott, Donald Colin MacKenzie, Vincenzo Re
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Patent number: 6727322Abstract: The present invention provides high mechanical strength amphiphilic polymeric networks and implantable biological devices made therefrom that are capable of encasing and, thus, immunoisolating biological material from an immunological response of a host individual. The present invention also provides methods for making the amphiphilic networks and implantable biological devices. The present invention also provides a method for the treatment of type I diabetes mellitus comprising the steps of encasing a sufficient amount of islet of Langerhans cells within said biological device, wherein said biological device is capable of immunoisolating said encased islet cells upon implantation into an individual; implanting said biological device into a diabetic host individual; allowing said implanted biological device to remain implanted in said diabetic individual for a time sufficient to normalize the blood glucose level in said diabetic individual.Type: GrantFiled: April 1, 2002Date of Patent: April 27, 2004Assignee: The University of AkronInventors: Joseph P. Kennedy, Irada S. Isayeva
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Publication number: 20040076670Abstract: Pulverulent active substance formulations composed ofType: ApplicationFiled: October 3, 2003Publication date: April 22, 2004Inventors: Bernd Klinksiek, Lars Obendorf, Rainer Bellinghausen, Marcus Eichmann
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Publication number: 20040067256Abstract: The present invention is directed to a multiparticulate, modified release solid dispersion formulation, comprising a drug substance having a water-solubility of, or below, 8 mg/ml at room temperature; a hydrophobic matrix former which is a water insoluble, non-swelling amphiphilic lipid; and a hydrophilic matrix former which is a meltable, water-soluble excipient; wherein the weight ratio hydrophobic matrix former/hydrophilic matrix former is ≧1; and the particle size is less than 300 &mgr;m. Also a unit dosage of the same, as well as process for the preparation thereof and the use of the formulation and unit dosage are claimed.Type: ApplicationFiled: August 11, 2003Publication date: April 8, 2004Inventor: Anne Juppo