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WO2009034540A1 - Composition pharmaceutique à base de sevelamer - Google Patents

Composition pharmaceutique à base de sevelamer Download PDF

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Publication number
WO2009034540A1
WO2009034540A1 PCT/IB2008/053671 IB2008053671W WO2009034540A1 WO 2009034540 A1 WO2009034540 A1 WO 2009034540A1 IB 2008053671 W IB2008053671 W IB 2008053671W WO 2009034540 A1 WO2009034540 A1 WO 2009034540A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
sevelamer
hydroxypropyl cellulose
tablet
cellulose
Prior art date
Application number
PCT/IB2008/053671
Other languages
English (en)
Inventor
Swati Aggarwal
Rohit Lowalekar
Romi Barat Singh
Original Assignee
Ranbaxy Laboratories Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Limited filed Critical Ranbaxy Laboratories Limited
Publication of WO2009034540A1 publication Critical patent/WO2009034540A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/74—Synthetic polymeric materials
    • A61K31/785—Polymers containing nitrogen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • compositions for oral administration comprising sevelamer or pharmaceutically acceptable salts thereof in an amount less than 80% by weight of composition, wherein the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • compositions in the form of tablets comprising sevelamer or pharmaceutically acceptable salt thereof; and hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low- substituted hydroxypropyl cellulose and has a tablet disintegration time of less than 5 minutes.
  • Sevelamer is a phosphate binding polymer indicated for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis. It binds phosphorus in the gastrointestinal tract to facilitate phosphorus excretion in feces, by inhibiting phosphorus absorption from the gut, and thereby lowering the plasma phosphorus concentration.
  • CKD Chronic Kidney Disease
  • the use of sevelamer and its pharmaceutical compositions, and processes for its preparation are disclosed in U.S. Patent No. 5,496,545.
  • sevelamer hydrochloride and sevelamer carbonate are being marketed under the trade name of Renagel® and Renvela® respectively.
  • the recommended starting dose of sevelamer is 800 to 1600 mg.
  • the high dose and the hygroscopic nature of sevelamer make it difficult to formulate it in a suitably dosage form.
  • U.S. Patent No. 6,733,780 discloses a tablet comprising a core and a coating wherein at least 95% by weight of the core comprises sevelamer. Further, it discloses water-based coating for sevelamer tablets.
  • U.S. Publication 2002/0054903 discloses a tablet comprising a compressed tablet core comprising at least about 80% of sevelamer.
  • U.S. Patent No. 6,383,518 discloses a tablet comprising a phosphate binding polymer having an average particle size of 400 ⁇ m or less together with crystalline cellulose and low-substituted hydroxypropyl cellulose. Further, it discloses that crystalline cellulose and low- substituted hydroxypropyl cellulose are desired to obtain a tablet disintegration time of less than 15 minutes, which is not obtained by using additives other than low- substituted hydroxypropyl cellulose or crystalline cellulose.
  • compositions for an oral administration comprising sevelamer or pharmaceutically acceptable salts thereof in an amount less than 80% by weight of composition wherein the composition is free of crystalline cellulose and low- substituted hydroxypropyl cellulose is presented herein.
  • compositions in the form of a tablet comprising sevelamer or pharmaceutically acceptable salts thereof and hydroxypropyl cellulose wherein the pharmaceutical composition is found to have desired hardness and disintegratability.
  • a pharmaceutical composition for oral administration comprising: a) less than 80% w/w of sevelamer or pharmaceutically acceptable salts thereof; and b) pharmaceutically acceptable inert excipients; wherein the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • a pharmaceutical composition for oral administration comprising: a) from about 40 to 75% w/w of sevelamer or pharmaceutically acceptable salts thereof; and b) from about 25 to 60% w/w of pharmaceutically acceptable inert excipients; wherein the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • a pharmaceutical composition for oral administration comprising: a) from about 50 to 75% by weight of sevelamer or pharmaceutically acceptable salts thereof; b) from about 5 to 40% by weight of diluents selected from, for example, dextrates, dextrins, dextrose, fructose, kaolin, lactitol, lactose, mannitol, sorbitol, starch, sucrose, and the like; and c) from about 0.1 tol0% by weight of other pharmaceutically acceptable inert excipients; wherein the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • a process for the preparation of a pharmaceutical composition for oral administration comprising the steps of: i) blending sevelamer or pharmaceutically acceptable salts thereof with pharmaceutically acceptable inert excipients; ii) optionally granulating the blend; iii) lubricating the blend or granules; iv) compressing the blend or granules into suitably sized tablets; and v) optionally coating the tablets; wherein sevelamer or salts is present in an amount less than 80% by weight of composition and the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • CKD Chronic Kidney Disease
  • a pharmaceutical composition for oral administration comprising: a) less than 80% w/w of sevelamer or pharmaceutically acceptable salts thereof; and b) pharmaceutically acceptable inert excipients; wherein the composition is free of crystalline cellulose and low-substituted hydroxypropyl cellulose.
  • a pharmaceutical composition in the form of a tablet comprising: a) sevelamer or pharmaceutically acceptable salts thereof; and b) hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and has a tablet disintegration time of less than 5 minutes.
  • a pharmaceutical composition in the form of a tablet comprising: a) less than 80 % w/w of sevelamer or pharmaceutically acceptable salts thereof; and b) about 1 to 10% w/w of hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • a pharmaceutical composition in the form of a tablet comprising: a) about 40-75% w/w of sevelamer or pharmaceutically acceptable salts thereof; and b) about 1 to 10% w/w of a low-viscosity hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • a pharmaceutical composition in the form of a tablet comprising: a) about 40-70% w/w of sevelamer or pharmaceutically acceptable salts thereof; b) about 1 to 10% w/w of a low-viscosity hydroxypropyl cellulose; and c) about 5 to 20% w/w of mannitol; wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • a pharmaceutical composition in the form of a tablet comprising: a) sevelamer or pharmaceutically acceptable salts thereof; b) a low-viscosity hydroxypropyl cellulose; and c) a medium-viscosity hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • a pharmaceutical composition in the form of a tablet comprising sevelamer or pharmaceutically acceptable salt thereof and hydroxypropyl cellulose alone or in combination with other binders selected from, for example, methyl cellulose, hydroxyl propyl methycellulose, povidone, pregelatinized starch, carboxymethyl cellulose and copovidone; wherein the tablet is free of crystalline cellulose and low- substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • a process for the preparation of a pharmaceutical composition in the form of a tablet comprising the steps of: i) blending sevelamer or pharmaceutically acceptable salts thereof, hydroxypropyl cellulose along with other pharmaceutically acceptable excipients; ii) optionally, granulating the blend of step i); iii) lubricating, the blend of step i) or granules of step ii); iv) compressing, the blend or granules of step iii) into a suitably sized tablet; and v) optionally, coating the tablet of step iv); wherein the tablet is free of crystalline cellulose and low-substituted hydroxypropyl cellulose and the tablet has a disintegration time of less than 5 minutes.
  • a method for the control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis comprising administering a pharmaceutical composition in the form of a tablet comprising: a) sevelamer or pharmaceutically acceptable salts thereof; and b) hydroxypropyl cellulose; wherein the tablet is free of crystalline cellulose and low- substituted hydroxypropyl cellulose and has a disintegration time of less than 5 minutes.
  • CKD Chronic Kidney Disease
  • sevelamer as used herein includes hydrated or anhydrate form of sevelamer.
  • the pharmaceutically acceptable salts thereof include hydrochloride, carbonate, hydrobromide, phosphate, sulfate and the like.
  • the compressibility of sevelamer is dependent on moisture content of sevelamer, hence to obtain desired compressibility, sevelamer may be hydrated to a desired moisture content, which may vary from about 1 to about 14%, in particular about 6-9%.
  • the moisture level of hydrated or anhydrate API may be determined by the Karl Fischer method. Further, it was observed that no hydration of sevelamer would be required with compositions containing less than about 70% of sevelamer.
  • the tablet compositions comprise sevelamer or salts in amounts less than 80% by weight of the composition.
  • the tablet can comprise about 40 to 75% w/w of sevelamer or salts, more particularly of about 50-75% w/w of sevelamer or salts.
  • the pharmaceutical composition may further comprise one or more pharmaceutically acceptable inert excipients.
  • pharmaceutically acceptable inert excipients includes binders, diluents, disintegrants, lubricants, glidants, surfactants and coating additives.
  • binders include methyl cellulose, hydroxyl propyl methylcellulose, povidone, pregelatinized starch, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, hydroxypropyl cellulose and copovidone; in particular hydroxypropyl cellulose.
  • Hydroxypropyl cellulose is used in the composition as a binder. It may be present in amounts of about 1-10% w/w. Hydroxypropyl cellulose may be selected from the various grades such as a low- viscosity, a medium- viscosity or combination thereof, in particular low- viscosity.
  • the various marketed grades of low-viscosity hydroxypropyl cellulose include Klucel® JF, Klucel® LF, having viscosity 150-400 and 75-150 mpas of 5% aqueous solution respectively and Klucel® EF, having viscosity 200-600 mpas of 10% aqueous solution.
  • the various marketed grades of medium-viscosity hydroxypropyl cellulose include Klucel® MF and Klucel® GF, having viscosity 4000-6500 mpas and 150-400 mpas of 2% aqueous solution respectively.
  • Hydroxypropyl cellulose may be present either alone or in combination with other binders selected from, for example, methyl cellulose, hydroxyl propyl methylcellulose, povidone, pregelatinized starch, carboxymethyl cellulose and copovidone.
  • hydroxypropyl methylcellulose and polyvinyl pyrrolidone may be present in an amount of about 1-5 % w/w.
  • diluents examples include dextrates, dextrins, dextrose, fructose, kaolin, lactitol, lactose, mannitol, sorbitol, starch, sucrose, and the like.
  • disintegrants examples include starch, crospovidone and the like.
  • lubricants and glidants examples include colloidal anhydrous silica, silicon dioxide (Aerosil® 200), stearic acid, magnesium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acids, microcrystalline wax, yellow beeswax, white beeswax and the like.
  • Surfactants include polyethoxylated fatty acids and its derivatives, for example polyethylene glycol 400 distearate, polyethylene glycol - 20 dioleate, polyethylene glycol 4 -150 mono dilaurate, polyethylene glycol -20 glyceryl stearate; alcohol - oil transesterification products, for example polyethylene glycol - 6 corn oil; polyglycerized fatty acids, for example polyglyceryl - 6 pentaoleate; propylene glycol fatty acid esters, for example propylene glycol monocaprylate; mono and diglycerides for example glyceryl ricinoleate; sterol and sterol derivatives; sorbitan fatty acid esters and its derivatives, for example polyethylene glycol - 20 sorbitan monooleate, sorbitan monolaurate; polyethylene glycol alkyl ether or phenols, for example polyethylene glycol - 20 cetyl ether, polyethylene glycol - 10 - 100
  • the pharmaceutical composition of the invention may optionally be coated with a film forming polymer along with other coating additives, which may include both functional and nonfunctional coating.
  • coating additives may include one or more of plasticizers, coloring agents, opacifiers, solvents and lubricants/glidants.
  • film-forming polymers examples include ethyl cellulose, hydroxypropyl methylcellulose, methylcellulose, carboxy methylcellulose, hydroxymethyl cellulose, hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, cellulose acetate trimellitate; waxes such as polyethylene glycol; methacrylic acid polymers such as Eudragit® RL and RS; gums such as xanthan gum, and the like.
  • commercially available coating compositions comprising film-forming polymers marketed under various trade names, such as Opadry® may also be used for coating.
  • plasticizers include acetylated triacetin, triethyl citrate, tributyl citrate, glycerol tributyrate, diacetylated monoglyceride, polyethylene glycols, propylene glycol, sesame oil, acetyl tributyl citrate, acetyl triethyl citrate, diethyl oxalate, diethyl phthalate, diethyl maleate, diethyl fumarate, dibutyl succinate, diethylmalonate, dioctyl phthalate, dibutyl sebacate, and the like.
  • opacifiers include titanium dioxide and the like.
  • coloring agents include Iron oxide, Ferric Oxide Yellow, Lake of Tartrazine, Allura Red, Lake of Quinoline Yellow, Lake of Erythrosine.
  • a polymer solution or dispersion may be prepared in various solvents, including water, ethanol, isopropyl alcohol, acetone, ether or mixtures thereof.
  • the composition may be coated using techniques such as spray coating in conventional coating pan or fluidized bed processor, or dip coating.
  • the coating options that can be used for the coating of the composition may include, for example: i) hydroxypropyl methylcellulose, diacetylated monoglyceride and purified water; or ii) polyvinyl alcohol, xanthan gum, lecithin, talc, titanium dioxide and purified water; or iii) hydroxypropyl methylcellulose, polyethylene glycol, talc, titanium dioxide, isopropyl alcohol and dichloromethane.
  • Tablets may be prepared by conventional methods like direct compression or dry granulation or wet granulation, in particular non-aqueous granulation.
  • the tablet is prepared by direct compression process, the process comprising the steps of: i) hydrating sevelamer or salts by exposing sevelamer or salts to the atmosphere for 1-2 hours till the moisture level is at a desired level; ii) blending hydrated sevelamer or salts with pharmaceutically acceptable inert excipients; iii) lubricating the blend; iv) compressing the blend into a suitably sized tablet; and v) optionally, coating the tablet.
  • the tablet is prepared by direct compression process, the process comprising the steps of: i) blending sevelamer or salts with pharmaceutically acceptable inert excipients; ii) lubricating the blend; iii) compressing the blend into a suitably sized tablet; and iv) optionally, coating the tablet.
  • the tablet is prepared by dry granulation process, the process comprising the steps of: i) blending sevelamer or salts with pharmaceutically acceptable inert excipients; ii) granulating the above blend using slugging or roller compaction; iii) optionally blending with pharmaceutically acceptable inert extragranular excipients; iv) lubricating the granules/blend; v) compressing the lubricated granule/blend into suitably sized tablet cores; and vi) optionally, coating the tablet cores.
  • the tablet is prepared by direct compression process, the process comprising the steps of: i) blending sevelamer or salts with hydroxypropyl cellulose and other pharmaceutically acceptable inert excipients; ii) lubricating the blend of step i); iii) compressing the blend of step ii) into suitably sized tablet; and iv) optionally, coating the tablet of step iii).
  • the tablet is prepared by dry granulation process, the process comprising the steps of i) blending sevelamer or salts with hydroxypropyl cellulose and other pharmaceutically acceptable inert excipients; ii) granulating the blend of step i) using slugging or roller compaction; iii) optionally, blending granules of step ii) with pharmaceutically acceptable inert extragranular excipients; iv) lubricating the granules of step ii) or blend of step iii); v) compressing the lubricated granules or blend of step iv) into suitably sized tablet core; and vi) optionally, coating the tablet core of step v).
  • the tablet is prepared by direct compression process, the process comprising the steps of: i) hydrating sevelamer by exposing sevelamer or salts to the atmosphere for 1-2 hours or by spraying water to achieve the desired moisture level; ii) blending the hydrated sevelamer or salts of step i) with hydroxypropyl cellulose and other pharmaceutically acceptable inert excipients; iii) lubricating the blend of step ii); iv) compressing the blend step iii) into suitably sized tablet; and v) optionally, coating the tablet of step iv).
  • step 2 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Example 2
  • Sevelamer HCl (initial moisture content of 2.35%) was hydrated by exposing it to atmosphere for 1-2 hours to obtain a moisture level of 6.72%.
  • step 2 The blend of step 2 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer HCl, hydroxypropyl cellulose (low- viscosity), silicon dioxide and lactose were blended together.
  • step 1 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer HCl, copovidone, lactose and hydroxypropyl cellulose (low-viscosity) were blended together.
  • step 2 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer hydrochloride, povidone, lactose and hydroxypropyl cellulose (low- viscosity) were blended together.
  • step 1 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer hydrochloride, copovidone, lactose, hydroxypropyl cellulose (low- viscosity) and hydroxypropyl cellulose (medium- viscosity) were blended together.
  • step 2 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer hydrochloride, povidone, mannitol, silicon dioxide, hydroxypropyl cellulose (low-viscosity) and pregelatinized starch were blended together.
  • step 1 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer hydrochloride, povidone, mannitol, silicon dioxide, hydroxypropyl cellulose (low-viscosity) and crospovidone were blended together.
  • step 2 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Sevelamer hydrochloride, povidone, mannitol, silicon dioxide, hydroxypropyl cellulose (low- viscosity) and corn starch were blended together.
  • step 1 The blend of step 1 was lubricated with stearic acid and compressed into suitably sized tablets.
  • Table 1 summarizes the results of disintegration testing and hardness testing of each tablet prepared as per Examples 3-9.
  • the disintegration time of each tablet was determined using USP-30 disintegration time apparatus and hardness of each tablet was measured with a Schleuniger Hardness Tester.
  • step 3 Compress the lubricated blend of step 2 into suitably sized tablets.
  • step 2 Lubricate blend of step 1 with stearic acid and compress into a suitably sized tablets.
  • step 2 Lubricate the blend of step 1 with stearic acid and compress into suitably sized tablets.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
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Abstract

La présente invention concerne une composition pharmaceutique destinée à l'administration par voie orale et comprenant du sevelamer ou un sel, acceptable sur le plan pharmaceutique, de celui-ci, ledit sevelamer ou sel devant être présent à hauteur de moins de 80 % en poids de la composition et ladite composition étant exempte de cellulose cristalline et d'hydroxypropylcellulose à faible degré de substitution.
PCT/IB2008/053671 2007-09-11 2008-09-11 Composition pharmaceutique à base de sevelamer WO2009034540A1 (fr)

Applications Claiming Priority (2)

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IN1923DE2007 2007-09-11
IN1923/DEL/2007 2007-09-11

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WO2009034540A1 true WO2009034540A1 (fr) 2009-03-19

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010149230A1 (fr) * 2009-06-26 2010-12-29 Combino Pharm, S.L. Nouvelle composition pharmaceutique comprenant du chlorhydrate de poly(allylamine-co-n,n'-diallyl-1,3-diamino-2-hydroxypropane)
WO2011047700A1 (fr) * 2009-10-22 2011-04-28 Synthon B.V. Compositions pharmaceutiques de sévélamer
WO2010149794A3 (fr) * 2009-06-26 2011-06-16 Combino Pharm, S.L. Nouvelle composition pharmaceutique comprenant du poly(allylamine-co-n,n'-diallyl-1,3-diamino-2-hydroxypropane)
EP2445507A4 (fr) * 2009-06-24 2012-12-19 Navinta Llc Noyau de comprimé de polyallylamine réticulée
WO2013185789A1 (fr) * 2012-06-15 2013-12-19 Pharmathen S.A. Composition pharmaceutique contenant un polymère de liaison au phosphate
CN108338975A (zh) * 2017-01-25 2018-07-31 北京泰德制药股份有限公司 一种含有司维拉姆或其药用盐的组合物及其制备方法
CN111773190A (zh) * 2020-06-24 2020-10-16 北京瑞迪道森医药科技有限公司 一种提高制剂安全性的碳酸司维拉姆片及其制备方法

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EP0997148A1 (fr) * 1997-04-04 2000-05-03 Chugai Seiyaku Kabushiki Kaisha Preparations polymeres se fixant au phosphate
WO2001028527A2 (fr) * 1999-10-19 2001-04-26 Geltex Pharmaceuticals, Inc. Noyau de comprime polymere par compression directe
WO2005041902A2 (fr) * 2003-11-03 2005-05-12 Ilypsa, Inc. Polymeres liant les anions et leur utilisation
EP1818048A1 (fr) * 2006-02-14 2007-08-15 Teva Pharmaceutical Industries, Inc. Compositions pharmceutiques des polymères aminées aliphatiques et procedé pour les produire
WO2007094779A1 (fr) * 2006-02-14 2007-08-23 Teva Pharmaceutical Industries Ltd. Formules pharmaceutiques de polymères d'amines aliphatiques et méthodes de fabrication desdites formules
WO2008018556A1 (fr) * 2006-08-09 2008-02-14 Mitsubishi Tanabe Pharma Corporation Comprimé

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Publication number Priority date Publication date Assignee Title
EP0997148A1 (fr) * 1997-04-04 2000-05-03 Chugai Seiyaku Kabushiki Kaisha Preparations polymeres se fixant au phosphate
WO2001028527A2 (fr) * 1999-10-19 2001-04-26 Geltex Pharmaceuticals, Inc. Noyau de comprime polymere par compression directe
WO2005041902A2 (fr) * 2003-11-03 2005-05-12 Ilypsa, Inc. Polymeres liant les anions et leur utilisation
EP1818048A1 (fr) * 2006-02-14 2007-08-15 Teva Pharmaceutical Industries, Inc. Compositions pharmceutiques des polymères aminées aliphatiques et procedé pour les produire
WO2007094779A1 (fr) * 2006-02-14 2007-08-23 Teva Pharmaceutical Industries Ltd. Formules pharmaceutiques de polymères d'amines aliphatiques et méthodes de fabrication desdites formules
WO2008018556A1 (fr) * 2006-08-09 2008-02-14 Mitsubishi Tanabe Pharma Corporation Comprimé

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DATABASE WPI Derwent World Patents Index; AN 2008-g25224 [39], XP002510633 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2445507A4 (fr) * 2009-06-24 2012-12-19 Navinta Llc Noyau de comprimé de polyallylamine réticulée
WO2010149230A1 (fr) * 2009-06-26 2010-12-29 Combino Pharm, S.L. Nouvelle composition pharmaceutique comprenant du chlorhydrate de poly(allylamine-co-n,n'-diallyl-1,3-diamino-2-hydroxypropane)
WO2010149794A3 (fr) * 2009-06-26 2011-06-16 Combino Pharm, S.L. Nouvelle composition pharmaceutique comprenant du poly(allylamine-co-n,n'-diallyl-1,3-diamino-2-hydroxypropane)
WO2011047700A1 (fr) * 2009-10-22 2011-04-28 Synthon B.V. Compositions pharmaceutiques de sévélamer
EA024699B1 (ru) * 2009-10-22 2016-10-31 Синтон Б. В. Фармацевтическая таблетка с немедленным высвобождением, содержащая севеламера карбонат
WO2013185789A1 (fr) * 2012-06-15 2013-12-19 Pharmathen S.A. Composition pharmaceutique contenant un polymère de liaison au phosphate
AU2012382602B2 (en) * 2012-06-15 2016-02-11 Pharmathen S.A. Pharmaceutical composition containing phosphate binding polymer
US9849147B2 (en) 2012-06-15 2017-12-26 Pharmathen S.A. Pharmaceutical composition containing phosphate binding polymer
CN108338975A (zh) * 2017-01-25 2018-07-31 北京泰德制药股份有限公司 一种含有司维拉姆或其药用盐的组合物及其制备方法
CN111773190A (zh) * 2020-06-24 2020-10-16 北京瑞迪道森医药科技有限公司 一种提高制剂安全性的碳酸司维拉姆片及其制备方法

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