WO1995001795A1 - Combinaison antiacide-alginate-antagoniste h¿2? - Google Patents

Combinaison antiacide-alginate-antagoniste h¿2? Download PDF

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Publication number
WO1995001795A1
WO1995001795A1 PCT/US1994/007519 US9407519W WO9501795A1 WO 1995001795 A1 WO1995001795 A1 WO 1995001795A1 US 9407519 W US9407519 W US 9407519W WO 9501795 A1 WO9501795 A1 WO 9501795A1
Authority
WO
WIPO (PCT)
Prior art keywords
gastrointestinal
relief
antacid
alginate
amount effective
Prior art date
Application number
PCT/US1994/007519
Other languages
English (en)
Inventor
Robert T. Sims
William Slivka
Original Assignee
Merck & Co., Inc.
Mcneil-Ppc, Inc.
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 Merck & Co., Inc., Mcneil-Ppc, Inc. filed Critical Merck & Co., Inc.
Priority to CA002166731A priority Critical patent/CA2166731A1/fr
Priority to AU72181/94A priority patent/AU7218194A/en
Priority to EP94921465A priority patent/EP0707484A4/fr
Priority to JP7504108A priority patent/JPH08512321A/ja
Publication of WO1995001795A1 publication Critical patent/WO1995001795A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/08—Oxides; Hydroxides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • A61K33/10—Carbonates; Bicarbonates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants

Definitions

  • H2 antagonists are commonly prescribed to treat and prevent ulcers in the walls of the stomach, duodenum or esophagus. H2 antagonists are also used to treat non-ulcerative conditions. Damage to the mucus lining surrounding these tissues enables destructive action of stomach acids which erodes the underlying tissue. Commonly known H2 antagonists for the treatment of ulcers include cimetidine, ranitidine, nizatidine, roxatidine and famotidine.
  • H2 antagonists an alginate added to treat gastroesophageal reflux can promote oxidation of the H2 antagonist to a biological inactive form and additional ingredients have to be added to prevent this reaction.
  • Combinations of antacids and alginates have been used to provide symptomatic relief of gastroesophageal reflux. See Martindale's Extra Pharmacopoeia at page 1432.
  • Combinations of H2 antagonists and antacids have been disclosed: See FR2648710, GB2219940, EP- 294933-A, EP-286 . 781-A, SU 1,362,477-A, U.S. 4,824,664, EP 233,853 and WO 9209286 Al.
  • Additional antoxidants may be added to the claimed famotidine/ alginate/antacid combination to prevent oxidation of famotidine to a less active metabolite.
  • a combination wherein an advantage is that the overall symptoms of gastrointestinal distress can be effectively treated with a combination of the most powerful H2 antagonist available with an alginate and an antacid such as a carbonate salt or magnesium or aluminum hydroxide wherein the combination simultaneously relieves and prevents symptoms associated with excess gastric acid secretion or evolution in the stomach and esophagus respectively.
  • the present invention therefore provides an effective synergistic treatment of gastrointestinal disorders using the combination of famotidine and its salts, hydrates, or pharmacologically active stereoisomers or polymorphs with an alginate and an antacid.
  • the claimed combination is particularly useful for treating gastro ⁇ esophageal reflux disorder at nightime since famotidine or the biologically active forms of famotidine has a long-lasting effect (9 hours) thereby aiding in the prevention of heartburn and other gastrointestinal distress while the alginate aids in eliminating the rafting effect and the antacid provides rapid buffering relief in the stomach.
  • Other H2 antagonists that may be employed in this invention include cimeditine, ranitidine, nizatidine, and roxatidine.
  • compositions for use in the treatment of mild stomach and esophagus disorders including the prevention and treatment of heartburn.
  • the composition comprises: (i) an ampunt effective in the relief of gastrointestinal or esophagus disorders of an H2 antagonist selected from a compound of the formula:
  • This invention is also directed to a method of preventing and treating indigestion, sour stomach, heartburn, overindulgence, gastroesophageal reflux and other gastrointestinal disorders in mammals, including humans, in need of treatment thereof, comprising administering to such organism:
  • mammals or mammalian organism includes but is not limited to humans, dogs, cats, horses and cows.
  • treatment encompasses the complete range of therapeutically positive effects associated with pharmaceutical medication including reduction of, alleviation of and relief from the symptoms or illness which affect the organism.
  • Famotidine may be purchased in bulk or other suitable quantities as it is currently available on the market and formulated via typical formulation processes with alginates selected from alginic acid which is suitable for tablet formulations or sodium alginate which is suitable for liquid formulations of the claimed combination and antacids which are also known including calcium carbonate and other carbonate salts as well as aluminum and magnesium hydroxides.
  • alginates selected from alginic acid which is suitable for tablet formulations or sodium alginate which is suitable for liquid formulations of the claimed combination and antacids which are also known including calcium carbonate and other carbonate salts as well as aluminum and magnesium hydroxides.
  • simethicone a known antiflatulent, may be added to the above combination to provide maximum and broad relief of gastrointestinal disturbances and distress. Famotidine as a prescription drug product is sold in the United States under the trademark PEPCID®.
  • compositions of the present invention are useful in the treatment of various mild gastrointestinal disorders including indigestion, sour stomach, overindulgence and heartburn.
  • an alginate and antacid combined with an H2 antagonist selected from famotidine, a compound of the formula:
  • the claimed combination is used to treat the symptoms associated with gastric acid secretion while simultaneously treating the symptoms of gastroesophageal reflux and flatulence.
  • the animal, patient, or organism in need of treatment thereof therefore benefits from the claimed pharmaceutical composition.
  • H2 antagonists are well known in the treatment of ulcers and other gastrointestinal disorders and may be used, according to the present invention, in combination with an alginate and an antacid and optional anti-flatulent.
  • H2 antagonists used for ulcer therapy fall into four major structural classes: imidazole derivatives; substituted furans; aminoalkylphenoxy derivatives and guanidinothiazole compounds.
  • Famotidine N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio] propanimidamide
  • Famotidine N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4- thiazolyl]methyl]thio] propanimidamide
  • Famotidine is a competitive inhibitor of histamine H2-receptors and its primary pharmacological activity is the inhibition of gastric acid secretion.
  • Famotidine suppresses both the acid concentration and the volume of gastric acid secretion. Famotidme is well tolerated and has minimal side effects and thus advantageously may be used in the present invention in combination with an alginate and an antacid. Famotidine is also the most potent and selective H2 antagonist.
  • the combination of famotidine or its pharmaceutically effective salts, hydrates, stereoisomers or polymo ⁇ hs with an antacid and an alginate and optionally simethicone provides a combination which simultaneously and selectively provides relief from and prevention of discomfort and injury to the stomach, esophagus, or duodenum from excess production of gastric acid.
  • famotidine in combination with an alginate and an antacid may not interact with alcohol so that it may be administered prior to or during ingestion of meals or beverages which contain alcohol and, therefore, a patient in need of rapid treatment of gastrointestinal distress may take the drug combination at an appropriate time which may be during a meal in which alcohol was consumed.
  • the combination of an alginate and antacid with famotidine provides relief of gastroesophageal reflux while also providing long acting relief from and treatment of gastrointestinal disorders associated with gastric acid secretion.
  • the antacid administered in the claimed combination provides both a buffering effect and simultaneously generates carbon dioxide to aerate the alginate raft formed from the alginate.
  • the raft has a lower density after this aeration effect and floats on the stomach contents.
  • a therapeutically active stereoisomer or polymo ⁇ h of famotidine may be employed substantially free of other stereoisomeric forms of polymo ⁇ hs, substantially free should be taken to mean at least 90% of one distinct stereoisomer or polymo ⁇ h.
  • famotidine which is a highly potent H2 antagonist with an alginate and an antacid reduces the size and weight of all pharmaceutical delivery forms or combination formulations and therefore improves patient compliance or tolerance.
  • the tablet or capsule form of this combination is more readily swallowable by patients in need of treatment thereof.
  • Famotidine or its pharmaceutically acceptable salts, hydrates, stereoisomers or polymo ⁇ hs is advantageously used in the present invention in combination with alginic acid or sodium alginate and calcium carbonate.
  • suitable and known antacids such as the aluminum hydroxide or magnesium hydroxide salts or mixtures or combinations thereof may be used in the claimed formulation.
  • a one to one ratio of magnesium hydroxide to aluminum hydroxide salts may be utilized in the present invention.
  • the amount of famotidine used in the present invention in humans may range from 2.5 mg/day to 80 mg/day.
  • 2.5 to 40 mgs/day is administered in combination with 200-500 mgs/day mg of an alginate and 250-750 mgs/day of calcium carbonate.
  • the quantities of each of the active ingredients may vary depending upon the severity of the condition and the particular biochemistry and need of the patient or other organism in need of treatment thereof. A physician or clinician or veterinarian of ordinary skill in the art may readily determine suitable dosages of any prescription medication containing the claimed invention.
  • the combination claimed in the instant invention is advantageously administered orally.
  • the antacid employed herein may be selected from any of the commercially available or known antacids or combinations thereof such as aluminum hydroxide, calcium carbonate, magnesium hydroxide or sodium bicarbonate.
  • the simethicone optionally employed herein is also available commerically and the administered oral dosage may range in humans from 10-1,000 mgs/day.
  • ADG may be employed as an anti ⁇ flatulent in doses of 290 to 31,000 Galactosidase International Units (GalU) particularly 675 to 2250 GalU.
  • the present composition may be administered to a patient in need of treatment thereof in the form of tablets, caplets, gelcaps, capsules, elixirs, lozenges, wafers, effervescent formulations, chewable tablets, syrups, or suspensions or via other known and effective delivery methods.
  • the active ingredients may be admixed with a pharmaceutically acceptable diluent such as lactose, sucrose, cellulose, dicalcium phosphate, calcium sulfate, mannitol, and, in a liquid composition, ethyl alcohol.
  • Acceptable emulsifying or suspending agents such as PVP, gelatin, natural sugars, corn sweeteners, natural and synthetic gums such as acacia, sodium alginate, guar gum, agar, bentonite, carboxymethylcellulose sodium, polyethylene glycol and waxes, may also be admixed with the active components.
  • lubricants such as magnesium stearic acid talc or magnesium stearate, and disintegrators or superdisintegrators such as starch, sodium starch glycolate or cross-linked PVP may also be included.
  • Electrolytes such as dicalcium phosphate, sodium benzoate, sodium acetate and sodium chloride may also be used.
  • the inactive ingredients may also include magnesium or aluminum trisilicate, sodium or potassium salts including carbonate salts, aluminum hydroxide gel, lactose, sorbitol, aspartame or sodium saccharide.
  • the active components may also be formulated in sustained release or effervescent formulations.
  • the sustained release formulations also include layered formulations which provide for distinct release ratios and thus may be more effective in allowing for short and long term relief.
  • Simethicone may be added to each of the above formulations or examples to provide anti-flatulent relief.
  • the quantity of simethicone administered to a patient in need of treatment thereof is the typical known dosage range to treat flatulence.
  • the dose may be, for example 20-40 mgs of simethicone per 5 mis of a liquid form claimed combination or per chewable tablet wherein the other active ingredients include famotidine (20-40 mgs), magnesium hydroxide (200 mg), aluminum hydroxide (dried gel, 200 mg).
  • the inactive ingredients in the tablet form may further include dextrates, mannitol, magnesium stearate, Yellow 10, collodial silicon dioxide and Blue 1 or Red 27 while the liquid form(s) may further include inactives such as butylparaben, carboxymethylcellulose sodium, flavors, hydroxypropyl methylcellulose, microcrystalline cellulose, propylparaben, and purified water.
  • inactives such as butylparaben, carboxymethylcellulose sodium, flavors, hydroxypropyl methylcellulose, microcrystalline cellulose, propylparaben, and purified water.
  • the previous examples are to be construed as non-limiting and additional dosages and dosage forms or routes of administration may be varied depending upon the individual patient being treated for either the primary (excess acid leading to gastrointestinal or esophageal disturbance or damage) or secondary (infections) symptoms of gastrointestinal disorders.
  • known pharmaceutically acceptable excipients or agents may be added as inactive ingredients to the claimed active combination in a variety of forms including tablets, capsules

Abstract

Cette invention concerne des compositions pharmaceutiques utilisables dans le traitement et le soulagement des indigestions, des aigreurs d'estomac, des brûlures d'estomac et des autres troubles gastro-intestinaux chez les mammifères, y compris l'homme. Ce traitement comprend l'administration de compositions comportant: (i) une quantité, efficace pour le soulagement des troubles gastro-intestinaux ou de l'÷sophage, d'un antagoniste H2 sélectionné parmi un composé de la formule (I) et ses sels, hydrates, stéréo-isomères ou composés polymorphes pharmaceutiquement acceptables et (ii) une quantité, efficace pour le soulagement des troubles gastro-intestinaux ou de l'÷sophage, d'au moins un alginate et (iii) une quantité, efficace pour le soulagement des embarras gastro-intestinaux, d'un antiacide procurant un effet régulateur et générant du dioxyde de carbone pour aérer l'alginate.
PCT/US1994/007519 1993-07-06 1994-07-05 Combinaison antiacide-alginate-antagoniste h¿2? WO1995001795A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002166731A CA2166731A1 (fr) 1993-07-06 1994-07-05 Combinaisons d'antacide, d'alginate et d'antagoniste des recepteurs de h2
AU72181/94A AU7218194A (en) 1993-07-06 1994-07-05 H2 antagonist-alginate-antacid combinations
EP94921465A EP0707484A4 (fr) 1993-07-06 1994-07-05 Combinaison antiacide-alginate-antagoniste h 2?
JP7504108A JPH08512321A (ja) 1993-07-06 1994-07-05 Ｈ▲下２▼拮抗剤−アルギネート−制酸剤の組合せ物

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US8793793A 1993-07-06 1993-07-06
US087,937 1993-07-06

Publications (1)

Publication Number Publication Date
WO1995001795A1 true WO1995001795A1 (fr) 1995-01-19

Family

ID=22208161

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1994/007519 WO1995001795A1 (fr) 1993-07-06 1994-07-05 Combinaison antiacide-alginate-antagoniste h¿2?

Country Status (5)

Country Link
EP (1) EP0707484A4 (fr)
JP (1) JPH08512321A (fr)
AU (1) AU7218194A (fr)
CA (1) CA2166731A1 (fr)
WO (1) WO1995001795A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997040843A2 (fr) * 1996-05-02 1997-11-06 Warner-Lambert Company Methode de prevention de troubles gastro-intestinaux
WO1998023272A1 (fr) * 1996-11-27 1998-06-04 The Procter & Gamble Company Compositions et procedes pour le traitement de troubles gastro-intestinaux
WO2000025754A2 (fr) * 1998-11-04 2000-05-11 Mcneil-Ppc, Inc. Formes posologiques solides a administration par voie orale renfermant de l'acide alginique et de la famotidine
AU728423B2 (en) * 1996-10-04 2001-01-11 Mcneil-Ppc, Inc. Methods and compositions for preventing and treating heartburn
US6183776B1 (en) 1996-01-08 2001-02-06 Astra Aktiebolag Oral pharmaceutical dosage forms comprising a proton pump inhibitor and an antacid agent or alginate
WO2004009077A1 (fr) * 2002-07-17 2004-01-29 Reliant Pharmaceuticals, Llc Composition pharmaceutique liquide a gout masque, comprenant un complexe d'un antagoniste h2 d'histamine et un alginate
WO2007102726A1 (fr) * 2006-03-09 2007-09-13 World-Trade Import-Export, Wtie, Ag. Combinaison synergique d'inhibiteurs des récepteurs h2, de silicone inerte et d'un complexe d'aluminate d'hydroxymagnésium
WO2008017337A1 (fr) 2006-08-08 2008-02-14 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pharmaceutique comprenant un agent liant et/ou neutralisant l'acide gastrique et un dérivé d'acide alginique
DE102008019339A1 (de) * 2008-04-16 2009-10-22 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Zusammensetzung für die medizinische Anwendung, insbesondere Antazidum
US20180140630A1 (en) * 2016-11-23 2018-05-24 M. Michael Wolfe Combination of an h2-receptor antagonist, antacid, and alginic acid to treat episodic heartburn
IT201800002625A1 (it) * 2018-02-13 2019-08-13 Drugs Minerals And Generics Italia S R L In Forma Abbreviata D M G Italia S R L Composizione in forma solida per uso nel trattamento dei sintomi extra-esofagei del reflusso gastrico
IT202100029657A1 (it) * 2021-11-24 2023-05-24 Mauro Leonardis Sciroppo anti-reflusso sterile senza conservanti

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5229137A (en) * 1992-05-06 1993-07-20 Brigham And Women's Hospital, Inc. Methods and pharmaceutical compositions for treating episodic heartburn

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2222772B (en) * 1988-09-20 1992-05-13 Glaxo Group Ltd Pharmaceutical compositions
GB9224855D0 (en) * 1992-11-27 1993-01-13 Smithkline Beecham Plc Pharmaceutical compositions
AU7218294A (en) * 1993-07-06 1995-02-06 Mcneil-Ppc, Inc. H2 antagonist-alginate combinations

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5229137A (en) * 1992-05-06 1993-07-20 Brigham And Women's Hospital, Inc. Methods and pharmaceutical compositions for treating episodic heartburn

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0707484A4 *

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6183776B1 (en) 1996-01-08 2001-02-06 Astra Aktiebolag Oral pharmaceutical dosage forms comprising a proton pump inhibitor and an antacid agent or alginate
WO1997040843A2 (fr) * 1996-05-02 1997-11-06 Warner-Lambert Company Methode de prevention de troubles gastro-intestinaux
WO1997040843A3 (fr) * 1996-05-02 1997-12-18 Warner Lambert Co Methode de prevention de troubles gastro-intestinaux
AU728423B2 (en) * 1996-10-04 2001-01-11 Mcneil-Ppc, Inc. Methods and compositions for preventing and treating heartburn
WO1998023272A1 (fr) * 1996-11-27 1998-06-04 The Procter & Gamble Company Compositions et procedes pour le traitement de troubles gastro-intestinaux
WO2000025754A2 (fr) * 1998-11-04 2000-05-11 Mcneil-Ppc, Inc. Formes posologiques solides a administration par voie orale renfermant de l'acide alginique et de la famotidine
WO2000025754A3 (fr) * 1998-11-04 2000-09-08 Mcneil Ppc Inc Formes posologiques solides a administration par voie orale renfermant de l'acide alginique et de la famotidine
US6930119B2 (en) 2002-07-17 2005-08-16 Reliant Pharmaceuticals, Inc. Liquid pharmaceutical composition
WO2004009077A1 (fr) * 2002-07-17 2004-01-29 Reliant Pharmaceuticals, Llc Composition pharmaceutique liquide a gout masque, comprenant un complexe d'un antagoniste h2 d'histamine et un alginate
WO2007102726A1 (fr) * 2006-03-09 2007-09-13 World-Trade Import-Export, Wtie, Ag. Combinaison synergique d'inhibiteurs des récepteurs h2, de silicone inerte et d'un complexe d'aluminate d'hydroxymagnésium
WO2008017337A1 (fr) 2006-08-08 2008-02-14 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Composition pharmaceutique comprenant un agent liant et/ou neutralisant l'acide gastrique et un dérivé d'acide alginique
DE102008019339A1 (de) * 2008-04-16 2009-10-22 Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh Zusammensetzung für die medizinische Anwendung, insbesondere Antazidum
US20180140630A1 (en) * 2016-11-23 2018-05-24 M. Michael Wolfe Combination of an h2-receptor antagonist, antacid, and alginic acid to treat episodic heartburn
IT201800002625A1 (it) * 2018-02-13 2019-08-13 Drugs Minerals And Generics Italia S R L In Forma Abbreviata D M G Italia S R L Composizione in forma solida per uso nel trattamento dei sintomi extra-esofagei del reflusso gastrico
WO2019159073A1 (fr) * 2018-02-13 2019-08-22 Drugs Minerals And Generics Italia S.R.L. In Forma Abbreviata D.M.G. Italia S.R.L. Composition sous forme solide destinée à être utilisée dans le traitement de symptômes extra-œsophagiens du reflux gastrique
IT202100029657A1 (it) * 2021-11-24 2023-05-24 Mauro Leonardis Sciroppo anti-reflusso sterile senza conservanti

Also Published As

Publication number Publication date
AU7218194A (en) 1995-02-06
CA2166731A1 (fr) 1995-01-19
EP0707484A4 (fr) 1998-07-01
EP0707484A1 (fr) 1996-04-24
JPH08512321A (ja) 1996-12-24

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