WO1995011671A1 - Formes posologiques a dissolution rapide contenant du silicate de magnesium et d'aluminium et plusieurs ingredients actifs - Google Patents

Formes posologiques a dissolution rapide contenant du silicate de magnesium et d'aluminium et plusieurs ingredients actifs Download PDF

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Publication number
WO1995011671A1
WO1995011671A1 PCT/US1994/012018 US9412018W WO9511671A1 WO 1995011671 A1 WO1995011671 A1 WO 1995011671A1 US 9412018 W US9412018 W US 9412018W WO 9511671 A1 WO9511671 A1 WO 9511671A1
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
composition according
aluminum silicate
magnesium aluminum
mixtures
Prior art date
Application number
PCT/US1994/012018
Other languages
English (en)
Inventor
Michelle Elizabeth Brideau
Anne Marie Carella
Original Assignee
The Procter & Gamble Company
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 The Procter & Gamble Company filed Critical The Procter & Gamble Company
Priority to EP94931939A priority Critical patent/EP0725630A1/fr
Priority to AU80845/94A priority patent/AU8084594A/en
Priority to JP7512714A priority patent/JPH09504293A/ja
Publication of WO1995011671A1 publication Critical patent/WO1995011671A1/fr

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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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches

Definitions

  • the present invention relates to a good tasting, fast dissolving adsorbate composition consisting of magnesium aluminum silicate with two or more pharma ⁇ ceutically acceptable active ingredients.
  • magnesium aluminum silicate as useful in mask ⁇ ing the taste of pharmacologically active compounds
  • the prior art disclosures of immediate release dosage forms contain- ing magnesium aluminum silicate as the taste masking agent generally focus on masking the taste of a single pharmaceutically active ingredient. This may be attrib ⁇ uted to the assumption that any increase in the amount of the bitter tasting compo ⁇ nents) used (e.g. higher doses of the initial compound or the admixing of an addi ⁇ tional compound(s)) would require a corresponding increase in the amount of mag- nesium aluminum silicate used.
  • the present invention relates to a pharmaceutical composition
  • a pharmaceutical composition comprising:
  • a safe and effective amount of two or more pharmaceutically acceptable active ingredients selected from the group consisting of an antitussive; an a ⁇ tinauseant a nutritional supplement; a laxative; an appetite suppressant; an analgesic; an antiasthmatic; an antihistamine; a decongesta ⁇ t; an expectorant; an antacid; an antidiarrheal, a H2-Receptor antagonist and mixtures thereof, and (c) a pharmaceutically acceptable carrier wherein said pharmaceutically acceptable carrier can be rapidly disintegrated in aqueous solution.
  • the present invention further relates to methods of treating symptoms such as those associated with the common cold, respiratory disorders, cough, cold, cold-like and or fiu symptoms associated with the common cold, gastrointestinal disorders and allergies; comprising the administration of a safe and effective amount of the com ⁇ positions of the present invention.
  • compositions of the present invention contain essential components as well as various nonessential components as indicated below.
  • the first essential component of the present invention is a safe and effective amount of magnesium aluminum silicate of the formula Al2MgOgSi2.
  • Magnesium aluminum silicate occurs naturally in such smectite minerals as colerainite, saponhe, sapphirine, sheridanite zebedassite and has been used extensively in a variety of cos- metic and pharmaceutical formulations.
  • the refined magnesium aluminum silicates used in the present example, Veegum® HS is available from and manufactured by R.T. Vanderbilt Company, Inc., Norwalk, CT.
  • a Typical chemical analysis of Veegum® HS is as follows: Silicon dioxide 63.0
  • Ignition loss 7.5 having a combined density of 2.6mg/m ⁇ .
  • compositions of this invention typically comprise from about 0.01% to about 50%, preferably from about 0.1% to about 25%, more preferably from about 1.0% to about 10% and most preferably from about 1.0% to about 5%, by weight of a magnesium aluminum silicate.
  • the two or more pharmaceutically acceptable actives useful in the present invention may be selected from among the various groups of chemical compounds or materials suitable for oral administration and having a pharmacological action. These pharmaceutically acceptable active compounds or materials should be compatible with the other essential ingredients and compatible in combination with other in ⁇ cluded active materials or compounds.
  • the pharmaceutically acceptable active com ⁇ pounds or materials are present at a level from about 0.01% to about 75%, preferably from about 0.1% to about 50%, more preferably from about 1.0% to about 25% and most preferably from about 1.0% to about 10%.
  • Useful pharmaceutically acceptable active materials or compounds may include, but are not limited to: bronchodilators, anorexiants, antihistamines, nutritional supplements (such as vitamins, minerals, fatty acids, amino acids, and the like), laxatives, analgesics, antacids, H2 ⁇ receptor antago- nists, antidiarrheals, decongestants, antitussives, antinauseants, antimicrobials, anti- fungals, antivirals, expectorants, anti-inflammatory agents, antipyretics, their pharma ⁇ ceutically acceptable salts and mixtures thereof.
  • salts refers to salts prepared from pharmaceutically acceptable non-toxic bases including inorganic bases and organic bases. Salts derived from inorganic bases include sodium, potassium, lithium, am ⁇ monia, calcium, magnesium, ferrous, zinc, manganous, aluminum, ferric, manganic salts and the like.
  • Salts derived from pharmaceutically acceptable organic non-toxic bases include salts of primary, secondary, tertiary and quaternary amines, substituted amines including naturally occurring substituted amines, cyclic amines and basic ion exchange resins, such as triethyiamine, tripropylamine, 2-dimethyiaminoethanol, 2- diethylaminoethanol, lysine, arginine, histidine, caffeine, procaine, N-ethylpiperidine, hydrabamine, choline, betaine, ethylenediamine, glucosamine, methylglycaniine, theo- bromine, purines, piperazine, piperidine, polyamine resins and the like.
  • basic ion exchange resins such as triethyiamine, tripropylamine, 2-dimethyiaminoethanol, 2- diethylaminoethanol, lysine, arginine, histidine, caffeine, procaine, N-e
  • Examples of decongestants useful in the compositions of the present inven ⁇ tion include pseudoephedrine, phenylpropanolamine, phenylephrine and ephedrine, their pharmaceutically acceptable salts, and mixtures thereof.
  • Examples of antitussives useful in the compositions of the present invention include dextromethorphan, chlopedianol, carbetapentane, caramiphen, noscapine, diphenhydramine, codeine, hydrocodone, hydromorphone, their pharmaceutically ac ⁇ ceptable salts, and mixtures thereof.
  • expectorants also known as mucolytic agents
  • examples of expectorants include; glyc ⁇ yi guaiacolate, terpin hydrate, ammonium chloride, N- acetylcysteine, and a broxol, their pharmaceutically acceptable salts, and mixtures thereof
  • analgesics useful in the present invention include; morphine, co ⁇ characteristic, meperidine, pentazo ⁇ ne, propoxyphene, acetaminophen, allopurinol, acetyl- salicylic acid, choline salicylate, ketoprofen, magnesium silicate, fenoprofen, ibupro- fen, indomethacin, naproxen, and many others and their pharmaceutically acceptable salts and mixtures thereof.
  • antihistamines useful in the present invention include; brom- pheniramine, chlorpheniramine, clemastine, dexchlorpheniramine, diphenhydramine, doxylamine, promethazine, terfenadine, triprolidine and many others and their phar ⁇ maceutically acceptable salts and mixtures thereof.
  • gastrointestinal agents suitable for use in the present invention include anticholinergics, including atropine, clidinium and dicyclominc; antacids, in- eluding aluminum hydroxide, bismuth subsalicylate, simethicone, calcium carbonate and magaldrate; H2-receptor antagonists including: cimetidine, famotidine, nizatidine and ranitidine; laxatives, including: phenolphthalein and casanthrol; and antidiar- rheals including: diphenoxylate and loperamide.
  • anticholinergics including atropine, clidinium and dicyclominc
  • antacids in- eluding aluminum hydroxide, bismuth subsalicylate, simethicone, calcium carbonate and magaldrate
  • H2-receptor antagonists including: cimetidine, famotidine, nizatidine and ranitidine
  • laxatives including: phenolphthalein and
  • analgesics decongestants, antitussives, expecto ⁇ rants and antihistamines as well as bronchodilators, anorexiants, laxatives, antiemet- ics, antimicrobials, antibacterial*, ant ⁇ ungals, anti-inflammatory agents, antivirala, antipyretics, nutritional supplements, anticholinexgjcs, antacids, H2-receptor antago ⁇ nists, antidia rheals and other misceflaneous gastrointestinal compounds and their ac- ceptable dosage ranges are described in Remington's Pharmaceutical Sciences, pp.
  • Nonessential components include, but are not limited to: coloring agents; flavoring agents, including: vanilla, cherry, grape, orange, peppermint, spearmint, anise, blueberry raspberry, banana, chocolate, caramel, strawberry, lemon, menthol and ProsweetTM MM50 (a combination of natu- ral and artificial flavors and propylene giycol, available from Virginia Dare Extract Co., Inc., Brooklyn, NY); sweeteners, including saccharin, dextrose, levulose, su ⁇ crose, cyclamate, mannitol and aspartate, along with many others; suspending agents, including xanthum gum, acacia gum, carboxymethylcellulose, starch and methylcellu- lose; preservatives; releasing agents, including polysorbate 80, sodium lauryl sulfate, vegetable oils and magnesium stearate; and water.
  • coloring agents including: vanilla, cherry, grape, orange, peppermint, spearmint, anise, blueberry raspberry, banana, chocolate, caramel
  • Another preferred nonessential component of the present invention is a cool ⁇ ing agent or a combination of cooling agents.
  • Suitable cooling agents are those des ⁇ cribed in U.S. Patent 4.136.163. January 23, 1979, to Watson et al., U.S. Patent 4.230.668. October 28, 1980, to Rowsell et al. and U.S. Patent 4.032.661, to Rowsell et al., all of which are herein incorporated by reference.
  • a particulariy pre ⁇ ferred cooling agent is N-ethji-p-menthane-3-carboxamide (WS-3 supplied by Ster ⁇ ling Organics), taught by the above incorporated U.S. Patent 4.136.163.
  • Another particularly preferred cooling agent is 3-1-menthoxypropane 1,2-diol (TK-10 sup ⁇ plied by Takasago Perfumery Co., Ltd., Tokyo, Japan).
  • TK-10 3-1-menthoxypropane 1,2-diol
  • This material is described in detail in U.S. Patent 4.459.425. July 10, 1984 to Amano et al. and incorporated herein by reference.
  • METHOD OF MANUFACTURE Good tasting pharmaceutical adsorbate compositions of the present invention are prepared using art-recognized principles and methodologies in mixing the ingre ⁇ washers together and in choosing the type of mixing equipment to be used.
  • the magnesium aluminum silicate and various multiply charged cationic drugs e.g.
  • multiply charged cationic drugs means compounds containing more than one positively charged substhuent
  • the crucial steps involve maintaining the pH in a range equal to or above that of the pKa of the multiply charged cationic drug(s) and, additionally, reserving the addition of said multiply charged cationic dmg(s) until after the addition of at least one other cationic compound.
  • the mixture may then be compounded with effervescent or other water-dispersible substances and dried into dosage forms that rapidly disintegrate upon coming into contact with an aqueous liquid.
  • effervescent technology is described in chapter 6 of Phar- maceutical Dosape Forms: Tablets. Vol. I, 2 nd ed., A Lieberman ed., 1989, Marcel Dekker, Inc. herein incorporated by reference.
  • the above mentioned compounding and drying process may be accomplished by using any of a multitude of solid dosage forming techniques and equipment. Methods of solid dosage formulation are well known in the art and any appropriate method may be utilized. Further information regarding solid dosage formulation can be found in Remington's Pharmaceutical Sri- ences. pp. 1633-1664, (Alfonso R. Gennaro, editor) (18th ed. 1990).
  • the resultant fast dissolving dosage form may be achieved by freeze drying.
  • Freeze-drying or ryophilization facilitates disintegration of the com ⁇ position by forming the dried composition into an open matrix network. In most cases, this results in rapid permeation by the aqueous media, promoting timely delivery of the product's active ingredients.
  • Suitable methods of freeze drying are well known in the art and commonly employed. Any suitable conventional method of freeze-drying or vacuum-drying may be utilized.
  • a preferable method of freezing and drying is to fast freeze the composition and then dry the composition to a final moisture content of about 2% to about 5%. Suitable methods of freeze-drying and production are taught by U.S. Patent 4.642.903. February 17, 1987, to Davies, U.S. Patent 4.946.684.
  • ProsweetTM MM24 2 0.50000 sodium saccharin 0.05000 aspartame 0.30000 monoammonium gtycy ⁇ hizate ⁇ 0.03000 sucrose 5.00000 mannitol 10.00000
  • LightninTM mixer (model #TS2010 (or a high shear homogenizer set at 30 to 50 RPM)) mixing at approximately 250 to 1000 RPM, add the following agents allowing each to dissolve before adding the next: water, phenylpropanolamine HC1, Veegum® HS.
  • Heat using a hot plate, keeping solution at 77°C, and mix vigorously (250 to 1000 RPM) for 30 minutes. Turn heat off and allow mixture to cool to room temperature (25°C) while mixing for a minimum of an additional 15 minutes.
  • ProsweetTM MM24 0.50000 sodium saccharin 0.05000 aspartame 0.30000 monoammonium glycyrrhizate 0.03000 sucrose 5.00000 mannitol 10.00000
  • ProsweetTM MM24 0.50000 sodium saccharin 0.05000 aspartame 0.30000 monoammonium glycyrrhizate 0.03000
  • ProsweetTM MM24 0.50000 sodium saccharin 0.15000 aspartame 0.30000
  • ProsweetTM MM24 0.50000 sodium saccharin 0.15000 aspartame 0.30000 monoammonium glycyrrhizate 0.03000 sucrose 5.00000 mannitol 10.00000
  • Examples II- VI are further examples of combinations used in treating the symptoms of a respiratory illness or allergy in a human and are manufactured in a manner substantially similar to Example I. Administration of two tablets is the nor ⁇ mal and customary dosage.
  • Examples V ⁇ -DC are further examples of combinations used in treating the symptoms of gastrointestinal illnesses in humans and are manufactured in a manner substantially similar to Example I. Administration of two tablets is the normal and customary dosage.

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Abstract

Composition d'adsorbat comprenant du silicate de magnésium et d'aluminium et au moins deux substances actives pharmaceutiquement acceptables, présentée sous une forme posologique se dissolvant rapidement.
PCT/US1994/012018 1993-10-28 1994-10-20 Formes posologiques a dissolution rapide contenant du silicate de magnesium et d'aluminium et plusieurs ingredients actifs WO1995011671A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP94931939A EP0725630A1 (fr) 1993-10-28 1994-10-20 Formes posologiques a dissolution rapide contenant du silicate de magnesium et d'aluminium et plusieurs ingredients actifs
AU80845/94A AU8084594A (en) 1993-10-28 1994-10-20 Fast dissolving dosage forms containing magnesium aluminum silicate and multiple active ingredients
JP7512714A JPH09504293A (ja) 1993-10-28 1994-10-20 マグネシウムアルミニウムシリケート及び複数の活性成分を含有した速溶解性剤形

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US14459293A 1993-10-28 1993-10-28
US08/144,592 1993-10-28

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WO1995011671A1 true WO1995011671A1 (fr) 1995-05-04

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EP (1) EP0725630A1 (fr)
JP (1) JPH09504293A (fr)
AU (1) AU8084594A (fr)
WO (1) WO1995011671A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998001134A1 (fr) * 1996-07-10 1998-01-15 Novartis Consumer Health S.A. Combinaisons pharmaceutiques de composes antihistaminiques et de terpenoides destinees a etre administrees par voie orale
EP1003383A1 (fr) † 1997-08-11 2000-05-31 Warner-Lambert Company Compositions d'aromatisation ameliorees renfermant du n-ethyl-p-methane-3-carboxamide et leur procede de fabrication et d'utilisation
WO2002045714A1 (fr) * 2000-12-04 2002-06-13 The Procter & Gamble Company Formulation medicamenteuse a tolerabilite orale amelioree
US7101573B2 (en) * 2001-09-28 2006-09-05 Mcneil-Pcc, Inc. Simethicone solid oral dosage form
US7588793B1 (en) 1998-06-05 2009-09-15 Cadbury Adams Usa, Llc Enhanced flavoring compositions containing N-ethyl-p-menthane-3-carboxamide and method of making and using same
US8022032B2 (en) 2004-11-19 2011-09-20 Smithkline Beecham Corporation Method for customized dispensing of variable dose drug combination products for individualizing of therapies
US8097271B2 (en) 2004-08-11 2012-01-17 Kraft Foods Global Brands Llc Warming compositions and delivery systems therefor
US8846007B2 (en) 2005-12-23 2014-09-30 Intercontinental Great Brands Llc Compositions providing a heating sensation for oral or dermal delivery
US8980229B2 (en) 2009-04-01 2015-03-17 Colgate-Palmolive Company Dentifrice compositions and methods for treating and preventing damage to tooth surfaces
US9011946B2 (en) 2011-04-29 2015-04-21 Intercontinental Great Brands Llc Encapsulated acid, method for the preparation thereof, and chewing gum comprising same

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ID29270A (id) * 1998-11-20 2001-08-16 Rtp Pharma Inc Partikel-partikel mikro yang distabilkan oleh fosfolipid yang dapat menyebar

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0239542A2 (fr) * 1986-03-27 1987-09-30 Warner-Lambert Company Adsorbats de médicaments avec des magnésium-aluminium silicates et leur préparation
WO1992017164A1 (fr) * 1991-04-04 1992-10-15 The Procter & Gamble Company Compositions pharmaceutiques administrees par voie buccale dans le traitement de troubles de la partie superieure des voies gastro-intestinales
WO1994020074A1 (fr) * 1993-03-12 1994-09-15 The Procter & Gamble Company Compositions a base d'adsorbats

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0239542A2 (fr) * 1986-03-27 1987-09-30 Warner-Lambert Company Adsorbats de médicaments avec des magnésium-aluminium silicates et leur préparation
WO1992017164A1 (fr) * 1991-04-04 1992-10-15 The Procter & Gamble Company Compositions pharmaceutiques administrees par voie buccale dans le traitement de troubles de la partie superieure des voies gastro-intestinales
WO1994020074A1 (fr) * 1993-03-12 1994-09-15 The Procter & Gamble Company Compositions a base d'adsorbats

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998001134A1 (fr) * 1996-07-10 1998-01-15 Novartis Consumer Health S.A. Combinaisons pharmaceutiques de composes antihistaminiques et de terpenoides destinees a etre administrees par voie orale
EP1003383B2 (fr) † 1997-08-11 2009-11-11 Cadbury Adams USA LLC Compositions d'aromatisation ameliorees renfermant du n-ethyl-p-methane-3-carboxamide et leur procede de fabrication et d'utilisation
EP1003383A1 (fr) † 1997-08-11 2000-05-31 Warner-Lambert Company Compositions d'aromatisation ameliorees renfermant du n-ethyl-p-methane-3-carboxamide et leur procede de fabrication et d'utilisation
US7588793B1 (en) 1998-06-05 2009-09-15 Cadbury Adams Usa, Llc Enhanced flavoring compositions containing N-ethyl-p-menthane-3-carboxamide and method of making and using same
WO2002045714A1 (fr) * 2000-12-04 2002-06-13 The Procter & Gamble Company Formulation medicamenteuse a tolerabilite orale amelioree
US7691409B2 (en) 2001-09-28 2010-04-06 Mcneil-Ppc, Inc. Simethicone solid oral dosage form
US7101573B2 (en) * 2001-09-28 2006-09-05 Mcneil-Pcc, Inc. Simethicone solid oral dosage form
US8097271B2 (en) 2004-08-11 2012-01-17 Kraft Foods Global Brands Llc Warming compositions and delivery systems therefor
US8101208B2 (en) 2004-08-11 2012-01-24 Kraft Foods Global Brands Llc Sensate compositions and delivery systems therefor
US8022032B2 (en) 2004-11-19 2011-09-20 Smithkline Beecham Corporation Method for customized dispensing of variable dose drug combination products for individualizing of therapies
US8383579B2 (en) 2004-11-19 2013-02-26 GlaxoSmithKline, LLC Method for customized dispensing of variable dose drug combination products for individualizing of therapies
US8846007B2 (en) 2005-12-23 2014-09-30 Intercontinental Great Brands Llc Compositions providing a heating sensation for oral or dermal delivery
US8980229B2 (en) 2009-04-01 2015-03-17 Colgate-Palmolive Company Dentifrice compositions and methods for treating and preventing damage to tooth surfaces
US9011946B2 (en) 2011-04-29 2015-04-21 Intercontinental Great Brands Llc Encapsulated acid, method for the preparation thereof, and chewing gum comprising same
US9737082B2 (en) 2011-04-29 2017-08-22 Intercontinental Great Brands Llc Chewing gum composition comprising encapsulated acid

Also Published As

Publication number Publication date
AU8084594A (en) 1995-05-22
EP0725630A1 (fr) 1996-08-14
JPH09504293A (ja) 1997-04-28

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