WO1995003785A1 - Medications effervescentes a gout agreable contre les refroidissements et les allergies - Google Patents

Medications effervescentes a gout agreable contre les refroidissements et les allergies Download PDF

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Publication number
WO1995003785A1
WO1995003785A1 PCT/US1994/008551 US9408551W WO9503785A1 WO 1995003785 A1 WO1995003785 A1 WO 1995003785A1 US 9408551 W US9408551 W US 9408551W WO 9503785 A1 WO9503785 A1 WO 9503785A1
Authority
WO
WIPO (PCT)
Prior art keywords
cold
medication
allergy
adsorbate
weight
Prior art date
Application number
PCT/US1994/008551
Other languages
English (en)
Inventor
Stanley Lech
John Denick, Jr.
A. Mark Schobel
Original Assignee
Warner-Lambert 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 Warner-Lambert Company filed Critical Warner-Lambert Company
Priority to AU74071/94A priority Critical patent/AU7407194A/en
Publication of WO1995003785A1 publication Critical patent/WO1995003785A1/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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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

Definitions

  • the present invention relates generally to cold and allergy medications that provide relief from the symptoms such as itchy, watery eyes, runny nose, clogged sinuses and the like in an orally administered form that is pleasant tasting and easily ingested.
  • liquid elixir and syrup forms many medications may be and are orally administrable in liquid elixir and syrup forms but again, these are not often desirable as the liquid carrier may present dissolution problems with respect to the active and/or the active itself may be bitter tasting so that any liquid delivery of the medication tastes terrible. This is often worsened by the lingering after taste as the liquid coats the mouth, throat and tongue. Moreover, the bulky bottles and packaging necessary for liquid preparations are an inconvenience in certain circumstances.
  • Chewable tablets are one way in which this end has been achieved.
  • United States Patent No. 2,887,437 relates to a chewable or swallowable tablet for vitamins that is flavored and generally acceptable to most children.
  • Another approach to this end is the use of an effervescent tablet that self disintegrates when placed in the mouth as it comes in contact with the water component of saliva. The tablet “fizzes” as a gas such a carbon dioxide is released therefrom and this generally produces a very pleasing organoleptic sensation wnich, when combined with the simultaneous release of flavors, makes taking the medication "fun” for children and may enhance patient compliance.
  • Effervescent administration of active agents is not a new phenomena in the pharmaceutical arts and numerous compositions have been prepared utilizing this form of technology.
  • United States Patent No. 4,962,417 to Howell and U.S. Patent No. 4,753,792 to Aberg disclose effervescent dental tablets that foam in the mouth and provide a tooth-cleansing action
  • U.S. Patent No. 4,613,497 to Chavkin discloses an effervescent medicinal delivery system that is swallowed whole and foams in the stomach in order to provide release of the drug for absorption.
  • EPO Patent Appln. No. 396,335 to Bolt discloses and claims a chewable medicinal tablet comprising a pharmaceutical active dispersed in a chewable base comprised of mannitol. ith an effervescent reaction system such as citric acid/sodium bicarbonate. The system serves to taste mask any bitter tasting drugs and a disintegrating agent such as microcrystalline cellulose may also be incorporated so as to allow for the dispersion of the active in water.
  • a chewable medicinal tablet comprising a pharmaceutical active dispersed in a chewable base comprised of mannitol. ith an effervescent reaction system such as citric acid/sodium bicarbonate. The system serves to taste mask any bitter tasting drugs and a disintegrating agent such as microcrystalline cellulose may also be incorporated so as to allow for the dispersion of the active in water.
  • United States Patent No. 5,055,306 to Barry discloses an effervescent medicinal tablet with sustained release properties in which the tablet is comprised of an agglomeration of granules consisting of an active core coated with a water insoluble but water swellable acrylic polymer and a hydroxylated cellulosic derivative. It is asserted that as the tablet is chewed and/or dissolved in the mouth, any bad taste due to the pharmaceutical active is effectively masked by the polymer coating and effervescence until the drug reaches the stomach.
  • United States Patent No. 4,940,588 to Sparkes et. al. discloses a controlled release powder comprising a pharmaceutical active that is dispersed as micro-particles in at least one non- toxic polymer.
  • An effervescent tablet is suggested as one possible carrier vehicle for the powder, but little else is pursued in this area.
  • United States Patent No. 5,178,878 to ehling et. al. teaches and discloses an effervescent tablet for the oral administration of a wide variety of drugs and other active pharmaceutical agents.
  • the tablets are dissolved in the mouth and the active agent of choice is microencapsulated for dissolution and absorption in the stomach.
  • the microcapsules allegedly provide a taste-masking function for bitter- tasting drugs.
  • the tablet must not be chewed or crushed within the mouth since this would cause a rupture of the microcapsules and a release of the actives therein which would result in a bitter, unpleasant taste and a drawback to patient compliance.
  • microencapsulated drugs tend to have slow and unpredictable release profiles.
  • the present invention provides a pleasant tasting, organoleptically pleasing medication for the relief of colds, sinus and allergy by taste- masking a bitter-tasting pharmaceutical such as a decongestant, antihistamine and/or expectorant by adsorption of the drug(s) onto a complex silica adsorbate and combining the resultant mixture with a carbonate-acid effervescent system.
  • a bitter-tasting pharmaceutical such as a decongestant, antihistamine and/or expectorant by adsorption of the drug(s) onto a complex silica adsorbate and combining the resultant mixture with a carbonate-acid effervescent system.
  • Decongestants, antihistamines and expectorants are generally bitter tasting chemical compositions that must be encapsulated or taste- masked in some fashion when orally administered in order to allow them to pass through the mouth undetected for dissolution and absorption in the stomach.
  • the problem with most attempts by the prior art to do this is that they also hamper the release of the drug and hence its bioavailability to the system which delays any relief provided thereby.
  • the present invention comprises adsorbing any or all of the bitter tasting drugs onto a complex magnesium trisilicate and then mixing the drug carrier system thus formed with an effervescent component comprised of a carbonate- acid reaction system which is then dried and tableted for oral administration.
  • the drugs of interest are first adsorbed onto the flake-like structures of the magnesium trisilicate by methods known in the art (see Peters et. al. '232) .
  • fumed silica that is commercially available as Cab-o-Sil* EH5 is added and mixed until granules are formed.
  • the adsorbate, comprised of the flaked magnesium trisilicate, the drug disposed therein and the fumed silica disposed thereon is dried to a LOD of not more than 2.0%. This adsorbate serves as the active component about which the effervescent tablet is made.
  • the drug adsorbate is then combined with an effervescent disintegration agent which dissolves rapidly and completely once the tablet is placed within the patients mouth without the need for any chewing or voluntary muscular contraction such as sucking.
  • the effervescence is generated by a combination of an alkali metal salt of bicarbonate or carbonate with an edible food grade carboxylic acid that produces a chemical reaction when the composition contacts the water component of saliva in the mouth. This reaction generally results in the release of carbon dioxide gas which produces the fizzy or bubbly sensation of effervescence.
  • Suitable alkaline earth metal salts of bicarbonate include sodium bicarbonate, sodium carbonate, potassium carbonate and bicarbonate, calcium carbonate and bicarbonate and the like.
  • Suitable food grade acids include citric acid, tartaric acid, malic acid, adipic acid, fumaric acid, succinic acid and mixtures thereof.
  • the effervescent composition of the present invention will be comprised of a mixture of sodium bicarbonate and citric acid.
  • the combination of the drug adsorbate and effervescent composition provides for an oral delivery system for otherwise bitter tasting medicaments that is both pleasant tasting and organoleptically pleasing due to the release of gas by the chemical reaction.
  • the carbonate and acid are mixed and employed in amounts that will release about 20 ccs. to about 120 ccs. of gas per tablet. Additional sweeteners, flavors and the like may also be added in order to make the tablet even more pleasing to the taste and as additional aids in the taste masking of the bitter tasting drugs.
  • the delivery system of the present invention may be used to taste mask and deliver nearly any suitable orally administrable bitter tasting drug
  • the preferred pharmaceutical actives are decongestants, antihistamines and expectorants which by themselves are especially bitter tasting yet provide the needed relief to allergy, cold and flu symptoms.
  • the present invention will comprise a drug adsorbate in which a decongestant, pseudoephedrine hydrochloride and an antihistamine, diphenhydramine hydrochloride are adsorbed onto a magnesium trisilicate/fumed silica adsorbate which is then combined with the carbonate/carboxylic acid mixture to form the orally administrable effervescent tablet which provides a dual action form of relief.
  • an antitussives such as dextromethorphan or dextromethorphan hydrobromide and/or an expectorant such as guafenesin may be added.
  • the decongestant and antihistamine may be added in amounts in a ratio from about 4:1 to about 1:4 respectively, and in amounts conventionally called for or required as per the dosage regimen involved.
  • the usual dosage of the decongestant pseudoephedrine hydrochloride is generally about 15 mg. to about 60 mg. per tablet, or from about 1.0% to about 85% by weight while the antihistamine diphenhydramine hydrochloride is generally employed in amounts of from about 12.5 mg. to 25 mg. per tablet.
  • the actives generally comprise from about 1.0% to about 70% of the entire cold/sinus composition by weight.
  • an antitussive such as dextromethorphan hydrobromide or an expectorant such as guafenesin
  • these are generally incorporated in amounts of from about 10 mg. to about 30 mg. per tablet and from about 50 mg. to about 200 mg. per tablet, respectively.
  • the magnesium trisilicate composition is comprised as set forth in the Peters et. al. '232 patent and is combined with the fumed silica in approximately a 1:1 ratio of trisilicate/silica on a weight basis, respectively.
  • the bicarbonate or carbonate salt and acid are also combined in approximately a 1 :1 to approximately a 4: 1 weight ratio to ensure a complete effervescent reaction during administration.
  • the amount of carbonate salt/carboxylic acid composition used in the formation of the tablets of the present invention will comprise from about 5% to about 90% by weight of the entire tablet composition.
  • the effervescent reactants will comprise from about 15% to about 30% by weight of the total weight of the tablet and most preferably in an amount of from about 20% to about 25% by weight of the composition.
  • the amounts of effervescent composition employed should be enough to create a distinct fizzing or bubbling sensation within the mouth as the tablet disintegrates. To provide an adequate sensation in this manner, the amount of effervescent material should provide from about 10 ccs. to about 100 ccs. of carbon dioxide gas per tablet, and preferably, from about 20 ccs. to about 40 ccs. of gas per tablet.
  • the adsorbate/effervescent cold/sinus tablets of the present invention will preferably also include sweeteners, flavors, colorants, binders, fillers, lubricants, tabletting agents and the like to aid in the taste masking and the tablet formation process.
  • Suitable sweeteners include those sweeteners both natural and artificial well known in the art such as monosaccharides, disaccharides and polysaccharides such as xylose, ribose, glucose, mannose, galactose, fructose, dextrose, sucrose, maltose, partially hydrolyzed starch or corn syrup solids and sugar alcohols such as sorbitol, xylitol, mannitol and mixtures thereof. These may be utilized in amounts from about 5% to about 30% and preferably from about 5% to about 20% by weight of the tablet composition.
  • Water soluble artificial sweeteners such as saccharin and saccharin salts such as sodium or calcium, cyclamate salts , acesulfame-K, aspartame and the like and mixtures thereof may be utilized in amounts from about 0.001% to about 5% by weigh of the tablet composition.
  • Flavorants may also be added to enhance the overall taste perception and these include both natural and artificial flavors, mints such as spearmint, peppermint and menthol, vanilla, artificial vanilla, chocolate, artificial chocolate, cinnamon, various fruit flavors, both individual and mixtures thereof may be utilized in amounts of from about 0.5% to about 5.0% by weight of the total weight of the final tablet composition.
  • Colorants useful in the present invention include pigments which may be incorporated in amount up to about 6% by weight of the composition.
  • a preferred pigment, titanium dioxide, may be incorporated in amounts up to about 1%.
  • the colorants may include other dyes suitable for food, drug and cosmetic applications such as F.D.&C. dyes and the like. Such dyes are generally present in amounts up to about 0.25% and preferably from about 0.05% to about 0.2% by weight of the tablet.
  • Decolorizing agents such as sodium metabisulfite, ascorbic acid and the like may be incorporated into the tablet composition to prevent color changes due to aging. In general, amounts up to about 0.25% and preferably from about 0.05% to about 0.2% by weight of the tablet are used.
  • the dried adsorbate granules were then milled using a comil equipped with .032 inch screen and a .25 inch spacer.
  • the adsorbate granules thus formed were then mixed with the effervescent mixture comprising a binder, annitol (311 mg./tab), sodium bicarbonate (80 g./tab) citric acid (50 mg./tab) and tartaric acid (30 mg./tab) in a twin-shell blender (Fitzpatrick-Kelly, S. Plainfield, N.J.) and mixed until the granules were completely coated by the effervescent powder to insure proper homogeneity.
  • sweeteners and flavors such as aspartame (7.5 mg./tab) acesulfame-K (8.0 mg./tab), and natural cherry extract (10.0 mg./tab). These were mixed continuously for an additional fifteen (15) minutes during which time magnesium stearate (6.0 mg./tab) a lubricant/tabletting agent is added. The mixture was then removed from the blender and the adsorbate-effervescent powder was compressed into 900 mg. tablets using a standard hand tablet press.
  • the tablets when taken orally displayed a high degree of effervescence ("fizziness") and upfront cherry flavor with no noticeable bitter aftertaste attributable to either the pseudoephedrine HC1, diphenhydramine HC1 or dextromethrophan Hbr.

Abstract

On décrit une médication effervescente à goût agréable, contre les refroidissements et les allergies, qui prend la forme de cachets. On masque efficacement le goût amer d'agents décongestionnants, antihistaminiques, antitussifs et expectorants avec un adsorbat de trisilicate de magnésium/silice fumée qui est indétectable pendant la dissolution dans la bouche mais procure un degré élevé de biodisponibilité des substances lorsqu'il parvient dans le milieu acidifère de l'estomac.
PCT/US1994/008551 1993-08-03 1994-07-27 Medications effervescentes a gout agreable contre les refroidissements et les allergies WO1995003785A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU74071/94A AU7407194A (en) 1993-08-03 1994-07-27 Pleasant tasting effervescent cold/allergy medications

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US10095693A 1993-08-03 1993-08-03
US08/100,956 1993-08-03

Publications (1)

Publication Number Publication Date
WO1995003785A1 true WO1995003785A1 (fr) 1995-02-09

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Application Number Title Priority Date Filing Date
PCT/US1994/008551 WO1995003785A1 (fr) 1993-08-03 1994-07-27 Medications effervescentes a gout agreable contre les refroidissements et les allergies

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AU (1) AU7407194A (fr)
WO (1) WO1995003785A1 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996021431A1 (fr) * 1995-01-10 1996-07-18 Warner-Lambert Company Reduction des forces electrostatiques entre adsorbats de trisilicate de magnesium
EP1145711A1 (fr) * 2000-04-12 2001-10-17 Bristol-Myers Squibb Company Forme de dosage orale très fondante
WO2002045684A2 (fr) * 2000-12-06 2002-06-13 Pharmacia Corporation Composition pharmaceutique a dispersion rapide
US6610266B2 (en) 2001-11-28 2003-08-26 Michael C. Withiam Calcium metasilicates and methods for making
WO2005063199A1 (fr) * 2003-12-19 2005-07-14 Bayer Healthcare Ag Preparation effervescente d'une substance basique a action pharmaceutique
EP0975336A4 (fr) * 1997-04-16 2006-02-01 Cima Labs Inc Dissolution rapide de forme posologique de bonne tenue
US7507396B2 (en) * 2003-10-17 2009-03-24 Amerilab Technologies, Inc. Effervescent composition and method of making an effervescent composition including a viscous component
US8017168B2 (en) 2006-11-02 2011-09-13 The Coca-Cola Company High-potency sweetener composition with rubisco protein, rubiscolin, rubiscolin derivatives, ace inhibitory peptides, and combinations thereof, and compositions sweetened therewith
US8236349B2 (en) 2004-04-12 2012-08-07 Bend Research Inc. Taste-masked drugs in rupturing multiparticulates
US9101160B2 (en) 2005-11-23 2015-08-11 The Coca-Cola Company Condiments with high-potency sweetener
WO2016140630A1 (fr) * 2015-03-05 2016-09-09 PHARMACTIVE ILAÇ SANAYI VE TlCARET A. Ş. Composition effervescente comprenant de la lévocétirizine et de la pseudoéphédrine
US10357462B2 (en) 2006-11-30 2019-07-23 Ben Research, Inc. Multiparticulates of spray-coated drug and polymer on a meltable core
US11116728B2 (en) 2006-11-30 2021-09-14 Bend Research, Inc. Multiparticulates of spray-coated drug and polymer on a meltable core

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0085376A2 (fr) * 1982-02-02 1983-08-10 Bayer Ag Granulés dispersibles ou solubles dans l'eau, procédé de leur préparation et leur utilisation
EP0132472A1 (fr) * 1983-07-20 1985-02-13 Warner-Lambert Company Produits pharmaceutiques contenant un adsorbant à base d'un trisilicate de magnésium avec un agent pharmaceutique adsorbé là-dessus
EP0239542A2 (fr) * 1986-03-27 1987-09-30 Warner-Lambert Company Adsorbats de médicaments avec des magnésium-aluminium silicates et leur préparation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0085376A2 (fr) * 1982-02-02 1983-08-10 Bayer Ag Granulés dispersibles ou solubles dans l'eau, procédé de leur préparation et leur utilisation
EP0132472A1 (fr) * 1983-07-20 1985-02-13 Warner-Lambert Company Produits pharmaceutiques contenant un adsorbant à base d'un trisilicate de magnésium avec un agent pharmaceutique adsorbé là-dessus
EP0239542A2 (fr) * 1986-03-27 1987-09-30 Warner-Lambert Company Adsorbats de médicaments avec des magnésium-aluminium silicates et leur préparation

Cited By (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5626878A (en) * 1995-01-10 1997-05-06 Warner Lambert Company Reduction of electrostatic forces between magnesium trisilicate adsorbates
WO1996021431A1 (fr) * 1995-01-10 1996-07-18 Warner-Lambert Company Reduction des forces electrostatiques entre adsorbats de trisilicate de magnesium
EP0975336A4 (fr) * 1997-04-16 2006-02-01 Cima Labs Inc Dissolution rapide de forme posologique de bonne tenue
EP2266538A3 (fr) * 1997-04-16 2013-02-13 Cima Labs, Inc. Formule de dosage robuste à dissolution rapide
EP2147669A3 (fr) * 1997-04-16 2010-03-10 Cima Labs Inc. Formule de dosage robuste à dissolution rapide
US8518421B2 (en) 2000-04-12 2013-08-27 Bristol-Myers Squibb Company Flashmelt oral dosage formulation
CN100353933C (zh) * 2000-04-12 2007-12-12 布里斯托尔-迈尔斯斯奎布公司 快速溶化口服药物制剂
EP1145711A1 (fr) * 2000-04-12 2001-10-17 Bristol-Myers Squibb Company Forme de dosage orale très fondante
WO2002045684A2 (fr) * 2000-12-06 2002-06-13 Pharmacia Corporation Composition pharmaceutique a dispersion rapide
WO2002045684A3 (fr) * 2000-12-06 2003-03-13 Pharmacia Corp Composition pharmaceutique a dispersion rapide
US6610266B2 (en) 2001-11-28 2003-08-26 Michael C. Withiam Calcium metasilicates and methods for making
US7507396B2 (en) * 2003-10-17 2009-03-24 Amerilab Technologies, Inc. Effervescent composition and method of making an effervescent composition including a viscous component
US7919126B2 (en) 2003-10-17 2011-04-05 Amerilab Technologies, Inc. Effervescent composition and method of making an effervescent composition including a viscous component
WO2005063199A1 (fr) * 2003-12-19 2005-07-14 Bayer Healthcare Ag Preparation effervescente d'une substance basique a action pharmaceutique
US8236349B2 (en) 2004-04-12 2012-08-07 Bend Research Inc. Taste-masked drugs in rupturing multiparticulates
US9101160B2 (en) 2005-11-23 2015-08-11 The Coca-Cola Company Condiments with high-potency sweetener
US8017168B2 (en) 2006-11-02 2011-09-13 The Coca-Cola Company High-potency sweetener composition with rubisco protein, rubiscolin, rubiscolin derivatives, ace inhibitory peptides, and combinations thereof, and compositions sweetened therewith
US10357462B2 (en) 2006-11-30 2019-07-23 Ben Research, Inc. Multiparticulates of spray-coated drug and polymer on a meltable core
US11116728B2 (en) 2006-11-30 2021-09-14 Bend Research, Inc. Multiparticulates of spray-coated drug and polymer on a meltable core
WO2016140630A1 (fr) * 2015-03-05 2016-09-09 PHARMACTIVE ILAÇ SANAYI VE TlCARET A. Ş. Composition effervescente comprenant de la lévocétirizine et de la pseudoéphédrine

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