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 PDFInfo
- 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
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pharmaceutical composition
- composition according
- aluminum silicate
- magnesium aluminum
- mixtures
- Prior art date
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- SNAAJJQQZSMGQD-UHFFFAOYSA-N aluminum magnesium Chemical compound [Mg].[Al] SNAAJJQQZSMGQD-UHFFFAOYSA-N 0.000 title claims abstract description 27
- 239000004480 active ingredient Substances 0.000 title claims description 8
- 239000002552 dosage form Substances 0.000 title abstract description 7
- 239000000203 mixture Substances 0.000 claims abstract description 43
- 239000008194 pharmaceutical composition Substances 0.000 claims description 12
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 12
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 12
- 229920000053 polysorbate 80 Polymers 0.000 claims description 12
- 229940068968 polysorbate 80 Drugs 0.000 claims description 12
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 claims description 12
- 108010011485 Aspartame Proteins 0.000 claims description 11
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 11
- 229930195725 Mannitol Natural products 0.000 claims description 11
- 229930006000 Sucrose Natural products 0.000 claims description 11
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 11
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 11
- 239000000605 aspartame Substances 0.000 claims description 11
- 235000010357 aspartame Nutrition 0.000 claims description 11
- 229960003438 aspartame Drugs 0.000 claims description 11
- 239000000594 mannitol Substances 0.000 claims description 11
- 235000010355 mannitol Nutrition 0.000 claims description 11
- 239000005720 sucrose Substances 0.000 claims description 11
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 10
- DLNKOYKMWOXYQA-UHFFFAOYSA-N dl-pseudophenylpropanolamine Natural products CC(N)C(O)C1=CC=CC=C1 DLNKOYKMWOXYQA-UHFFFAOYSA-N 0.000 claims description 10
- 239000000796 flavoring agent Substances 0.000 claims description 10
- 229940041616 menthol Drugs 0.000 claims description 10
- DLNKOYKMWOXYQA-APPZFPTMSA-N phenylpropanolamine Chemical compound C[C@@H](N)[C@H](O)C1=CC=CC=C1 DLNKOYKMWOXYQA-APPZFPTMSA-N 0.000 claims description 10
- 229960000395 phenylpropanolamine Drugs 0.000 claims description 10
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 claims description 9
- ILRKKHJEINIICQ-OOFFSTKBSA-N Monoammonium glycyrrhizinate Chemical compound N.O([C@@H]1[C@@H](O)[C@H](O)[C@H](O[C@@H]1O[C@H]1CC[C@]2(C)[C@H]3C(=O)C=C4[C@@H]5C[C@](C)(CC[C@@]5(CC[C@@]4(C)[C@]3(C)CC[C@H]2C1(C)C)C)C(O)=O)C(O)=O)[C@@H]1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@H]1O ILRKKHJEINIICQ-OOFFSTKBSA-N 0.000 claims description 8
- VUNOFAIHSALQQH-UHFFFAOYSA-N Ethyl menthane carboxamide Chemical compound CCNC(=O)C1CC(C)CCC1C(C)C VUNOFAIHSALQQH-UHFFFAOYSA-N 0.000 claims description 7
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical class [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 6
- 235000005979 Citrus limon Nutrition 0.000 claims description 6
- 244000131522 Citrus pyriformis Species 0.000 claims description 6
- 230000000954 anitussive effect Effects 0.000 claims description 6
- 239000000739 antihistaminic agent Substances 0.000 claims description 6
- 229940124584 antitussives Drugs 0.000 claims description 6
- 239000002826 coolant Substances 0.000 claims description 6
- 239000003172 expectorant agent Substances 0.000 claims description 6
- 235000009499 Vanilla fragrans Nutrition 0.000 claims description 5
- 244000263375 Vanilla tahitensis Species 0.000 claims description 5
- 235000012036 Vanilla tahitensis Nutrition 0.000 claims description 5
- 229940069428 antacid Drugs 0.000 claims description 5
- 239000003159 antacid agent Substances 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 239000000850 decongestant Substances 0.000 claims description 5
- ZZVUWRFHKOJYTH-UHFFFAOYSA-N diphenhydramine Chemical compound C=1C=CC=CC=1C(OCCN(C)C)C1=CC=CC=C1 ZZVUWRFHKOJYTH-UHFFFAOYSA-N 0.000 claims description 5
- 230000003419 expectorant effect Effects 0.000 claims description 5
- 239000002830 appetite depressant Substances 0.000 claims description 4
- 229960003291 chlorphenamine Drugs 0.000 claims description 4
- SOYKEARSMXGVTM-UHFFFAOYSA-N chlorphenamine Chemical compound C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 SOYKEARSMXGVTM-UHFFFAOYSA-N 0.000 claims description 4
- 235000015872 dietary supplement Nutrition 0.000 claims description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 4
- 235000016623 Fragaria vesca Nutrition 0.000 claims description 3
- 240000009088 Fragaria x ananassa Species 0.000 claims description 3
- 235000011363 Fragaria x ananassa Nutrition 0.000 claims description 3
- 244000246386 Mentha pulegium Species 0.000 claims description 3
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- 235000004357 Mentha x piperita Nutrition 0.000 claims description 3
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- 235000009122 Rubus idaeus Nutrition 0.000 claims description 3
- GUGOEEXESWIERI-UHFFFAOYSA-N Terfenadine Chemical compound C1=CC(C(C)(C)C)=CC=C1C(O)CCCN1CCC(C(O)(C=2C=CC=CC=2)C=2C=CC=CC=2)CC1 GUGOEEXESWIERI-UHFFFAOYSA-N 0.000 claims description 3
- 239000004927 clay Substances 0.000 claims description 3
- 239000003937 drug carrier Substances 0.000 claims description 3
- 235000013355 food flavoring agent Nutrition 0.000 claims description 3
- 235000001050 hortel pimenta Nutrition 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- MIDXCONKKJTLDX-UHFFFAOYSA-N 3,5-dimethylcyclopentane-1,2-dione Chemical compound CC1CC(C)C(=O)C1=O MIDXCONKKJTLDX-UHFFFAOYSA-N 0.000 claims description 2
- 241000167854 Bourreria succulenta Species 0.000 claims description 2
- 244000024873 Mentha crispa Species 0.000 claims description 2
- 235000014749 Mentha crispa Nutrition 0.000 claims description 2
- 240000008790 Musa x paradisiaca Species 0.000 claims description 2
- 235000018290 Musa x paradisiaca Nutrition 0.000 claims description 2
- 240000009023 Myrrhis odorata Species 0.000 claims description 2
- 235000007265 Myrrhis odorata Nutrition 0.000 claims description 2
- 235000012550 Pimpinella anisum Nutrition 0.000 claims description 2
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 2
- 244000299461 Theobroma cacao Species 0.000 claims description 2
- 240000000851 Vaccinium corymbosum Species 0.000 claims description 2
- 235000003095 Vaccinium corymbosum Nutrition 0.000 claims description 2
- 235000017537 Vaccinium myrtillus Nutrition 0.000 claims description 2
- 235000009754 Vitis X bourquina Nutrition 0.000 claims description 2
- 235000012333 Vitis X labruscana Nutrition 0.000 claims description 2
- 240000006365 Vitis vinifera Species 0.000 claims description 2
- 235000014787 Vitis vinifera Nutrition 0.000 claims description 2
- 230000000202 analgesic effect Effects 0.000 claims description 2
- 230000001458 anti-acid effect Effects 0.000 claims description 2
- 230000001088 anti-asthma Effects 0.000 claims description 2
- 230000001387 anti-histamine Effects 0.000 claims description 2
- 239000000924 antiasthmatic agent Substances 0.000 claims description 2
- 239000002579 antinauseant Substances 0.000 claims description 2
- 239000007864 aqueous solution Substances 0.000 claims description 2
- 235000021014 blueberries Nutrition 0.000 claims description 2
- 235000013736 caramel Nutrition 0.000 claims description 2
- 235000019693 cherries Nutrition 0.000 claims description 2
- 235000019219 chocolate Nutrition 0.000 claims description 2
- 235000003599 food sweetener Nutrition 0.000 claims description 2
- 239000003485 histamine H2 receptor antagonist Substances 0.000 claims description 2
- 235000019359 magnesium stearate Nutrition 0.000 claims description 2
- 239000011159 matrix material Substances 0.000 claims description 2
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 2
- 239000003765 sweetening agent Substances 0.000 claims description 2
- 239000002156 adsorbate Substances 0.000 abstract description 6
- -1 magnesium aluminum silicates Chemical class 0.000 description 13
- 150000003839 salts Chemical class 0.000 description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 12
- 150000001875 compounds Chemical class 0.000 description 11
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- 229920001285 xanthan gum Polymers 0.000 description 8
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 description 7
- MDVYIGJINBYKOM-UHFFFAOYSA-N 3-[[5-Methyl-2-(1-methylethyl)cyclohexyl]oxy]-1,2-propanediol Chemical group CC(C)C1CCC(C)CC1OCC(O)CO MDVYIGJINBYKOM-UHFFFAOYSA-N 0.000 description 7
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- DBAKFASWICGISY-BTJKTKAUSA-N Chlorpheniramine maleate Chemical compound OC(=O)\C=C/C(O)=O.C=1C=CC=NC=1C(CCN(C)C)C1=CC=C(Cl)C=C1 DBAKFASWICGISY-BTJKTKAUSA-N 0.000 description 4
- 229940035676 analgesics Drugs 0.000 description 4
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- KWGRBVOPPLSCSI-WPRPVWTQSA-N (-)-ephedrine Chemical compound CN[C@@H](C)[C@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WPRPVWTQSA-N 0.000 description 2
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 description 2
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- ZREIPSZUJIFJNP-UHFFFAOYSA-K bismuth subsalicylate Chemical compound C1=CC=C2O[Bi](O)OC(=O)C2=C1 ZREIPSZUJIFJNP-UHFFFAOYSA-K 0.000 description 2
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Classifications
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- 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
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- 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
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
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 |
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 |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14459293A | 1993-10-28 | 1993-10-28 | |
US08/144,592 | 1993-10-28 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1995011671A1 true WO1995011671A1 (fr) | 1995-05-04 |
Family
ID=22509264
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1994/012018 WO1995011671A1 (fr) | 1993-10-28 | 1994-10-20 | Formes posologiques a dissolution rapide contenant du silicate de magnesium et d'aluminium et plusieurs ingredients actifs |
Country Status (4)
Country | Link |
---|---|
EP (1) | EP0725630A1 (fr) |
JP (1) | JPH09504293A (fr) |
AU (1) | AU8084594A (fr) |
WO (1) | WO1995011671A1 (fr) |
Cited By (10)
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 |
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 |
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 |
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IL143197A0 (en) * | 1998-11-20 | 2002-04-21 | Rtp Pharma Inc | Dispersible phospholipid stabilized microparticles |
Citations (3)
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 |
-
1994
- 1994-10-20 WO PCT/US1994/012018 patent/WO1995011671A1/fr active Search and Examination
- 1994-10-20 EP EP94931939A patent/EP0725630A1/fr not_active Withdrawn
- 1994-10-20 JP JP7512714A patent/JPH09504293A/ja active Pending
- 1994-10-20 AU AU80845/94A patent/AU8084594A/en not_active Abandoned
Patent Citations (3)
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 (14)
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 |
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 |
US7101573B2 (en) * | 2001-09-28 | 2006-09-05 | Mcneil-Pcc, Inc. | Simethicone solid oral dosage form |
US7691409B2 (en) | 2001-09-28 | 2010-04-06 | Mcneil-Ppc, Inc. | Simethicone solid oral dosage form |
US8101208B2 (en) | 2004-08-11 | 2012-01-24 | Kraft Foods Global Brands Llc | Sensate compositions and delivery systems therefor |
US8097271B2 (en) | 2004-08-11 | 2012-01-17 | Kraft Foods Global Brands Llc | Warming 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 |
JPH09504293A (ja) | 1997-04-28 |
EP0725630A1 (fr) | 1996-08-14 |
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