AU2005202244A1 - Improved Pullulan Free Edible Film Compositions and Methods of Making the Same - Google Patents
Improved Pullulan Free Edible Film Compositions and Methods of Making the Same Download PDFInfo
- Publication number
- AU2005202244A1 AU2005202244A1 AU2005202244A AU2005202244A AU2005202244A1 AU 2005202244 A1 AU2005202244 A1 AU 2005202244A1 AU 2005202244 A AU2005202244 A AU 2005202244A AU 2005202244 A AU2005202244 A AU 2005202244A AU 2005202244 A1 AU2005202244 A1 AU 2005202244A1
- Authority
- AU
- Australia
- Prior art keywords
- agent
- effective amount
- composition
- film
- film composition
- Prior art date
- Legal status (The legal status 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 status listed.)
- Abandoned
Links
- 239000000203 mixture Substances 0.000 title claims description 160
- 239000004373 Pullulan Substances 0.000 title claims description 72
- 229920001218 Pullulan Polymers 0.000 title claims description 72
- 235000019423 pullulan Nutrition 0.000 title claims description 72
- 238000000034 method Methods 0.000 title claims description 70
- 239000003795 chemical substances by application Substances 0.000 claims description 138
- 210000000214 mouth Anatomy 0.000 claims description 39
- 239000003814 drug Substances 0.000 claims description 31
- 239000000945 filler Substances 0.000 claims description 29
- 239000002562 thickening agent Substances 0.000 claims description 24
- 239000002269 analeptic agent Substances 0.000 claims description 17
- 239000008375 oral care agent Substances 0.000 claims description 17
- 239000000796 flavoring agent Substances 0.000 claims description 16
- 235000019634 flavors Nutrition 0.000 claims description 16
- 206010006326 Breath odour Diseases 0.000 claims description 14
- 208000032139 Halitosis Diseases 0.000 claims description 14
- 208000005946 Xerostomia Diseases 0.000 claims description 13
- 206010013781 dry mouth Diseases 0.000 claims description 13
- 238000004519 manufacturing process Methods 0.000 claims description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 10
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- 208000007565 gingivitis Diseases 0.000 claims description 9
- 229920003086 cellulose ether Polymers 0.000 claims description 8
- 239000000654 additive Substances 0.000 claims description 7
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 7
- 239000011707 mineral Substances 0.000 claims description 7
- 229920000642 polymer Polymers 0.000 claims description 7
- 239000011782 vitamin Substances 0.000 claims description 7
- 235000013343 vitamin Nutrition 0.000 claims description 7
- 229940088594 vitamin Drugs 0.000 claims description 7
- 229930003231 vitamin Natural products 0.000 claims description 7
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 6
- 239000002202 Polyethylene glycol Substances 0.000 claims description 6
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims description 6
- 235000010980 cellulose Nutrition 0.000 claims description 6
- 229920002678 cellulose Polymers 0.000 claims description 6
- 239000001913 cellulose Substances 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- 235000021436 nutraceutical agent Nutrition 0.000 claims description 6
- 239000008177 pharmaceutical agent Substances 0.000 claims description 6
- 229920001223 polyethylene glycol Polymers 0.000 claims description 6
- 241000196324 Embryophyta Species 0.000 claims description 5
- 229920000881 Modified starch Polymers 0.000 claims description 5
- 230000000996 additive effect Effects 0.000 claims description 5
- 239000011230 binding agent Substances 0.000 claims description 5
- 239000003995 emulsifying agent Substances 0.000 claims description 5
- 235000003599 food sweetener Nutrition 0.000 claims description 5
- 239000003205 fragrance Substances 0.000 claims description 5
- 235000011187 glycerol Nutrition 0.000 claims description 5
- 235000019426 modified starch Nutrition 0.000 claims description 5
- 239000004094 surface-active agent Substances 0.000 claims description 5
- 239000003765 sweetening agent Substances 0.000 claims description 5
- 241001474374 Blennius Species 0.000 claims description 4
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 4
- 240000008042 Zea mays Species 0.000 claims description 4
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 claims description 4
- 235000002017 Zea mays subsp mays Nutrition 0.000 claims description 4
- 239000003086 colorant Substances 0.000 claims description 4
- 235000005822 corn Nutrition 0.000 claims description 4
- 239000000284 extract Substances 0.000 claims description 4
- 235000013312 flour Nutrition 0.000 claims description 4
- 229920001206 natural gum Polymers 0.000 claims description 4
- 239000000419 plant extract Substances 0.000 claims description 4
- 229920001908 Hydrogenated starch hydrolysate Polymers 0.000 claims description 3
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 claims description 3
- 229910000019 calcium carbonate Inorganic materials 0.000 claims description 3
- 239000001506 calcium phosphate Substances 0.000 claims description 3
- 229910000389 calcium phosphate Inorganic materials 0.000 claims description 3
- 235000011010 calcium phosphates Nutrition 0.000 claims description 3
- 239000004927 clay Substances 0.000 claims description 3
- 239000000416 hydrocolloid Substances 0.000 claims description 3
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 3
- 239000001095 magnesium carbonate Substances 0.000 claims description 3
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 3
- 239000000391 magnesium silicate Substances 0.000 claims description 3
- 229910052919 magnesium silicate Inorganic materials 0.000 claims description 3
- 235000019792 magnesium silicate Nutrition 0.000 claims description 3
- 229920005862 polyol Polymers 0.000 claims description 3
- 150000003077 polyols Chemical class 0.000 claims description 3
- 239000006188 syrup Substances 0.000 claims description 3
- 235000020357 syrup Nutrition 0.000 claims description 3
- 239000000454 talc Substances 0.000 claims description 3
- 229910052623 talc Inorganic materials 0.000 claims description 3
- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 3
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 3
- 239000004368 Modified starch Substances 0.000 claims description 2
- 239000004408 titanium dioxide Substances 0.000 claims description 2
- 108010009736 Protein Hydrolysates Proteins 0.000 claims 1
- 229910052570 clay Inorganic materials 0.000 claims 1
- HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 claims 1
- 235000012222 talc Nutrition 0.000 claims 1
- 235000010215 titanium dioxide Nutrition 0.000 claims 1
- 239000010408 film Substances 0.000 description 175
- 239000004615 ingredient Substances 0.000 description 16
- 238000009472 formulation Methods 0.000 description 13
- 230000008901 benefit Effects 0.000 description 12
- 238000011282 treatment Methods 0.000 description 8
- 229920001525 carrageenan Polymers 0.000 description 5
- 238000004090 dissolution Methods 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 235000010755 mineral Nutrition 0.000 description 5
- XSQUKJJJFZCRTK-UHFFFAOYSA-N Urea Chemical compound NC(N)=O XSQUKJJJFZCRTK-UHFFFAOYSA-N 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 4
- WNLRTRBMVRJNCN-UHFFFAOYSA-N adipic acid Chemical compound OC(=O)CCCCC(O)=O WNLRTRBMVRJNCN-UHFFFAOYSA-N 0.000 description 4
- 230000002882 anti-plaque Effects 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- NOOLISFMXDJSKH-UTLUCORTSA-N (+)-Neomenthol Chemical compound CC(C)[C@@H]1CC[C@@H](C)C[C@@H]1O NOOLISFMXDJSKH-UTLUCORTSA-N 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 3
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 description 3
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 3
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 3
- 239000004376 Sucralose Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 3
- 229940041616 menthol Drugs 0.000 description 3
- 239000000600 sorbitol Substances 0.000 description 3
- 230000000638 stimulation Effects 0.000 description 3
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 3
- 235000019408 sucralose Nutrition 0.000 description 3
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 description 2
- 229920002907 Guar gum Polymers 0.000 description 2
- 235000006679 Mentha X verticillata Nutrition 0.000 description 2
- 235000002899 Mentha suaveolens Nutrition 0.000 description 2
- 235000001636 Mentha x rotundifolia Nutrition 0.000 description 2
- 229910019142 PO4 Inorganic materials 0.000 description 2
- XEFQLINVKFYRCS-UHFFFAOYSA-N Triclosan Chemical compound OC1=CC(Cl)=CC=C1OC1=CC=C(Cl)C=C1Cl XEFQLINVKFYRCS-UHFFFAOYSA-N 0.000 description 2
- 206010052428 Wound Diseases 0.000 description 2
- WHMDKBIGKVEYHS-IYEMJOQQSA-L Zinc gluconate Chemical compound [Zn+2].OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C([O-])=O WHMDKBIGKVEYHS-IYEMJOQQSA-L 0.000 description 2
- 239000001361 adipic acid Substances 0.000 description 2
- 235000011037 adipic acid Nutrition 0.000 description 2
- 239000000872 buffer Substances 0.000 description 2
- 239000004202 carbamide Substances 0.000 description 2
- 229940112822 chewing gum Drugs 0.000 description 2
- 235000015218 chewing gum Nutrition 0.000 description 2
- 208000002925 dental caries Diseases 0.000 description 2
- 239000000975 dye Substances 0.000 description 2
- 235000013399 edible fruits Nutrition 0.000 description 2
- 150000004673 fluoride salts Chemical class 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 235000010417 guar gum Nutrition 0.000 description 2
- 239000000665 guar gum Substances 0.000 description 2
- 229960002154 guar gum Drugs 0.000 description 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 2
- 235000010445 lecithin Nutrition 0.000 description 2
- 239000000787 lecithin Substances 0.000 description 2
- 229940067606 lecithin Drugs 0.000 description 2
- ZADYMNAVLSWLEQ-UHFFFAOYSA-N magnesium;oxygen(2-);silicon(4+) Chemical compound [O-2].[O-2].[O-2].[Mg+2].[Si+4] ZADYMNAVLSWLEQ-UHFFFAOYSA-N 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 210000004400 mucous membrane Anatomy 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 235000019198 oils Nutrition 0.000 description 2
- 235000021317 phosphate Nutrition 0.000 description 2
- 150000003013 phosphoric acid derivatives Chemical class 0.000 description 2
- 210000003079 salivary gland Anatomy 0.000 description 2
- 239000010409 thin film Substances 0.000 description 2
- 229960003500 triclosan Drugs 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 229920001285 xanthan gum Polymers 0.000 description 2
- 235000011478 zinc gluconate Nutrition 0.000 description 2
- 239000011670 zinc gluconate Substances 0.000 description 2
- 229960000306 zinc gluconate Drugs 0.000 description 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 description 1
- OWEGMIWEEQEYGQ-UHFFFAOYSA-N 100676-05-9 Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC2C(OC(O)C(O)C2O)CO)O1 OWEGMIWEEQEYGQ-UHFFFAOYSA-N 0.000 description 1
- GJCOSYZMQJWQCA-UHFFFAOYSA-N 9H-xanthene Chemical compound C1=CC=C2CC3=CC=CC=C3OC2=C1 GJCOSYZMQJWQCA-UHFFFAOYSA-N 0.000 description 1
- 244000215068 Acacia senegal Species 0.000 description 1
- 229920001817 Agar Polymers 0.000 description 1
- 244000247812 Amorphophallus rivieri Species 0.000 description 1
- 235000001206 Amorphophallus rivieri Nutrition 0.000 description 1
- 108010011485 Aspartame Proteins 0.000 description 1
- 241000416162 Astragalus gummifer Species 0.000 description 1
- 235000017399 Caesalpinia tinctoria Nutrition 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 1
- 235000013912 Ceratonia siliqua Nutrition 0.000 description 1
- 240000008886 Ceratonia siliqua Species 0.000 description 1
- 235000019499 Citrus oil Nutrition 0.000 description 1
- 229920002261 Corn starch Polymers 0.000 description 1
- 244000303965 Cyamopsis psoralioides Species 0.000 description 1
- 208000006558 Dental Calculus Diseases 0.000 description 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229920000084 Gum arabic Polymers 0.000 description 1
- 229920002752 Konjac Polymers 0.000 description 1
- 240000007472 Leucaena leucocephala Species 0.000 description 1
- 235000010643 Leucaena leucocephala Nutrition 0.000 description 1
- 229920000161 Locust bean gum Polymers 0.000 description 1
- 229920002774 Maltodextrin Polymers 0.000 description 1
- 239000005913 Maltodextrin Substances 0.000 description 1
- GUBGYTABKSRVRQ-PICCSMPSSA-N Maltose Natural products O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@@H](CO)OC(O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-PICCSMPSSA-N 0.000 description 1
- 235000007265 Myrrhis odorata Nutrition 0.000 description 1
- 241000201940 Oena Species 0.000 description 1
- 240000004760 Pimpinella anisum Species 0.000 description 1
- 235000012550 Pimpinella anisum Nutrition 0.000 description 1
- -1 Polyethylene Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 235000015125 Sterculia urens Nutrition 0.000 description 1
- 240000001058 Sterculia urens Species 0.000 description 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 description 1
- 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 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- 240000004584 Tamarindus indica Species 0.000 description 1
- 235000004298 Tamarindus indica Nutrition 0.000 description 1
- 241000388430 Tara Species 0.000 description 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 description 1
- 229920001615 Tragacanth Polymers 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000000205 acacia gum Substances 0.000 description 1
- YGCFIWIQZPHFLU-UHFFFAOYSA-N acesulfame Chemical class CC1=CC(=O)NS(=O)(=O)O1 YGCFIWIQZPHFLU-UHFFFAOYSA-N 0.000 description 1
- 229960005164 acesulfame Drugs 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000008272 agar Substances 0.000 description 1
- 235000010443 alginic acid Nutrition 0.000 description 1
- 229920000615 alginic acid Polymers 0.000 description 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 description 1
- 230000003610 anti-gingivitis Effects 0.000 description 1
- 239000008122 artificial sweetener Substances 0.000 description 1
- 235000021311 artificial sweeteners Nutrition 0.000 description 1
- 239000011668 ascorbic acid Substances 0.000 description 1
- 235000010323 ascorbic acid Nutrition 0.000 description 1
- 229960005070 ascorbic acid Drugs 0.000 description 1
- 239000000605 aspartame Substances 0.000 description 1
- 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 description 1
- 235000010357 aspartame Nutrition 0.000 description 1
- 229960003438 aspartame Drugs 0.000 description 1
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 description 1
- GUBGYTABKSRVRQ-QUYVBRFLSA-N beta-maltose Chemical compound OC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@H](O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@@H]1O GUBGYTABKSRVRQ-QUYVBRFLSA-N 0.000 description 1
- 239000003139 biocide Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000001680 brushing effect Effects 0.000 description 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 235000015165 citric acid Nutrition 0.000 description 1
- 239000010500 citrus oil Substances 0.000 description 1
- 239000010634 clove oil Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 239000008121 dextrose Substances 0.000 description 1
- 230000003467 diminishing effect Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000000686 essence Substances 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000007983 food acid Nutrition 0.000 description 1
- 235000002864 food coloring agent Nutrition 0.000 description 1
- 239000001530 fumaric acid Substances 0.000 description 1
- 235000011087 fumaric acid Nutrition 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 description 1
- 229920003063 hydroxymethyl cellulose Polymers 0.000 description 1
- 229940031574 hydroxymethyl cellulose Drugs 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 235000010485 konjac Nutrition 0.000 description 1
- 239000000252 konjac Substances 0.000 description 1
- 239000004310 lactic acid Substances 0.000 description 1
- 235000014655 lactic acid Nutrition 0.000 description 1
- 229940076522 listerine Drugs 0.000 description 1
- 235000010420 locust bean gum Nutrition 0.000 description 1
- 239000000711 locust bean gum Substances 0.000 description 1
- 239000007937 lozenge Substances 0.000 description 1
- 239000001630 malic acid Substances 0.000 description 1
- 235000011090 malic acid Nutrition 0.000 description 1
- 229940035034 maltodextrin Drugs 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000001525 mentha piperita l. herb oil Substances 0.000 description 1
- 239000001683 mentha spicata herb oil Substances 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- OSWPMRLSEDHDFF-UHFFFAOYSA-N methyl salicylate Chemical compound COC(=O)C1=CC=CC=C1O OSWPMRLSEDHDFF-UHFFFAOYSA-N 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000021096 natural sweeteners Nutrition 0.000 description 1
- 239000002417 nutraceutical Substances 0.000 description 1
- 239000013588 oral product Substances 0.000 description 1
- SOQBVABWOPYFQZ-UHFFFAOYSA-N oxygen(2-);titanium(4+) Chemical compound [O-2].[O-2].[Ti+4] SOQBVABWOPYFQZ-UHFFFAOYSA-N 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 235000019477 peppermint oil Nutrition 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001592 potato starch Polymers 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 235000002639 sodium chloride Nutrition 0.000 description 1
- 235000019721 spearmint oil Nutrition 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 239000011975 tartaric acid Substances 0.000 description 1
- 235000002906 tartaric acid Nutrition 0.000 description 1
- 235000010487 tragacanth Nutrition 0.000 description 1
- 239000000196 tragacanth Substances 0.000 description 1
- 229940116362 tragacanth Drugs 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 238000011277 treatment modality Methods 0.000 description 1
- 239000000341 volatile oil Substances 0.000 description 1
- 239000009637 wintergreen oil Substances 0.000 description 1
- 239000002023 wood Substances 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
Description
vZ-so0-sO (P-IN-A) eaeO 69:61 aWLL :e!lejisnv dl Aq paaoeaH ZZLLZ£9C9LO-IGS :ON ci S&F Ref: 632984D1
AUSTRALIA
PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT Name and Address of Applicant Actual Inventor(s): Address for Service: Invention Title: Wm. Wrigley Jr. Company, of 410 North Michigan Avenue, Chicago, Illinois, 60611, United States of America David G. Barkalow Albert H. Chapedelaine Michael J. Dzija Spruson Ferguson St Martins Tower Level 31 Market Street Sydney NSW 2000 (CCN 3710000177) Improved Pullulan Free Edible Film Compositions and Methods of Making the Same The following statement is a full description of this invention, including the best method of performing it known to me/us:- 5845c [R:\LIBHJ05251 .doc:NXL t Ad 89C 'ON 98t1926 2 19 NOSfMl O NOS 9aS 9P:6 1 G0 'AW'NH tZ-go-0ooZ(P-n-A) a;e( eg:6L awu. :eqwejsriydl Aq PGAiOOQ LLrC9UI--IIYJS :o0 o3SLNOO
O
O
SPECIFICATION
IMLE
"IMPROVED PULLULAN FREE EDIBLE FILM COMPOSITIONS AND METHODS OF MAKING THE SAME" 0 ^C "BACKGROUND OF THE INVENTION o 10 The present invention generally relates to edible films. More specifically, the present irivention relates to pullulan free edible film compositions and methods of making the same.
Oral cleansing and breath freshening may be difficult or inconvenient at times, depending on the nature of the breath freshening desred .and ,the situation in which the breath freshening must occur. Brushing, flossing, cleaningayour tongue and gargling using a variety of devices and compositions are common oral care practices well-suited for the privacy of one's home. However, such devices and compositions are less convenient to use away from the home where bathroom facilities might be scarce, unavailable or unsanitary. However, less obtrusive oral products have been developed. These include breath-freshening gums, lozenges, mouth sprays, and edible films.
Many thin edible films are made of pullulan, which may be used to deliver medicaments or other agents such as flavors and sweeteners to the oral cavity.
However, pullulan is an expensive ingredient to use in the manufactilre of such edible films because it has limited availability within ticlmfqrunlation industry.
Other edible materials such as modified starches and cellulosics havb been employed as a replacement for pullulan within edible film compositions. Unfortunately, such materials typically lack one or more of pullulan's desirable film properties. Those properties include for example: rapid dissolution, flexibility, non-hygroscopity, clean mouth feel, clean flavor and ease of manufacture.
Therefore, there is a need within the film formulation industry for an improved pullulan free edible film composition and method of making the same comprised of film ingredients that have widespread availability, low cost, case of manufacture, and which exhibit the desirable film properties found within pullulanbased edible films.
1 A 'd t8S 'ON 98t1926 2 19 NOSH N A N OS6ds 9P:61 0 'HVW' 1'Z-90-OOZ EG 69:61. aUJ!j :e!ieJlsnV dl Aq paAioatJ LLZ9ZI.O-INgS :ON CI1 SINOO 0 SUM1MARY OF THE INVENTION The present -invention provides improved pullulan free edible film compositions and methods of making the same. Moreover, the present invention further provides improved methods of delivering a medicament, treating halitosis, C 5 treating xerostomia and treating plaque or gingivitis utilizing the improved pullulan C free edible film compositions.
(C To this end, the present invention provides a pullulan free edible film 0 composition comprising an effective amount of at least one film forming agent; an Seffective amount of at least one bulk filler agent, and an effective amount of at least one plasticizing agent.
In an -mbodiment, the effective amount of the film forming agent ranges rot rvKfral roxiniately about 10% to about 90% dry weight of the composition.
In an embodiment, the film forming agent is chosen from the group consisting of; cellulose ethers; .modified starches; natural gums; edible polymers; hydrocolloid flours; seaweed extracts; land plant extracts; derivatives thereof and combinations thereof.
In an embodiment, the effective amount of the bulk filler agent ranges from approximately about 10% to about 90% dry weight of the comnposition.
In an embodiment, the bulk filler agent is chosen from the group consisting of: magnesium carbonate; calcium carbonate; calcium phosphate; calcium sulfate; magnesium silicate; aluminum silicate; ground limestone; clay; talc; titanium dioxid.micaocrystalline cellulose; cellulose polymers; derivatives thereof and q m "coinbinations thereof.
In an embodiment, the effecotive amount of the plasticizing agent ranges up to approximately about 20% dry weight of the composition.
In an embodiment, the plasticizing agent is chosen from the group consisting of: glycerin; polyethylene glycol; propylene glycol; polyols; hydrogenated starch hydrolysates; corn syrups; derivatives thereof and combinations thereof In an embodiment, the pullulan free edible film composition further includes an effective amount of at least one thickening agent In an embodiment, the thickening agent is at least one cellulose ether, In an embodiment, the pullulan free edible film composition further includes an effective amount of at least one medicament.
9 'a Hq '09 9891926 2 19 NOSINA NOSdS L :61 HE lu H tZ-o0-00o ee 69g:6. (wJ:H) uIJ!.L :e!Iej;snv dl Aq pA!aOa ZLLZC9 O-IfiGS :ON 1 SINOo 0 0i In an embodiment, the medicament is chosen from a group consisting ofi pH T control agents; oral care agents; breath freshening agents; pharmaceutical agents; nutraceutical agents; salivary stimulant agents; vitamins; minerals; derivatives thereof and combinations thereof.
5 In an embodiment, the pullulan free edible film composition further includes an effective amount of at least one additive agent.
Ci In an embodiment, the additive agent is chosen from the group consisting of: surfactants; binding agents; coloring agents; sweeteners; flavorants; fragrances; Cl emulsifiers; derivatives thereof and combinations thereof, The present invention also provides a method of making a pullulan free edible film composition comprising the steps of providing an effective amount of at least one film forming agent and adding an effective amount -of at' least one bulk filler agent and an eflbctive amount of at least one plasticizing agent with the film forming agent to produce the resultant pullulan free edible film composition.
In an embodiment, the method further includes the step of adding an effective amount of at least one thickening agent to form the pullulan free edible film Composition.
Additionally, the present invention also provides a method of delivering a medicament comprising the steps of: providing a pillulan free edible film composition which includes an effective amount of at least medicament in the film composition to an individual, wherein the film composition further comprises an effective amount of at least one film forming agent; an effei, ar.m.out of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the medicament into the oral cavity for absorption.
In an embodiment of the method, the medicament is a member chosen from a group consisting of pH control agents; oral care agents; breath freshening agents; pharmaceutical agents; nutraceutical agents; salivary stimulant agents; vitamins; minerals; derivatives thereof; and combinations thereof In an embodiment of the method, the method further includes the step of incorporating an effective amount of at least one thickening agent into the film composition.
3 i'd t8G£ 'ON 98t996 2 19 NOSHNAm NOMSdS9 0:61 UN DW H z-So-9SooZ (P-Il-A) a;ea 69:61. !iLj :B!Ijesnv dl Aq paA!ae LLZ£9L.O-IIS9S :ON SV OO 0 0 Moreover, the present invention also provides a method of treating halitosis comprising the steps of: providing a pullulan free edible jilm composition which includes an effective amount of at least one breath freshening agent to an individual, wherein the film composition further comprises an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the, film composition by the individual to release the breath freshening agent into the oral cavity to treat halitosis.
NC1 In an embodiment of the method, the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition. 'o Additionally, the present invention further provides a method of treating xerostomia comprising the steps of: providing a pullulan free edible film composition which includes an-effective amount of at least one salivary stimulant agent to an individual, wherein the film composition further comprises an effective amount of at least one film forming agent; an effective amount of at least, one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the salivary stimulant agent into the oral cavity to treat xerostomia.
In an embodiment of the method, the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition.
S' In a still further embodiment, the present invention provides a method of treating plaque or gingivitis comprising the stops of providing a pullulan free edible film composition which inbludes an effective amount of at least one oral care agent to an individual, wherein the film..composition further comprises an effective amount of at least one film forming agent; and effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the oral care agent into the oral cavity to treat plaque or gingivitis.
In an embodiment of the method, the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition.
4 d t89 'ON 98t1926 2 19 NOSONA I Nosnads L :6i H0 'V 'Z n-o-gooZ(p-nY-fk~lB(ej :6L 8W!1 :R!12isfV dl Aq paAlea LLZC9ULO-Ifl9S :o0 CI srYo
O
O
ci Therefore, it is, an advantage of the present invention to provide an improved C ullulan free edible film composition and a method for making the same which comprises ingredients that have widespread availability.
Another advantage of the present invention is to provide an improved CI 5 pullulan free edible film composition and method for making the same which are Sinexpensive.
A farther advantage of the present invention is to provide a pullulan free edible film composition that exhibits rapid dissolution, flexibility, non-hygroscopity, 1 clean mouth feel, clean flavor and case of manufacture.
A still further advantage of the present invention is to provide a chewing gum composition that includes a pullulan free edible film composition having widespread ingredient availability. Additionally,,another advantage of the present invention to provide a method of delivering a medicament to an individual utilizing a pullulan free edible film composition having widespread ingredient availability which is physiologically acceptable, to the oral cavity, well adapted to adhere to oral surfaces and rapidly dissolves to release the medicament into the oral cavity for absorption via an open wound or mucous membrane.
Moreover, another advantage of the present invention is to provide an improved method of treating halitosis by delivering an effective amount of at least one breath freshening agent to the oral cavity of an individual using a pullulan free edible film composition having a film forming agent which entraps the breath freshening agent within the oral cavity to provide extended breath freshening efficacy.
Another advantage of the present invention is to provide an improved method of treating xerostomia by delivering an effective amount of at least one salivary stimulant agent to the oral cavity of an individual using a pullulan free edible film composition having a film forming agent which entraps the salivary stimulant agent within the oral cavity to provide extended salivary gland stimulation.
A .further advantage of the present invention is to provide an improved method of treating plaque or gingivitis by delivering an effective amount of at least one oral care agent to the oral cavity of an individual using a pullulan free edible 6 'd t8 £'ON 9891926 Z 19 NOSHA I NOSfldS 0:61 HN VWN 17Z-90-0OZ 8120 69:61 OWuJ!L :e!lejsnv dl fAq peA~laoe LZC9L.O-IINY9S :ON QI SIOO 0 0 ci film composition having a film fonnrming agent which entraps the oral care agent .4 within the oral cavity to provide extended anti-plaque or anti-gingival effects.
Additional features and advantages of the present invention are described in and will apparent from, the detailed description of the presently preferred embodiments.
DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBQODIMENTS 0 Pursuant to the present invention, improved pullulan free edible film compositions and methods of making the same are provided. Additionally, improved methods of delivering a medicament and treatment of halitosis, xerostomia and plaque or gingivitis using the edible film compositions of the present invention are provided as well.
To this end, in an embodiment of the present invention a pullulan free edible film composition is provided. The composition includes an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent The film forming agent provides structure for the formed pullulan free edible.
film of the present invention. The effective amount of the film forming agent ranges from approximately about 10% to about 90%, more preferably 25% to about dry weight of the film composition.
Film forming agents which can be used within the pullulan free edible film compositions of the present invention include, but ire not limited to, cellulose ethers; modified starches; natural gums; edible polymers; hydrocolloid flours; seaweed extracts; land plant extracts; derivatives thereof; and combinations thereof.
Examples of cellulose ethers include, but are not limited to, methylcellulose; ethylcellulose; hydroxymethylcellulose; hydroxyethylcolllose; hydroxypropylmethylcellulose; carboxymethylcellulose; derivatives thereof and combinations thereof. Modified starch examples include, but are not limited to, acid and enzyme hydrolyzed corn and potato starches. Further, examples of natural gums include, but are not limited to, gum arabic; guar gum; locust bean gum; carageenan gum; acacia; karaya; ghatti; tragacanth agar; tamarind gum; xanthan gum; derivatives thereof;.and combinations thereof.
6 01 'd Hqc 'ON 9891926 E 19 NOSHOA NOSBadS P:61 HOZ IVN 'N v,-S0-90o aea 69:61. GW!j :E!leJisnv dl Aq pOAaoeH ZZZ 9LO-Ird9S :ON G( SIPYOO 0 0 ci Examples of edible polymers include, but are not limited to, microcrystalline cellulose; cellulose ethers; xanthan; derivatives thereof; and combinations thereof Moreover, examples ofhydrocolloid flour include, but are not limited to, guar gum; locust bean; microcrystalline cellulose; tara; derivatives thereof and combinations thereof.
Seaweed extract examples include, but are not limited to, alginates; NC' carageenans; derivatives thereof; and combinations thereof. Land plant extract 0 examples include, but are not limited to, konjac; pectin; arabinoglactan; derivatives C' thereof; and combinations thereof.
The preferred film forming agent of the present invention is carageenan.
It should be appreciated by those skilled in the art, that other edible watersoluble film forming agents which exhibit the desirable properties of the present invention and have widespread availability can also be used. The bulk filler agent of the present invention is added to the pullulan free edible film compositions to reduce the "slimy" texture of the compositions. The effective amount of the bulk filler agent ranges from approximately 10% to about 90%, more preferably 25% to about 75% by dry weight of the film composition.
Suitable bulk filler agents 'of the -present invention include, but are not limited to, magnesium carbonate; calcium carbonate; calcium phosphate; calcium sulfate; magnesium silicate; aluminum silicate; ground lime stone; clay; talc; titanium dioxide; microcrystalline cellulose; cellulose polymers such as wood; derivatives thereof;.and combinations thereof The preferred bulk filler agent of the present invention is microcrystalline cellulose, To improve flexibility and reduce brittleness of the pullulan free edible film compositions of the present invention, a softener, also known as a plasticizing agent, is used. The effective amount of the plasticizing agent of the present invention ranges from approximately 0% up to about 20%, more preferably 2% to about 8% dry weight of the film composition.
Suitable plasticizing agents of the present invention include, but are not limited to, polyols such as sorbitol; glycerin; polyethylene glycol; propylene glycol; hydrogenated starch hydrolysates; corn syrups; derivatives thereof; and combinations thereof. The preferred plasticizing agent of the present invention is polyethylene glycol.
7 11 'd HGC 'ON 9891926 2 19 NOSfOOH 2 NOSfldS P 6 1 HN VW aea 6g:61. aW!l :E!IleJlsnv dl Aq paA!aoH LL/ 9ZLO-IVIS :ON CI SINOO 0 0 To further enhance the structure of the film compositions of the present invention, an effective amount of at least one thickening agent may be used.
Suitable thickening agents of the present invention include, but are not limited to, cellulose ethers. The preferred thickening agent of the present invention is hydroxyethyl cellulose, In a preferred embodiment of the present invention, the pullulan free edible film composition comprises an effective amount of carageenan as a film forming agent; an effective amount ofmicrocrystalline cellulose as a bulk filler agent; and an CI effective amount of polyethylene glycol as a plasticizing agent. Additionally, to enhanc the structure of the formed film, an effective amount of hydroxyethyl cellulose as a thickening agent can be incorporated into the preferred embodiment.
The pullulan free edible film compositions of the present invention offer numerous advantages over comparable films within the prior art. The edible films of the present invention do not require the use of pullulan which significantly reduces their manufacturing cost. Because the components 6f the edible films of the present invention have widespread availability unlike pullulan-based films, the present invention offers an economic savings without loss of desirable properties.
Although not wanting to be bound to any particular theory, it is believed that the unique combination of film forming agents; bulk filler agents; plasticizing agents; and optionally thickening agents of the present invention produces a "stand alone" edible film composition which exhibits many of the same desirable properties found within more expensive pullulan-based films. It has been discovered that the pullulan free edible film compositions of the present invention exhibit rapid dissolution, non-hygroscopity, clean mouth feel, clean flavor and ease of manufacture like that of currently available pullulan-based films.
Moreover, the edible film compositions of the present invention overcome the deficiencies of other currently available pullulan free film compositions. The present invention provides a "stand alone" edible film which does not need the incorporation of expensive structural support ingredients. The present invention also exhibits more desirable edible film properties than other currently available pullulan free edible film compositions.
The film compositions of the present invention can also include an effective amount of at least one. medicament and/or an effective amount of at least one 8 I A Hqc 'ON 981919Z6 2 19 NOS9NA NOSfldS P 6 1 HN IYN 'S-S0-SOZO (P-rd-A) alBI 6S:6. aw!L :E!leJsnv dl Aq paA!aoeH LLZC9U0-liaS :ON (3I SIOO
O
O
additive agent. Medicaments which can be incorporated into the edible films of the present invention include, but are not limited to, pH control agents; oral care agents; breath freshening agents; pharmaceutical agents; nutraceutical agents;' salivary stimulant agents; vitamins; minerals; derivatives thereof; and combinations thereof.
CN 5 Examples of pH control agents include, but are not limited to, urea and orally o acceptable buffers. Oral care agent examples include, but are not limited to, caries control agents such as phosphates and fluorides; anti-plaque/anti-gingivitis agents such as chlorohexidene, cetylpyridium chloride and triclosan; germ killing agents; C' and salivary stimulant agents such citric acid, lactic acid, malic acid, succinic acid, ascorbic acid, adipic acid, fumaric acid, tartaric acid and other edible food acids.
Breath- freshening agents include, but are not limited to, zinc gluconate, citrus oils; fruit essences; peppermint oil; spearmint oil; other mint oils; clove oils; oil of wintergreen; anise; and menthol, Pharmaceutical, nutraceutical, vitamin and mineral medicaments which may be incorporated within the edible film compositions of the present invention include, -but are not limited to, those agents which are suitable for oral consumption and can be placed within film formulations.
Additives which can be incorporated into the edible film compositions of the present .invention include, but are not limited to, surfactants; binding agents; coloring agents; sweeteners; flavorants; fragrances; emulsifiers; derivatives thereot and combinations thereof.
Examples of surfactants and binding agents include any currently available edible surfactants and binding agents known within the film formulation arts.
Coloring agent examples include, but are not limited to, food colors and dyes suitable for food, drug and cosmetic applications such as FD&C lakes and dyes.
Sweeteners include, but are not limited to, natural sweeteners. such as sucrose, dextrose, and maltose, and artificial sweeteners such as sucralose, aspartame, and salts of acesulfame.
A variety of flavorants can be used within edible films of the present invention too. Preferably, the flavorant domprises approximately 0.1 to about more preferably 10% to about 15% by dry weight of the edible film composition.
Suitable flavorants include, but are not limited to, essential oils and synthetic flavors or mixtures derived from plants and fruits. Artificial flavorants can also be used.
9 C I 'd H c 'ON 98t1926 2 19 NOSHON NOSUdS 6 :61 UN IM N n7-so-90oa(p-VY-,.) aleBj 59:5 OW!1El~e lV dl Aq PeA~eOeO LLZS9ULO-IVY9S O0JCIISbNOO
O
O
Natural and artificial flavorants may be combined in any sensorially acceptable fashion.
Fragrance examples include, but are not limited to, any fragrance which is Ssuitable for use within edible film formulations such as mint oils.
5 Emulsifiers which are suitable for use within the present invention include, but are not limited to, any emulsifier which is acceptable for use within edible film formulations such as partially hydrogenated vegetable oils.
It should be appreciated by those skilled in the art that other medicaments NC', and additives not listed herein which are suitable for use within edible film formulations can be incorporated into the pullulan free film compositions of the present invention.
By way of example, and not limitation, the pullulan free edible film formulations set forth within Examples 1-12 below illustrate diflfernt embodiments of the present invention. It should be appreciated by those skilled in the art that-the film formulations of the present invention can be produced in a variety of different manners that are appropriate for their intended purpose and market Of course, many other formulations are possible and can be appreciated by a skilled technician once the fundamental concepts and principles of the present invention are grasped.
A wide range of changes and modifications. to the embodiments of the present invention described below will be apparent to those skilled in the, art. The following examples are not to be considered as imposing limitations on the present invention, but are merely included to illustrate various embodiments only.
Examples 1-12 dry weight) Ingredient Example I Example2 EXmple3 Example 4 Lusthvcar* 75,00 82.00 7B.00 71.25 Leithin 3.50 1.65 2,50 330 Sorbitol 2.50 3.75 Glycerin 4:50 4.00 2.00 3.50 Flavor 13.90 11.25 12.75 14.00 Sucralose 2.5 1.00 1.00 tl 'd M9£'ON 981926 2 19 NOSnOH NOS6Hds 6P:6i O 'mW'n n,-go-goa (p-Vj-.kO e(169:6L GWlj:RiljWln' dlAq peA!eoe LLZC9UL0-IVY9S:o0jcI swoo Asprtxr -1.00 2,25 (qibicAcd 1.00 Menthol 0.25 0.75 Color 0.10 0.10 0.25 0120 ci100.00 100.0 100.00 100.00 Jagrediet Erumples5 Examzple 6 Example 7 Exaznelaa cn se2.04C125 27.85 Cfnqeeiwn 54.00 34.00 5U.0 42.00 Polyethylene Olyco 2.00 Rmo Hytuxyethyl 1.50 3.30 CeluOO Culeium~aouIMte -390 Lecithin 3.00 -2.00 2.00 Sorbitol 1.50 1.00 Glycerin 10.00 2.00 4MO Flavor 9.00 21.75 13.00 .10.50 sucrulme 1.13 1.50 2.00 Asp&-rme 0.50 Citric Adid 0.7 Mento 0.65 US.2 Color (f .10 In 100.00 100.00 200.00 100.00 Ingnedleat ExmlezEamnple 10 Examiple 11 Examiple 12 Microctystalline Cellulose -19.00 44.00 Guar GaM 42.i0 Careeenn -4&35 30.35 AlgJnatc 37-50 ?olyethylene lCol 330 &.00 Hyrxci hyl 300 6.50 q I 'd t9q 'ON 91 d 898 O 98t9926 19 NOSOON3 I NOME~S Bt1982/N4 6 :61 Hoz IVA H t'Z-SO-cOOZ eaeO 69:61 OW!L :eileJlsnv dl Aq paA!oeNa LZC£9U0I.O-IVtS :ON 01 SrtOO 0 0 Calcium Cationate 39.40 14.00 32.00 Lecithin 0.50 150 Hydrogenated Sth Hydrolysaes 5.00 Xylhtl 1.50 2.00 Glycein 2.00 4.00 lavor 13.90 1.00 8,00 10.00 Sucralose 100 2.50 Cl AculfarnmcK 1.00 3.00 2.00 'Chlorherdene 2.00 Adipic Acid ,00 Menthol 0.50 1.00 Color i .15 5 0.00 100.00 100.00 10000 100.00 Examples 1-4 To produce the film formulations of Examples 1-4, LustreClearl (a trademark of the FMC Corporation, intended for use as a clear coating for pharmaceutical tablets) is added to water while stirring. LustreClear® contains microcrystalline cellulose, carageenan, polyethylene glycol, hydroxyethyl cellulose and maltodextrin.
The mixture is then heated to 50*C and other ingredients listed are added during stirring. Other ingredients may be added with the LustreClear® component before heating as well. While the mixture is warm, the mixture is poured onto a glass plate and drawn down to form a thin film with a 0.08" blade. 'The film composition is then dried at 50°C for approximately 15 minutes. The film will then thicken upon standing.
It was determined that the produced films of Examples .1-4 exhibited good flexibility, non-hygroscopity and ease of manufacture. Additionally, following formation of the films within Exampies 1-4, a benchmark level sensory analysis was completed. It was determined that the films produced within Examples 1-4 exhibited good mouth feel, rapid dissolution, clean flavor and texture.
12 91 'd M89£ 'ON 98t1926 2 19 NOSONA NOMSfladS 0q: 61 S00UI'mN 'Z-o0-S90 8)e8 69:61. auW!l. :e!lEJlsnv dl Aq paA!aOa LLZEC9I.O-IIN9S :ON (31 SIOO 0 0 Examples 5-12 iN To produce the film formulations of Examples 5-12, a film forming agent, bulk filler agent and plasticizing agent are added to water while stirring. The mixture is then heated to a temperature of 50°C and other ingredients may be added N 5 while stirring the mixture. While the mixture is warm, the mixture is poured onto a O glass plate and drawn down with an appropriately sized blade to form a thin film.
The film is then dried at 50°C for 15 minutes to thicken the film. It was determined 0 0 that the produced films of Examples 5-12 exhibited good flexibility, nonhygroscopity and ease of manufacture, Examples 1-12 illustrate that the edible pullulan free film formulations of the present invention utilize ingredients which have widespread ingredient availability.
Moreover, those ingredients in such a unique combination exhibit desirable film properties which could only previously ,be produced within more expensive.
pullulan-based edible film formulations. However, because of the widespread availability of the ingredients of the present invention, a lower cost film exhibiting rapid dissolution, clean mouth feel, flexibility and ease of manufacture can now be produced.
In an embodiment, the present invention provides a method of making a pullulan free edible film composition as a "stand alone" film is provided. The method comprises the steps of providing an effective amount of at least one film forming agent; and adding an effective amount of at least one bulk filler agent and an effective amount of at least one plasticizing agent to the film forming agent to produce a pullulan free edible film composition.
The method may further comprises the step of adding an effective amount of at least one thickening agent to the edible film composition to enhance the structure of the film. Unlike currently available edible films, the method of the present invention produces a pullulan free edible film composition which is "stand alone." As a result, the pullulan free edible film compositions produced according to the method of the present invention do not require the use of additional expensive structural forming components such as pullulan and the like. Rather, the films are produced using ingredients that have widespread availability which lessens the cost of producing such films.
13 SI 'd teqc 'ON 989I926 2 19 NOSHOH NOSMaS 09:61 q00I 'n vZ-so-s0oo(P-Vu-Ak) alec 6g:6(w:H)w) Q!:eI-ilsnv dlAq pBA!GOOH LLZC9ULOIf9S :oNjCI SIPJO 0 0 ci Further, when the ingredients of the films of the present invention are combined in a such a unique manner, desirable film properties can be achieved which until the present invention could only be accomplished by pullulan-based jedible films. The method of the present invention offers a cost-effective alternative to pullulan-based films without loss of desirable film properties. In a still further embodiment of the present invention, a method of delivering a medicament is provided. The method comprises the steps of providing a pullulan free edible film o composition which includes an effective amount of at least one medicament in the 0, film composition to an individual, wvherein the film composition farther comprises an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent and an effective amount of at least one plasticizing agent; and having the individual orally consume the film composition to 'release the medicament into the oral cavity for absorption.
Medicaments suitable, for location within the pullulan free edible film composition include, but are not limited to, pH control agents; oral care agents; breath freshening agents; pharmaceutical agents; nutraccutical agents; salivary stimulant agents; vitamins; minerals; derivatives thereof and combinations thereof The method further comprises -the step of incorporating an effective amount of at least one thickening agent into the film composition to enhance the structure of the film as a vehicle for delivery of the medicament. Again, although not wanting to be bound to any particular theory, it is believed that the edible film compositions of the present invention are more adapted to adhere to oral surfaces; more iphysiologically acceptable to the oral cavity; and more rapidly dissolve within the oral environment than currently available pullulan and pullulan free edible film compositions, In doing so; it is believed that the pullulan free edible film compositions of the present invention more uniformly release the medicanment into the oral cavity for absorption via an open wound or mucous membrane in a greater manner than could be previously achieved. Moreover, it is also believed that the film forming agent of the present invention entraps the medicament within the oral cavity for an extended period of time to prolong and enhance the effects of the medicament. In addition, by extending the contact time of the medicament within the oral cavity, the medicament is absorbed to a greater extent thereby increasing its bioavailability.
14 81I 'a tHE '09 98t1926 Z 19 NOSH3A NOMdS1 09:61 SON 'VW 'N tIs-90-o00o ale( 6g:61. aw!l :E!lEJsnv dl Aq paAiaoal LZ£9ZO-1rdGS :ON GI SbOO
O
O
cx In another embodiment of the present invention, a method .of treating halitosis is provided. Halitosis is often referred to as a conditions of mal-odorous breath. The method of treatment comprises the steps of providing a pullulan free edible film composition which includes an effective amount of at least one breath freshening agent to an individual, wherein the film composition further comprises an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and 0 having the individual orally consume the film composition to release the breath C'l freshening agent into the oral cavity to treat halitosis. The method may further comprise the step of incorporating an effective amount of at least one thickening agent into the film composition to enhance the structure of the film.
In a preferred embodiment of the method, the breath freshening agent is zinc gluconate. It is believed the halitosis treatment method of the present invention is more effective than currently available halitosis treatment modalities because the pullulan free edible film composition entraps the breath freshening agent within the oral cavity. By entrapping the breath freshening agent, the agent remains within the oral cavity for a longer period of time to provide extended breath freshening effects.
Thus, the method of treating halitosis of the present invention reduces the number of treatments an individual would require utilizing conventional halitosis aids. Because the breath freshening agent exists within the oral cavity via the 'method of the present invention, re-treatment with the breath freshening agent frequently is not required.
In a further embodiment of the present invention, a method of treating xerostomia is provided. Xerostomia is a medical condition in which an excessive dryness within the oral cavity occurs. A variety of medical conditions and pharmaceutical treatments cause xerostomia, requiring a need for a xerostomic treatment.
The method of treating xerostomia of the present invention comprises the steps of providing a pullulan free edible film composition which includes an effective amount of at least one salivary stimulant agent to an individual, wherein the film composition comprises an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and having the individual orally consume the film 61 'd t8 'ON 989196 2 19 NOSlONA NOSlES 09:61 sea 69:61. W!.l :eilejlsnv dl Aq pOA!iOGe LL/S9i.O-If9S :ON 1 SInO0o 0 0 composition to release the salivary stimulant agent into the oral cavity to treat xerostomia. Additionally, the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition to enhance the structure of the film.
Ci 5 By entrapping the salivary stimulant agent within the oral cavity via the o pullulan free edible film composition of the present invention, extended salivary lC gland stimulation can be achieved to a greater extent than could be previously accomplished with currently available xerostomic aids. Additionally, because the Ci salivary stimulant agent is kept within the oral cavity for an extended period of time, salivary gland stimulation occurs over a longer period of time which decreases the need for frequent re-treatments.
Moreover, the method of treating xerostomia of the present invention- also provides the additional advantage of allowing a xerostomic patient the ability to discreetly treat such a condition. The patient merely keeps the edible film or chewing gum composition of the present invention in a conventional storage mechanism such as a wrapper, and then conspicuously place the film or gum within the mouth when needed to provide salivary relief.
In a still further embodiment of the present invention, a method of treating plaque or gingivitis is provided. The method comprises the steps of providing a pullulan free edible film composition which includes an effective amount of at least one oral care agent to an individual, wherein the film composition further comprises an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and having the individual orally consume the film composition to release the oral care agent into the oral cavity to treat plaque or gingivitis. The method may further comprise the step of incorporating an effective ambunt of at least one thickening agent into the film composition to enhance the structure of the film.
Oral care agents which are suitable for use within the method include, but are not limited to, pH control agents such as urea and buffers; tartar or caries control agents such as phosphates and fluorides; anti-plaque/anti-gingival agents such as dhlorohexidene, cetylpyridium chloride and triclosan; and germ killing combinations like that found within the brand name product, Listerine@.
16 0 'd Hqc 'ON 98t1926 19 NOSnOA NOSIHdS 1q:61 HN IVW 1Z-SO-SOOZ alea 69:61 aW!i :eijeJsnv dl Aq peAaoa LLZS9e,-l-IVa9S :ON (1 SINOO 0 0 The method provides a manner of entrapping the oral care agent within the Soral cavity to extend the anti-plaque and/or anti-gingival effects of the agent. In doing so, the method of the present invention enhances the anti-cavity effects of these agents by keeping them within the oral cavity for a longer period of time than C 5 currently available edible film compositions: As a result, this method of the present 0 invention allows individuals to achieve increased levels of dental care than could be Spreviously done.
o It should be understood that various changes and modifications of the C' presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.
17 IU 'd HSC 'ON 98t9196 19 NosOaN NOSMSaS I9:6 GH w m'N
Claims (19)
1. A pullulan free edible film composition comprising: an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent.' o
2. The composition of Claim 1, wherein the effective amount of the film forming agent ranges from approximately about 10% to about 90% dry weight of the composition.
3. The composition of Claim 2, wherein the film forming agent is a member selected from the group consisting of a cellulose ether, a modified starch, a natural gum, an edible polymer, a hydrocolloid flour, a seaweed extract, a land plant extract, derivatives thereof and combinations thereof.
4. The composition of Claim 1, wherein the effective amount of the bulk filler agent ranges from approximately about 10% to about 90% dry weight of the composition, The composition of Claim 4, wherein the bulk filler agent is a member selected from the group consisting of magnesium carbonate, calcium carbonate, calcium phosphate, calcium sulfate, magnesium silicate, aluminum silicate, ground limestone, clay, talc, titanium dioxide, microcrystalline cellulose, cellulose polymers, derivatives thereof and combinations thereof.
6. The composition of Claim 1, wherein the effective amount of the plasticizing agent ranges up to approximately about 20% dry weight of the composition.
7. The composition of Claim 6, wherein the plasticizing agent is a member selected from the group consisting of a glycerin, a polyethylene glycol, a 18 U 'd t89£ 'ON 9891926 Z 19 NOSIO9N NOSMdS IS:6I HK0 'n fZ-So-SoOZ al]B 6S:61 uOWLL :e!leJlsnv dl Sq pa9a3oal LZrE9U0-VYMS :ON GI SIflOO 0 0 i propylene glycol, a polyol, a hydrogenated starch hydrolysate, a corn syrup, N, derivatives thereof and combinations thereof.
8. The composition of Claim 1, wherein the composition farther C, 5 includes an effective amount of at least one thickening agent. 0 t 9. The composition of Claim 8, whereia the thickening agent is at least one cellulose ether.
10. The composition of Claim 1, wherein the composition further includes an effective amount of at least one medicament.
11. The composition of Claim 10, wherein the medicament is a member selected from the group consisting of a pH control agent, an oral care agent, a breath freshening agent, a pharmaceutical agent a nutraceutical agent, a salivary stimulant agent, a vitamin, a mineral, derivatives thereof and combinations thereof
12. The composition of Claim 1, wherein the composition further includes an effective amount of at least one additive agent.
13. The composition of Claim 12, wherein the additive agent is a member selected from the group consisting of a surfactant, a binding agent, a coloring agent, a sweetener, a flavorant, a fragrance, an emulsifier, derivatives thereof and combinations thereof.
14. A method of making a pullulan free edible film composition comprising the steps of: providing an effective amount of at least one film forming agent; and adding an effective amount of at least one bulk filler agent and an effective amount of at least one plasticizing agent with the film forming agent to produce a pullulan free edible film composition. 19 Z 'a mG 'ON 98t1926 2 19 NOSONHA NosMa8s ZS:61 HHIm'H viZ-90-O9O a, ea 69:61 aOwL :e!Ilsnv dl Aq paAaoa8 ZLLZC9LO-IIV9S :ON cI SwIOO 0 0 The method of Claim 18, wherein the method further includes the -step of adding an effective amount of at least one thickening agent to form the pullulan free edible film composition.
16. A method of delivering a medicament comprising the steps of: o providing a pullulan free edible film composition which includes an effective Samount of at least one medicament in the film composition to an individual, wherein o the film composition further comprises: an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and ai effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the medicament into the oral cavity.
17. The method of Claim 20, wherein the medicament is a member selected from the group consisting of a pH control agent, an oral care agent, a breath freshening agent, a pharmaceutical agent, a nutraceutical agent, a salivary stimulant agent, a vitamin, a mineral, derivatives, thereof and combinations thereof,
18. The method of Claim 20, wherein the method further includes the step of incorporating an effective amount of at least one thickening agent into the film composition.
19. A method of treating halitosis comprising the steps of: providing a pullulan free edible film composition which includes an effective amount of at- least one breath freshening agent to an individual, wherein the film composition further.comprises: an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the breath freshening agent into the oral cavity to treat halitosis. Z A tBH 'ON 989196 Z 19 NOSH3 A NOSMdS2 S:61 HN IVW 'N al( 69:61. aW!l :eilBJsnv dl Aq paA!aOa LLZ£C9l.O-IVlaS :ON (31 SIlOO 0 0 The method of Claim 23, wherein the method fbther comprises the Cstep of incorporating an effective amount of at least one thickening agent into the film composition. S 5 21. A method of treating xerostomia comprising the steps of: o providing a pullulan free edible film composition which includes an effective N amount of at least one salivary stimulant agent to an individual, wherein the film o composition further comprises: an effective amount of at least one film forming agent; an effective amount of at least one bulk filler agent; and an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the salivary stimulant agent into the oral cavity to treat xerostomia.
22. The method of Claim 25, wherein the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition.
23. A method of treating plaque or gingivitis comprising the steps of; providing a pullulan free edible film composition which includes an effective amount of at least one oral care agent to an individual, wherein the film composition further comprises: an effective amount of at least one film forming agent; an effective. amount of at least one bulk filler agent; an effective amount of at least one plasticizing agent; and orally consuming the film composition by the individual to release the oral care agent into the oral cavity to treat plaque or gingivitis.
24. The method of Claim 27, wherein the method further comprises the step of incorporating an effective amount of at least one thickening agent into the film composition. 21 A Hq 'ONm 98tq96 19 NOSf A I NOSNJS :6 1 q W 0 'n t
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US60/250,601 | 2000-11-30 | ||
| AU1778902A AU1778902A (en) | 2000-11-30 | 2001-11-21 | Improved pullulan free edible film compositions and methods of making the same |
| PCT/US2001/043397 WO2002043657A2 (en) | 2000-11-30 | 2001-11-21 | Improved pullulan free edible film compositions and methods of making the same |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2002217789A Division AU2002217789B2 (en) | 2000-11-30 | 2001-11-21 | Improved pullulan free edible film compositions and methods of making the same |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2005202244A1 true AU2005202244A1 (en) | 2005-06-09 |
Family
ID=34637656
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2005202244A Abandoned AU2005202244A1 (en) | 2000-11-30 | 2005-05-24 | Improved Pullulan Free Edible Film Compositions and Methods of Making the Same |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2005202244A1 (en) |
-
2005
- 2005-05-24 AU AU2005202244A patent/AU2005202244A1/en not_active Abandoned
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU2002217789B2 (en) | Improved pullulan free edible film compositions and methods of making the same | |
| AU2002217789A1 (en) | Improved pullulan free edible film compositions and methods of making the same | |
| US6656493B2 (en) | Edible film formulations containing maltodextrin | |
| AU2006320846B2 (en) | Vehicles for oral care with Magnolia Bark Extract | |
| US7632525B2 (en) | Breath freshening and oral cleansing product with magnolia bark extract in combination with surface active agents | |
| EP1453488B1 (en) | Improved edible film formulations containing maltodextrin | |
| US7347985B2 (en) | Breath freshening and oral cleansing product with magnolia bark extract | |
| AU2005316974B2 (en) | Tartar control oral care composition containing extract of magnolia | |
| JP2005503402A (en) | Oral compositions that provide enhanced overall cleansing | |
| WO1988000463A1 (en) | Compositions for the prolonged action of anti-plaque agents | |
| US6071500A (en) | Breath spray with tooth decay and halitosis prevention characteristics | |
| JPH1171253A (en) | Salivation accelerator and composition for oral cavity | |
| WO1996015770A1 (en) | Antimicrobial oral compositions | |
| AU2005202244A1 (en) | Improved Pullulan Free Edible Film Compositions and Methods of Making the Same | |
| CN114096225B (en) | Oral care compositions comprising Jiang Erchun and methods of making the same | |
| Pader | Dental products | |
| JP2002284691A (en) | Composition for oral cavity taken before meal |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MK4 | Application lapsed section 142(2)(d) - no continuation fee paid for the application |