US20090017085A1 - Self-supporting films for pharmaceutical and food use - Google Patents
Self-supporting films for pharmaceutical and food use Download PDFInfo
- Publication number
- US20090017085A1 US20090017085A1 US10/577,408 US57740804A US2009017085A1 US 20090017085 A1 US20090017085 A1 US 20090017085A1 US 57740804 A US57740804 A US 57740804A US 2009017085 A1 US2009017085 A1 US 2009017085A1
- Authority
- US
- United States
- Prior art keywords
- self
- supporting films
- group
- active principle
- films
- 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
- 235000013305 food Nutrition 0.000 title claims abstract description 20
- 239000005913 Maltodextrin Substances 0.000 claims abstract description 17
- 229920002774 Maltodextrin Polymers 0.000 claims abstract description 17
- 229940035034 maltodextrin Drugs 0.000 claims abstract description 17
- 239000004014 plasticizer Substances 0.000 claims abstract description 14
- 239000000416 hydrocolloid Substances 0.000 claims abstract description 9
- 239000000126 substance Substances 0.000 claims abstract description 4
- 239000000203 mixture Substances 0.000 claims description 46
- 238000000034 method Methods 0.000 claims description 13
- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 claims description 11
- 210000000214 mouth Anatomy 0.000 claims description 9
- 229960005489 paracetamol Drugs 0.000 claims description 9
- 230000001225 therapeutic effect Effects 0.000 claims description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 7
- 239000002904 solvent Substances 0.000 claims description 7
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical group CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 6
- 238000001125 extrusion Methods 0.000 claims description 6
- 239000008187 granular material Substances 0.000 claims description 6
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 238000004519 manufacturing process Methods 0.000 claims description 5
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- 239000004480 active ingredient Substances 0.000 claims description 4
- RRAFCDWBNXTKKO-UHFFFAOYSA-N eugenol Chemical compound COC1=CC(CC=C)=CC=C1O RRAFCDWBNXTKKO-UHFFFAOYSA-N 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- BQJCRHHNABKAKU-KBQPJGBKSA-N morphine Chemical compound O([C@H]1[C@H](C=C[C@H]23)O)C4=C5[C@@]12CCN(C)[C@@H]3CC5=CC=C4O BQJCRHHNABKAKU-KBQPJGBKSA-N 0.000 claims description 4
- 239000002798 polar solvent Substances 0.000 claims description 4
- 229920001296 polysiloxane Polymers 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 239000011782 vitamin Substances 0.000 claims description 4
- 229940088594 vitamin Drugs 0.000 claims description 4
- 229930003231 vitamin Natural products 0.000 claims description 4
- 235000013343 vitamin Nutrition 0.000 claims 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 claims description 3
- NOOLISFMXDJSKH-UHFFFAOYSA-N DL-menthol Natural products CC(C)C1CCC(C)CC1O NOOLISFMXDJSKH-UHFFFAOYSA-N 0.000 claims description 3
- 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 claims description 3
- 239000008121 dextrose Substances 0.000 claims description 3
- 229960002428 fentanyl Drugs 0.000 claims description 3
- 239000000796 flavoring agent Substances 0.000 claims description 3
- 235000011187 glycerol Nutrition 0.000 claims description 3
- 229940041616 menthol Drugs 0.000 claims description 3
- 235000016709 nutrition Nutrition 0.000 claims description 3
- 229960005343 ondansetron Drugs 0.000 claims description 3
- 230000009469 supplementation Effects 0.000 claims description 3
- 230000009885 systemic effect Effects 0.000 claims description 3
- FELGMEQIXOGIFQ-CYBMUJFWSA-N (3r)-9-methyl-3-[(2-methylimidazol-1-yl)methyl]-2,3-dihydro-1h-carbazol-4-one Chemical compound CC1=NC=CN1C[C@@H]1C(=O)C(C=2C(=CC=CC=2)N2C)=C2CC1 FELGMEQIXOGIFQ-CYBMUJFWSA-N 0.000 claims description 2
- DIWRORZWFLOCLC-HNNXBMFYSA-N (3s)-7-chloro-5-(2-chlorophenyl)-3-hydroxy-1,3-dihydro-1,4-benzodiazepin-2-one Chemical compound N([C@H](C(NC1=CC=C(Cl)C=C11)=O)O)=C1C1=CC=CC=C1Cl DIWRORZWFLOCLC-HNNXBMFYSA-N 0.000 claims description 2
- FJIKWRGCXUCUIG-HNNXBMFYSA-N (3s)-7-chloro-5-(2-chlorophenyl)-3-hydroxy-1-methyl-3h-1,4-benzodiazepin-2-one Chemical compound O=C([C@H](O)N=1)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1Cl FJIKWRGCXUCUIG-HNNXBMFYSA-N 0.000 claims description 2
- METKIMKYRPQLGS-GFCCVEGCSA-N (R)-atenolol Chemical compound CC(C)NC[C@@H](O)COC1=CC=C(CC(N)=O)C=C1 METKIMKYRPQLGS-GFCCVEGCSA-N 0.000 claims description 2
- PPKXEPBICJTCRU-XMZRARIVSA-N (R,R)-tramadol hydrochloride Chemical compound Cl.COC1=CC=CC([C@]2(O)[C@H](CCCC2)CN(C)C)=C1 PPKXEPBICJTCRU-XMZRARIVSA-N 0.000 claims description 2
- VMIYHDSEFNYJSL-UHFFFAOYSA-N Bromazepam Chemical compound C12=CC(Br)=CC=C2NC(=O)CN=C1C1=CC=CC=N1 VMIYHDSEFNYJSL-UHFFFAOYSA-N 0.000 claims description 2
- ZKLPARSLTMPFCP-UHFFFAOYSA-N Cetirizine Chemical compound C1CN(CCOCC(=O)O)CCN1C(C=1C=CC(Cl)=CC=1)C1=CC=CC=C1 ZKLPARSLTMPFCP-UHFFFAOYSA-N 0.000 claims description 2
- NPBVQXIMTZKSBA-UHFFFAOYSA-N Chavibetol Natural products COC1=CC=C(CC=C)C=C1O NPBVQXIMTZKSBA-UHFFFAOYSA-N 0.000 claims description 2
- 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 claims description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 2
- 239000004150 EU approved colour Substances 0.000 claims description 2
- 239000005770 Eugenol Substances 0.000 claims description 2
- UVMRYBDEERADNV-UHFFFAOYSA-N Pseudoeugenol Natural products COC1=CC(C(C)=C)=CC=C1O UVMRYBDEERADNV-UHFFFAOYSA-N 0.000 claims description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 2
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 claims description 2
- VREFGVBLTWBCJP-UHFFFAOYSA-N alprazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1 VREFGVBLTWBCJP-UHFFFAOYSA-N 0.000 claims description 2
- 229960004538 alprazolam Drugs 0.000 claims description 2
- 230000000202 analgesic effect Effects 0.000 claims description 2
- 239000000730 antalgic agent Substances 0.000 claims description 2
- 230000000844 anti-bacterial effect Effects 0.000 claims description 2
- 230000003474 anti-emetic effect Effects 0.000 claims description 2
- 230000001387 anti-histamine Effects 0.000 claims description 2
- 230000003276 anti-hypertensive effect Effects 0.000 claims description 2
- 239000002260 anti-inflammatory agent Substances 0.000 claims description 2
- 230000003110 anti-inflammatory effect Effects 0.000 claims description 2
- 230000002460 anti-migrenic effect Effects 0.000 claims description 2
- 230000001857 anti-mycotic effect Effects 0.000 claims description 2
- 230000000648 anti-parkinson Effects 0.000 claims description 2
- 230000000561 anti-psychotic effect Effects 0.000 claims description 2
- 239000000924 antiasthmatic agent Substances 0.000 claims description 2
- 239000002111 antiemetic agent Substances 0.000 claims description 2
- 239000000739 antihistaminic agent Substances 0.000 claims description 2
- 239000002220 antihypertensive agent Substances 0.000 claims description 2
- 239000002282 antimigraine agent Substances 0.000 claims description 2
- 239000002543 antimycotic Substances 0.000 claims description 2
- 239000000939 antiparkinson agent Substances 0.000 claims description 2
- 239000000164 antipsychotic agent Substances 0.000 claims description 2
- 239000003443 antiviral agent Substances 0.000 claims description 2
- 239000002249 anxiolytic agent Substances 0.000 claims description 2
- 230000000949 anxiolytic effect Effects 0.000 claims description 2
- 229960005070 ascorbic acid Drugs 0.000 claims description 2
- 235000010323 ascorbic acid Nutrition 0.000 claims description 2
- 239000011668 ascorbic acid Substances 0.000 claims description 2
- 229960002274 atenolol Drugs 0.000 claims description 2
- 239000002876 beta blocker Substances 0.000 claims description 2
- 229960002729 bromazepam Drugs 0.000 claims description 2
- 229960001803 cetirizine Drugs 0.000 claims description 2
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical class OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 2
- 229960004170 clozapine Drugs 0.000 claims description 2
- QZUDBNBUXVUHMW-UHFFFAOYSA-N clozapine Chemical compound C1CN(C)CCN1C1=NC2=CC(Cl)=CC=C2NC2=CC=CC=C12 QZUDBNBUXVUHMW-UHFFFAOYSA-N 0.000 claims description 2
- 239000008119 colloidal silica Substances 0.000 claims description 2
- 239000000645 desinfectant Substances 0.000 claims description 2
- AAOVKJBEBIDNHE-UHFFFAOYSA-N diazepam Chemical compound N=1CC(=O)N(C)C2=CC=C(Cl)C=C2C=1C1=CC=CC=C1 AAOVKJBEBIDNHE-UHFFFAOYSA-N 0.000 claims description 2
- 229960003529 diazepam Drugs 0.000 claims description 2
- KPHWPUGNDIVLNH-UHFFFAOYSA-M diclofenac sodium Chemical compound [Na+].[O-]C(=O)CC1=CC=CC=C1NC1=C(Cl)C=CC=C1Cl KPHWPUGNDIVLNH-UHFFFAOYSA-M 0.000 claims description 2
- 229960002217 eugenol Drugs 0.000 claims description 2
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 claims description 2
- 235000003599 food sweetener Nutrition 0.000 claims description 2
- 239000003326 hypnotic agent Substances 0.000 claims description 2
- 230000000147 hypnotic effect Effects 0.000 claims description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 2
- DKYWVDODHFEZIM-UHFFFAOYSA-N ketoprofen Chemical compound OC(=O)C(C)C1=CC=CC(C(=O)C=2C=CC=CC=2)=C1 DKYWVDODHFEZIM-UHFFFAOYSA-N 0.000 claims description 2
- 229960000991 ketoprofen Drugs 0.000 claims description 2
- 229960004391 lorazepam Drugs 0.000 claims description 2
- 229960004033 lormetazepam Drugs 0.000 claims description 2
- 239000000845 maltitol Substances 0.000 claims description 2
- VQHSOMBJVWLPSR-WUJBLJFYSA-N maltitol Chemical compound OC[C@H](O)[C@@H](O)[C@@H]([C@H](O)CO)O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O VQHSOMBJVWLPSR-WUJBLJFYSA-N 0.000 claims description 2
- 235000010449 maltitol Nutrition 0.000 claims description 2
- 229940035436 maltitol Drugs 0.000 claims description 2
- 239000011707 mineral Substances 0.000 claims description 2
- 229960005181 morphine Drugs 0.000 claims description 2
- 239000003158 myorelaxant agent Substances 0.000 claims description 2
- 230000001670 myorelaxant effect Effects 0.000 claims description 2
- HYIMSNHJOBLJNT-UHFFFAOYSA-N nifedipine Chemical compound COC(=O)C1=C(C)NC(C)=C(C(=O)OC)C1C1=CC=CC=C1[N+]([O-])=O HYIMSNHJOBLJNT-UHFFFAOYSA-N 0.000 claims description 2
- 229960001597 nifedipine Drugs 0.000 claims description 2
- 229940006093 opthalmologic coloring agent diagnostic Drugs 0.000 claims description 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 2
- QYSPLQLAKJAUJT-UHFFFAOYSA-N piroxicam Chemical compound OC=1C2=CC=CC=C2S(=O)(=O)N(C)C=1C(=O)NC1=CC=CC=N1 QYSPLQLAKJAUJT-UHFFFAOYSA-N 0.000 claims description 2
- 229960002702 piroxicam Drugs 0.000 claims description 2
- 239000003755 preservative agent Substances 0.000 claims description 2
- 235000013772 propylene glycol Nutrition 0.000 claims description 2
- 230000001105 regulatory effect Effects 0.000 claims description 2
- 229960002052 salbutamol Drugs 0.000 claims description 2
- 150000003329 sebacic acid derivatives Chemical class 0.000 claims description 2
- MEZLKOACVSPNER-GFCCVEGCSA-N selegiline Chemical compound C#CCN(C)[C@H](C)CC1=CC=CC=C1 MEZLKOACVSPNER-GFCCVEGCSA-N 0.000 claims description 2
- 229960003946 selegiline Drugs 0.000 claims description 2
- 239000000600 sorbitol Substances 0.000 claims description 2
- 235000010356 sorbitol Nutrition 0.000 claims description 2
- 150000005846 sugar alcohols Polymers 0.000 claims description 2
- KQKPFRSPSRPDEB-UHFFFAOYSA-N sumatriptan Chemical compound CNS(=O)(=O)CC1=CC=C2NC=C(CCN(C)C)C2=C1 KQKPFRSPSRPDEB-UHFFFAOYSA-N 0.000 claims description 2
- 229960003708 sumatriptan Drugs 0.000 claims description 2
- 239000003765 sweetening agent Substances 0.000 claims description 2
- 239000000454 talc Substances 0.000 claims description 2
- 229910052623 talc Inorganic materials 0.000 claims description 2
- 230000000699 topical effect Effects 0.000 claims description 2
- 229960003107 tramadol hydrochloride Drugs 0.000 claims description 2
- JOFWLTCLBGQGBO-UHFFFAOYSA-N triazolam Chemical compound C12=CC(Cl)=CC=C2N2C(C)=NN=C2CN=C1C1=CC=CC=C1Cl JOFWLTCLBGQGBO-UHFFFAOYSA-N 0.000 claims description 2
- 229960003386 triazolam Drugs 0.000 claims description 2
- 150000003722 vitamin derivatives Chemical class 0.000 claims description 2
- ZAFYATHCZYHLPB-UHFFFAOYSA-N zolpidem Chemical compound N1=C2C=CC(C)=CN2C(CC(=O)N(C)C)=C1C1=CC=C(C)C=C1 ZAFYATHCZYHLPB-UHFFFAOYSA-N 0.000 claims description 2
- 229960001475 zolpidem Drugs 0.000 claims description 2
- 239000001692 EU approved anti-caking agent Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 claims 1
- 238000005096 rolling process Methods 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 238000009472 formulation Methods 0.000 description 21
- 238000002360 preparation method Methods 0.000 description 8
- 238000004090 dissolution Methods 0.000 description 7
- 238000001727 in vivo Methods 0.000 description 7
- 239000004373 Pullulan Substances 0.000 description 5
- 229920001218 Pullulan Polymers 0.000 description 5
- 238000003556 assay Methods 0.000 description 5
- 235000019423 pullulan Nutrition 0.000 description 5
- 239000006188 syrup Substances 0.000 description 5
- 235000020357 syrup Nutrition 0.000 description 5
- 210000003296 saliva Anatomy 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 230000008034 disappearance Effects 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000008213 purified water Substances 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- QQONPFPTGQHPMA-UHFFFAOYSA-N Propene Chemical group CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000000338 in vitro Methods 0.000 description 2
- 230000035807 sensation Effects 0.000 description 2
- 235000019615 sensations Nutrition 0.000 description 2
- 229920000881 Modified starch Polymers 0.000 description 1
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 235000010980 cellulose Nutrition 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N ethylene glycol Natural products OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 238000003892 spreading Methods 0.000 description 1
- 238000002604 ultrasonography Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—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
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
- A23L29/30—Foods or foodstuffs containing additives; Preparation or treatment thereof containing carbohydrate syrups; containing sugars; containing sugar alcohols, e.g. xylitol; containing starch hydrolysates, e.g. dextrin
- A23L29/35—Degradation products of starch, e.g. hydrolysates, dextrins; Enzymatically modified starches
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
- A23P20/20—Making of laminated, multi-layered, stuffed or hollow foodstuffs, e.g. by wrapping in preformed edible dough sheets or in edible food containers
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P30/00—Shaping or working of foodstuffs characterised by the process or apparatus
- A23P30/20—Extruding
- A23P30/25—Co-extrusion of different foodstuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/196—Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/437—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a five-membered ring having nitrogen as a ring hetero atom, e.g. indolizine, beta-carboline
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4422—1,4-Dihydropyridines, e.g. nifedipine, nicardipine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
- A61K31/5415—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame ortho- or peri-condensed with carbocyclic ring systems, e.g. phenothiazine, chlorpromazine, piroxicam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
- A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
- A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
Definitions
- the present description relates to rapidly dissolving self-supporting films for pharmaceutical or food use
- compositions based on edible films are already commercially available. Most of these products use pullulan as the filmogenic component. Pullulan is an expensive ingredient and not easily available. Other materials have been used in place of pullulan. These materials comprise modified starches such as maltodextrin and hydrocolloids such as cellulosic materials, as described for example in US20030053962.
- the self-supporting films of the invention present disintegration times determined in vitro of less than 1 minute, and in vivo actually less than 45 seconds.
- the self-supporting films impart a clean mouth sensation and in addition can be prepared using simple preparation methods, easily achievable with industrial machinery.
- a further aspect of the present invention is directed towards various processes for preparing the self-supporting edible films of the present invention.
- one preparation process for the aforesaid self-supporting film comprises in particular the following steps:
- Another preparation process according to the present invention comprises in particular the following steps:
- Another preparation process according to the present invention comprises in particular the following steps:
- Table 1 in FIG. 1 shows formulations used for preparing the films of the present invention as described in example 1.
- Table 2 in FIG. 2 shows formulations used for preparing the films of the present invention as described in example 2.
- FIG. 3 shows a graph of the in vivo bioavailability of the film of the present invention prepared as described in example 2 and containing paracetamol (formulation 6 in table 2), and by way of a syrup (Tachipirina syrup), where the y-axis shows paracetamol concentration expressed in gg/ml whereas the x-axis shows time in minutes.
- the maltodextrin used in the self-supporting film of the present invention has a dextrose content of less than 50 equivalents, preferably between 11 and 40.
- the plasticiser used in the self-supporting films of the present invention is preferably chosen from the group consisting of polyalcohols, citric acid esters, sebacic acid esters or their mixtures. Propylene glycol, glycerine, sorbitol, maltitol or their relative mixtures are particularly preferred.
- the active principle for food use is preferably an active principle with a refreshing action on the breath and indicated for oral hygiene, preferably eugenol and menthol or an active principle suitable for nutritional supplementation, preferably mineral salts chosen from those normally used for such purposes or one or more vitamins, the vitamin being ascorbic acid in a particularly preferred embodiment.
- the active principle for therapeutic use can be a principle with an essentially topical activity for the oral cavity chosen from antibacterial, antimycotic, antiviral agents or disinfectants of the oral cavity, or can be an active principle with an essentially systemic action chosen from the class consisting of anti-inflammatory, analgesic, antipsychotic, hypnotic, anxiolytic, antihypertensive, myorelaxant, antimigraine, antiparkinsonian, antiemetic, antihistaminic, beta blocking and antiasthmatic agents.
- the active principles contained in said films are preferably chosen from the class consisting of: Piroxicam, Ketoprofen, Sodium diclofenac, Tramadol hydrochloride, Morphine, Nifedipine, Diazepam, Lorazepam, Alprazolam, Bromazepam, Triazolam, Lormetazepam, Zolpidem, Paracetamol, Selegiline, Atenolol, Salbutamol, Sumatriptan, Clozapine, Cetirizine, Ondansetron, Fentanyl and their pharmaceutically acceptable salts.
- the self-supporting films of the present invention contain maltodextrin in concentrations preferably between 40 and 80% by weight, plasticiser in concentrations between 15 and 55% by weight and active principle for food or pharmaceutical use in quantities between 0.05 and 30% by weight on the total weight of said film, and can possibly contain other excipients chosen from antisticking agents such as microcrystalline cellulose, colloidal silica or talc, sweeteners, flavourings, colouring agents, preservatives, acidity regulating systems or mixtures thereof.
- antisticking agents such as microcrystalline cellulose, colloidal silica or talc, sweeteners, flavourings, colouring agents, preservatives, acidity regulating systems or mixtures thereof.
- the extrusion step (ii) is preferably conducted at a temperature between 60 and 120° C. in a single screw extruder.
- the polar solvent used in step (i) is preferably chosen from water, water-miscible solvents or relative mixtures.
- the solvent consists of water or a mixture of water and ethanol.
- the temperature of said step, when a mixture of the aforesaid solvents are used, is preferably between 60 and 105° C.
- the self-supporting films of the present invention can be prepared using other methods such as by compacting the filmogenic formulation by the ultrasound technique.
- formulations for the self-supporting films of the present invention some processes for preparing said self-supporting films, as well as in vitro and in vivo disintegration tests conducted on films obtained with some of the illustrated formulations are given by way of non limiting examples.
- Disintegration time no. (in seconds) 2 50 ⁇ 4 5 54 ⁇ 4 6 40 ⁇ 1 8 30 ⁇ 1 11 32 ⁇ 2 17 19 ⁇ 1 In vivo Dissolution Assay
- the test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
- dissolution time was less than a minute.
- the components of the formulations given in table 2 of FIG. 2 are dispersed in the mixture of solvents, given in the same table, and maintained at 80° C.
- the mixture, maintained at the same temperature, is rolled onto silicon paper and dried.
- Purified water maintained at 37° C. was used as the medium.
- the result is the average of 3 determinations ⁇ standard deviation.
- Disintegration time no. (in seconds) 4 27 ⁇ 4 5 36 ⁇ 4 6 50 ⁇ 3 7 37 ⁇ 8 13 32 ⁇ 2 In vivo dissolution assay
- a 4 cm 2 sample of the formulation under examination was administered to each of 6 healthy volunteers.
- the test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
- the object of this pilot study was to evaluate the absorption and pharmacokinetic profile after a single administration of 50 mg paracetamol carried by Formula 6 (table 2) and by a commercial syrup containing paracetamol (Tachipirina syrup) in 3 healthy volunteers aged between 23 and 24 years.
- the experiment was conducted as a crossover with a 15 day wash-out period.
- saliva and blood samples were taken before application and at 10 min, 20 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h after administration.
- Paracetamol was determined in the saliva.
- the components were mixed into a sigma blade mixer; the time of mixing was 1 hour for formulation B and 30 minutes for formulation A, C and D.
- the mixture was transferred in an oscillating granulator and microcrystalline cellulose was added as antisticking agent.
- the granules are stored for at least 12 hours at ambient temperature and then sieved.
- the granules were extruded with a single screw extruder.
- the extruder temperatures were set in the range 85-130° C.
- the test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
Abstract
Rapidly dissolving self-supporting films for food or pharmaceutical use comprising: a) a filmogenic substance consisting of a maltodextrin; b) a plasticiser; c) an active principle for food or pharmaceutical use, characterised in that said films are free of hydrocolloids.
Description
- The present description relates to rapidly dissolving self-supporting films for pharmaceutical or food use
- Self-supporting films for pharmaceutical or food use have been known for some time.
- For example compositions based on edible films are already commercially available. Most of these products use pullulan as the filmogenic component. Pullulan is an expensive ingredient and not easily available. Other materials have been used in place of pullulan. These materials comprise modified starches such as maltodextrin and hydrocolloids such as cellulosic materials, as described for example in US20030053962.
- However, these films do not present one or more characteristics typical of pullulan such as rapid dissolution, clean mouth feel, clean flavour and ease of manufacture.
- That these films do not provide a clean mouth sensation is due to the fact that the hydrocolloids tend to gel on contact with saliva.
- One solution to the aforesaid drawbacks is proposed in WO03/011259 from which is noted that, to obtain properties equivalent to those of pullulan, it is crucial that maltodextrin, smaller quantities of hydrocolloid and, additionally, an inert filler are present simultaneously in the filmogenic composition. In this prior patent, therefore, the hydrocolloid content is reduced by virtue of introducing an inert filler at a concentration between 1 and 30% into the film composition. According to said document, however, the hydrocolloid content cannot be reduced below 10% in that according to this prior patent, as in the preceding US20030053962, the presence of this component in the filmogenic composition appears essential for achieving rapid disintegration of the film.
- Therefore the need was felt for a rapidly dissolving edible film which would not pose the problems of known edible films for pharmaceutical or food use.
- The Applicant has now surprisingly found that self-supporting edible films for food or pharmaceutical use containing maltodextrin as the filmogenic substance can be prepared which dissolve rapidly despite their not containing hydrocolloids.
- In particular an aspect of the present invention are self-supporting films comprising:
-
- a) a filmogenic substance consisting of a maltodextrin,
- b) a plasticiser
- c) an active principle for food or pharmaceutical use,
- characterised in that said films are free of hydrocolloids.
- In particular, as seen from the tests described below, the self-supporting films of the invention present disintegration times determined in vitro of less than 1 minute, and in vivo actually less than 45 seconds. Moreover, the self-supporting films impart a clean mouth sensation and in addition can be prepared using simple preparation methods, easily achievable with industrial machinery.
- In this respect a further aspect of the present invention is directed towards various processes for preparing the self-supporting edible films of the present invention.
- For example, one preparation process for the aforesaid self-supporting film comprises in particular the following steps:
-
- i) the maltodextrin, plasticiser and active ingredient for food or therapeutic use are mixed,
- ii) the mixture derived from the preceding step is extruded in an extruder.
- Another preparation process according to the present invention comprises in particular the following steps:
-
- i) the maltodextrin, plasticiser and active principle for therapeutic or food use are dispersed in a polar solvent,
- ii) the mixture obtained in the preceding step is rolled onto silicone paper and then dried,
- iii) the silicone paper is removed from the film obtained in the preceding step.
- Another preparation process according to the present invention comprises in particular the following steps:
-
- i) the maltodextrin, plasticiser and active ingredient for food or therapeutic use are mixed,
- ii) the mixture was granulated, sieved and mixed with an anti sticking agent
- iii) the granules were stored at least for 12 h
- iv) the granules derived from the preceding steps were extruded in an extruder for obtaining the edible film.
- Table 1 in
FIG. 1 shows formulations used for preparing the films of the present invention as described in example 1. - Table 2 in
FIG. 2 shows formulations used for preparing the films of the present invention as described in example 2. -
FIG. 3 shows a graph of the in vivo bioavailability of the film of the present invention prepared as described in example 2 and containing paracetamol (formulation 6 in table 2), and by way of a syrup (Tachipirina syrup), where the y-axis shows paracetamol concentration expressed in gg/ml whereas the x-axis shows time in minutes. - The maltodextrin used in the self-supporting film of the present invention has a dextrose content of less than 50 equivalents, preferably between 11 and 40.
- The plasticiser used in the self-supporting films of the present invention is preferably chosen from the group consisting of polyalcohols, citric acid esters, sebacic acid esters or their mixtures. Propylene glycol, glycerine, sorbitol, maltitol or their relative mixtures are particularly preferred.
- The active principle for food use is preferably an active principle with a refreshing action on the breath and indicated for oral hygiene, preferably eugenol and menthol or an active principle suitable for nutritional supplementation, preferably mineral salts chosen from those normally used for such purposes or one or more vitamins, the vitamin being ascorbic acid in a particularly preferred embodiment. The active principle for therapeutic use can be a principle with an essentially topical activity for the oral cavity chosen from antibacterial, antimycotic, antiviral agents or disinfectants of the oral cavity, or can be an active principle with an essentially systemic action chosen from the class consisting of anti-inflammatory, analgesic, antipsychotic, hypnotic, anxiolytic, antihypertensive, myorelaxant, antimigraine, antiparkinsonian, antiemetic, antihistaminic, beta blocking and antiasthmatic agents.
- The active principles contained in said films are preferably chosen from the class consisting of: Piroxicam, Ketoprofen, Sodium diclofenac, Tramadol hydrochloride, Morphine, Nifedipine, Diazepam, Lorazepam, Alprazolam, Bromazepam, Triazolam, Lormetazepam, Zolpidem, Paracetamol, Selegiline, Atenolol, Salbutamol, Sumatriptan, Clozapine, Cetirizine, Ondansetron, Fentanyl and their pharmaceutically acceptable salts.
- The self-supporting films of the present invention contain maltodextrin in concentrations preferably between 40 and 80% by weight, plasticiser in concentrations between 15 and 55% by weight and active principle for food or pharmaceutical use in quantities between 0.05 and 30% by weight on the total weight of said film, and can possibly contain other excipients chosen from antisticking agents such as microcrystalline cellulose, colloidal silica or talc, sweeteners, flavourings, colouring agents, preservatives, acidity regulating systems or mixtures thereof.
- In the process for preparing edible self-supporting films by extrusion, a further aspect of the present invention, the extrusion step (ii) is preferably conducted at a temperature between 60 and 120° C. in a single screw extruder. In the second preparation process, a further aspect of the present invention, the polar solvent used in step (i) is preferably chosen from water, water-miscible solvents or relative mixtures. In accordance with a particularly preferred embodiment the solvent consists of water or a mixture of water and ethanol. The temperature of said step, when a mixture of the aforesaid solvents are used, is preferably between 60 and 105° C.
- The self-supporting films of the present invention can be prepared using other methods such as by compacting the filmogenic formulation by the ultrasound technique.
- Some examples of formulations for the self-supporting films of the present invention, some processes for preparing said self-supporting films, as well as in vitro and in vivo disintegration tests conducted on films obtained with some of the illustrated formulations are given by way of non limiting examples.
- The components of the formulations given in table 1 of
FIG. 1 are mixed and extruded with a single screw extruder at a temperature of 105° C. - The test was undertaken in accordance with the method in the European Pharmacopoeia 5.01 Ed., 2.9.1. Disintegration of tablets and capsules (01/2005:20901)
- Purified water maintained at 37° C. was used as the medium. The result is the average of 3 determinations ±standard deviation. The results are given in table 3.
-
TABLE 3 Disintegration time Form. Disintegration time no. (in seconds) 2 50 ± 4 5 54 ± 4 6 40 ± 1 8 30 ± 1 11 32 ± 2 17 19 ± 1
In vivo Dissolution Assay - Three 4 cm2 samples of the formulation under examination were administered to 6 healthy volunteers. The test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
- The test was conducted on formulations no. 2, 5, 17 (table 1).
- In each case dissolution time was less than a minute.
- The components of the formulations given in table 2 of
FIG. 2 are dispersed in the mixture of solvents, given in the same table, and maintained at 80° C. The mixture, maintained at the same temperature, is rolled onto silicon paper and dried. - The test was undertaken in accordance with the method in the European Pharmacopoeia 5.01 Ed., 2.9.1. Disintegration of tablets and capsules (01/2005:20901)
- Purified water maintained at 37° C. was used as the medium. The result is the average of 3 determinations ±standard deviation.
- The results are given in table 4
-
TABLE 4 Disintegration time Form. Disintegration time no. (in seconds) 4 27 ± 4 5 36 ± 4 6 50 ± 3 7 37 ± 8 13 32 ± 2
In vivo dissolution assay - A 4 cm2 sample of the formulation under examination was administered to each of 6 healthy volunteers. The test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
- The test was conducted on formulations no. 3, 6, 13 (table 1).
- In each case dissolution time was less than 45 seconds.
- Determination of in vivo Bioavailability
- The object of this pilot study was to evaluate the absorption and pharmacokinetic profile after a single administration of 50 mg paracetamol carried by Formula 6 (table 2) and by a commercial syrup containing paracetamol (Tachipirina syrup) in 3 healthy volunteers aged between 23 and 24 years. The experiment was conducted as a crossover with a 15 day wash-out period.
- With the aim of evaluating the pharmacokinetic profiles of the two formulations, saliva and blood samples were taken before application and at 10 min, 20 min, 45 min, 1 h, 2 h, 3 h, 4 h, 6 h after administration. Paracetamol was determined in the saliva.
- The salivary concentrations of paracetamol determined in saliva after administration of the syrup and of the rapidly disintegrating film overlap completely as shown in
FIG. 3 . -
-
Film composition Formulation Formulation Formulation Formulation A B C D Components (% m/m) (% m/m) (% m/m) (% m/m) Maltodextrin 71 47 70 71.4 (DE 11) Glycerol 16 — 16 16.5 Menthol 1 — — — Microcrystal- 12 10 12 12 line cellulose Paracetamol — 21 — — Ondansetron — — 2 — Fentanyl — — — 0.1 Propylene — 20 — — Glycol Sodium citrate — 2 — — - The components, with the exception of the microcrystalline cellulose, were mixed into a sigma blade mixer; the time of mixing was 1 hour for formulation B and 30 minutes for formulation A, C and D.
- The mixture was transferred in an oscillating granulator and microcrystalline cellulose was added as antisticking agent. The granules are stored for at least 12 hours at ambient temperature and then sieved.
- The granules were extruded with a single screw extruder. The extruder temperatures were set in the range 85-130° C.
- The test was undertaken in accordance with the method in the European Pharmacopoeia 5.01 Ed., 2.9.1. Disintegration of tablets and capsules (01/2005:20901)
- Purified water maintained at 37° C. was used as the medium. The results were the average of 3 determinations ±standard deviation.
- The disintegration times were less of 45 sec for all the formulations.
- In vivo Dissolution Assay
- Three 4 cm2 samples of the formulation A were administered to 6 healthy volunteers. The test consists of retaining the film sample in the mouth, and determining the time needed to sense its disappearance.
- In each case dissolution time was less than 15 sec.
Claims (27)
1. Self-supporting films comprising:
a) a filmogenic substance consisting of a maltodextrin,
b) a plasticiser,
c) an active ingredient for food or pharmaceutical use, wherein said films are free from hydrocolloids.
2. Self-supporting films as claimed in claim 1 , wherein the maltodextrin (a) has a dextrose content of less than 50 expressed in equivalents.
3. Self-supporting films as claimed in claim 2 wherein said 1o dextrose content is between 11 and 40.
4. Self-supporting films as claimed in claims 1 , wherein the plasticiser is selected from the group consisting of polyalcohols, citric acid esters, sebacic acid esters or their mixtures.
5. Self-supporting films as claimed in claims 1 , wherein the plasticiser is selected from the group consisting of propylene glycol, glycerine, sorbitol, maltitol and their relative mixtures.
6. Self-supporting films as claimed in claims 1 , wherein the active principle for food use is an active principle with a breath freshening action and/or indicated for oral hygiene or an active principle suitable for nutritional supplementation.
7. Self-supporting films as claimed in claim 6 , wherein said active principle for food use is selected from the group consisting of menthol and eugenol.
8. Self-supporting films as claimed in claim 6 wherein said active principle suitable for nutritional supplementation is selected from the group consisting of mineral salts normally used for such purpose and vitamins.
9. Self-supporting films as claimed in claim 8 wherein the vitamin is ascorbic acid.
10. Self-supporting films as claimed in claims 1 , wherein said active principle for therapeutic use is selected from the group consisting of active principles with essentially lo topical activity.
11. Self-supporting films as claimed in claim 10 , wherein said active principle is selected from the group consisting of antibacterial, antimycotic, antiviral agents and disinfectants of the oral cavity.
12. Self-supporting films as claimed in claims 1 wherein the active principle for therapeutic use is selected from the group consisting of active principles with essentially systemic activity.
13. Self-supporting films as claimed in claim 12 , wherein said active principle with essentially systemic activity is selected from the group consisting of anti-inflammatory, analgesic, antipsychotic, hypnotic, anxiolytic, antihypertensive, myorelaxant, antimigraine, antiparkinsonian, antiemetic, antihistaminic, beta blocking and antiasthmatic agents.
14. Self-supporting films as claimed in claim 1 , wherein said principle is selected from the group consisting of: Piroxicam, Ketoprofen, Sodium diclofenac, Tramadol hydrochloride, Morphine, Nifedipine, Diazepam, Lorazepam, Alprazolam, Bromazepam, Triazolam, Lormetazepam, Zolpidem, Paracetamol, Selegiline, Atenolol, Salbutamol, Sumatriptan, Clozapine, Cetirizine, Ondansetron, Fentanyl and their pharmaceutically acceptable salts.
15. Self-supporting films as claimed in claim 14 , containing maltodextrin at concentrations between 40 and 80% by weight, plasticiser in concentrations between 15 and 55% by weight and the active principle for food or pharmaceutical use in a quantity between 0.05% and 30% by weight on the total weight of said film.
16. Self-supporting films as claimed in claims 1 , containing other excipients selected from the group consisting of anticaking agents, sweeteners, flavourings, colouring agents, preservatives, acidity regulating systems and mixtures thereof.
17. Self-supporting films as claimed in claim 16 , wherein said antisticking agents are selected from the group consisting of microcrystalline cellulose, colloidal silica and talc.
18. Process for preparing self-supporting films claimed in claim 1 , comprising the following steps:
i) mixing the maltodextrin, plasticiser and active principle for food or therapeutic use,
ii) extruding the mixture coming from the preceding step .
19. Process as claimed in claim 18 , wherein the extrusion step (ii) is preferably conducted at a temperature between 60 and 120° C.
20. Process as claimed in claim 18 , conducted in a single screw extruder.
21. Process for preparing self-supporting films claimed in claim 1 , comprising the following steps:
i) dispersing the maltodextrin, plasticiser and the active principle for therapeutic or food use in a polar solvent at a temperature between 60 and 105° C.,
ii) rolling the mixture obtained in the preceding step onto a silicone paper and drying it,
iii) removing the silicone paper from the film obtained in the preceding step.
22. The process as claimed in claim 21 , wherein the polar solvent used in step (i) is selected from the group consisting of water, a water miscible solvent and mixtures thereof.
23. Process as claimed in claim 22 , wherein said solvent consists of water and a water-ethanol mixture.
24. Process as claimed in claim 23 , wherein the temperature of steps (i) and (ii) is between 60 and 105° C.
25. Process for preparing self-supporting films claimed in claim 1 , comprising the following steps:
i) mixing the maltodextrin, plasticiser and active ingredient for food or therapeutic use,
ii) granulating and sieving the mixture and mixing it with an anti sticking agent,
iii) storing the granules at least for 12 h,
iv) extruding the granules coming from the preceding step thereby obtaining the edible film.
26. Process as claimed in claim 25 , wherein the extrusion step (ii) is conducted at a temperature between 70 and 140° C.
27. (canceled)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US15/218,744 US10426725B2 (en) | 2003-10-27 | 2016-07-25 | Self-supporting films for pharmaceutical and food use |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
ITMI2003A002087 | 2003-10-27 | ||
IT002087A ITMI20032087A1 (en) | 2003-10-27 | 2003-10-27 | SELF-SUPPORTING FILMS FOR PHARMACEUTICAL AND FOOD USE. |
PCT/EP2004/052672 WO2005039543A1 (en) | 2003-10-27 | 2004-10-27 | Self-supporting films for pharmaceutical and food use |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2004/052672 A-371-Of-International WO2005039543A1 (en) | 2003-10-27 | 2004-10-27 | Self-supporting films for pharmaceutical and food use |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/218,744 Continuation US10426725B2 (en) | 2003-10-27 | 2016-07-25 | Self-supporting films for pharmaceutical and food use |
Publications (1)
Publication Number | Publication Date |
---|---|
US20090017085A1 true US20090017085A1 (en) | 2009-01-15 |
Family
ID=34509460
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/577,408 Abandoned US20090017085A1 (en) | 2003-10-27 | 2004-10-27 | Self-supporting films for pharmaceutical and food use |
US15/218,744 Active 2024-11-16 US10426725B2 (en) | 2003-10-27 | 2016-07-25 | Self-supporting films for pharmaceutical and food use |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/218,744 Active 2024-11-16 US10426725B2 (en) | 2003-10-27 | 2016-07-25 | Self-supporting films for pharmaceutical and food use |
Country Status (10)
Country | Link |
---|---|
US (2) | US20090017085A1 (en) |
EP (1) | EP1689374B1 (en) |
AT (1) | ATE397920T1 (en) |
CA (1) | CA2543857C (en) |
DE (1) | DE602004014404D1 (en) |
DK (1) | DK1689374T3 (en) |
ES (1) | ES2308266T3 (en) |
IT (1) | ITMI20032087A1 (en) |
PL (1) | PL1689374T3 (en) |
WO (1) | WO2005039543A1 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012053006A3 (en) * | 2010-10-18 | 2012-08-02 | Panacea Biotec Ltd | Improved oral fast dissolving films comprising combination of polymers and method of preparation thereof |
US20150231065A1 (en) * | 2012-09-28 | 2015-08-20 | Pharmafilm S.R.L. | Orodispersible films having quick dissolution times for therapeutic and food use |
US9993558B2 (en) | 2004-10-01 | 2018-06-12 | Ramscor, Inc. | Sustained release eye drop formulations |
US10028965B2 (en) | 2013-05-24 | 2018-07-24 | Icon Bioscience, Inc. | Use of sustained release dexamethasone in post-cataract surgery inflammation |
US10226450B2 (en) * | 2014-09-25 | 2019-03-12 | Shilpa Medicare Limited | Pharmaceutical film composition |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AR051397A1 (en) | 2004-10-21 | 2007-01-10 | Novartis Ag | PHARMACEUTICAL COMPOSITION |
US8580830B2 (en) * | 2006-10-02 | 2013-11-12 | Labtec Gmbh | Non-mucoadhesive film dosage forms |
WO2011119287A1 (en) * | 2010-03-26 | 2011-09-29 | Dow Global Technologies Llc | Melt-extruded film |
CN103446077B (en) * | 2012-06-01 | 2016-08-24 | 黑龙江福和华星制药集团股份有限公司 | Salbutamol sulfate oral instant membrane and preparation method |
IT202100004880A1 (en) | 2021-03-02 | 2022-09-02 | Altergon Sa | SOLID Orodispersible PHARMACEUTICAL COMPOSITION IN FILM CONTAINING LORAZEPAM |
EP4340949A1 (en) | 2021-05-20 | 2024-03-27 | Smile Makers, LLC | Oral hygiene compositions and methods of use |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4222973A (en) * | 1978-07-10 | 1980-09-16 | The Mead Corporation | Process for producing casting release paper and product |
US20030068378A1 (en) * | 1999-01-21 | 2003-04-10 | Lavipharm Laboratories Inc. | Compositions and methods for mucosal delivery |
US20040028732A1 (en) * | 2000-07-04 | 2004-02-12 | Falkenhausen Christian Von | Rapidly-decomposing administrable form for releasing active ingredients in the oral cavity or in bodily cavities |
US20040096569A1 (en) * | 2002-11-15 | 2004-05-20 | Barkalow David G. | Edible film products and methods of making same |
US20050118217A1 (en) * | 2003-10-24 | 2005-06-02 | Barnhart Scott D. | Rapidly disintegrating films for delivery of pharmaceutical of cosmetic agents |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE19512252C2 (en) * | 1995-03-31 | 2000-05-31 | Fraunhofer Ges Forschung | Process for the production of films from starch and films produced by this process |
IT1303753B1 (en) * | 1998-11-13 | 2001-02-23 | Ct Lab Farm Srl | ORAL ADMINISTRABLE PHARMACEUTICAL COMPOSITIONS CONTAINING A RESISTANT COATING BASED ON ACRYLIC POLYMERS. |
US6660292B2 (en) | 2001-06-19 | 2003-12-09 | Hf Flavoring Technology Llp | Rapidly disintegrating flavored film for precooked foods |
WO2003011259A1 (en) | 2001-07-30 | 2003-02-13 | Wm. Wrigley Jr. Company | Improved edible film formulations containing maltodextrin |
US6656493B2 (en) * | 2001-07-30 | 2003-12-02 | Wm. Wrigley Jr. Company | Edible film formulations containing maltodextrin |
WO2004019802A2 (en) * | 2002-08-27 | 2004-03-11 | Wm. Wrigley Jr. Company | Breath freshening and oral cleansing product using carvacrol |
US7232577B2 (en) * | 2002-10-21 | 2007-06-19 | L. Perrigo Company | Readily dispersible dietary fiber composition |
US8007852B2 (en) * | 2002-11-18 | 2011-08-30 | Olam West Coast, Inc. | Method for production of frozen vegetables or fruits |
US8012505B2 (en) * | 2003-02-28 | 2011-09-06 | Alk-Abello A/S | Dosage form having a saccharide matrix |
EP1605908A2 (en) * | 2003-03-26 | 2005-12-21 | The Procter & Gamble Company | Rapidly dissolving edible film compositions with improved film strength and stability |
-
2003
- 2003-10-27 IT IT002087A patent/ITMI20032087A1/en unknown
-
2004
- 2004-10-27 AT AT04791317T patent/ATE397920T1/en not_active IP Right Cessation
- 2004-10-27 DE DE602004014404T patent/DE602004014404D1/en active Active
- 2004-10-27 PL PL04791317T patent/PL1689374T3/en unknown
- 2004-10-27 DK DK04791317T patent/DK1689374T3/en active
- 2004-10-27 ES ES04791317T patent/ES2308266T3/en active Active
- 2004-10-27 CA CA2543857A patent/CA2543857C/en active Active
- 2004-10-27 EP EP04791317A patent/EP1689374B1/en active Active
- 2004-10-27 WO PCT/EP2004/052672 patent/WO2005039543A1/en active IP Right Grant
- 2004-10-27 US US10/577,408 patent/US20090017085A1/en not_active Abandoned
-
2016
- 2016-07-25 US US15/218,744 patent/US10426725B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4222973A (en) * | 1978-07-10 | 1980-09-16 | The Mead Corporation | Process for producing casting release paper and product |
US20030068378A1 (en) * | 1999-01-21 | 2003-04-10 | Lavipharm Laboratories Inc. | Compositions and methods for mucosal delivery |
US20040028732A1 (en) * | 2000-07-04 | 2004-02-12 | Falkenhausen Christian Von | Rapidly-decomposing administrable form for releasing active ingredients in the oral cavity or in bodily cavities |
US20040096569A1 (en) * | 2002-11-15 | 2004-05-20 | Barkalow David G. | Edible film products and methods of making same |
US20050118217A1 (en) * | 2003-10-24 | 2005-06-02 | Barnhart Scott D. | Rapidly disintegrating films for delivery of pharmaceutical of cosmetic agents |
Non-Patent Citations (1)
Title |
---|
Definition of "self-supporting" from the Free Dictionary, accessed from the internet on June 26, 2013 from the site: http://www.thefreedictionary.com/self-supporting). * |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9993558B2 (en) | 2004-10-01 | 2018-06-12 | Ramscor, Inc. | Sustained release eye drop formulations |
US10744202B2 (en) | 2004-10-01 | 2020-08-18 | Ramscor, Inc. | Sustained release eye drop formulations |
WO2012053006A3 (en) * | 2010-10-18 | 2012-08-02 | Panacea Biotec Ltd | Improved oral fast dissolving films comprising combination of polymers and method of preparation thereof |
US20150231065A1 (en) * | 2012-09-28 | 2015-08-20 | Pharmafilm S.R.L. | Orodispersible films having quick dissolution times for therapeutic and food use |
CN104884041A (en) * | 2012-09-28 | 2015-09-02 | 法玛费尔姆有限责任公司 | Orodispersible films having quick dissolution times for therapeutic and food use |
US11123287B2 (en) * | 2012-09-28 | 2021-09-21 | Pharmafilm S.R.L. | Orodispersible films having quick dissolution times for therapeutic and food use |
US10028965B2 (en) | 2013-05-24 | 2018-07-24 | Icon Bioscience, Inc. | Use of sustained release dexamethasone in post-cataract surgery inflammation |
US10226450B2 (en) * | 2014-09-25 | 2019-03-12 | Shilpa Medicare Limited | Pharmaceutical film composition |
Also Published As
Publication number | Publication date |
---|---|
EP1689374B1 (en) | 2008-06-11 |
PL1689374T3 (en) | 2008-11-28 |
US20170035692A1 (en) | 2017-02-09 |
DE602004014404D1 (en) | 2008-07-24 |
WO2005039543A1 (en) | 2005-05-06 |
ITMI20032087A1 (en) | 2005-04-28 |
EP1689374A1 (en) | 2006-08-16 |
ES2308266T3 (en) | 2008-12-01 |
ATE397920T1 (en) | 2008-07-15 |
CA2543857C (en) | 2012-07-10 |
CA2543857A1 (en) | 2005-05-06 |
DK1689374T3 (en) | 2008-10-13 |
US10426725B2 (en) | 2019-10-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10426725B2 (en) | Self-supporting films for pharmaceutical and food use | |
EP2415466B1 (en) | Orally disintegrating coated tablet | |
JP5177447B2 (en) | Film preparation having fast solubility and flexibility | |
KR101435199B1 (en) | Stable tablet containing droxidopa | |
EP3793534B1 (en) | An oral tablet for delivery of active ingredients to the gastrointestinal tract | |
Thakur et al. | Orally disintegrating preparations: recent advancement in formulation and technology | |
JP7475286B2 (en) | Disintegrating oral tablets suitable for active pharmaceutical ingredients | |
EP3793533B1 (en) | A tablet dosage form for buccal absorption of active ingredients | |
Vishali et al. | Orodispersible tablets: A review | |
Manyikana et al. | A review of formulation techniques that impact the disintegration and mechanical properties of oradispersible drug delivery technologies | |
Sah et al. | Sublingual tablets: an overview | |
Kulkarni et al. | A systematic review on oral drug delivery as a fast dissolving film to improve therapeutic effectiveness | |
Gupta et al. | An overview of novel techniques employed in mouth dissolving drug delivery system | |
Reddy | An Introduction to Fast Dissolving Oral Thin Film Drug Delivery Systems: A Review | |
Aarti et al. | Orodispersible tablets: A comprehensive review | |
Gupta et al. | An overview of mouth dissolving films: Formulation aspects | |
JP2005232072A (en) | Filmy preparation and filmy food stable both under high and low humidity | |
Ravichandiran et al. | Fast dissolving tablets: A Review | |
WO2019219150A1 (en) | An oral tablet for delivery of active ingredients to the throat comprising non-directly compressible sugar alcohol particles | |
Liew et al. | Orally Disintegrating Film: A Review of Its Formulation and Manufacturing Method. | |
Nagar et al. | Fast dissolving tablet-A review | |
CN116916890A (en) | Solid orodispersible pharmaceutical composition in a membrane comprising lorazepam | |
JPWO2018074496A1 (en) | Composition for controlling drug elution in vivo | |
Malodia et al. | Fast Dissolving Drug Delivery System: A Review |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: PHARMAFILM S.R.L., ITALY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:CILURZO, FRANCESCO;MINGHETTI, PAOLA;MONTANARI, LUISA;REEL/FRAME:017848/0283 Effective date: 20041105 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- AFTER EXAMINER'S ANSWER OR BOARD OF APPEALS DECISION |