EP4370096A1 - Composition pharmaceutique sous forme de nano-émulsion à base d'huile végétale, composition multiphase et procédé de préparation de ces compositions - Google Patents
Composition pharmaceutique sous forme de nano-émulsion à base d'huile végétale, composition multiphase et procédé de préparation de ces compositionsInfo
- Publication number
- EP4370096A1 EP4370096A1 EP22783381.1A EP22783381A EP4370096A1 EP 4370096 A1 EP4370096 A1 EP 4370096A1 EP 22783381 A EP22783381 A EP 22783381A EP 4370096 A1 EP4370096 A1 EP 4370096A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- mass
- parts
- polysaccharide
- phase
- amount
- 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.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 88
- 239000007908 nanoemulsion Substances 0.000 title claims abstract description 70
- 235000015112 vegetable and seed oil Nutrition 0.000 title claims abstract description 15
- 239000008158 vegetable oil Substances 0.000 title claims abstract description 15
- 238000000034 method Methods 0.000 title claims description 29
- 238000002360 preparation method Methods 0.000 title claims description 17
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 12
- 150000004676 glycans Chemical class 0.000 claims abstract description 109
- 229920001282 polysaccharide Polymers 0.000 claims abstract description 109
- 239000005017 polysaccharide Substances 0.000 claims abstract description 109
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims abstract description 38
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 32
- 235000019484 Rapeseed oil Nutrition 0.000 claims abstract description 20
- 229960004022 clotrimazole Drugs 0.000 claims abstract description 20
- VNFPBHJOKIVQEB-UHFFFAOYSA-N clotrimazole Chemical compound ClC1=CC=CC=C1C(N1C=NC=C1)(C=1C=CC=CC=1)C1=CC=CC=C1 VNFPBHJOKIVQEB-UHFFFAOYSA-N 0.000 claims abstract description 19
- 239000004310 lactic acid Substances 0.000 claims abstract description 19
- 235000014655 lactic acid Nutrition 0.000 claims abstract description 19
- 239000003921 oil Substances 0.000 claims abstract description 18
- 235000019198 oils Nutrition 0.000 claims abstract description 16
- 229920005862 polyol Polymers 0.000 claims abstract description 14
- 150000003077 polyols Chemical class 0.000 claims abstract description 14
- 239000008213 purified water Substances 0.000 claims abstract description 13
- ZORQXIQZAOLNGE-UHFFFAOYSA-N 1,1-difluorocyclohexane Chemical compound FC1(F)CCCCC1 ZORQXIQZAOLNGE-UHFFFAOYSA-N 0.000 claims abstract description 10
- 239000001593 sorbitan monooleate Substances 0.000 claims abstract description 10
- 229940035049 sorbitan monooleate Drugs 0.000 claims abstract description 10
- 235000011069 sorbitan monooleate Nutrition 0.000 claims abstract description 10
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims abstract description 9
- 229920001400 block copolymer Polymers 0.000 claims abstract description 9
- 239000000126 substance Substances 0.000 claims description 29
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 23
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 15
- 238000000265 homogenisation Methods 0.000 claims description 15
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 14
- 239000013543 active substance Substances 0.000 claims description 14
- 239000000839 emulsion Substances 0.000 claims description 14
- 238000003756 stirring Methods 0.000 claims description 14
- 229960004063 propylene glycol Drugs 0.000 claims description 11
- 229920003171 Poly (ethylene oxide) Polymers 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- -1 polyoxyethylene Polymers 0.000 claims description 9
- GOOHAUXETOMSMM-UHFFFAOYSA-N Propylene oxide Chemical compound CC1CO1 GOOHAUXETOMSMM-UHFFFAOYSA-N 0.000 claims description 8
- 229920001993 poloxamer 188 Polymers 0.000 claims description 8
- 229940044519 poloxamer 188 Drugs 0.000 claims description 8
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 claims description 7
- FGUUSXIOTUKUDN-IBGZPJMESA-N C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 Chemical compound C1(=CC=CC=C1)N1C2=C(NC([C@H](C1)NC=1OC(=NN=1)C1=CC=CC=C1)=O)C=CC=C2 FGUUSXIOTUKUDN-IBGZPJMESA-N 0.000 claims description 6
- 239000004480 active ingredient Substances 0.000 claims description 6
- 239000004907 Macro-emulsion Substances 0.000 claims description 5
- CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 1
- QQONPFPTGQHPMA-UHFFFAOYSA-N propylene Natural products CC=C QQONPFPTGQHPMA-UHFFFAOYSA-N 0.000 abstract 1
- 125000004805 propylene group Chemical group [H]C([H])([H])C([H])([*:1])C([H])([H])[*:2] 0.000 abstract 1
- 239000003814 drug Substances 0.000 description 19
- 229940079593 drug Drugs 0.000 description 18
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 13
- 239000003981 vehicle Substances 0.000 description 12
- 229920002148 Gellan gum Polymers 0.000 description 9
- 239000000216 gellan gum Substances 0.000 description 8
- 235000010492 gellan gum Nutrition 0.000 description 8
- 239000004615 ingredient Substances 0.000 description 8
- 210000004877 mucosa Anatomy 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- 238000009472 formulation Methods 0.000 description 7
- 210000001215 vagina Anatomy 0.000 description 7
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 description 5
- 201000007096 Vulvovaginal Candidiasis Diseases 0.000 description 5
- 230000000843 anti-fungal effect Effects 0.000 description 5
- 230000001580 bacterial effect Effects 0.000 description 5
- 229920000642 polymer Polymers 0.000 description 5
- 239000000829 suppository Substances 0.000 description 5
- 239000004094 surface-active agent Substances 0.000 description 5
- 238000002560 therapeutic procedure Methods 0.000 description 5
- 208000010484 vulvovaginitis Diseases 0.000 description 5
- 206010061218 Inflammation Diseases 0.000 description 4
- 230000000844 anti-bacterial effect Effects 0.000 description 4
- 229940121375 antifungal agent Drugs 0.000 description 4
- 239000007864 aqueous solution Substances 0.000 description 4
- 210000003756 cervix mucus Anatomy 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000011156 evaluation Methods 0.000 description 4
- 230000002538 fungal effect Effects 0.000 description 4
- 230000004054 inflammatory process Effects 0.000 description 4
- 230000008569 process Effects 0.000 description 4
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- 241000186660 Lactobacillus Species 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 3
- 239000003795 chemical substances by application Substances 0.000 description 3
- 239000003349 gelling agent Substances 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 239000011874 heated mixture Substances 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000004530 micro-emulsion Substances 0.000 description 3
- 244000005700 microbiome Species 0.000 description 3
- 229920001983 poloxamer Polymers 0.000 description 3
- 229960000502 poloxamer Drugs 0.000 description 3
- 229920001992 poloxamer 407 Polymers 0.000 description 3
- 229940044476 poloxamer 407 Drugs 0.000 description 3
- 230000000306 recurrent effect Effects 0.000 description 3
- 230000009885 systemic effect Effects 0.000 description 3
- LRHPLDYGYMQRHN-UHFFFAOYSA-N Butanol Natural products CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 description 2
- 241000792859 Enema Species 0.000 description 2
- 241000736262 Microbiota Species 0.000 description 2
- 239000005662 Paraffin oil Substances 0.000 description 2
- 201000008100 Vaginitis Diseases 0.000 description 2
- 230000001032 anti-candidal effect Effects 0.000 description 2
- 230000003110 anti-inflammatory effect Effects 0.000 description 2
- 239000003429 antifungal agent Substances 0.000 description 2
- 239000003904 antiprotozoal agent Substances 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000018109 developmental process Effects 0.000 description 2
- 238000002296 dynamic light scattering Methods 0.000 description 2
- 239000007920 enema Substances 0.000 description 2
- 229940079360 enema for constipation Drugs 0.000 description 2
- 210000005002 female reproductive tract Anatomy 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 239000008240 homogeneous mixture Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 229940039696 lactobacillus Drugs 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 238000003760 magnetic stirring Methods 0.000 description 2
- 230000002906 microbiologic effect Effects 0.000 description 2
- 210000004400 mucous membrane Anatomy 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 230000004962 physiological condition Effects 0.000 description 2
- 230000001850 reproductive effect Effects 0.000 description 2
- 238000012552 review Methods 0.000 description 2
- 230000009897 systematic effect Effects 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 238000011282 treatment Methods 0.000 description 2
- OZFAFGSSMRRTDW-UHFFFAOYSA-N (2,4-dichlorophenyl) benzenesulfonate Chemical compound ClC1=CC(Cl)=CC=C1OS(=O)(=O)C1=CC=CC=C1 OZFAFGSSMRRTDW-UHFFFAOYSA-N 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 208000004926 Bacterial Vaginosis Diseases 0.000 description 1
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 241000606124 Bacteroides fragilis Species 0.000 description 1
- 240000002791 Brassica napus Species 0.000 description 1
- 235000004977 Brassica sinapistrum Nutrition 0.000 description 1
- 241000222122 Candida albicans Species 0.000 description 1
- 241000194033 Enterococcus Species 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 206010017533 Fungal infection Diseases 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- 241000207201 Gardnerella vaginalis Species 0.000 description 1
- 241000606768 Haemophilus influenzae Species 0.000 description 1
- 241000203736 Mobiluncus Species 0.000 description 1
- 208000031888 Mycoses Diseases 0.000 description 1
- 208000012868 Overgrowth Diseases 0.000 description 1
- 208000030852 Parasitic disease Diseases 0.000 description 1
- 229920000148 Polycarbophil calcium Polymers 0.000 description 1
- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 241000193985 Streptococcus agalactiae Species 0.000 description 1
- 208000005448 Trichomonas Infections Diseases 0.000 description 1
- 206010044620 Trichomoniasis Diseases 0.000 description 1
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 description 1
- 206010046914 Vaginal infection Diseases 0.000 description 1
- 208000032159 Vaginal inflammation Diseases 0.000 description 1
- 208000037009 Vaginitis bacterial Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003905 agrochemical Substances 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 210000003484 anatomy Anatomy 0.000 description 1
- 239000002260 anti-inflammatory agent Substances 0.000 description 1
- 230000002141 anti-parasite Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 208000022362 bacterial infectious disease Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 229960000074 biopharmaceutical Drugs 0.000 description 1
- 230000008195 breast development Effects 0.000 description 1
- 229940095731 candida albicans Drugs 0.000 description 1
- 201000003984 candidiasis Diseases 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 238000012512 characterization method Methods 0.000 description 1
- 230000035606 childbirth Effects 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 230000003750 conditioning effect Effects 0.000 description 1
- 238000012937 correction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 238000009513 drug distribution Methods 0.000 description 1
- 229940088679 drug related substance Drugs 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 239000003889 eye drop Substances 0.000 description 1
- 229940012356 eye drops Drugs 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 229940047650 haemophilus influenzae Drugs 0.000 description 1
- 230000002440 hepatic effect Effects 0.000 description 1
- 230000013632 homeostatic process Effects 0.000 description 1
- 230000003054 hormonal effect Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000002262 irrigation Effects 0.000 description 1
- 238000003973 irrigation Methods 0.000 description 1
- 230000000622 irritating effect Effects 0.000 description 1
- 238000009533 lab test Methods 0.000 description 1
- 210000002429 large intestine Anatomy 0.000 description 1
- 210000005001 male reproductive tract Anatomy 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 229940126601 medicinal product Drugs 0.000 description 1
- 125000004108 n-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 description 1
- 230000037125 natural defense Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 230000003287 optical effect Effects 0.000 description 1
- 230000027758 ovulation cycle Effects 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 229950005134 polycarbophil Drugs 0.000 description 1
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 1
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 1
- 229920000053 polysorbate 80 Polymers 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 230000002294 pubertal effect Effects 0.000 description 1
- 210000004994 reproductive system Anatomy 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 206010046901 vaginal discharge Diseases 0.000 description 1
- 229940044950 vaginal gel Drugs 0.000 description 1
- 239000000029 vaginal gel Substances 0.000 description 1
- 239000000003 vaginal tablet Substances 0.000 description 1
- 239000008307 w/o/w-emulsion Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- 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
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
-
- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
- A61K9/0036—Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
-
- 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
- A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/10—Antimycotics
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Reproductive Health (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Dispersion Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Gynecology & Obstetrics (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Inorganic Chemistry (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Endocrinology (AREA)
- Communicable Diseases (AREA)
- Oncology (AREA)
- Medicinal Preparation (AREA)
- Edible Oils And Fats (AREA)
Abstract
Le premier objet de l'invention est une composition de nano-émulsion à base d'huile végétale, caractérisée en ce qu'elle comprend de l'huile végétale, qui est l'huile de colza, en une quantité de 10 à 60 parties en masse d'huile de colza, de 12 à 20 parties en masse de copolymère séquencé P188 d'oxyde d'éthylène et d'oxyde de propylène, de 40 à 60 parties en masse d'eau purifiée, de 1 à 12 parties en masse de monooléate de sorbitane, de 5 à 20 parties en masse de polyol, de 0,10 à 0,50 partie en masse d'acide lactique, de 0,5 à 5,0 parties en masse de clotrimazole, les gouttelettes de phase huileuse ayant un diamètre hydrodynamique allant de 50 nm à 70 nm. Le second objet de l'invention est une composition à phases multiples basée sur une nano-émulsion d'huile végétale, caractérisée en ce qu'elle contient une phase polysaccharidique en une quantité de 10 à 50 parties en masse et une nano-émulsion selon le premier objet de l'invention en une quantité de 50 à 90 parties en masse, la composition multiphase étant sous la forme d'un nanoemulgel, la composition multiphase ayant une viscosité dynamique comprise entre 220 mPa•s et 580 mPa•s.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PL438501A PL438501A1 (pl) | 2021-07-16 | 2021-07-16 | Kompozycja w postaci nanoemulsji na bazie oleju roślinnego, kompozycja wielofazowa oraz sposób wytwarzania tych kompozycji |
PCT/PL2022/000039 WO2023287309A1 (fr) | 2021-07-16 | 2022-07-15 | Composition pharmaceutique sous forme de nano-émulsion à base d'huile végétale, composition multiphase et procédé de préparation de ces compositions |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4370096A1 true EP4370096A1 (fr) | 2024-05-22 |
Family
ID=83546936
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP22783381.1A Pending EP4370096A1 (fr) | 2021-07-16 | 2022-07-15 | Composition pharmaceutique sous forme de nano-émulsion à base d'huile végétale, composition multiphase et procédé de préparation de ces compositions |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP4370096A1 (fr) |
PL (1) | PL438501A1 (fr) |
WO (1) | WO2023287309A1 (fr) |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ES2094688B1 (es) * | 1994-08-08 | 1997-08-01 | Cusi Lab | Manoemulsion del tipo de aceite en agua, util como vehiculo oftalmico y procedimiento para su preparacion. |
KR20040028336A (ko) * | 2002-09-30 | 2004-04-03 | 김종국 | 신규한 질내 투여용 항균 온도감응성 겔 조성물 |
CN1931163A (zh) * | 2006-09-20 | 2007-03-21 | 西北农林科技大学 | 一种克霉唑纳米乳液药物及其制备方法 |
PL210178B1 (pl) * | 2007-06-15 | 2011-12-30 | Politechnika Wroclawska | Sposób wytwarzania mikroemulsji stabilizowanej surfaktantami |
US9649275B2 (en) * | 2007-11-28 | 2017-05-16 | Commonwealth Scientific And Industrial Research Organisation | Nanoemulsions |
DE102008034944B4 (de) * | 2008-07-26 | 2017-03-16 | Arivine Pharma Ag | Mikroemulsion |
DE202014010412U1 (de) * | 2014-02-21 | 2015-09-01 | Ursapharm Arzneimittel Gmbh | Mikro- oder Nanoemulsion zur ophthalmologischen Anwendung |
CN110664733A (zh) * | 2019-10-09 | 2020-01-10 | 华欧研创生物科技(深圳)有限公司 | 用于女性阴道护理的玻尿酸纳米乳凝胶剂 |
-
2021
- 2021-07-16 PL PL438501A patent/PL438501A1/pl unknown
-
2022
- 2022-07-15 WO PCT/PL2022/000039 patent/WO2023287309A1/fr active Application Filing
- 2022-07-15 EP EP22783381.1A patent/EP4370096A1/fr active Pending
Also Published As
Publication number | Publication date |
---|---|
WO2023287309A1 (fr) | 2023-01-19 |
PL438501A1 (pl) | 2023-01-23 |
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