FR3122572A1 - Bioadhesive pharmaceutical composition comprising PVPI - Google Patents
Bioadhesive pharmaceutical composition comprising PVPI Download PDFInfo
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- FR3122572A1 FR3122572A1 FR2104854A FR2104854A FR3122572A1 FR 3122572 A1 FR3122572 A1 FR 3122572A1 FR 2104854 A FR2104854 A FR 2104854A FR 2104854 A FR2104854 A FR 2104854A FR 3122572 A1 FR3122572 A1 FR 3122572A1
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- pharmaceutical composition
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- pvpi
- pvp
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- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 17
- 239000000227 bioadhesive Substances 0.000 title claims abstract description 9
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 31
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 31
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 29
- 239000003349 gelling agent Substances 0.000 claims abstract description 19
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 19
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 18
- 239000000203 mixture Substances 0.000 claims abstract description 18
- ZCYVEMRRCGMTRW-UHFFFAOYSA-N 7553-56-2 Chemical compound [I] ZCYVEMRRCGMTRW-UHFFFAOYSA-N 0.000 claims abstract description 12
- 229910052740 iodine Inorganic materials 0.000 claims abstract description 12
- 239000011630 iodine Substances 0.000 claims abstract description 12
- 210000002850 nasal mucosa Anatomy 0.000 claims abstract description 9
- 238000011282 treatment Methods 0.000 claims abstract description 8
- 239000003814 drug Substances 0.000 claims abstract description 4
- 230000002421 anti-septic effect Effects 0.000 claims description 6
- 208000031888 Mycoses Diseases 0.000 claims description 5
- 230000001580 bacterial effect Effects 0.000 claims description 4
- 208000035143 Bacterial infection Diseases 0.000 claims description 3
- 230000003612 virological effect Effects 0.000 claims description 2
- 230000001013 cariogenic effect Effects 0.000 claims 1
- 235000003599 food sweetener Nutrition 0.000 claims 1
- 239000004615 ingredient Substances 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 239000003765 sweetening agent Substances 0.000 claims 1
- 239000000243 solution Substances 0.000 description 10
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
- 230000003647 oxidation Effects 0.000 description 5
- 238000007254 oxidation reaction Methods 0.000 description 5
- 235000010418 carrageenan Nutrition 0.000 description 4
- 229920001525 carrageenan Polymers 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000000178 monomer Substances 0.000 description 4
- KWYUFKZDYYNOTN-UHFFFAOYSA-M Potassium hydroxide Chemical compound [OH-].[K+] KWYUFKZDYYNOTN-UHFFFAOYSA-M 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 229920002125 Sokalan® Polymers 0.000 description 3
- 235000010443 alginic acid Nutrition 0.000 description 3
- 229920000615 alginic acid Polymers 0.000 description 3
- 238000004500 asepsis Methods 0.000 description 3
- 239000000679 carrageenan Substances 0.000 description 3
- 230000002538 fungal effect Effects 0.000 description 3
- 239000002674 ointment Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 239000002562 thickening agent Substances 0.000 description 3
- NIXOWILDQLNWCW-UHFFFAOYSA-N 2-Propenoic acid Natural products OC(=O)C=C NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 2
- FHVDTGUDJYJELY-UHFFFAOYSA-N 6-{[2-carboxy-4,5-dihydroxy-6-(phosphanyloxy)oxan-3-yl]oxy}-4,5-dihydroxy-3-phosphanyloxane-2-carboxylic acid Chemical compound O1C(C(O)=O)C(P)C(O)C(O)C1OC1C(C(O)=O)OC(OP)C(O)C1O FHVDTGUDJYJELY-UHFFFAOYSA-N 0.000 description 2
- AEMOLEFTQBMNLQ-BZINKQHNSA-N D-Guluronic Acid Chemical compound OC1O[C@H](C(O)=O)[C@H](O)[C@@H](O)[C@H]1O AEMOLEFTQBMNLQ-BZINKQHNSA-N 0.000 description 2
- AEMOLEFTQBMNLQ-VANFPWTGSA-N D-mannopyranuronic acid Chemical compound OC1O[C@H](C(O)=O)[C@@H](O)[C@H](O)[C@@H]1O AEMOLEFTQBMNLQ-VANFPWTGSA-N 0.000 description 2
- 206010017533 Fungal infection Diseases 0.000 description 2
- 108010010803 Gelatin Proteins 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 2
- 208000006311 Pyoderma Diseases 0.000 description 2
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 description 2
- 208000036142 Viral infection Diseases 0.000 description 2
- 229940072056 alginate Drugs 0.000 description 2
- 208000022362 bacterial infectious disease Diseases 0.000 description 2
- 229940113118 carrageenan Drugs 0.000 description 2
- 239000000499 gel Substances 0.000 description 2
- 229920000159 gelatin Polymers 0.000 description 2
- 235000019322 gelatine Nutrition 0.000 description 2
- 235000011852 gelatine desserts Nutrition 0.000 description 2
- 150000004676 glycans Chemical class 0.000 description 2
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 229960003511 macrogol Drugs 0.000 description 2
- 239000002324 mouth wash Substances 0.000 description 2
- 229940051866 mouthwash Drugs 0.000 description 2
- 230000003472 neutralizing effect Effects 0.000 description 2
- 239000007800 oxidant agent Substances 0.000 description 2
- 230000001590 oxidative effect Effects 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 238000006116 polymerization reaction Methods 0.000 description 2
- 229920001282 polysaccharide Polymers 0.000 description 2
- 239000005017 polysaccharide Substances 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- 230000008719 thickening Effects 0.000 description 2
- 229940098465 tincture Drugs 0.000 description 2
- 230000009385 viral infection Effects 0.000 description 2
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 2
- LNAZSHAWQACDHT-XIYTZBAFSA-N (2r,3r,4s,5r,6s)-4,5-dimethoxy-2-(methoxymethyl)-3-[(2s,3r,4s,5r,6r)-3,4,5-trimethoxy-6-(methoxymethyl)oxan-2-yl]oxy-6-[(2r,3r,4s,5r,6r)-4,5,6-trimethoxy-2-(methoxymethyl)oxan-3-yl]oxyoxane Chemical compound CO[C@@H]1[C@@H](OC)[C@H](OC)[C@@H](COC)O[C@H]1O[C@H]1[C@H](OC)[C@@H](OC)[C@H](O[C@H]2[C@@H]([C@@H](OC)[C@H](OC)O[C@@H]2COC)OC)O[C@@H]1COC LNAZSHAWQACDHT-XIYTZBAFSA-N 0.000 description 1
- CPKVUHPKYQGHMW-UHFFFAOYSA-N 1-ethenylpyrrolidin-2-one;molecular iodine Chemical compound II.C=CN1CCCC1=O CPKVUHPKYQGHMW-UHFFFAOYSA-N 0.000 description 1
- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 description 1
- 208000002874 Acne Vulgaris Diseases 0.000 description 1
- 241001480043 Arthrodermataceae Species 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- 241000222120 Candida <Saccharomycetales> Species 0.000 description 1
- 241001185363 Chlamydiae Species 0.000 description 1
- SHZGCJCMOBCMKK-UHFFFAOYSA-N D-mannomethylose Natural products CC1OC(O)C(O)C(O)C1O SHZGCJCMOBCMKK-UHFFFAOYSA-N 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- IAJILQKETJEXLJ-UHFFFAOYSA-N Galacturonsaeure Natural products O=CC(O)C(O)C(O)C(O)C(O)=O IAJILQKETJEXLJ-UHFFFAOYSA-N 0.000 description 1
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 description 1
- 239000004354 Hydroxyethyl cellulose Substances 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- PNNNRSAQSRJVSB-UHFFFAOYSA-N L-rhamnose Natural products CC(O)C(O)C(O)C(O)C=O PNNNRSAQSRJVSB-UHFFFAOYSA-N 0.000 description 1
- 229920000881 Modified starch Polymers 0.000 description 1
- 241001430197 Mollicutes Species 0.000 description 1
- 229920000604 Polyethylene Glycol 200 Polymers 0.000 description 1
- 229920002594 Polyethylene Glycol 8000 Polymers 0.000 description 1
- 208000004210 Pressure Ulcer Diseases 0.000 description 1
- 241000206572 Rhodophyta Species 0.000 description 1
- 206010046914 Vaginal infection Diseases 0.000 description 1
- 201000008100 Vaginitis Diseases 0.000 description 1
- 208000000558 Varicose Ulcer Diseases 0.000 description 1
- 206010052428 Wound Diseases 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 206010000496 acne Diseases 0.000 description 1
- IAJILQKETJEXLJ-RSJOWCBRSA-N aldehydo-D-galacturonic acid Chemical group O=C[C@H](O)[C@@H](O)[C@@H](O)[C@H](O)C(O)=O IAJILQKETJEXLJ-RSJOWCBRSA-N 0.000 description 1
- PNNNRSAQSRJVSB-BXKVDMCESA-N aldehydo-L-rhamnose Chemical compound C[C@H](O)[C@H](O)[C@@H](O)[C@@H](O)C=O PNNNRSAQSRJVSB-BXKVDMCESA-N 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 230000003260 anti-sepsis Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 239000012736 aqueous medium Substances 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- 150000007514 bases Chemical class 0.000 description 1
- AEMOLEFTQBMNLQ-UHFFFAOYSA-N beta-D-galactopyranuronic acid Natural products OC1OC(C(O)=O)C(O)C(O)C1O AEMOLEFTQBMNLQ-UHFFFAOYSA-N 0.000 description 1
- 229940064804 betadine Drugs 0.000 description 1
- 229960001631 carbomer Drugs 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 210000002421 cell wall Anatomy 0.000 description 1
- 229920002678 cellulose Polymers 0.000 description 1
- 239000001913 cellulose Substances 0.000 description 1
- 229920003086 cellulose ether Polymers 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 238000010668 complexation reaction Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000037304 dermatophytes Effects 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000002500 effect on skin Effects 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 235000013373 food additive Nutrition 0.000 description 1
- 239000002778 food additive Substances 0.000 description 1
- 239000008273 gelatin Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 230000000887 hydrating effect Effects 0.000 description 1
- XMBWDFGMSWQBCA-UHFFFAOYSA-N hydrogen iodide Chemical compound I XMBWDFGMSWQBCA-UHFFFAOYSA-N 0.000 description 1
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 description 1
- 230000003993 interaction Effects 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 239000006193 liquid solution Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 235000019426 modified starch Nutrition 0.000 description 1
- 230000003020 moisturizing effect Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- TZBAVQKIEKDGFH-UHFFFAOYSA-N n-[2-(diethylamino)ethyl]-1-benzothiophene-2-carboxamide;hydrochloride Chemical compound [Cl-].C1=CC=C2SC(C(=O)NCC[NH+](CC)CC)=CC2=C1 TZBAVQKIEKDGFH-UHFFFAOYSA-N 0.000 description 1
- 239000001814 pectin Substances 0.000 description 1
- 235000010987 pectin Nutrition 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 229940127557 pharmaceutical product Drugs 0.000 description 1
- 229920000570 polyether Polymers 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000011321 prophylaxis Methods 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000002453 shampoo Substances 0.000 description 1
- 239000000344 soap Substances 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 239000012873 virucide Substances 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 229920003169 water-soluble polymer Polymers 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/18—Iodine; Compounds thereof
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/0043—Nose
-
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/02—Local antiseptics
-
- 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
- A61P31/04—Antibacterial agents
-
- 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
-
- 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
- A61P31/12—Antivirals
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)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Oncology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Communicable Diseases (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Virology (AREA)
- Otolaryngology (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
L’invention se rapporte à une composition pharmaceutique bioadhésive comprenant du polyvinylpyrrolidone iodée (PVPI) et au moins un gélifiant choisi parmi le polyéthylène glycol (PEG), ses dérivés, le polyvinylpyrrolidone (PVP) et leurs mélanges. L’invention est également destinée à être utilisée comme médicament dans le traitement de la sphère oropharyngée ou buccale et/ou de la muqueuse nasaleThe invention relates to a bioadhesive pharmaceutical composition comprising polyvinylpyrrolidone iodine (PVPI) and at least one gelling agent chosen from polyethylene glycol (PEG), its derivatives, polyvinylpyrrolidone (PVP) and mixtures thereof. The invention is also intended to be used as a medicament in the treatment of the oropharyngeal or buccal sphere and/or the nasal mucosa.
Description
L’invention se rapporte à une composition à visée antiseptique. Plus particulièrement l’invention concerne une composition pharmaceutique bioadhésive comprenant du polyvinylpyrrolidone iodée (PVPI) et au moins un gélifiant choisi parmi le polyéthylène glycol (PEG), ses dérivés, le polyvinylpyrrolidone (PVP) et leurs mélanges, caractérisée en ce que la composition n’est pas sous forme de pommade. L’invention est également destinée à être utilisée comme médicament dans le traitement de la sphère oropharyngée ou buccale et/ou de la muqueuse nasale.The invention relates to a composition for antiseptic purposes. More particularly the invention relates to a bioadhesive pharmaceutical composition comprising polyvinylpyrrolidone iodine (PVPI) and at least one gelling agent chosen from polyethylene glycol (PEG), its derivatives, polyvinylpyrrolidone (PVP) and mixtures thereof, characterized in that the composition is not in the form of an ointment. The invention is also intended for use as a medicament in the treatment of the oropharyngeal or buccal sphere and/or the nasal mucosa.
Dans le domaine pharmaceutique, l'iode est utilisé depuis longtemps sous diverses formes (solution, teinture) pour la désinfection fine de petites blessures. Malgré la bonne efficacité du produit, son application est limitée car il présente un certain nombre d'effets secondaires, tels que l’apparition d’irritations voire l’apparition de réactions allergiques.In the pharmaceutical field, iodine has long been used in various forms (solution, tincture) for the fine disinfection of small wounds. Despite the good effectiveness of the product, its application is limited because it has a number of side effects, such as the appearance of irritation or even the appearance of allergic reactions.
La polyvinylpyrrolidone iodée (PVPI) est un complexe de polyvinylpyrrolidone (PVP) et d'iode, en particulier d’iode complexé et d’iode libre qui s’équilibrent au sein du complexe. En raison de sa complexation avec la molécule de polyvinylpyrrolidone, l'iode contenu dans le complexe est libéré lentement et progressivement. La PVPI offre ainsi une meilleure tolérance que les teintures d’iode.Polyvinylpyrrolidone iodine (PVPI) is a complex of polyvinylpyrrolidone (PVP) and iodine, specifically complexed iodine and free iodine which balance each other within the complex. Due to its complexation with the polyvinylpyrrolidone molecule, the iodine contained in the complex is released slowly and gradually. PVPI thus offers better tolerance than iodine tinctures.
Le PVPI est un antiseptique à large spectre, en particulier un bactéricide sur l'ensemble des bactéries y compris chlamydiae et mycoplasmes, un antifongique vis-à-vis des dermatophytes et candidas, et un virucide sur une large étendue de germes.PVPI is a broad spectrum antiseptic, in particular a bactericide on all bacteria including chlamydiae and mycoplasmas, an antifungal against dermatophytes and candidas, and a virucide on a wide range of germs.
Ainsi, la PVPI est couramment utilisée dans le domaine pharmaceutique et a supplanté l’utilisation de la teinture d’iode, en particulier :
- dans le domaine de la prophylaxie notamment pour la désinfection des mains, en particulier en chirurgie et pour l’antisepsie de la peau et des muqueuses, et
- dans le domaine de la thérapie : dans les mycoses cutanées, les pyodermies et l'acné, dans le traitement des vaginites et dans le traitement des brûlures, du décubitus et des ulcères variqueux.
- in the field of prophylaxis, in particular for disinfection of the hands, in particular in surgery and for antisepsis of the skin and mucous membranes, and
- in the field of therapy: in cutaneous mycoses, pyoderma and acne, in the treatment of vaginitis and in the treatment of burns, decubitus and varicose ulcers.
La polyvinylpyrrolidone iodée (PVPI) est généralement présentée sous forme de solution à usage dermique pour aseptiser les champs opératoires, en solution moussante dite scrub pour le lavage de la peau, en solution vaginale et en gargarisme. On la trouve également sous forme de tulle imprégné et d’ovules vaginales.Polyvinylpyrrolidone iodine (PVPI) is generally presented in the form of a solution for dermal use to sanitize the operating fields, in a foaming solution called scrub for washing the skin, in a vaginal solution and as a gargle. It is also found in the form of impregnated tulle and vaginal ovules.
Il est également connu des formes destinées à l’hygiène buccale et nasale. En particulier il est connu une solution de faible viscosité dosée à 10% de PVPI nécessitant d’être diluée dix fois de façon extemporanée avant l’utilisation (Bétadine® 10% bain de bouche). Or, une telle solution n’est pas satisfaisante pour le patient et exclu un usage ambulatoire.Forms intended for oral and nasal hygiene are also known. In particular, a low-viscosity solution containing 10% PVPI is known, which needs to be diluted ten times extemporaneously before use (Bétadine® 10% mouthwash). However, such a solution is not satisfactory for the patient and excludes ambulatory use.
Une autre préparation prête à l’emploi sous forme d’une solution liquide dosée à 1% de PVPI est proposée (Iso-Bétadine® Buccale 1%). Une telle solution est plus satisfaisante que la solution à 10%. Toutefois, elle est de faible viscosité et ne présente que peu de propriétés bioadhésives et donc une rémanence faible.Another ready-to-use preparation in the form of a liquid solution containing 1% PVPI is available (Iso-Bétadine® Buccale 1%). Such a solution is more satisfactory than the 10% solution. However, it is of low viscosity and has only few bioadhesive properties and therefore low remanence.
Or, une asepsie de la sphère buccale et/ou de la muqueuse nasale pendant une période de temps étendue peut s’avérer nécessaire pour de nombreuses applications, en particulier pour prévenir ou combattre des infections bactériennes, fongiques et/ou virales.However, asepsis of the oral sphere and/or of the nasal mucosa for an extended period of time may prove necessary for numerous applications, in particular for preventing or combating bacterial, fungal and/or viral infections.
Il existe donc un besoin pour une composition antiseptique à base de PVPI qui soit prête à l’emploi, facile d’utilisation et qui présente un effet rémanent afin de garantir l’asepsie de la sphère buccale et/ou de la muqueuse nasale pendant une période de temps étendue.There is therefore a need for an antiseptic composition based on PVPI which is ready to use, easy to use and which has a residual effect in order to guarantee asepsis of the oral sphere and/or of the nasal mucosa for a extended period of time.
Pour répondre à ce besoin, l’invention propose une composition bioadhésive à base de PVPI faiblement dosée destinée à l’usage buccale et/ou nasale, de viscosité importante (supérieure à 1mPa.s).To meet this need, the invention proposes a bioadhesive composition based on low dose PVPI intended for oral and/or nasal use, of high viscosity (greater than 1 mPa.s).
Afin d’augmenter la viscosité d’une composition, il est connu d’utiliser un gélifiant. Toutefois, la PVPI est un oxydant puissant et donc incompatible avec la plupart des gélifiants classiquement utilisés dans l’industrie pharmaceutique et démontrant des propriétés bioadhésives.In order to increase the viscosity of a composition, it is known to use a gelling agent. However, PVPI is a powerful oxidant and therefore incompatible with most gelling agents conventionally used in the pharmaceutical industry and demonstrating bioadhesive properties.
Ainsi, les dérivés de l’amidon utilisés de façon courante dans l’industrie pharmaceutique sont sensibles à l’oxydation et révèlent une interaction chimique qui aboutit à la réduction de l’iode en iodure au détriment de l’efficacité antiseptique.Thus, starch derivatives commonly used in the pharmaceutical industry are sensitive to oxidation and reveal a chemical interaction that results in the reduction of iodine to iodide to the detriment of antiseptic efficacy.
La gélatine d’origine animale ou végétale utilisée comme gélifiant est également incompatible car sensible à l'oxydation ce qui a été clairement démontré. Au niveau structural, la quantité de triples hélices et leur stabilité au chauffage ont diminué, tandis que la quantité de random coil et les β sheet ont augmenté.Gelatin of animal or vegetable origin used as a gelling agent is also incompatible because it is sensitive to oxidation, which has been clearly demonstrated. At the structural level, the amount of triple helices and their heating stability decreased, while the amount of random coil and β sheets increased.
La pectine également utilisée comme gélifiant de différentes formes pharmaceutiques est un polysaccharide issu des parois végétales. Elle se compose principalement de motifs de répétition d'acide D-galacturonique reliés par des liaisons glycosidiques de type α 1-4. Cette structure régulière est toutefois interrompue par des monomères de L-rhamnose et des chaînes latérales contenant d'autres sucres. Ce gélifiant est très sensible à l’oxydation est donc incompatible avec la PVPI.Pectin, also used as a gelling agent in various pharmaceutical forms, is a polysaccharide derived from plant cell walls. It is mainly composed of D-galacturonic acid repeat units linked by α 1-4 type glycosidic bonds. This regular structure is, however, interrupted by L-rhamnose monomers and side chains containing other sugars. This gelling agent is very sensitive to oxidation and therefore incompatible with PVPI.
L’alginate fréquemment utilisé comme gélifiant dans l’industrie pharmaceutique est un polymère formé de deux monomères liés ensemble : le mannuronate ou acide mannuronique dont certains sont acétylés et le guluronate ou acide guluronique. La liaison se fait via β-1-4. La proportion et la distribution de ces deux monomères est déterminantes pour une large expansion des propriétés physiques et chimiques de l'alginate. Cependant les alginates sont sensibles à l’oxydation et sont donc incompatibles avec la PVPI.The alginate frequently used as a gelling agent in the pharmaceutical industry is a polymer formed from two monomers bonded together: mannuronate or mannuronic acid, some of which are acetylated, and guluronate or guluronic acid. Binding is via β-1-4. The proportion and distribution of these two monomers is critical for a broad expansion of the physical and chemical properties of alginate. However, alginates are sensitive to oxidation and are therefore incompatible with PVPI.
Le carraghénane (ou carraghénine) est un polysaccharide (galactane) extrait d'algues rouges servant d'agent d'épaississement et de stabilisation dans l'industrie alimentaire et pharmaceutique. Il porte le code E407 de la classification des additifs alimentaires. Les carraghénanes permettent de former des gels à chaud (jusqu'à 60 C) et présentent donc un intérêt par rapport aux gélatines animales traditionnelles. Cependant ce gélifiant est sensible aux oxydants et est donc incompatible avec la PVPI.Carrageenan (or carrageenan) is a polysaccharide (galactan) extracted from red algae used as a thickening and stabilizing agent in the food and pharmaceutical industry. It carries the code E407 of the classification of food additives. Carrageenans make it possible to form hot gels (up to 60 C) and are therefore of interest compared to traditional animal gelatins. However, this gelling agent is sensitive to oxidants and is therefore incompatible with PVPI.
Les dérivés de la cellulose sont couramment utilisés comme gélifiant dans le domaine de la pharmacie (éthers de la cellulose, carboxyméthylcellulose sodique, hydroxypropyl cellulose méthylcellulose, éthylcellulose, hydroxypropyl méthyl cellulose, hydroxyéthyl cellulose). Là encore, ils sont sensibles à l’oxydation et donc incompatibles avec le fort pouvoir oxydant de la PVPI.Cellulose derivatives are commonly used as gelling agents in the pharmaceutical field (cellulose ethers, sodium carboxymethylcellulose, hydroxypropyl cellulose methylcellulose, ethylcellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose). Here again, they are sensitive to oxidation and therefore incompatible with the strong oxidizing power of PVPI.
Les Carbomères (Carbomère®) sont des polymères hydrosolubles de l’acide acrylique utilisés comme agent épaississant et gélifiant dans de nombreuses formulations pharmaceutiques. L’effet gélifiant est activé en deux étapes, premièrement par la dispersion et l’hydratation du Carbomère, et deuxièmement par la « neutralisation » de la solution par l’ajout de produits chimiques augmentant le pH. Les agents neutralisants comprennent la triéthanolamine (TEA), l’hydroxyde de sodium et l’hydroxyde de potassium, composés fortement basiques. Cependant la PVPI est stable à des pH compris entre 5 et 6 ce qui est incompatible avec l’utilisation de ces gélifiants (US patent N° 4,954,351 Sep. 4, 1990). De plus, les carbomères sont sensibles à l’environnement ionique qui influe sur la viscosité des solutions les rendant là encore inappropriés pour cet usage.Carbomers (Carbomère®) are water-soluble polymers of acrylic acid used as a thickening and gelling agent in many pharmaceutical formulations. The gelling effect is activated in two steps, first by dispersing and hydrating the Carbomer, and second by "neutralizing" the solution by adding pH-raising chemicals. Neutralizing agents include triethanolamine (TEA), sodium hydroxide, and potassium hydroxide, which are strongly basic compounds. However, PVPI is stable at pHs between 5 and 6, which is incompatible with the use of these gelling agents (US patent No. 4,954,351 Sep. 4, 1990). In addition, carbomers are sensitive to the ionic environment which influences the viscosity of the solutions making them again unsuitable for this use.
L’invention vise donc à surmonter les inconvénients de l’art antérieur en proposant d’utiliser du polyéthylène glycol (PEG) ou polyvinylpyrrolidone (PVP). En particulier, l’invention a pour objet une composition pharmaceutique bioadhésive comprenant du polyvinylpyrrolidone iodée (PVPI) et au moins un gélifiant choisi parmi le polyéthylène glycol (PEG), les dérivés du PEG, le polyvinylpyrrolidone (PVP) et leurs mélanges, la concentration en PVPI dans la composition étant comprise entre 0,1 et 5% (p/p).The invention therefore aims to overcome the disadvantages of the prior art by proposing the use of polyethylene glycol (PEG) or polyvinylpyrrolidone (PVP). In particular, the subject of the invention is a bioadhesive pharmaceutical composition comprising polyvinylpyrrolidone iodine (PVPI) and at least one gelling agent chosen from polyethylene glycol (PEG), derivatives of PEG, polyvinylpyrrolidone (PVP) and their mixtures, the concentration in PVPI in the composition being between 0.1 and 5% (w/w).
Le polyéthylène glycol ou PEG est un polymère polyéther linéaire de faible masse molaire (inférieure à 20 000 g/mol) fabriqués à partir de monomères d'éthylène glycol. Ces propriétés hydrosolubles en fait un produit utilisé dans un grand nombre d'industries. Il sert par exemple comme épaississant ou gélifiant à la base de nombreux produits cosmétiques (savons liquides, crèmes hydratantes, shampoings) paramédicaux (gels hydroalcooliques, lubrifiants intimes) et pharmaceutiques. On l’appelle également macrogol.Polyethylene glycol or PEG is a low molecular weight (less than 20,000 g/mol) linear polyether polymer made from ethylene glycol monomers. These water-soluble properties make it a product used in a large number of industries. It is used, for example, as a thickener or gelling agent at the base of numerous cosmetic (liquid soaps, moisturizing creams, shampoos), paramedical (hydroalcoholic gels, intimate lubricants) and pharmaceutical products. It is also called macrogol.
Il est décliné selon de nombreux poids moléculaires différents (PEG 200 à PEG 8000). L’utilisation des PEG avec de la PVPI a déjà été décrit sous forme d’une pommade de Bétadine (Macrogol 400, macrogol 4000, macrogol 600). Cependant, la concentration en PVPI est de 10% dans ces pommades et la viscosité est trop importante et donc non satisfaisante pour être compatible avec un bain de bouche ou une application sur la muqueuse nasale.It is declined according to many different molecular weights (PEG 200 to PEG 8000). The use of PEGs with PVPI has already been described in the form of Betadine ointment (Macrogol 400, macrogol 4000, macrogol 600). However, the concentration of PVPI is 10% in these ointments and the viscosity is too high and therefore unsatisfactory to be compatible with a mouthwash or an application to the nasal mucosa.
De plus le goût est fortement amer et incompatible avec une administration buccaleIn addition, the taste is strongly bitter and incompatible with oral administration.
La PVP (polyvinylpyrrolidone ou povidone) est un polymère soluble en milieu aqueux, obtenu par polymérisation de la N-vinylpyrrolidone. La PVP est utilisée, comme gélifiant pour différentes formes pharmaceutiques.PVP (polyvinylpyrrolidone or povidone) is a polymer soluble in an aqueous medium, obtained by polymerization of N-vinylpyrrolidone. PVP is used as a gelling agent for various pharmaceutical forms.
En fonction des conditions de polymérisation, la PVP peut être préparée avec des masses moléculaires variables comprise entre 2 500 et 1 100 000.Depending on the polymerization conditions, PVP can be prepared with varying molecular weights between 2,500 and 1,100,000.
Le standard le plus largement accepté, pour des raisons techniques et de calibration, est la méthode de la viscosité moyenne. De ce fait, les PVP de différentes masses moléculaires sont distinguées par ce qu’on appelle leur « valeur K » qui est basée sur des mesures de viscosité. Cette valeur K a permis de classer les molécules de PVP en plusieurs grades de masse moléculaire qui sont inscrits dans les Pharmacopées validées en Europe, aux USA et au Japon.The most widely accepted standard, for technical and calibration reasons, is the average viscosity method. Because of this, PVPs of different molecular weights are distinguished by what is called their “K value” which is based on viscosity measurements. This K value made it possible to classify the PVP molecules into several molecular mass grades which are listed in the Pharmacopoeias validated in Europe, the USA and Japan.
De façon surprenante, la PVPI associée soit au PEG, soit au PVP permet d’obtenir une composition stable et bioadhésive tout en étant suffisamment liquide pour être utilisée dans le traitement de la sphère oropharyngée ou buccale et/ou de la muqueuse nasale. La stabilité, la viscosité et la bioadhésivité de la composition, ainsi que le dosage particulier en PVPI, permettent d’obtenir un effet rémanent garantissant l’asepsie de la sphère buccale et/ou de la muqueuse nasale pendant une période de temps étendue pour prévenir ou combattre efficacement des infections bactériennes, fongiques et/ou virales.Surprisingly, the PVPI combined either with PEG or with PVP makes it possible to obtain a stable and bioadhesive composition while being sufficiently liquid to be used in the treatment of the oropharyngeal or buccal sphere and/or of the nasal mucosa. The stability, viscosity and bioadhesiveness of the composition, as well as the particular dosage of PVPI, make it possible to obtain a residual effect guaranteeing the asepsis of the oral sphere and/or the nasal mucosa for an extended period of time to prevent or effectively combat bacterial, fungal and/or viral infections.
Avantageusement, la composition est prête à l’emploi et facile d’utilisation. De plus, le procédé de fabrication est simple et économique et présente une péremption équivalente aux formes actuellement commercialisées.Advantageously, the composition is ready for use and easy to use. In addition, the manufacturing process is simple and economical and has an expiry date equivalent to the forms currently marketed.
La composition selon l’invention est particulièrement adaptée pour être utilisée comme médicament, préférentiellement comme antiseptique dans le traitement de la sphère oropharyngée ou buccale et/ou de la muqueuse nasale, et notamment pour prévenir et/ou lutter contre des maladies virales, bactériennes et/ou fongiques.The composition according to the invention is particularly suitable for use as a medicament, preferably as an antiseptic in the treatment of the oropharyngeal or oral sphere and/or the nasal mucosa, and in particular for preventing and/or combating viral, bacterial and /or fungal.
L’invention concerne également spécifiquement un stick unidose comprenant la composition selon l’invention.The invention also specifically relates to a single-dose stick comprising the composition according to the invention.
D’autres caractéristiques et avantages ressortiront de la description détaillée de l’invention et des exemples qui vont suivre.Other characteristics and advantages will emerge from the detailed description of the invention and the examples which follow.
Claims (13)
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US4954351A (en) | 1983-03-02 | 1990-09-04 | Euroceltique S.A. | Method of producing standardized povidone iodine preparations and such preparations |
US5660823A (en) * | 1995-10-11 | 1997-08-26 | Isp Investments Inc. | Fast drying, film forming iodine release solution |
US20090169647A1 (en) * | 2007-12-31 | 2009-07-02 | 3M Innovative Properties Company | Liquid antiseptic compositions containing iodine and a sugar and/or sugar alcohol |
WO2016118424A1 (en) * | 2015-01-20 | 2016-07-28 | Veloce Biopharma Llc | Novel iodophor composition and methods of use |
WO2018085384A1 (en) * | 2016-11-02 | 2018-05-11 | Veloce Biopharma, Llc | Composition and method for treating otitis |
WO2020232515A1 (en) * | 2019-06-10 | 2020-11-26 | Firebrick Pharma Pty Ltd | Prevention of infection by highly pathogenic viruses using topical application of povidone-iodine on mucous membranes |
WO2021034421A1 (en) * | 2019-08-18 | 2021-02-25 | Iview Therapeutics, Inc. | Stable pharmaceutical articles containing dilute povidone iodine formulations |
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- 2021-05-07 FR FR2104854A patent/FR3122572A1/en active Pending
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US4954351A (en) | 1983-03-02 | 1990-09-04 | Euroceltique S.A. | Method of producing standardized povidone iodine preparations and such preparations |
US5660823A (en) * | 1995-10-11 | 1997-08-26 | Isp Investments Inc. | Fast drying, film forming iodine release solution |
US20090169647A1 (en) * | 2007-12-31 | 2009-07-02 | 3M Innovative Properties Company | Liquid antiseptic compositions containing iodine and a sugar and/or sugar alcohol |
WO2016118424A1 (en) * | 2015-01-20 | 2016-07-28 | Veloce Biopharma Llc | Novel iodophor composition and methods of use |
WO2018085384A1 (en) * | 2016-11-02 | 2018-05-11 | Veloce Biopharma, Llc | Composition and method for treating otitis |
WO2020232515A1 (en) * | 2019-06-10 | 2020-11-26 | Firebrick Pharma Pty Ltd | Prevention of infection by highly pathogenic viruses using topical application of povidone-iodine on mucous membranes |
WO2021034421A1 (en) * | 2019-08-18 | 2021-02-25 | Iview Therapeutics, Inc. | Stable pharmaceutical articles containing dilute povidone iodine formulations |
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