BR102018074940A2 - drug composition for the treatment of bedsores and stasis ulcers - Google Patents
drug composition for the treatment of bedsores and stasis ulcers Download PDFInfo
- Publication number
- BR102018074940A2 BR102018074940A2 BR102018074940A BR102018074940A BR102018074940A2 BR 102018074940 A2 BR102018074940 A2 BR 102018074940A2 BR 102018074940 A BR102018074940 A BR 102018074940A BR 102018074940 A BR102018074940 A BR 102018074940A BR 102018074940 A2 BR102018074940 A2 BR 102018074940A2
- Authority
- BR
- Brazil
- Prior art keywords
- treatment
- ulcers
- concentration
- bedsores
- drug composition
- Prior art date
Links
- 238000011282 treatment Methods 0.000 title claims abstract description 26
- 239000000203 mixture Substances 0.000 title claims abstract description 24
- 239000003814 drug Substances 0.000 title claims abstract description 15
- 229940079593 drug Drugs 0.000 title claims abstract description 14
- 208000004210 Pressure Ulcer Diseases 0.000 title abstract description 21
- 208000000558 Varicose Ulcer Diseases 0.000 title description 5
- 208000025865 Ulcer Diseases 0.000 claims abstract description 16
- 231100000397 ulcer Toxicity 0.000 claims abstract description 16
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 13
- 239000003974 emollient agent Substances 0.000 claims abstract description 13
- VAOCPAMSLUNLGC-UHFFFAOYSA-N metronidazole Chemical compound CC1=NC=C([N+]([O-])=O)N1CCO VAOCPAMSLUNLGC-UHFFFAOYSA-N 0.000 claims abstract description 13
- 229960000282 metronidazole Drugs 0.000 claims abstract description 13
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 claims abstract description 12
- 108010001478 Bacitracin Proteins 0.000 claims abstract description 7
- 229930193140 Neomycin Natural products 0.000 claims abstract description 7
- 229960003071 bacitracin Drugs 0.000 claims abstract description 7
- 229930184125 bacitracin Natural products 0.000 claims abstract description 7
- CLKOFPXJLQSYAH-ABRJDSQDSA-N bacitracin A Chemical compound C1SC([C@@H](N)[C@@H](C)CC)=N[C@@H]1C(=O)N[C@@H](CC(C)C)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H]1C(=O)N[C@H](CCCN)C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@H](CC=2C=CC=CC=2)C(=O)N[C@@H](CC=2N=CNC=2)C(=O)N[C@H](CC(O)=O)C(=O)N[C@@H](CC(N)=O)C(=O)NCCCC1 CLKOFPXJLQSYAH-ABRJDSQDSA-N 0.000 claims abstract description 7
- 229960004927 neomycin Drugs 0.000 claims abstract description 7
- 229960000988 nystatin Drugs 0.000 claims abstract description 7
- VQOXZBDYSJBXMA-NQTDYLQESA-N nystatin A1 Chemical compound O[C@H]1[C@@H](N)[C@H](O)[C@@H](C)O[C@H]1O[C@H]1/C=C/C=C/C=C/C=C/CC/C=C/C=C/[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@](O)(C[C@H](O)[C@H]2C(O)=O)O[C@H]2C1 VQOXZBDYSJBXMA-NQTDYLQESA-N 0.000 claims abstract description 7
- 235000019371 penicillin G benzathine Nutrition 0.000 claims abstract description 6
- 229940056360 penicillin g Drugs 0.000 claims abstract description 6
- 150000003839 salts Chemical class 0.000 claims description 12
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 6
- 235000011187 glycerol Nutrition 0.000 claims description 3
- 239000007788 liquid Substances 0.000 claims description 3
- 235000019271 petrolatum Nutrition 0.000 claims description 3
- 229920001296 polysiloxane Polymers 0.000 claims description 3
- 239000007787 solid Substances 0.000 claims description 3
- JUHORIMYRDESRB-UHFFFAOYSA-N benzathine Chemical compound C=1C=CC=CC=1CNCCNCC1=CC=CC=C1 JUHORIMYRDESRB-UHFFFAOYSA-N 0.000 claims 1
- 230000000699 topical effect Effects 0.000 abstract description 17
- 239000004480 active ingredient Substances 0.000 abstract description 9
- 208000015181 infectious disease Diseases 0.000 abstract description 9
- 208000027418 Wounds and injury Diseases 0.000 abstract description 8
- 239000000546 pharmaceutical excipient Substances 0.000 abstract description 3
- 230000002195 synergetic effect Effects 0.000 abstract description 3
- 239000004599 antimicrobial Substances 0.000 abstract description 2
- 238000000034 method Methods 0.000 abstract description 2
- 230000008569 process Effects 0.000 abstract description 2
- 238000011084 recovery Methods 0.000 abstract description 2
- 230000008929 regeneration Effects 0.000 abstract description 2
- 238000011069 regeneration method Methods 0.000 abstract description 2
- 230000035876 healing Effects 0.000 description 14
- 239000003242 anti bacterial agent Substances 0.000 description 7
- 229940088710 antibiotic agent Drugs 0.000 description 7
- 230000015572 biosynthetic process Effects 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 206010052428 Wound Diseases 0.000 description 5
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 5
- 230000002265 prevention Effects 0.000 description 5
- 238000001228 spectrum Methods 0.000 description 5
- 206010011985 Decubitus ulcer Diseases 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 239000003792 electrolyte Substances 0.000 description 4
- 235000016709 nutrition Nutrition 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 241000894006 Bacteria Species 0.000 description 3
- 230000003115 biocidal effect Effects 0.000 description 3
- 235000005911 diet Nutrition 0.000 description 3
- 230000037213 diet Effects 0.000 description 3
- 235000015872 dietary supplement Nutrition 0.000 description 3
- 208000035475 disorder Diseases 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 208000014674 injury Diseases 0.000 description 3
- 230000000813 microbial effect Effects 0.000 description 3
- 239000000843 powder Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- YBJHBAHKTGYVGT-ZKWXMUAHSA-N (+)-Biotin Chemical compound N1C(=O)N[C@@H]2[C@H](CCCCC(=O)O)SC[C@@H]21 YBJHBAHKTGYVGT-ZKWXMUAHSA-N 0.000 description 2
- GHOKWGTUZJEAQD-ZETCQYMHSA-N (D)-(+)-Pantothenic acid Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-ZETCQYMHSA-N 0.000 description 2
- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 2
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 2
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 description 2
- -1 N-substituted methacrylamide Chemical class 0.000 description 2
- AUNGANRZJHBGPY-SCRDCRAPSA-N Riboflavin Chemical compound OC[C@@H](O)[C@@H](O)[C@@H](O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-SCRDCRAPSA-N 0.000 description 2
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 230000002421 anti-septic effect Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 210000000170 cell membrane Anatomy 0.000 description 2
- 210000002421 cell wall Anatomy 0.000 description 2
- 230000004087 circulation Effects 0.000 description 2
- 210000001072 colon Anatomy 0.000 description 2
- 239000006071 cream Substances 0.000 description 2
- 230000006378 damage Effects 0.000 description 2
- 238000001804 debridement Methods 0.000 description 2
- 201000010099 disease Diseases 0.000 description 2
- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 230000001965 increasing effect Effects 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 229910052500 inorganic mineral Inorganic materials 0.000 description 2
- 238000002955 isolation Methods 0.000 description 2
- 210000003141 lower extremity Anatomy 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 244000005700 microbiome Species 0.000 description 2
- 239000011707 mineral Substances 0.000 description 2
- 235000010755 mineral Nutrition 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 235000019198 oils Nutrition 0.000 description 2
- 239000002674 ointment Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000003755 preservative agent Substances 0.000 description 2
- 230000002035 prolonged effect Effects 0.000 description 2
- 235000018102 proteins Nutrition 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 description 2
- 210000000664 rectum Anatomy 0.000 description 2
- 230000004936 stimulating effect Effects 0.000 description 2
- 238000003786 synthesis reaction Methods 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 230000017423 tissue regeneration Effects 0.000 description 2
- PZNPLUBHRSSFHT-RRHRGVEJSA-N 1-hexadecanoyl-2-octadecanoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCCCC(=O)O[C@@H](COP([O-])(=O)OCC[N+](C)(C)C)COC(=O)CCCCCCCCCCCCCCC PZNPLUBHRSSFHT-RRHRGVEJSA-N 0.000 description 1
- FPIPGXGPPPQFEQ-UHFFFAOYSA-N 13-cis retinol Natural products OCC=C(C)C=CC=C(C)C=CC1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-UHFFFAOYSA-N 0.000 description 1
- 239000004475 Arginine Substances 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- GHOKWGTUZJEAQD-UHFFFAOYSA-N Chick antidermatitis factor Natural products OCC(C)(C)C(O)C(=O)NCCC(O)=O GHOKWGTUZJEAQD-UHFFFAOYSA-N 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- VYZAMTAEIAYCRO-UHFFFAOYSA-N Chromium Chemical compound [Cr] VYZAMTAEIAYCRO-UHFFFAOYSA-N 0.000 description 1
- XYGMEFJSKQEBTO-KUJXMBTLSA-N Clostebol acetate Chemical compound C1CC2=C(Cl)C(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](OC(=O)C)[C@@]1(C)CC2 XYGMEFJSKQEBTO-KUJXMBTLSA-N 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- AUNGANRZJHBGPY-UHFFFAOYSA-N D-Lyxoflavin Natural products OCC(O)C(O)C(O)CN1C=2C=C(C)C(C)=CC=2N=C2C1=NC(=O)NC2=O AUNGANRZJHBGPY-UHFFFAOYSA-N 0.000 description 1
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 1
- SNPLKNRPJHDVJA-ZETCQYMHSA-N D-panthenol Chemical compound OCC(C)(C)[C@@H](O)C(=O)NCCCO SNPLKNRPJHDVJA-ZETCQYMHSA-N 0.000 description 1
- 235000004866 D-panthenol Nutrition 0.000 description 1
- 239000011703 D-panthenol Substances 0.000 description 1
- 206010051814 Eschar Diseases 0.000 description 1
- 241000192125 Firmicutes Species 0.000 description 1
- 241000233866 Fungi Species 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 208000022559 Inflammatory bowel disease Diseases 0.000 description 1
- 206010052098 Iodine allergy Diseases 0.000 description 1
- 208000034693 Laceration Diseases 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 208000002720 Malnutrition Diseases 0.000 description 1
- 239000005913 Maltodextrin Substances 0.000 description 1
- 229920002774 Maltodextrin Polymers 0.000 description 1
- ABSPRNADVQNDOU-UHFFFAOYSA-N Menaquinone 1 Natural products C1=CC=C2C(=O)C(CC=C(C)C)=C(C)C(=O)C2=C1 ABSPRNADVQNDOU-UHFFFAOYSA-N 0.000 description 1
- ZOKXTWBITQBERF-UHFFFAOYSA-N Molybdenum Chemical compound [Mo] ZOKXTWBITQBERF-UHFFFAOYSA-N 0.000 description 1
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 description 1
- 206010028980 Neoplasm Diseases 0.000 description 1
- DFPAKSUCGFBDDF-UHFFFAOYSA-N Nicotinamide Chemical compound NC(=O)C1=CC=CN=C1 DFPAKSUCGFBDDF-UHFFFAOYSA-N 0.000 description 1
- 108090000526 Papain Proteins 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 description 1
- 241000295644 Staphylococcaceae Species 0.000 description 1
- 229920006328 Styrofoam Polymers 0.000 description 1
- 235000019486 Sunflower oil Nutrition 0.000 description 1
- JZRWCGZRTZMZEH-UHFFFAOYSA-N Thiamine Natural products CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N JZRWCGZRTZMZEH-UHFFFAOYSA-N 0.000 description 1
- 208000031737 Tissue Adhesions Diseases 0.000 description 1
- FPIPGXGPPPQFEQ-BOOMUCAASA-N Vitamin A Natural products OC/C=C(/C)\C=C\C=C(\C)/C=C/C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-BOOMUCAASA-N 0.000 description 1
- 229930003779 Vitamin B12 Natural products 0.000 description 1
- 229930003268 Vitamin C Natural products 0.000 description 1
- QYSXJUFSXHHAJI-XFEUOLMDSA-N Vitamin D3 Natural products C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C/C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-XFEUOLMDSA-N 0.000 description 1
- 229930003427 Vitamin E Natural products 0.000 description 1
- 108010046377 Whey Proteins Proteins 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 229920006322 acrylamide copolymer Polymers 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 150000001298 alcohols Chemical class 0.000 description 1
- FPIPGXGPPPQFEQ-OVSJKPMPSA-N all-trans-retinol Chemical compound OC\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C FPIPGXGPPPQFEQ-OVSJKPMPSA-N 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000000843 anti-fungal effect Effects 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 229940121375 antifungal agent Drugs 0.000 description 1
- 238000011203 antimicrobial therapy Methods 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 238000004500 asepsis Methods 0.000 description 1
- 239000003899 bactericide agent Substances 0.000 description 1
- 230000004888 barrier function Effects 0.000 description 1
- 229960002685 biotin Drugs 0.000 description 1
- 235000020958 biotin Nutrition 0.000 description 1
- 239000011616 biotin Substances 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 108010033929 calcium caseinate Proteins 0.000 description 1
- 239000000828 canola oil Substances 0.000 description 1
- 235000019519 canola oil Nutrition 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- OEYIOHPDSNJKLS-UHFFFAOYSA-N choline Chemical compound C[N+](C)(C)CCO OEYIOHPDSNJKLS-UHFFFAOYSA-N 0.000 description 1
- 229960001231 choline Drugs 0.000 description 1
- 229910052804 chromium Inorganic materials 0.000 description 1
- 239000011651 chromium Substances 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 229960002039 clostebol acetate Drugs 0.000 description 1
- AGVAZMGAQJOSFJ-WZHZPDAFSA-M cobalt(2+);[(2r,3s,4r,5s)-5-(5,6-dimethylbenzimidazol-1-yl)-4-hydroxy-2-(hydroxymethyl)oxolan-3-yl] [(2r)-1-[3-[(1r,2r,3r,4z,7s,9z,12s,13s,14z,17s,18s,19r)-2,13,18-tris(2-amino-2-oxoethyl)-7,12,17-tris(3-amino-3-oxopropyl)-3,5,8,8,13,15,18,19-octamethyl-2 Chemical compound [Co+2].N#[C-].[N-]([C@@H]1[C@H](CC(N)=O)[C@@]2(C)CCC(=O)NC[C@@H](C)OP(O)(=O)O[C@H]3[C@H]([C@H](O[C@@H]3CO)N3C4=CC(C)=C(C)C=C4N=C3)O)\C2=C(C)/C([C@H](C\2(C)C)CCC(N)=O)=N/C/2=C\C([C@H]([C@@]/2(CC(N)=O)C)CCC(N)=O)=N\C\2=C(C)/C2=N[C@]1(C)[C@@](C)(CC(N)=O)[C@@H]2CCC(N)=O AGVAZMGAQJOSFJ-WZHZPDAFSA-M 0.000 description 1
- 230000000295 complement effect Effects 0.000 description 1
- 239000000356 contaminant Substances 0.000 description 1
- 229910052802 copper Inorganic materials 0.000 description 1
- 239000010949 copper Substances 0.000 description 1
- 239000003431 cross linking reagent Substances 0.000 description 1
- 230000001086 cytosolic effect Effects 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 229960003949 dexpanthenol Drugs 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 239000003085 diluting agent Substances 0.000 description 1
- 230000002708 enhancing effect Effects 0.000 description 1
- 231100000333 eschar Toxicity 0.000 description 1
- 235000020774 essential nutrients Nutrition 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 229960000304 folic acid Drugs 0.000 description 1
- 235000019152 folic acid Nutrition 0.000 description 1
- 239000011724 folic acid Substances 0.000 description 1
- 230000037406 food intake Effects 0.000 description 1
- 235000012631 food intake Nutrition 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- PGBHMTALBVVCIT-VCIWKGPPSA-N framycetin Chemical compound N[C@@H]1[C@@H](O)[C@H](O)[C@H](CN)O[C@@H]1O[C@H]1[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](N)C[C@@H](N)[C@@H]2O)O[C@@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CN)O2)N)O[C@@H]1CO PGBHMTALBVVCIT-VCIWKGPPSA-N 0.000 description 1
- 230000000855 fungicidal effect Effects 0.000 description 1
- 230000001408 fungistatic effect Effects 0.000 description 1
- WIGCFUFOHFEKBI-UHFFFAOYSA-N gamma-tocopherol Natural products CC(C)CCCC(C)CCCC(C)CCCC1CCC2C(C)C(O)C(C)C(C)C2O1 WIGCFUFOHFEKBI-UHFFFAOYSA-N 0.000 description 1
- 230000002068 genetic effect Effects 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 230000001771 impaired effect Effects 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002452 interceptive effect Effects 0.000 description 1
- PNDPGZBMCMUPRI-UHFFFAOYSA-N iodine Chemical compound II PNDPGZBMCMUPRI-UHFFFAOYSA-N 0.000 description 1
- 229910052742 iron Inorganic materials 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 230000001071 malnutrition Effects 0.000 description 1
- 235000000824 malnutrition Nutrition 0.000 description 1
- 229940035034 maltodextrin Drugs 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 229940057917 medium chain triglycerides Drugs 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910052750 molybdenum Inorganic materials 0.000 description 1
- 239000011733 molybdenum Substances 0.000 description 1
- 229940053050 neomycin sulfate Drugs 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 229960003966 nicotinamide Drugs 0.000 description 1
- 235000005152 nicotinamide Nutrition 0.000 description 1
- 239000011570 nicotinamide Substances 0.000 description 1
- 239000002687 nonaqueous vehicle Substances 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 208000015380 nutritional deficiency disease Diseases 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000000399 orthopedic effect Effects 0.000 description 1
- 206010033675 panniculitis Diseases 0.000 description 1
- 229940055726 pantothenic acid Drugs 0.000 description 1
- 235000019161 pantothenic acid Nutrition 0.000 description 1
- 239000011713 pantothenic acid Substances 0.000 description 1
- 229940055729 papain Drugs 0.000 description 1
- 235000019834 papain Nutrition 0.000 description 1
- 230000007170 pathology Effects 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- 208000014999 perianal Crohn disease Diseases 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000000144 pharmacologic effect Effects 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 235000019175 phylloquinone Nutrition 0.000 description 1
- 239000011772 phylloquinone Substances 0.000 description 1
- SHUZOJHMOBOZST-UHFFFAOYSA-N phylloquinone Natural products CC(C)CCCCC(C)CCC(C)CCCC(=CCC1=C(C)C(=O)c2ccccc2C1=O)C SHUZOJHMOBOZST-UHFFFAOYSA-N 0.000 description 1
- MBWXNTAXLNYFJB-NKFFZRIASA-N phylloquinone Chemical compound C1=CC=C2C(=O)C(C/C=C(C)/CCC[C@H](C)CCC[C@H](C)CCCC(C)C)=C(C)C(=O)C2=C1 MBWXNTAXLNYFJB-NKFFZRIASA-N 0.000 description 1
- 229960001898 phytomenadione Drugs 0.000 description 1
- 150000004291 polyenes Chemical class 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 108090000765 processed proteins & peptides Proteins 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000001012 protector Effects 0.000 description 1
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 description 1
- 235000019192 riboflavin Nutrition 0.000 description 1
- 229960002477 riboflavin Drugs 0.000 description 1
- 239000002151 riboflavin Substances 0.000 description 1
- 239000011669 selenium Substances 0.000 description 1
- 229910052711 selenium Inorganic materials 0.000 description 1
- 229960003600 silver sulfadiazine Drugs 0.000 description 1
- UEJSSZHHYBHCEL-UHFFFAOYSA-N silver(1+) sulfadiazinate Chemical compound [Ag+].C1=CC(N)=CC=C1S(=O)(=O)[N-]C1=NC=CC=N1 UEJSSZHHYBHCEL-UHFFFAOYSA-N 0.000 description 1
- 206010040882 skin lesion Diseases 0.000 description 1
- 231100000444 skin lesion Toxicity 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 239000008347 soybean phospholipid Substances 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 239000003270 steroid hormone Substances 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 239000008261 styrofoam Substances 0.000 description 1
- 210000004304 subcutaneous tissue Anatomy 0.000 description 1
- 239000002600 sunflower oil Substances 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 238000011477 surgical intervention Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000007910 systemic administration Methods 0.000 description 1
- 238000009121 systemic therapy Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 235000019157 thiamine Nutrition 0.000 description 1
- 229960003495 thiamine Drugs 0.000 description 1
- 239000011721 thiamine Substances 0.000 description 1
- KYMBYSLLVAOCFI-UHFFFAOYSA-N thiamine Chemical compound CC1=C(CCO)SCN1CC1=CN=C(C)N=C1N KYMBYSLLVAOCFI-UHFFFAOYSA-N 0.000 description 1
- 238000011200 topical administration Methods 0.000 description 1
- 229940098956 topical powder Drugs 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 230000000472 traumatic effect Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000019155 vitamin A Nutrition 0.000 description 1
- 239000011719 vitamin A Substances 0.000 description 1
- 235000019163 vitamin B12 Nutrition 0.000 description 1
- 239000011715 vitamin B12 Substances 0.000 description 1
- 235000019158 vitamin B6 Nutrition 0.000 description 1
- 239000011726 vitamin B6 Substances 0.000 description 1
- 235000019154 vitamin C Nutrition 0.000 description 1
- 239000011718 vitamin C Substances 0.000 description 1
- QYSXJUFSXHHAJI-YRZJJWOYSA-N vitamin D3 Chemical compound C1(/[C@@H]2CC[C@@H]([C@]2(CCC1)C)[C@H](C)CCCC(C)C)=C\C=C1\C[C@@H](O)CCC1=C QYSXJUFSXHHAJI-YRZJJWOYSA-N 0.000 description 1
- 235000005282 vitamin D3 Nutrition 0.000 description 1
- 239000011647 vitamin D3 Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 229940045997 vitamin a Drugs 0.000 description 1
- 229940011671 vitamin b6 Drugs 0.000 description 1
- 229940021056 vitamin d3 Drugs 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
- 235000021119 whey protein Nutrition 0.000 description 1
- 239000011701 zinc Substances 0.000 description 1
- 229910052725 zinc Inorganic materials 0.000 description 1
Landscapes
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
composição medicamentosa para o tratamento de escaras e úlceras de estase, sendo que a invenção descreve uma composição medicamentosa para o tratamento de escaras e úlceras de estase, de uso tópico humano e animal, que compreende a associação sinérgica de nistatina, metronidazol, neomicina, bacitracina e benzilpenicilina, antimicrobianos com eficácia comprovada; ao menos um agente de oclusão de forma a manter os princípios ativos por mais tempo na ferida; ao menos um agente emoliente de forma a auxiliar no processo de regeneração dos tecidos e excipientes inertes formadores de formas farmacêuticas tópicas com o objetivo de tratar infecções, promover a recuperação da área lesada e aliviar a dor associada.drug composition for the treatment of stasis bedsores and ulcers, the invention describing a drug composition for the treatment of stasis bedsores and ulcers, for human and animal topical use, comprising the synergistic association of nystatin, metronidazole, neomycin, bacitracin and benzylpenicillin, antimicrobials with proven efficacy; at least one occlusion agent in order to keep the active ingredients in the wound longer; at least one emollient agent in order to assist in the regeneration process of tissues and inert excipients that form topical pharmaceutical forms in order to treat infections, promote the recovery of the injured area and relieve the associated pain.
Description
COMPOSIÇÃO MEDICAMENTOSA PARA O TRATAMENTO DEDRUG COMPOSITION FOR THE TREATMENT OF
ESCARAS E ÚLCERAS DE ESTASESCALES AND STASE ULCERS
Campo da InvençãoField of the Invention
- A presente patente de invenção descreve uma composição medicamentosa, de uso humano e animal, para o tratamento de escaras e úlceras de estase. Mais especificamente compreende uma composição contendo a associação dos princípios ativos nistatina, metronidazol, neomicina, bacitracina e benzilpenicilina, nas formas de base ou de seus sais derivados, acrescida de agentes de oclusão, emolientes e outros excipientes inertes formadores e estabilizadores de formas farmacêuticas tópicas. A associação atua de forma sinérgica contra infecções presentes na pele, potencializando a cicatrização da área lesada e, consequentemente, diminuindo o desconforto e dor gerados pelas feridas.- The present invention patent describes a drug composition, for human and animal use, for the treatment of bedsores and stasis ulcers. More specifically, it comprises a composition containing the association of the active ingredients nystatin, metronidazole, neomycin, bacitracin and benzylpenicillin, in the base forms or their derived salts, plus occlusion agents, emollients and other inert excipients that form and stabilize topical pharmaceutical forms. The association acts synergistically against infections present on the skin, enhancing the healing of the injured area and, consequently, reducing the discomfort and pain generated by the wounds.
Antecedentes da InvençãoBackground of the Invention
- Escaras e úlceras de estase são afecções da pele e de tecidos subcutâneos causadas pela interrupção da circulação sanguínea e do provimento de nutrientes das áreas afetadas. Com extensões e profundidades variáveis, estas afecções são motivadas pela pressão aumentada por um período prolongado, imobilidade, fricção, traumatismos, idade avançada, desnutrição, diabetes, dentre outras causas (James W.D., Berger T.G., Elston D.M. In: Andrews Diseases of the Skin: Clinical Dermatology. Ed.11. China: Ed. Elsevier, 2011).- Stasis sores and ulcers are disorders of the skin and subcutaneous tissues caused by the interruption of blood circulation and the supply of nutrients in the affected areas. With varying lengths and depths, these conditions are motivated by increased pressure for a prolonged period, immobility, friction, trauma, old age, malnutrition, diabetes, among other causes (James WD, Berger TG, Elston DM In: Andrews Diseases of the Skin : Clinical Dermatology. Ed.11. China: Ed. Elsevier, 2011).
- Diferentemente de boa parte das alterações de pele, estas afecções têm sido alvo de grande preocupação para os serviços de saúde, pois a sua ocorrência causa impacto tanto para os pacientes e seus familiares, quanto para o- Unlike most skin changes, these conditions have been a target of great concern for health services, as their occurrence causes an impact both for patients and their families, as well as for the patient.
Petição 870180157516, de 30/11/2018, pág. 11/22Petition 870180157516, of 11/30/2018, p. 11/22
I 10 próprio sistema de saúde, com o prolongamento de internações, riscos de infecção e outros agravos evitáveis (Protocolo para Prevenção e Tratamento de Úlceras de Pressão; Ministério da SaúdelANVISAlFiocruz, 2013).I 10 health system itself, with prolonged hospitalizations, risks of infection and other preventable diseases (Protocol for the Prevention and Treatment of Pressure Ulcers; Ministério da SaúdelANVISAlFiocruz, 2013).
- O tratamento, que varia de acordo com a gravidade e extensão das lesões, compreende desde cuidados básicos nutricionais, de limpeza e desinfecção do local afetado e de uso de curativos até intervenções medicamentosas e cirúrgicas. Os medicamentos utilizados, administrados local ou sistemicamente, objetivam principalmente o alívio da dor, o favorecimento da cicatrização e o controle da infecção (Singer A.J., Hollander J.E., Quinn J.V. Evaluation and management of traumatic lacerations. N Eng J Med; 1997; 337:1142-8).- The treatment, which varies according to the severity and extent of the lesions, ranges from basic nutritional care, cleaning and disinfection of the affected area and the use of dressings to medical and surgical interventions. The drugs used, administered locally or systemically, aim mainly at relieving pain, promoting healing and controlling infection (Singer AJ, Hollander JE, Quinn JV Evaluation and management of traumatic lacerations. N Eng J Med; 1997; 337: 1142-8).
Neste sentido, a terapia tópica é uma alternativa prática que pode ser única ou complementar à terapia sistêmica. A utilização de tratamento tópico apresenta como vantagens a facilidade de aplicação, altas concentrações dos princípios ativos no local da lesão, menor risco de desenvolvimento de resistência microbiana e menor incidência de eventos adversos (Cesur S. Topical antibiotics and clinical use. Mikrobiyol Bul 2002; 36(3-4):353-61).In this sense, topical therapy is a practical alternative that can be unique or complementary to systemic therapy. The use of topical treatment has the advantages of ease of application, high concentrations of active ingredients at the site of the injury, less risk of developing microbial resistance and less incidence of adverse events (Cesur S. Topical antibiotics and clinical use. Mikrobiyol Bul 2002; 36 (3-4): 353-61).
- Além disto, a terapia antimicrobiana tópica permite um melhor controle da colonização microbiana, reduzindo a formação de crostas, as quais facilitam a manutenção da infecção, prevenindo, assim, o desenvolvimento de infecções mais graves (Palmieri T.L., Greenhalgh D.G. Topical treatment of pediatric patients with burns: a practical guide. Am J Clin Dermatology 2002; 3(8):529-34).- In addition, topical antimicrobial therapy allows better control of microbial colonization, reducing the formation of crusts, which facilitate the maintenance of infection, thus preventing the development of more serious infections (Palmieri TL, Greenhalgh DG Topical treatment of pediatric patients with burns: a practical guide.Am J Clin Dermatology 2002; 3 (8): 529-34).
- Os tratamentos tópicos para escaras aprovados no Brasil incluem: óleos, que diminuem a fricção com tecidos, atuam na proteção quanto a entrada de sujidades e auxiliam na cicatrização; pomadas com papaína, que auxiliam na- Topical treatments for bedsores approved in Brazil include: oils, which reduce friction with tissues, act as protection against the entry of dirt and assist in healing; ointments with papain, which help in
Petição 870180157516, de 30/11/2018, pág. 12/22Petition 870180157516, of 11/30/2018, p. 12/22
I 10 regeneração tecidual, cremes contendo a associação entre acetato de clostebol, hormônio esteróide que age aumentando a produção de proteínas, essenciais para formação de novas células e sulfato de neomicina, antibiótico; pomadas contendo dexpantenol e cremes contendo sulfadiazina de prata.I 10 tissue regeneration, creams containing the association between clostebol acetate, a steroid hormone that acts by increasing the production of proteins, essential for the formation of new cells and neomycin sulfate, antibiotic; ointments containing dexpanthenol and creams containing silver sulfadiazine.
- Como estas intervenções medicamentosas precisam ser múltiplas, a adesão ao tratamento e, conseqüentemente, o sucesso terapêutico, podem ser prejudicados. De forma isolada cada um dos tratamentos tópicos não abrange todo o espectro antimicrobiano que a invenção proposta apresenta. Alguns atuam na prevenção, outros no estímulo da cicatrização e os que contém antibiótico possuem espectro reduzido.- As these drug interventions need to be multiple, adherence to treatment and, consequently, therapeutic success, may be impaired. In isolation, each of the topical treatments does not cover the entire antimicrobial spectrum that the proposed invention presents. Some act in prevention, others in stimulating healing and those containing antibiotics have a reduced spectrum.
- Dentre os antibióticos mais eficazes para o tratamento de infecções em escaras citam-se:- Among the most effective antibiotics for treating bedsore infections are:
- A) A nistatina que é um antibiótico antifúngico poliênico com ação fungistática e fungicida in vitro contra uma grande variedade de leveduras e fungos leveduriformes. Atua ligando-se aos esteróides existentes na membrana celular dos fungos susceptíveis, com resultante alteração na permeabilidade da membrana celular e consequente extravasamento do conteúdo citoplasmático (Brunton, L.L. Goodman & Gilman: As Bases Farmacológicas da Terapêutica. 12a ed. Rio de Janeiro: McGraw-Hill, 2012).- A) Nystatin, which is a polyene antifungal antibiotic with fungistatic and fungicidal action in vitro against a wide variety of yeasts and yeast fungus. It acts by binding to existing steroid in cell membranes of susceptible fungi, with resulting change in the permeability of the cell membrane and subsequent leakage of cytoplasmic contents (Brunton LL Goodman & Gilman: The Pharmacological Basis of Therapeutics 12th ed Rio de Janeiro..: McGraw-Hill, 2012).
- B) O metronidazol que é um anti-infeccioso de uso local do grupo dos nitro-5-imidazóis, com espectro de atividade antimicrobiana prevalente em microorganismos anaeróbios (H.P Rang e colaboradores: Farmacologia. 6a ed. Rio de Janeiro, Elsevier, 2007).- B) Metronidazole, which is an anti-infective used locally in the group of nitro-5-imidazoles, with a spectrum of antimicrobial activity prevalent in anaerobic microorganisms (HP Rang and collaborators: Pharmacology. 6th ed. Rio de Janeiro, Elsevier, 2007 ).
- C) A neomicina que determina um erro na leitura do código genético da bactéria, interferindo na síntese de suas proteínas. É eficaz contra bactérias- C) Neomycin that determines an error in the reading of the bacterium's genetic code, interfering in the synthesis of its proteins. It is effective against bacteria
Petição 870180157516, de 30/11/2018, pág. 13/22Petition 870180157516, of 11/30/2018, p. 13/22
I 10 gram-positivas, e particularmente contra as gram-negativas (H.P Rang e colaboradores: Farmacologia. 6a ed. Rio de Janeiro, Elsevier, 2007).I 10 gram-positive, particularly against gram-negative (HP Rang and employees Pharmacology 6 ed Rio de Janeiro, Elsevier, 2007..).
- D) A bacitracina que inibe a biossíntese da parede celular bacteriana. Seu espectro de ação compreende principalmente as bactérias grampositivas e algumas bactérias gram-negativas (H.P Rang e colaboradores: Farmacologia. 6a ed. Rio de Janeiro, Elsevier, 2007).- D) Bacitracin that inhibits bacterial cell wall biosynthesis. Its spectrum of action includes mainly gram-positive bacteria and some gram-negative bacteria (H.P Rang and collaborators: Pharmacology. 6th ed. Rio de Janeiro, Elsevier, 2007).
- E) A Benzilpenicilina que interfere com a síntese do peptideoglicano da parede celular bacteriana e é eficaz contra microorganismos resistentes a penicilina e estreptococcos, estafilococcos e pneumococos. (H.P Rang e colaboradores: Farmacologia. 6a ed. Rio de Janeiro, Elsevier, 2007)- E) Benzylpenicillin that interferes with the peptideoglycan synthesis of the bacterial cell wall and is effective against microorganisms resistant to penicillin and streptococci, staphylococci and pneumococci. (H.P Rang and collaborators: Pharmacology. 6th ed. Rio de Janeiro, Elsevier, 2007)
- Além de antimicrobianos, é fundamental que a forma farmacêutica tópica destinada a tratar escaras e úlceras de estase também contenha (Remington's Pharmaceutical Sciences, 18a ed. Philadelphia, Mack Publishing Company, 1990):- In addition to antibiotics, it is essential that the topical pharmaceutical form intended to treat bed sores and ulcers of stasis also contains (Remington's Pharmaceutical Sciences, 18th ed Philadelphia, Mack Publishing Company, 1990.):
- A) Agentes de oclusão, que são substâncias lipofílicas que tem a capacidade de ocluir a área onde a forma farmacêutica é aplicada de forma a manter os princípios ativos por mais tempo no local e evitar perda de água e eletrólitos.- A) Occlusion agents, which are lipophilic substances that have the ability to occlude the area where the pharmaceutical form is applied in order to keep the active ingredients in place for longer and avoid loss of water and electrolytes.
- B) A presença de substâncias emolientes associadas que facilitam a cicatrização da área lesada, auxiliando na regeneração da pele.- B) The presence of associated emollient substances that facilitate the healing of the injured area, helping in the regeneration of the skin.
Em buscas efetuadas no estado da arte pertinente ao campo técnico da invenção, foram encontradas as invenções descritas a seguir.In searches carried out in the state of the art pertinent to the technical field of the invention, the inventions described below were found.
- O documento PI 0313824-0 descreve uma composição tópica que compreende pelo menos 5 % em peso de metronidazol ou um seu derivado farmacologicamente aceitável, em um veículo não-aquoso. A composição é usada- PI 0313824-0 describes a topical composition comprising at least 5% by weight of metronidazole or a pharmacologically acceptable derivative thereof, in a non-aqueous vehicle. The composition is used
Petição 870180157516, de 30/11/2018, pág. 14/22Petition 870180157516, of 11/30/2018, p. 14/22
I 10 no tratamento de condições do cólon, reto, anorreto e região perianal, em particular doença inflamatória do intestino e doença de Crohn perianal. A composição também alivia a dor e inflamação e promove a cura do cólon, reto, anorreto e região perianal, em seguida a operações cirúrgicas. Uma vantagem da composição é que a administração tópica de metronidazol resulta em um efeito local primário e, assim, são evitados os efeitos colaterais observados pela administração sistêmica.I 10 in the treatment of conditions of the colon, rectum, anorectus and perianal region, in particular inflammatory bowel disease and perianal Crohn's disease. The composition also relieves pain and inflammation and promotes healing of the colon, rectum, anorectus and perianal region, following surgical operations. An advantage of the composition is that topical administration of metronidazole results in a primary local effect and, thus, side effects observed by systemic administration are avoided.
- O documento PI 0506557-7 trata do uso do metronidazol para a preparação de uma composição farmacêutica destinada ao tratamento de um distúrbio da vascularização cutânea.- PI 0506557-7 deals with the use of metronidazole for the preparation of a pharmaceutical composition for the treatment of a disorder of cutaneous vascularization.
- O documento PI 0901132-3 descreve um pó debridante e estimulante da cicatrização para úlcera de membros inferiores e escaras por decúbito. A patente de invenção refere-se a um pó para tratamento, principalmente, de úlceras dos membros inferiores (varicosas, venosas, escaras por decúbito e aquelas que apresentam circulação arterial presente em >50%, contra indicação absoluta em tumores alergia ao iodo relativas arteriais com circulação de < de 30%. Caracterizado por se tornar úmido rapidamente, favorece assim a estimulação da cicatrização, além de seu efeito debridante mecânico anti-séptico e bactericida.- Document PI 0901132-3 describes a debridement and healing stimulating powder for ulcers of the lower limbs and bedsores per decubitus. The invention patent refers to a powder for treating mainly lower limb ulcers (varicose, venous, bedsores per decubitus and those with arterial circulation present in> 50%, against absolute indication in relative arterial iodine allergy tumors with a circulation of <30%, characterized by becoming moist quickly, thus favoring the stimulation of healing, in addition to its mechanical antiseptic and bactericidal debridement effect.
- O documento PI 9706835-7, relata o preparo de um hidrogel de copolímero de uma metacrilamida ou acrilamida substituída em N, um agente de reticulação e um açúcar complexo ou derivado, um peptídeo de adesão ao tecido ou um conjugado de polímero com anticorpos, o polímero sendo heterogêneo, elasticamente deformável e tendo um teor de água de equilíbrio de pelo menos cerca de 80%. Pode ser usado para a regeneração de tecido e para a restauração dos órgãos, por exemplo, no sistema nervoso em desenvolvimento e adulto.- Document PI 9706835-7, reports the preparation of a N-substituted methacrylamide or acrylamide copolymer hydrogel, a cross-linking agent and a complex or derivative sugar, a tissue adhesion peptide or a polymer conjugate with antibodies, the polymer being heterogeneous, elastically deformable and having an equilibrium water content of at least about 80%. It can be used for tissue regeneration and organ restoration, for example, in the developing and adult nervous system.
- O documento PI 0401405-7 descreve o preparo de um composto- PI 0401405-7 describes the preparation of a compound
Petição 870180157516, de 30/11/2018, pág. 15/22Petition 870180157516, of 11/30/2018, p. 15/22
I 10 nutricional, de uso oral ou enteral, em pó instantâneo, composto pelos ingredientes maltodextrina, caseinato de cálcio, proteínas do soro do leite, triglicerídeos de cadeia média, I-arginina, óleo de girassol, óleo de canola, sais minerais (potássio, cloreto, fósforo, cálcio, sódio, magnésio, rnolibdênio, cromo, iodo, selênio, zinco, ferro, cobre), vitaminas (vitamina A, colina, ácido fólico, vitamina K1, vitamina C, biotina, niacinamida, vitamina E, vitamina D3, ácido pantotênico, vitamina B12, vitamina B6, riboflavina, tiamina), aroma natural e estabilizante lecitina de soja e o respectivo processo de industrialização.I 10 nutritional, oral or enteral use, instant powder, composed of the ingredients maltodextrin, calcium caseinate, whey proteins, medium chain triglycerides, I-arginine, sunflower oil, canola oil, mineral salts (potassium , chloride, phosphorus, calcium, sodium, magnesium, molybdenum, chromium, iodine, selenium, zinc, iron, copper), vitamins (vitamin A, choline, folic acid, vitamin K1, vitamin C, biotin, niacinamide, vitamin E, vitamin D3, pantothenic acid, vitamin B12, vitamin B6, riboflavin, thiamine), natural aroma and stabilizing soy lecithin and the respective industrialization process.
- O documento PI 0101286-0 descreve um colchão massageador contra escara. Trata-se de um sistema de massagem feito com bolinhas de borracha ou isopor. O sistema propriamente dito é composto de um aparelho elétrico dentro de um colchão, colchão esse em madeira na sua parte superior, uma camada de borracha, eixo com polias, motor elétrico, desenhados especificamente para atender as necessidades do projeto.- PI 0101286-0 describes a massage mattress against bed sores. It is a massage system made with rubber balls or Styrofoam. The system itself is composed of an electrical device inside a mattress, a wooden mattress on its upper part, a rubber layer, shaft with pulleys, an electric motor, designed specifically to meet the needs of the project.
- O documento PI 9504732-8 relata uma cama anti-escara que possui um conjunto com duas pernas suporte correspondente, conformando uma armação delimitada de uma padiola destinada a sustentar o paciente, que é caracterizado pela padiola constituída de painéis independentes e que, orientado transversalmente na padiola e numa disposição aproximadamente adjacente entre elas, são guiadas e com uma capacidade de distensão ascendente-descendente respeitando o plano de contentação da mesma padiola; de pelo menos dois conjuntos acionados independentes, que intercalados, alternam um com outro e que cada um é conectado a um conjunto excêntrico de alavancas rotativas projetada de pelo menos um eixo de roda de um dispositivo que se alterna angularmente, sendo disposto num conjunto de painéis em correspondência com- PI 9504732-8 reports an anti-bedsore bed that has a set with two corresponding support legs, forming a delimited frame of a stretcher designed to support the patient, which is characterized by the stretcher made up of independent panels and which, transversely oriented in the stretcher and in an approximately adjacent arrangement between them, they are guided and with an upward-downward distending capacity respecting the contentment plane of the same stretcher; of at least two independent driven sets, which intercalated, alternate with each other and that each is connected to an eccentric set of rotating levers projected from at least one wheel axis of an angularly alternating device, being arranged in a set of panels in correspondence with
Petição 870180157516, de 30/11/2018, pág. 16/22Petition 870180157516, of 11/30/2018, p. 16/22
I 10 diferentes disposições angulares que, no eixo de roda, tem um conjunto de alavancas no qual os ditos painéis são sustentados.I 10 different angular arrangements that, on the wheel axle, have a set of levers on which said panels are supported.
- O documento PI 9403328-5, descreve um aparelho ortopédico antiescara, composto por uma única peça, tem como objetivo evitar escaras e dar maior mobilidade e segurança ao paciente. O aparelho é constituído por protetores móveis anti-escaras, peça matamizada para ajudar na assepsia e lâminas de metal laterais com fitas de manobra e argolas para presilha e fitas de manobra e ganchos para fixação.- The document PI 9403328-5, describes an anti-mask orthopedic device, composed of a single piece, with the objective of avoiding bedsores and providing greater mobility and safety to the patient. The device consists of movable anti-bedsore protectors, mattised part to help with asepsis and lateral metal blades with maneuver tapes and loop clips and maneuver tapes and hooks for fixing.
- Os documentos 10 2016 024865-5 e PI 0504122-8 relatam um produto a base de visco elástico destinado à prevenção e tratamento de úlcera de pressão, apresentados na forma de almofada, colchão e manta interface.- Documents 10 2016 024865-5 and PI 0504122-8 report a product based on elastic visco for the prevention and treatment of pressure ulcers, presented in the form of a pillow, mattress and interface blanket.
- É possível observar que apenas quatro invenções relatam tratamento medicamentoso tópico: PI 0313824-0, PI 0506557-7, PI 0901132-3 e a PI 9706835-7. A primeira invenção descreve uma composição tópica contendo metronidazol para tratamento de dor e inflamação após processos cirúrgicos. Não está diretamente relacionada a úlceras de estase, mas também visa diminuição de lesões cutâneas assim como a dor associada. Nessa invenção apenas o uso do princípio ativo metronidazol é citado. Não há na composição o uso de outros antibióticos assim como componentes oclusivos, de consistência ou emolientes para favorecimento da cicatrização. O mesmo é observado no PI 0506557-7, onde apenas o princípio ativo metronidazol é citado para o tratamento de um distúrbio da vascularização cutânea. A invenção PI 0901132-3 descreve em sua composição agentes anti-sépticos e bactericidas além de agentes que tornam a úlcera úmida, favorecendo a cicatrização. No entanto, trata-se de um pó tópico. Não há na composição agentes de consistência, não há relatos de compostos hidrofóbicos- It is possible to observe that only four inventions report topical drug treatment: PI 0313824-0, PI 0506557-7, PI 0901132-3 and PI 9706835-7. The first invention describes a topical composition containing metronidazole for treating pain and inflammation after surgical procedures. It is not directly related to stasis ulcers, but it also aims at reducing skin lesions as well as the associated pain. In this invention only the use of the active ingredient metronidazole is mentioned. There is no use of other antibiotics in the composition as well as occlusive, consistency or emollient components to promote healing. The same is observed in PI 0506557-7, where only the active ingredient metronidazole is mentioned for the treatment of a disorder of cutaneous vascularization. The invention PI 0901132-3 describes in its composition antiseptic and bactericidal agents in addition to agents that make the ulcer moist, favoring healing. However, it is a topical powder. There are no consistency agents in the composition, there are no reports of hydrophobic compounds
Petição 870180157516, de 30/11/2018, pág. 17/22Petition 870180157516, of 11/30/2018, p. 17/22
I 10 capazes de ocluir a ferida e impedir saída de água e eletrólitos e proteger contra a entrada de agentes externos nem emolientes para auxiliar no processo de cicatrização. Já na invenção PI 9706835-7 não há ativos em sua composição que possam tratar possíveis infecções associadas. Trata-se de material inerte que possivelmente fará a oclusão de feridas de graus reduzidos, impedindo perda de líquidos e entrada de novos contaminantes. Em úlceras já formadas, no entanto, a eficácia possivelmente não ocorrerá pois já haverá infecção do local.I 10 able to occlude the wound and prevent water and electrolytes from escaping and protect against the entry of external agents or emollients to assist in the healing process. In the PI 9706835-7 invention, there are no active ingredients in its composition that can treat possible associated infections. It is an inert material that possibly will occlude wounds of reduced degrees, preventing loss of fluids and the entry of new contaminants. In ulcers already formed, however, the efficacy will possibly not occur as there will already be infection of the site.
- A invenção PI 0401405-7 descreve o preparo de suplemento alimentar. Sabe-se que a dieta é fator importante que auxilia na recuperação dos tecidos lesados, mas, de forma isolada, não trata a patologia. Segundo o Guia de Consulta Rápida para prevenção e Tratamento de Úlceras por Pressão (National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Australia; 2014.) para além da dieta habitual, pode-se oferecer suplementos nutricionais de elevado teor calórico e proteico para adultos em risco nutricional e em risco de desenvolver úlceras por pressão caso as exigências nutricionais não sejam satisfeitas através da ingestão alimentar. Sendo assim, o suplemento alimentar atuaria como prevenção em casos de dietas pobres em nutrientes essenciais.- The invention PI 0401405-7 describes the preparation of a food supplement. It is known that the diet is an important factor that helps in the recovery of injured tissues, but, in isolation, it does not treat the pathology. According to the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance, Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.) Cambridge Media: Osborne Park, Australia; 2014.) in addition to the usual diet, nutritional supplements with high calorie and protein content can be offered to adults at nutritional risk and at risk of developing pressure ulcers if nutritional requirements are not met through food intake. Thus, the food supplement would act as a prevention in cases of diets low in essential nutrients.
- As demais invenções encontradas relatam medidas físicas de prevenção de formação de escaras.- The other inventions found report physical measures to prevent the formation of bedsores.
- Formulações contendo mais do que um antibiótico conseguem atuar nos mais diversos espectros microbianos possivelmente presentes nas escaras. Além de conter esses antibióticos também é necessário formar uma barreira de- Formulations containing more than one antibiotic can act in the most diverse microbial spectra possibly present in bedsores. In addition to containing these antibiotics, it is also necessary to form a barrier to
Petição 870180157516, de 30/11/2018, pág. 18/22Petition 870180157516, of 11/30/2018, p. 18/22
I 10 forma ocluir a ferida, evitando perda de água e eletrólitos e mantendo os princípios ativos por mais tempo na escara, favorecendo sua cicatrização. Compostos emolientes também são requeridos para auxiliar na cicatrização.I 10 way to occlude the wound, avoiding loss of water and electrolytes and keeping the active ingredients in the eschar for longer, favoring its healing. Emollient compounds are also required to aid healing.
- Dessa forma, é objeto da presente invenção uma composição medicamentosa tópica para o tratamento de escaras e úlceras de estase com a associação sinérgica dos antibióticos neomicina, bacitracina, metronidazol, nistatina e benzilpenicilina; ao menos um agente de oclusão capaz de manter os ativos por mais tempo na ferida e evitando perda de água e eletrólitos e entrada de material estranho; e ao menos um emoliente, capaz de acelerar a cicatrização.Thus, the subject of the present invention is a topical drug composition for the treatment of stasis ulcers and ulcers with the synergistic association of the antibiotics neomycin, bacitracin, metronidazole, nystatin and benzylpenicillin; at least one occlusion agent capable of keeping the wound active longer and avoiding loss of water and electrolytes and the entry of foreign material; and at least one emollient, capable of accelerating healing.
Descrição Detalhada da InvençãoDetailed Description of the Invention
- A composição medicamentosa para o tratamento de escaras e úlceras de estase, objeto da presente patente de invenção, compreende um medicamento de uso tópico com a associação sinérgica dos princípios ativos nistatina na forma base ou seus sais, na concentração entre 5.000 a 15.000 Ullg, metronidazol, na forma base ou seus sais, na concentração entre 25 a 75 mglg, neomicina, na forma base ou seus sais, na concentração entre 0,25 a 0,75 mglg, bacitracina, na forma base ou seus sais, na concentração entre 15 a 45 Ullg elou benzilpenicilina benzatina, na concentração entre 5.000 a 15.000 Ulg. Contém ao menos um agente de oclusão, composto por substâncias lipofílicas, tanto de origem animal quando mineral, na concentração de 5 a 90%. Contém ao menos um emoliente, de origem sintética ou natural, na concentração de 2 a 50%.- The drug composition for the treatment of stasis ulcers and ulcers, object of the present invention patent, comprises a topical drug with the synergistic association of the active ingredients nystatin in base form or its salts, in the concentration between 5,000 to 15,000 Ullg, metronidazole, in the base form or its salts, in the concentration between 25 to 75 mglg, neomycin, in the base form or its salts, in the concentration between 0.25 to 0.75 mglg, bacitracin, in the base form or its salts, in the concentration between 15 to 45 Ullg or benzyl benzylpenicillin, at a concentration between 5,000 to 15,000 Ulg. It contains at least one occlusion agent, composed of lipophilic substances, both of animal and mineral origin, in a concentration of 5 to 90%. It contains at least one emollient, of synthetic or natural origin, in a concentration of 2 to 50%.
- Além destes compostos, visando viabilizar a obtenção de formas farmacêuticas de uso tópico, o medicamento contém excipientes inertes que incluem doadores de viscosidade, conservantes, estabilizantes, antioxidantes, diluentes (como a água, óleos, doadores de consistência (ceras, ácidos e álcoois- In addition to these compounds, aiming to obtain topical pharmaceutical forms, the drug contains inert excipients that include viscosity donors, preservatives, stabilizers, antioxidants, diluents (such as water, oils, consistency donors (waxes, acids and alcohols)
Petição 870180157516, de 30/11/2018, pág. 19/22Petition 870180157516, of 11/30/2018, p. 19/22
I 10 graxos, ésteres), tensoativos e conservantes.I 10 greases, esters), surfactants and preservatives.
- O agente de oclusão preferencialmente é a vaselina sólida elou líquida.- The occlusion agent is preferably solid or liquid petroleum jelly.
- O agente emoliente é selecionado entre o grupo dos silicones elou glicerina.- The emollient agent is selected from the group of silicones and / or glycerin.
Claims (6)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BR102018074940A BR102018074940A2 (en) | 2018-11-30 | 2018-11-30 | drug composition for the treatment of bedsores and stasis ulcers |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BR102018074940A BR102018074940A2 (en) | 2018-11-30 | 2018-11-30 | drug composition for the treatment of bedsores and stasis ulcers |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| BR102018074940A2 true BR102018074940A2 (en) | 2020-06-09 |
Family
ID=70977245
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR102018074940A BR102018074940A2 (en) | 2018-11-30 | 2018-11-30 | drug composition for the treatment of bedsores and stasis ulcers |
Country Status (1)
| Country | Link |
|---|---|
| BR (1) | BR102018074940A2 (en) |
-
2018
- 2018-11-30 BR BR102018074940A patent/BR102018074940A2/en active Search and Examination
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| ES2415362T3 (en) | External agent to treat wounds | |
| US20140213990A1 (en) | Compositions and methods for treating surface wounds | |
| EP3164139A1 (en) | Topical compositions and methods for treating wounds | |
| WO2004011032A1 (en) | External preparation | |
| TAŞBAKAN et al. | Intralesional epidermal growth factor therapy fordiabetic foot ulcers: an evaluation of 15 cases | |
| JP5294601B2 (en) | TRPV4 receptor inhibitor | |
| US20230338296A1 (en) | Devices and methods for delivery of oxygen to a wound | |
| US7374772B2 (en) | Topical antifungal treatment | |
| BR102018074940A2 (en) | drug composition for the treatment of bedsores and stasis ulcers | |
| US10960011B2 (en) | Compositions for the treatment of ischemic ulcers and stretch marks | |
| Sauer | Pentoxifylline (Trental) therapy for vasculitis of pityriasis lichenoides et varioliformis | |
| Friedman et al. | Treatment of dermabrasion wounds with a hydrocolloid occlusive dressing | |
| US8900601B2 (en) | Permeable mixtures, methods and compositions for the skin | |
| WO2020016155A1 (en) | Methods and compositions for promoting wound healing in a subject suffering from ectodermal dysplasias | |
| JPH0559092B2 (en) | ||
| Groel | Dimethyl Sulfoxide as a Vehicle for Corticosteroids: A Comparison With the Occlusive Dressing Technique | |
| CN111317853B (en) | Dressing for preventing and treating bedsore and preparation method thereof | |
| ES2577885B1 (en) | Composition of doxycycline in liposomes for the prevention, improvement and / or treatment of eye diseases. | |
| JPH04128219A (en) | Plaster for treating skin ulcer | |
| Shamimi et al. | Intravenous Semelil (ANGIPARS™) as a novel therapy for pressure Ulcers: A randomized clinical trial | |
| Safalı | What is the most effective topical method for preventing presacral pressure sores that occur after hip fractures? | |
| US10905729B1 (en) | Formulations and methods for wound treatment | |
| EP2068873B1 (en) | Isoniazid mediated healing of wounds and ulcers | |
| Liang et al. | Skin symptoms | |
| US20210052544A1 (en) | Methods of treating and/or preventing bedsores using nabilone |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B03A | Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette] | ||
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
|
| B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
| B25A | Requested transfer of rights approved |
Owner name: EMC PARTICIPACOES LTDA. (BR/RS) |