ITUB20152821A1 - Pharmaceutical compositions and formulations for topical application with astringent and antimicrobial effect - Google Patents
Pharmaceutical compositions and formulations for topical application with astringent and antimicrobial effect Download PDFInfo
- Publication number
- ITUB20152821A1 ITUB20152821A1 ITUB2015A002821A ITUB20152821A ITUB20152821A1 IT UB20152821 A1 ITUB20152821 A1 IT UB20152821A1 IT UB2015A002821 A ITUB2015A002821 A IT UB2015A002821A IT UB20152821 A ITUB20152821 A IT UB20152821A IT UB20152821 A1 ITUB20152821 A1 IT UB20152821A1
- Authority
- IT
- Italy
- Prior art keywords
- aluminum
- formulation according
- chloramine
- solution
- agents
- Prior art date
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- 238000009472 formulation Methods 0.000 title claims description 26
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 10
- 230000000699 topical effect Effects 0.000 title claims description 8
- 230000000845 anti-microbial effect Effects 0.000 title description 8
- 239000000203 mixture Substances 0.000 claims description 48
- HDYRYUINDGQKMC-UHFFFAOYSA-M acetyloxyaluminum;dihydrate Chemical compound O.O.CC(=O)O[Al] HDYRYUINDGQKMC-UHFFFAOYSA-M 0.000 claims description 30
- 229940009827 aluminum acetate Drugs 0.000 claims description 30
- VDQQXEISLMTGAB-UHFFFAOYSA-N chloramine T Chemical compound [Na+].CC1=CC=C(S(=O)(=O)[N-]Cl)C=C1 VDQQXEISLMTGAB-UHFFFAOYSA-N 0.000 claims description 28
- 239000012286 potassium permanganate Substances 0.000 claims description 27
- -1 transdermal patch Substances 0.000 claims description 11
- 239000006071 cream Substances 0.000 claims description 8
- 239000000499 gel Substances 0.000 claims description 8
- 238000011282 treatment Methods 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 7
- 239000000839 emulsion Substances 0.000 claims description 5
- HQQUTGFAWJNQIP-UHFFFAOYSA-K aluminum;diacetate;hydroxide Chemical group CC(=O)O[Al](O)OC(C)=O HQQUTGFAWJNQIP-UHFFFAOYSA-K 0.000 claims description 4
- 229940121375 antifungal agent Drugs 0.000 claims description 4
- SJUGPXBWZCQTKM-UHFFFAOYSA-N n-chloro-4-methylbenzenesulfonamide;sodium Chemical compound [Na].CC1=CC=C(S(=O)(=O)NCl)C=C1 SJUGPXBWZCQTKM-UHFFFAOYSA-N 0.000 claims description 4
- 208000034656 Contusions Diseases 0.000 claims description 3
- 201000004624 Dermatitis Diseases 0.000 claims description 3
- 206010015150 Erythema Diseases 0.000 claims description 3
- 208000006877 Insect Bites and Stings Diseases 0.000 claims description 3
- 206010042674 Swelling Diseases 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 3
- 229940088710 antibiotic agent Drugs 0.000 claims description 3
- 239000003963 antioxidant agent Substances 0.000 claims description 3
- 208000010668 atopic eczema Diseases 0.000 claims description 3
- 239000003937 drug carrier Substances 0.000 claims description 3
- 231100000321 erythema Toxicity 0.000 claims description 3
- 239000003589 local anesthetic agent Substances 0.000 claims description 3
- 229960005015 local anesthetics Drugs 0.000 claims description 3
- 239000000049 pigment Substances 0.000 claims description 3
- 239000003755 preservative agent Substances 0.000 claims description 3
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- 206010012438 Dermatitis atopic Diseases 0.000 claims description 2
- 208000009889 Herpes Simplex Diseases 0.000 claims description 2
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- 208000003251 Pruritus Diseases 0.000 claims description 2
- 206010040943 Skin Ulcer Diseases 0.000 claims description 2
- 206010042496 Sunburn Diseases 0.000 claims description 2
- 208000024780 Urticaria Diseases 0.000 claims description 2
- 239000002671 adjuvant Substances 0.000 claims description 2
- KLMDYFUUSKOJAX-UHFFFAOYSA-K aluminum;acetate;dihydroxide Chemical compound CC(=O)O[Al](O)O KLMDYFUUSKOJAX-UHFFFAOYSA-K 0.000 claims description 2
- 229940121363 anti-inflammatory agent Drugs 0.000 claims description 2
- 239000002260 anti-inflammatory agent Substances 0.000 claims description 2
- 230000003110 anti-inflammatory effect Effects 0.000 claims description 2
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- 108090000623 proteins and genes Proteins 0.000 claims 1
- 239000000243 solution Substances 0.000 description 39
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 29
- XQKKWWCELHKGKB-UHFFFAOYSA-L calcium acetate monohydrate Chemical compound O.[Ca+2].CC([O-])=O.CC([O-])=O XQKKWWCELHKGKB-UHFFFAOYSA-L 0.000 description 24
- 229940067460 calcium acetate monohydrate Drugs 0.000 description 18
- GUNGYIXTFIIJDK-UHFFFAOYSA-H dialuminum;trisulfate;tetradecahydrate Chemical group O.O.O.O.O.O.O.O.O.O.O.O.O.O.[Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O GUNGYIXTFIIJDK-UHFFFAOYSA-H 0.000 description 18
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- 229940071538 aluminum sulfate tetradecahydrate Drugs 0.000 description 7
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- 238000000034 method Methods 0.000 description 6
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- BUACSMWVFUNQET-UHFFFAOYSA-H dialuminum;trisulfate;hydrate Chemical compound O.[Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O BUACSMWVFUNQET-UHFFFAOYSA-H 0.000 description 4
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- 229920001353 Dextrin Polymers 0.000 description 3
- 229920002125 Sokalan® Polymers 0.000 description 3
- DIZPMCHEQGEION-UHFFFAOYSA-H aluminium sulfate (anhydrous) Chemical compound [Al+3].[Al+3].[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O.[O-]S([O-])(=O)=O DIZPMCHEQGEION-UHFFFAOYSA-H 0.000 description 3
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- DSSYKIVIOFKYAU-XCBNKYQSSA-N (R)-camphor Chemical compound C1C[C@@]2(C)C(=O)C[C@@H]1C2(C)C DSSYKIVIOFKYAU-XCBNKYQSSA-N 0.000 description 2
- DOUMFZQKYFQNTF-WUTVXBCWSA-N (R)-rosmarinic acid Chemical compound C([C@H](C(=O)O)OC(=O)\C=C\C=1C=C(O)C(O)=CC=1)C1=CC=C(O)C(O)=C1 DOUMFZQKYFQNTF-WUTVXBCWSA-N 0.000 description 2
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/18—Sulfonamides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
-
- 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
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
-
- 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
- A61K33/24—Heavy metals; Compounds thereof
- A61K33/32—Manganese; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
Description
DESCRIZIONE DESCRIPTION
Campo di applicazione Field of application
La presente invenzione si riferisce al settore dell’industria farmaceutica. The present invention refers to the pharmaceutical industry sector.
In particolare, l’invenzione riguarda una formulazione farmaceutica a base di acetato d’alluminio dotata di effetto astringente e di una azione an ti microbica potenziata, e una composizione in polvere atta a produrre dispersioni acquose contenenti acetato d’alluminio e dotate di effetto astringente e di una azione antimicrobica potenziata. In particular, the invention relates to a pharmaceutical formulation based on aluminum acetate having an astringent effect and an enhanced anti-microbial action, and a powder composition suitable for producing aqueous dispersions containing aluminum acetate and having an astringent effect. and enhanced antimicrobial action.
Arte nota Known art
L’acetato d’alluminio è lingrediente fondamentale della soluzione di Burow, utilizzata tradizionalmente sin dalla metà del diciannovesimo secolo per le sue proprietà astringenti e antibatteriche. Aluminum acetate is the fundamental ingredient of Burow's solution, traditionally used since the mid-nineteenth century for its astringent and antibacterial properties.
La. soluzione di Burow è utilizzata per il trattamento di svariate affezioni cutanee, tra le quali gonfiori, eczemi, eritemi, punture d’insetti e lividi, e in otologia. Burow's solution is used for the treatment of various skin conditions, including swelling, eczema, erythema, insect bites and bruises, and in otology.
La Farmacopea Statunitense riporta una procedura per la preparazione della soluzione di Burow, che comprende la reazione di solfato d'alluminio, carbonato di calcio e acido acetico, per formare acetato basico d’alluminio e un precipitato dì solfato di calcio, che viene eliminato per filtrazione. La successiva aggiunta di acido acetico al filtrato porta all’ottenimento della soluzione di Burow. The United States Pharmacopoeia reports a procedure for the preparation of Burow's solution, which includes the reaction of aluminum sulfate, calcium carbonate and acetic acid, to form basic aluminum acetate and a precipitate of calcium sulphate, which is eliminated by filtration. The subsequent addition of acetic acid to the filtrate leads to obtaining the Burow solution.
Negli Stati Uniti e in alcuni altri stati viene commercializzata una miscela in polvere di acetato di calcio e solfato d’alluminio, destinata alla preparazione della soluzione di Burow. In the United States and some other states, a powdered mixture of calcium acetate and aluminum sulphate is marketed, intended for the preparation of Burow's solution.
Il brevetto US 2 824 042 descrive una composizione dalla quale è possibile ottenere una soluzione di Burow piu stabile alla conservazione e al calore, senza bisogno di una fase di ili trazione. La composizione in questione comprende acetato dibasico d’alluminio stabilizzato con acido borico, acido acetico e un acetato di un metallo alcalino. US 2 824 042 discloses a composition from which it is possible to obtain a Burow solution more stable to storage and heat, without the need for an ili traction step. The composition in question includes dibasic aluminum acetate stabilized with boric acid, acetic acid and an alkali metal acetate.
Tale composizione può anche comprendere un cloruro d’ammonio quaternario o un sale feniimercurico, che le conferisce proprietà germicide e deodoranti. This composition can also include a quaternary ammonium chloride or a phenymercuric salt, which gives it germicidal and deodorant properties.
La soluzione di Burow è generalmente preparata ad una concentrazione del 13% però viene spesso diluita con acqua prima dell’applicazione a concentrazioni fino a 10 volte inferiori. Burow's solution is generally prepared at a concentration of 13% but is often diluted with water before application to concentrations up to 10 times lower.
La soluzione di Burow a concentrazioni di 1,3%, 3,25% e 13% è stata testata clinicamente nel trattamento di otiti (Thorp MA, Gardiner IB, Prescott CA<1>) ed ha esplicato azione antibatterica a tutte e tre le concentrazioni. Burow's solution at concentrations of 1.3%, 3.25% and 13% has been clinically tested in the treatment of otitis (Thorp MA, Gardiner IB, Prescott CA <1>) and has shown antibacterial action to all three concentrations.
Da dati riportati in letteratura (Thorp MA, Oliver SP, Kruger J, Prescott CA<2>)risulta che la soluzione dì Burow esercita un’azione antibatterica fino ad una concentrazione mìnima dello 0,08%. From data reported in the literature (Thorp MA, Oliver SP, Kruger J, Prescott CA <2>) it appears that the Burow solution exerts an antibacterial action up to a minimum concentration of 0.08%.
La soluzione di Burow è utilizzata piuttosto diffusamente negli Stati Uniti, dove è considerata dalla FDA<3>un farmaco di riconosciuta sicurezza ed efficacia ("GRASE” ovvero “gè ne rally recognized as safe and effective”), mentre in Europa il suo uso è nettamente meno frequente e ad essa vengono preferiti antisettici più potenti, pur se provvisti di effetto astringente inferiore o anche nullo. Burow's solution is used quite widely in the United States, where it is considered by the FDA <3> a drug of recognized safety and efficacy ("GRASE" or "gè ne rally recognized as safe and effective"), while in Europe its use it is much less frequent and more powerful antiseptics are preferred to it, even if they have a lower or even zero astringent effect.
In realtà la combinazione di effetti astringente e antibatterico della soluzione di Burow risulterebbe molto utile nel trattamento di certe affezioni cutanee in cui, oltre alla presenza di essudati, vi sia una effettiva o potenziale sovra infezione, come, ad esempio, quelle eczematose, bollose o ulcerative. In reality, the combination of astringent and antibacterial effects of Burow's solution would be very useful in the treatment of certain skin diseases in which, in addition to the presence of exudates, there is an actual or potential overinfection, such as, for example, those eczematous, bullous or ulcerative.
Un primo scopo della presente invenzione è stato quello di mettere a disposizione una composizione tale da fornire una soluzione simile a quella di Burow, formata estemporaneamente da reagenti distinti, e con le sue proprietà astringenti ma con un'azione antimicrobica potenziata. A first object of the present invention was to provide a composition such as to provide a solution similar to that of Burow, formed extemporaneously from distinct reagents, and with its astringent properties but with an enhanced antimicrobial action.
Un secondo scopo è stato quello di fornire nuove formulazioni farmaceutiche a base di acetato d’alluminio con effetti migliorati rispetto alle analoghe formulazioni della tecnica nota. A second purpose was to provide new pharmaceutical formulations based on aluminum acetate with improved effects compared to the analogous formulations of the known art.
Sommario dell'invenzione Summary of the invention
II suddetto primo scopo è stato raggiunto mettendo a disposizione una composizione in polvere comprendente acetato di calcio, solfato d’alluminio e almeno un terzo componente scelto tra permanganato di potassio (KMn04) e cloramina T (N-cloro-4-toluensolfonammidato di sodio). The aforementioned first object was achieved by providing a powder composition comprising calcium acetate, aluminum sulphate and at least a third component selected from potassium permanganate (KMn04) and chloramine T (sodium N-chloro-4-toluenesulfonamide) .
Preferibilmente l’acetato di calcio è acetato di calcio monoidrato e il solfato d’alluminio è solfato d’alluminio tetradecaidrato. Preferably, calcium acetate is calcium acetate monohydrate and aluminum sulfate is aluminum sulfate tetradecahydrate.
In un suo aspetto, tale composizione comprende, per una parte in peso di calcio acetato monoidrato, circa 1,41 parti di solfato d’alluminio tetradecaidrato e da 0,01 a 0,4 parti di permanganato di potassio. In one aspect, this composition comprises, for one part by weight of calcium acetate monohydrate, about 1.41 parts of aluminum sulfate tetradecahydrate and from 0.01 to 0.4 parts of potassium permanganate.
In un suo altro aspetto, tale composizione comprende, per una parte in peso di calcio acetato monoidrato, circa 1,41 parti di solfato d'alluminio tetradecaidrato e da 0,025 a 0,75 parti di cloramina T. In another aspect, this composition comprises, for one part by weight of calcium acetate monohydrate, about 1.41 parts of aluminum sulfate tetradecahydrate and from 0.025 to 0.75 parts of chloramine T.
Le suddette composizioni possono essere diluite con acqua in proporzioni tali da ottenere una concentrazione di acetato d’alluminio pari al 13% come per la soluzione di Burow ma la diluizione con acqua può essere spinta fino ad ottenere una concentrazione di acetato d’alluminio fino a 200 volte inferiore. The above compositions can be diluted with water in such proportions as to obtain a concentration of aluminum acetate equal to 13% as for Burow's solution but the dilution with water can be pushed up to obtain a concentration of aluminum acetate up to 200 times lower.
Diluendo con acqua la composizione secondo la presente invenzione si ottengono dispersioni acquose lievemente velate con formazione di un leggero deposito bianco a seguito della reazione del calcio acetato monoidrato con il solfato d’alluminio tetradecaidrato a dare l’acetato d’alluminio. La dispersione acquosa può tuttavia essere utilizzata come tale, senza bisogno di rimuovere il suddetto leggero deposito. By diluting the composition according to the present invention with water, slightly hazy aqueous dispersions are obtained with the formation of a light white deposit following the reaction of calcium acetate monohydrate with aluminum sulphate tetradecahydrate to give aluminum acetate. The aqueous dispersion can however be used as such, without the need to remove the aforementioned slight deposit.
Le dispersioni acquose così ottenute, aventi una concentrazione di acetato d’alluminio pari ad almeno lo 0,065% p/p, possono essere utilizzate per il trattamento topico di affezioni cutanee scelte dal gruppo comprendente gonfiori, orticaria, eczemi, eritemi, punture d’insetti, lividi, prurito, essudazioni in forma vescicolare o bollosa, lesioni crostose, ulcere cutanee, dermatite atopica, herpes zoster, herpes simplex, intertrigine e ustioni solari. The aqueous dispersions thus obtained, having an aluminum acetate concentration equal to at least 0.065% w / w, can be used for the topical treatment of skin diseases chosen by the group including swelling, hives, eczema, erythema, insect bites. , bruising, itching, vesicular or bullous exudations, crusted lesions, skin ulcers, atopic dermatitis, herpes zoster, herpes simplex, intertrigo and sunburn.
Le dispersioni acquose utilizzate per i suddetti trattamenti topici hanno una concentrazione di acetato d’alluminio compresa tra 0,065% e 13% p/p. e preferibilmente tra 0,13% e 0,5% p/p. The aqueous dispersions used for the aforementioned topical treatments have a concentration of aluminum acetate between 0.065% and 13% w / w. and preferably between 0.13% and 0.5% w / w.
Ovviamente, la composizione in polvere secondo la presente invenzione può essere preparata anche utilizzando acetato di calcio e solfato d’alluminio con diversi gradi di idratazione, purché si rispettino i rapporti molari tra tali componenti. Ad esempio, l’acetato di calcio può essere utilizzato anche in forma anidra o come emiidrato o diidrato e il solfato d’alluminio può essere utilizzato in forma anidra o con un numero di molecole d’acqua di idratazione variabile da 6 a 27, in particolare come esadecaidrato, eptadecaidrato o ottadecaidrato. Obviously, the powder composition according to the present invention can also be prepared using calcium acetate and aluminum sulfate with different degrees of hydration, provided that the molar ratios between these components are respected. For example, calcium acetate can also be used in anhydrous form or as a hemihydrate or dihydrate and aluminum sulphate can be used in anhydrous form or with a number of hydration water molecules ranging from 6 to 27, in particularly as hexadecahydrate, heptadecahydrate or octadecahydrate.
Infine, in un suo ulteriore aspetto, là presente invenzione riguarda una composizióne in polvere comprendente permanganato di potassio e cloramina T ed eventualmente uno o più eccipienti farmaceuticamente o cosmeticamente accettabili. Finally, in a further aspect, the present invention relates to a powder composition comprising potassium permanganate and chloramine T and optionally one or more pharmaceutically or cosmetically acceptable excipients.
Esempi di tali eccipienti sono costituiti da destrine o altri polisaccaridi idrosolubili. Examples of such excipients are constituted by dextrins or other water-soluble polysaccharides.
Tale composizione in polvere è preferibilmente costituita da permanganato di potassio e cloramina T. This powder composition is preferably constituted by potassium permanganate and chloramine T.
Il permanganato di potassio e la cloramina T si trovano preferibilmente in un rapporto ponderale variabile da 1:75 a 1:0,2, convenientemente in un rapporto ponderale variabile da 1:1,3 a 1:0,7 all’interno di tale composizione. Potassium permanganate and chloramine T are preferably found in a weight ratio ranging from 1:75 to 1: 0.2, conveniently in a weight ratio ranging from 1: 1.3 to 1: 0.7 within such composition.
LI suddetto secondo scopo è stato raggiunto, in un primo aspetto, mettendo a disposizione una formulazione farmaceutica per applicazione topica comprendente, quali componenti attivi, acetato di calcio, preferibilmente acetato di calcio monoidrato, solfato d’alluminio, preferibilmente solfato d’alluminio tetradecaidrato, e almeno un terzo componente attivo, scelto tra permanganato di potassio (KMn04) e cloramina T (N-cloro-4-toluensolfonammidato di sodio), e un veicolo farmaceuticamente accettabile. The aforementioned second object has been achieved, in a first aspect, by providing a pharmaceutical formulation for topical application comprising, as active components, calcium acetate, preferably calcium acetate monohydrate, aluminum sulphate, preferably aluminum sulphate tetradecahydrate, and at least a third active component, selected from potassium permanganate (KMn04) and chloramine T (sodium N-chloro-4-toluenesulfonamide), and a pharmaceutically acceptable vehicle.
In un suo aspetto, tale formulazione comprende, per una parte in peso di calcio acetato monoidrato, circa 1,41 parti di solfato d’alluminio tetradecaidrato e da 0,01 a 0,4 parti di permanganato di potassio. In one aspect, this formulation comprises, for one part by weight of calcium acetate monohydrate, about 1.41 parts of aluminum sulfate tetradecahydrate and from 0.01 to 0.4 parts of potassium permanganate.
in un suo altro aspetto, tale formulazione comprende, per una parte in peso di calcio acetato monoidrato, circa 1,41 parti di solfato d’alluminio tetradecaidrato e da 0,025 a 0,75 parti di cloramina T. in another aspect, this formulation comprises, for one part by weight of calcium acetate monohydrate, about 1.41 parts of aluminum sulfate tetradecahydrate and from 0.025 to 0.75 parts of chloramine T.
In un altro aspetto, il suddetto secondo scopo è stato raggiunto mettendo a disposizione una formulazione farmaceutica per applicazione topica comprendente, quali componenti attivi, acetato d’alluminio basico e almeno un ulteriore componente attivo scelto tra permanganato di potassio (KMnO.*) e cloramina T (N-cloro-4-toluensolfonammidato di sodio) , e un veicolo farmaceuticamente accettabile. In another aspect, the aforementioned second object has been achieved by providing a pharmaceutical formulation for topical application comprising, as active components, basic aluminum acetate and at least one further active component selected from potassium permanganate (KMnO. *) And chloramine T (sodium N-chloro-4-toluenesulfonamide), is a pharmaceutically acceptable carrier.
L’acetato d’alluminio basico può essere diacetato d’alluminio ((CH3COO)2AlOH} O monoacetato d’alluminio {(CH3COO)Al(OH}2). The basic aluminum acetate can be aluminum diacetate ((CH3COO) 2AlOH} Or aluminum monoacetate {(CH3COO) Al (OH} 2).
In un ulteriore aspetto, il suddetto secondo scopo è stato raggiunto mettendo a disposizione una formulazione farmaceutica per applicazione topica comprendente, quali componenti attivi, permanganato di potassio, cloramina T e un veicolo farmaceuticamente accettabile. In a further aspect, the aforementioned second object has been achieved by providing a pharmaceutical formulation for topical application comprising, as active components, potassium permanganate, chloramine T and a pharmaceutically acceptable vehicle.
Preferibilmente tale formulazione farmaceutica comprende, per una parte in peso di permanganato di potassio, da 0,2 a 75, convenientemente da 0,7 a 1,3, partì in peso di cloramìna T. La formulazione secondo l’invenzione è preferibilmente in forma di lozione, emulsione, gel idrofilo, crema, spray, schiuma e cerotto transdermico. Nel caso di una formulazione in crema, i suddetti componenti attivi sono contenuti nella fase acquosa dell’emulsione che costituisce la crema. Preferably, this pharmaceutical formulation comprises, for one part by weight of potassium permanganate, from 0.2 to 75, conveniently from 0.7 to 1.3, part by weight of chloramine T. The formulation according to the invention is preferably in the form of lotion, emulsion, hydrophilic gel, cream, spray, foam and transdermal patch. In the case of a cream formulation, the aforementioned active components are contained in the aqueous phase of the emulsion that makes up the cream.
La formulazione secondo l’invenzione può essere utilizzata anche come detergente cutaneo e shampoo. The formulation according to the invention can also be used as a skin cleanser and shampoo.
La formulazione secondo Fin ve azione può contenere uno o più adiuvanti farmaceuticamente accettabili, quali coloranti, profumi, emollienti, umidificanti, conservanti, colloidi protettivi, vitamine, chelanti, addensanti, gelificanti, antiossidanti, agenti fumogeni, agenti foto stabilizzanti, filtri solari, stabilizzanti, tensioattivi, modificatori della viscosità, agenti per aumentare la permeabilità attraverso la cute, polimeri e copolimeri, regolatori di pH, pigmenti. The formulation according to Fin ve action may contain one or more pharmaceutically acceptable adjuvants, such as dyes, perfumes, emollients, humectants, preservatives, protective colloids, vitamins, chelators, thickeners, gelling agents, antioxidants, smoke agents, photo stabilizing agents, sunscreens, stabilizers , surfactants, viscosity modifiers, agents to increase permeability through the skin, polymers and copolymers, pH regulators, pigments.
I veicoli farmaceuticamente accettabili che possono essere utilizzati nelle formulazioni topiche secondo la presente invenzione comprendono, senza limitazione, acqua, glicerina, alcoli C2-Cs, alcoli grassi, eteri di alcoli grassi, esteri di acidi grassi, glicoli, oli vegetali, oli minerali, liposomi, oli siiiconici e loro combinazioni. The pharmaceutically acceptable carriers that can be used in the topical formulations according to the present invention include, without limitation, water, glycerin, C2-Cs alcohols, fatty alcohols, fatty alcohol ethers, fatty acid esters, glycols, vegetable oils, mineral oils, liposomes, silicone oils and their combinations.
II veicolo della formulazione secondo la presente invenzione può essere in forma di fase acquosa, di gel, di emulsione olio in acqua, cera in acqua, silicone in acqua. The vehicle of the formulation according to the present invention can be in the form of aqueous phase, gel, oil in water emulsion, wax in water, silicone in water.
Quando il veicolo è in forma di fase acquosa, esso può contenere solo acqua o una miscela di acqua e almeno un solvente organico miscibile con acqua, quale un alcool avente da 1 a 5 atomi di carbonio, e in particolare etanolo o propanolo, un poliolo, ad es. propilenglicol, glicerolo, diglicerolo, pantenolo, polietilenglicol e loro miscele. When the carrier is in the form of an aqueous phase, it can contain only water or a mixture of water and at least one water-miscible organic solvent, such as an alcohol having 1 to 5 carbon atoms, and in particular ethanol or propanol, a polyol , e.g. propylene glycol, glycerol, diglycerol, panthenol, polyethylene glycol and their mixtures.
Quando la formulazione secondo Fin ve azione è in forma di gel idrofilo, si possono utilizzare gel ideanti scelti dal gruppo comprendente carbomer, in particolare carbomer 940, poliacrilammide, isoparaffinlaureth-7, gomma xantana, carragenina, gomma di acacia, gomma guar, gel di agar, alginati, metilidrossicellulosa, carbossimetilcellulosa, idrossipropilcellulosa, idrossipropil me til cellulosa, idrossietilcellulosa, etilcellulosa, poliacrìlati, polivinilalcool, polivinilpirrolidone, silice colloidale. When the formulation according to its action is in the form of a hydrophilic gel, it is possible to use design gels selected from the group comprising carbomer, in particular carbomer 940, polyacrylamide, isoparaffinlaureth-7, xanthan gum, carrageenan, acacia gum, guar gum, gel agar, alginates, methylhydroxycellulose, carboxymethylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose, hydroxyethylcellulose, ethylcellulose, polyacrylates, polyvinyl alcohol, polyvinylpyrrolidone, colloidal silica.
Quando la formulazione secondo finvenzione è in forma di emulsione, essa può comprendere un tensioattivo in quantità variabile da 0,1% a 30% in peso sul peso della formulazione. When the formulation according to the invention is in the form of an emulsion, it can comprise a surfactant in a quantity ranging from 0.1% to 30% by weight on the weight of the formulation.
Quando la formulazione secondo l'invenzione è in fase di crema o di emulsione in generale, la relativa fase lipofila può comprendere uno o più componenti oleosi scelti dal gruppo comprendente oli animali, trigliceridi di acidi grassi aventi da 4 a 10 atomi di carbonio, ad es. trigliceridi di acido eptanoico o ottanoico, oli vegetali quali olio di girasole, soia, mais, vinaccioli, ricino, avocado, trigliceride caprilico/caprico, olio di jojoba, paraffine liquide, esteri di alcoli grassi come ad esempio isopropil miristato, isostearil isostearato, esteri di pentaeritritolo, alcoli grassi contenenti da 12 a 26 atomi di carbonio, oli siliconici volatili e non volatili, lineari o ciclici, ad esempio ciclometiconi e dimeticom. When the formulation according to the invention is in the cream or emulsion phase in general, the relative lipophilic phase can comprise one or more oily components selected from the group comprising animal oils, triglycerides of fatty acids having from 4 to 10 carbon atoms, for example ex. triglycerides of heptanoic or octanoic acid, vegetable oils such as sunflower oil, soybean, corn, grape seed, castor, avocado, caprylic / capric triglyceride, jojoba oil, liquid paraffins, esters of fatty alcohols such as isopropyl myristate, isostearyl isostearate, esters of pentaerythritol, fatty alcohols containing from 12 to 26 carbon atoms, volatile and non-volatile, linear or cyclic silicone oils, for example cyclometicones and dimethicom.
Tra gli antiossidanti che possono essere compresi nella formulazione secondo la presente invenzione si menzionano in particolare acido ascorbico e suoi derivati, beta-carotene, catechine, curcumina, acido gallico e suoi derivati, lieopene, acido rosmarinico, acido tannico, tocoferolo e suoi derivati, glutatione, acido lipoico, acido tioglicolico, bisolfiti e metabisolfiti, parabeni, butilidrossianisolo e butilidrossitoluolo. Among the antioxidants that can be included in the formulation according to the present invention, ascorbic acid and its derivatives, beta-carotene, catechins, curcumin, gallic acid and its derivatives, lieopene, rosmarinic acid, tannic acid, tocopherol and its derivatives, are mentioned in particular, glutathione, lipoic acid, thioglycolic acid, bisulfites and metabisulfites, parabens, butylhydroxyanisole and butylhydroxytoluene.
Le formulazioni secondo la presente invenzione possono inoltre contenere una fase particolata comprendente pigmenti o opacizzanti, quali diossido di titanio, ossido di zinco, ossido di zirconio, ossido di ferro. The formulations according to the present invention can also contain a particulate phase comprising pigments or opacifiers, such as titanium dioxide, zinc oxide, zirconium oxide, iron oxide.
Le formulazioni secondo la presente invenzione possono inoltre comprendere almeno un ulteriore principio attivo, scelto dal gruppo comprendente antiinfiammatori steroidei e non steroidei, antibiotici, antimicotici e anestetici locali. The formulations according to the present invention can also comprise at least one further active principle, selected from the group comprising steroidal and non-steroidal anti-inflammatory drugs, antibiotics, antifungals and local anesthetics.
Gli antinfiammatori steroidei contenuti nella formulazione secondo l<'>invenzione sono preferibilmente scelti dal gruppo comprendente: cortisolo, cortisone, prednisone, prednisolone, metilprednisolone, meprednisolone, triameinolone, parametasone, fluprednisololone, betametasone e desametasone. The steroidal anti-inflammatories contained in the formulation according to the invention are preferably selected from the group comprising: cortisol, cortisone, prednisone, prednisolone, methylprednisolone, meprednisolone, triameinolone, paramethasone, fluprednisololone, betamethasone and dexamethasone.
Gli antinfiammatori non steroidei contenuti nella formulazione secondo l'invenzione sono preferibilmente scelti dal gruppo comprendente: acido acetilsalicilico, diflunisal, ibufenac, diclofenac, indometacina, sulindac, ibuprofene, naprossene, ketoprofene, fenoprofene, flurbiprofene, indoprofene, acido mefenamico, acido meclofenamico, acido flufenamico, acido niilumico, metamizolo, paracetamolo, piroxicam, meloxicam, tenoxicam, nimesulide, diflumidone, rofecoxib, celecoxib, suflamizolo , tiflamizolo, bromelina, serratio-peptidasi, benzidamina. The non-steroidal anti-inflammatories contained in the formulation according to the invention are preferably selected from the group comprising: acetylsalicylic acid, diflunisal, ibufenac, diclofenac, indomethacin, sulindac, ibuprofen, naproxen, ketoprofen, phenoprofen, flurbiprofen, indoprofen, mefenamic acid, meclofenamic acid, fluphenamic, niilumic acid, metamizole, paracetamol, piroxicam, meloxicam, tenoxicam, nimesulide, diflumidone, rofecoxib, celecoxib, suflamizole, tiflamizole, bromelain, serrathio-peptidase, benzydamine.
Gli antibiotici contenuti nella formulazione secondo l'invenzione sono preferibilmente scelti dal gruppo comprendente: ampicillina, amossicillina, carbenicillina, tica rei Dina, mezlocillina, piperacillina, azlocillina, apalcillina e altre penicilline, cefazolina, cefalexina, cefalotina, cefapirina, cefuroxima, cefonicid, cefac.lor, cefoxitina, cefotetan, cefotaxima, ceftriaxone, cefixima e altre cefalosporine, imìpenem, meropenem, ertapenem, bacitracina, ciprofloxacina, levofloxacina, trovafloxacina, eritromicina, claritromicina e azitromicina. The antibiotics contained in the formulation according to the invention are preferably selected from the group comprising: ampicillin, amoxicillin, carbenicillin, tica rei Dina, mezlocillin, piperacillin, azlocillin, apalcillin and other penicillins, cefazoline, cephalexin, cephalotin, cefapyrin, cefonicidime .lor, cefoxitin, cefotetan, cefotaxime, ceftriaxone, cefixime and other cephalosporins, imìpenem, meropenem, ertapenem, bacitracin, ciprofloxacin, levofloxacin, Trovafloxacin, erythromycin, clarithromycin and azithromycin.
Gli anestetici locali contenuti nella formulazione secondo l'invenzione sono preferibilmente scelti dal gruppo comprendente: 2,4-diclorobenzil alcool, benzocaina, benzil benzoato, bupivacaina, lidocaina e mepivacaina. The local anesthetics contained in the formulation according to the invention are preferably selected from the group comprising: 2,4-dichlorobenzyl alcohol, benzocaine, benzyl benzoate, bupivacaine, lidocaine and mepivacaine.
Gli antimicotici contenuti nella formulazione secondo l'invenzione sono preferibilmente scelti dal gruppo comprendente: miconazolo, econazolo, fluconazolo, clotrimazolo, itraeonazolo, nistatina, terbinafina, griseofulvina, acido undecilenico e acido usnico. The antifungals contained in the formulation according to the invention are preferably selected from the group comprising: miconazole, econazole, fluconazole, clotrimazole, itraeonazole, nystatin, terbinafine, griseofulvin, undecylenic acid and usnic acid.
Le formulazioni secondo la presente invenzione possono essere preparate mediante tecniche note all'esperto del settore, descrìtte ad esempio in Remington<;>s Pharmaceutical Sciences, XXII Ed. Alien, Loyd V., Jr.. The formulations according to the present invention can be prepared by techniques known to the skilled in the art, described for example in Remington <;> s Pharmaceutical Sciences, XXII Ed. Alien, Loyd V., Jr ..
Le composizioni e le formulazioni secondo la presente invenzione sono dotate di effetto astringente e di un'azione antimicrobica potenziata e sono utili per il trattamento topico di svariate affezioni, tra le quali gonfiori, orticaria, eczemi, eritemi, punture d’insetti, lividi, prurito, essudazioni in forma vescicolare o bollosa, lesioni crostose, ulcere, dermatite atopica, herpes zoster, herpes simplex, intertrigine e ustioni solari ove è presente o può esserlo una componente microbica che ne condiziona l'evoluzione. The compositions and formulations according to the present invention have an astringent effect and an enhanced antimicrobial action and are useful for the topical treatment of various diseases, including swelling, hives, eczema, erythema, insect bites, bruises, itching, vesicular or bullous exudations, crusted lesions, ulcers, atopic dermatitis, herpes zoster, herpes simplex, intertrigo and sunburn where there is or may be a microbial component that affects its evolution.
In particolare, è stato osservato per le composizioni e le fonnu) azioni secondo la presente invenzione un effetto sinergico in relazione alla loro azione antimicrobica. In particolare, i componenti attivi della composizione secondo la presente invenzione, come sarà dimostrato nella seguente descrizione dettagliata, hanno dimostrato di poter esplicare, quando combinati secondo gli insegnamenti della presente invenzione, un'efficace azione antimicrobica a concentrazioni inferiori alle rispettive concentrazioni minime inibenti. In particular, a synergistic effect in relation to their antimicrobial action has been observed for the compositions and formulations according to the present invention. In particular, the active components of the composition according to the present invention, as will be demonstrated in the following detailed description, have been shown to be able to exert, when combined according to the teachings of the present invention, an effective antimicrobial action at concentrations lower than the respective minimum inhibitory concentrations.
Descrizione dettagliata Detailed description
Verranno riportare qui di seguito, a scopo illustrativo e non limitativo, alcune forme di realizzazione della presente invenzione. Some embodiments of the present invention will be reported hereinafter, for illustrative and non-limiting purposes.
Esempio 1 Example 1
Bustine per la preparazione di una soluzione contenente acetato d’alluminio e permanganato di potassio Sachets for the preparation of a solution containing aluminum acetate and potassium permanganate
acetato di calcio monoidrato 0,99 1 g calcium acetate monohydrate 0.99 1 g
solfato d'alluminio tetradecaidrato 1,403 g permanganato di potassio 0,022 g aluminum sulphate tetradecahydrate 1.403 g potassium permanganate 0.022 g
destrina 0,300 g dextrin 0.300 g
Le bustine vengono preparate a partire da 2,416 g di una miscela di polveri ottenuta miscelando omogeneamente una parte in peso di acetato di calcio monoidrato con 1,41 parti in peso di solfato d’alluminio tetradecaidrato e 0,02 parti di permanganato di potassio. A questi 2,416 g di miscela di polveri vengono addizionati 0,300 g di destrina c il tutto viene ulteriormente miscelato lino a omogeneità. The sachets are prepared starting from 2.416 g of a mixture of powders obtained by homogeneously mixing one part by weight of calcium acetate monohydrate with 1.41 parts by weight of aluminum sulphate tetradecahydrate and 0.02 parts of potassium permanganate. To these 2.416 g of powder mixture are added 0.300 g of dextrin and the whole is further mixed with homogeneity.
Diluendo il contenuto di una bustina in 0,5 1 d'acqua si ottiene una soluzione opalescente contenente 0, 16% di a.cetato d’alluminio e 0,0044% di permanganato di potassio. By diluting the contents of a sachet in 0.5 1 of water, an opalescent solution is obtained containing 0.16% of aluminum acetate and 0.0044% of potassium permanganate.
Se si utilizzano due o tre bustine in 0,5 1 d’acqua si otterranno rispettivamente concentrazioni di acetato d’alluminio pari a 0,32% e 0,48% e concentrazioni di permanganato di potassio pari a 0,0088% e 0,0132%. If two or three sachets are used in 0.5 1 of water, aluminum acetate concentrations equal to 0.32% and 0.48% and potassium permanganate concentrations equal to 0.0088% and 0, respectively, will be obtained. 0132%.
Esempio 2 Example 2
Bustine per la preparazione di una soluzione contenente acetato d’alluminio e cloramina T. Sachets for the preparation of a solution containing aluminum acetate and chloramine T.
acetato di calcio monoidrato 0,991 g calcium acetate monohydrate 0.991 g
solfato d’alluminio tetradecaidrato 1,403 g aluminum sulfate tetradecahydrate 1.403 g
cloramina T 0,026 g chloramine T 0.026 g
Le bustine vengono preparate a partire da 2,420 g di una miscela di polveri ottenuta miscelando omogeneamente una parte in peso di acetato di calcio monoidrato con 1,41 parti in peso di solfato d’alluminio tetradecaidrato e 0,025 parti di cloramìna T. The sachets are prepared starting from 2.420 g of a mixture of powders obtained by homogeneously mixing one part by weight of calcium acetate monohydrate with 1.41 parts by weight of aluminum sulphate tetradecahydrate and 0.025 parts of chloramine T.
Diluendo il contenuto di una bustina in 0,5 1 d’acqua si ottiene una soluzione opalescente contenente 0,16% di acetato d’alluminio e 0,0052% di cloramina T. By diluting the contents of a sachet in 0.5 1 of water, an opalescent solution is obtained containing 0.16% of aluminum acetate and 0.0052% of chloramine T.
Se si utilizzano due o tre bustine in 0,5 1 d’acqua si otterranno rispettivamente concentrazioni di acetato d’alluminio pari a 0,32% e 0,48% e concentrazioni di cloraminaT a 0,0104% e 0,0156%. If two or three sachets are used in 0.5 1 of water, aluminum acetate concentrations of 0.32% and 0.48% and chloramine concentrations of 0.0104% and 0.0156% will be obtained, respectively.
Esempio 3 Example 3
Bustine per la preparazione di una soluzione contenente permanganato di potassio e cloramìna T. Sachets for the preparation of a solution containing potassium permanganate and chloramine T.
permanganato di potassio 0,040 g potassium permanganate 0.040 g
cloraminaT 0,100 g chloramine T 0.100 g
Diluendo il contenuto di una bustina in 0,5 1 d’acqua si ottiene una soluzione contenente 0,008% di permanganato di potassio e 0,02% di cloramìna T. By diluting the contents of a sachet in 0.5 1 of water, a solution containing 0.008% of potassium permanganate and 0.02% of chloramine T is obtained.
Esempio 4 Example 4
Gel idroalcolico (% in peso sul peso totale) Hydroalcoholic gel (% by weight of total weight)
acetato di calcio monoidrato 1,00 calcium acetate monohydrate 1.00
solfato d’alluminio tetradecaìdrato 1,41 aluminum sulphate tetradechydrate 1.41
cloramìna T 0,19 chloramine T 0.19
carbomer 1,50 carbomer 1.50
etanolo 96 31,56 ethanol 96 31.56
oli essenziali q.b. essential oils to taste
acqua dep. q.b. a 100 g dep. water q.s. to 100 g
Esempio 5 Example 5
Crema (% in peso sul peso totale) Cream (% by weight of total weight)
acetato di calcio monoidrato 1,00 solfato d’alluminio tetradecaidrato 1,41 cloramina T 0,09 gliceril monostearato 8,00 macrogol cetostearil etere 2,5 paraffina liquida 2,0 vaselina bianca 2,0 isostearil i soste arato 4,0 alcool miristilico 3,0 parabeni 0,3 acqua dep. q.b. a 100 g Esempio 6 calcium acetate monohydrate 1.00 aluminum sulphate tetradecahydrate 1.41 chloramine T 0.09 glyceryl monostearate 8.00 macrogol cetostearyl ether 2.5 liquid paraffin 2.0 white vaseline 2.0 isostearyl alcohol 4.0 myristyl alcohol 3.0 parabens 0.3 dep. Water q.s. at 100 g Example 6
Crema (% in peso sul peso totale) Cream (% by weight of total weight)
acetato di calcio monoidrato 1,00 solfato d’alluminio tetradecaidrato 1,41 permanganato di potassio 0,02 glicol propileinico 20,00 acido oleico 5,00 macrogol stearato 9,00 alcool cetostearilico 6,00 dimeticone 0,30 carbopol 980 0,30 trometamolo 0, 10 sodio solfito 0,10 butilìdrossian isolo 0,02 acqua dep. q.b. a 100 g Esempio 7 calcium acetate monohydrate 1.00 aluminum sulphate tetradecahydrate 1.41 potassium permanganate 0.02 propylene glycol 20.00 oleic acid 5.00 macrogol stearate 9.00 cetostearyl alcohol 6.00 dimethicone 0.30 carbopol 980 0.30 trometamol 0, 10 sodium sulphite 0,10 butyl hydroxyan isole 0,02 water dep. q.s. at 100 g Example 7
Gel (% in peso sul peso totale) Gel (% by weight of total weight)
Glicole dietilenico monoetiletere 43,00 Etanolo 96° 29,00 Olio di ricino polioxil 40 idrogenato 5,00 Canfora 3,00 Idrossipropilcellulosa. 2,00 acetato di calcio monoidrato 1,00 solfato d’alluminio tetradecaidrato 1,41 cloramina T 0,10 Oli essenziali 1,00 Salicilato di metile 0,80 acqua dep. q.b. a 100g Esempio 8 Monoethylether diethylene glycol 43.00 Ethanol 96 ° 29.00 Hydrogenated polyoxyl 40 castor oil 5.00 Camphor 3.00 Hydroxypropylcellulose. 2.00 calcium acetate monohydrate 1.00 aluminum sulphate tetradecahydrate 1.41 chloramine T 0.10 Essential oils 1.00 Methyl salicylate 0.80 water dep. q.s. at 100g Example 8
Crema antimicotica {% in peso sul peso totale) Fattylan 12,00 Trigliceride caprilico/caprico 10,00 Miristato di isopropile 10,00 Sorbitolo 4,00 Tween 60 2,00 Alluminio diacetato 4,00 permanganato dì potassio 0,20 acido usnico (soluz. 1%) 2,00 acido undecilenico 1,00 Antifungal cream {% by weight of total weight) Fattylan 12.00 Caprylic / capric triglyceride 10.00 Isopropyl myristate 10.00 Sorbitol 4.00 Tween 60 2.00 Aluminum diacetate 4.00 potassium permanganate 0.20 usnic acid ( solution 1%) 2.00 undecylenic acid 1.00
oli essenziali 0,50 essential oils 0.50
acqua dep. q.b. a 100 g dep. water q.s. to 100 g
Esempio 9 Example 9
Spray (% in peso sul peso totale) Spray (% by weight of total weight)
Glicole dietilenico monoetil etere 50,00 Diethylene glycol monoethyl ether 50.00
alcol etilico 95° 28,70 ethyl alcohol 95 ° 28.70
olio di ricino idrogenato polioxil 40 5,00 polyoxyl 40 5.00 hydrogenated castor oil
Canfora 2,00 Camphor 2.00
Alluminio diacetato 1,70 Aluminum diacetate 1.70
Cloramina T 0,10 Chloramine T 0.10
acqua depurata q.b. a 100 g Esempio 10 purified water q.s. at 100 g Example 10
Shampoo antiforfora (% in peso sul peso totale) Anti-dandruff shampoo (% by weight of total weight)
sodio lauriletere solfato 70% 16,00 cocoilbetaina sol. acquosa al 30% 6,00 sodium laureth sulfate 70% 16.00 cocoylbetaine sol. aqueous at 30% 6.00
acetato di calcio monoidrato 1,00 calcium acetate monohydrate 1.00
solfato d'alluminio tetradecaidrato 1,41 aluminum sulphate tetradecahydrate 1,41
cloramina T 0,10 conservanti q.b. chloramine T 0.10 preservatives to taste
acqua dep. q.b. a 100 g dep. water q.s. to 100 g
Esempio 1 1 Example 1 1
L’effetto sinergico della composizione secondo la presente invenzione in relazione alla sua attività antimicrobica è stato valutato con il metodo della tecnica a scacchiera ‘checkerboard’, come descritto da Hsieh MH et al<4>. The synergistic effect of the composition according to the present invention in relation to its antimicrobial activity was evaluated with the 'checkerboard' method, as described by Hsieh MH et al <4>.
Il metodo “checkerboard” prevede la valutazione della crescita microbica in pozzetti contenenti concentrazioni diverse di due composti da saggiare, corrispondenti a diverse frazioni della minima concentrazione inibente di ciascuno dei due composti. The "checkerboard" method involves the evaluation of microbial growth in wells containing different concentrations of two compounds to be tested, corresponding to different fractions of the minimum inhibitory concentration of each of the two compounds.
I ceppi microbici su cui è stato eseguito il test sono stati preparati e le minime concentrazioni inibenti (MCI) sono state determinate secondo quanto descritto da White RL et al<5>(per S. aureus, P. aeruginosa), da Chen Y~L et al<6>(per C. Albicans), da Perrins N et al<7>(per T. mentagrophytes ) e da Sopirala MM et al.<B>(per A. baumannii). The microbial strains tested were prepared and the minimum inhibitory concentrations (MCI) were determined as described by White RL et al <5> (for S. aureus, P. aeruginosa), by Chen Y ~ L et al <6> (for C. Albicans), by Perrins N et al <7> (for T. mentagrophytes) and by Sopirala MM et al. <B> (for A. baumannii).
II test ha permesso di calcolare un indice (indice FiC) ricavato dalla somma del rapporto tra le concentrazioni inibitorie di diluizioni delle sostanze in esame in combinazione e le rispettive MIC, che veniva interpretato come segue: sinergia definita da un indice FIC ≤ a 0.5; indifferenza da un indice > 0.5 and < 4; antagonismo in caso di FIC Index > 4 (si veda Hsieh MH et al<4>). The test allowed to calculate an index (FiC index) obtained from the sum of the ratio between the inhibitory concentrations of dilutions of the substances being tested in combination and the respective MICs, which was interpreted as follows: synergy defined by an FIC index ≤ 0.5; indifference from an index> 0.5 and <4; antagonism in case of FIC Index> 4 (see Hsieh MH et al <4>).
I risultati ottenuti sono riportati nelle seguenti tabelle 1 e 2. Tabella 1 The results obtained are reported in the following Tables 1 and 2. Table 1
Indice FIC di alluminio acetato più Specie Potassio Cloramina Benzalconìo Clorexidina permanganato T Cloruro FIC index of aluminum acetate plus Species Potassium Chloramine Benzalkonium Chlorhexidine permanganate T Chloride
S. aureus 0.5 (S) 0.5 (S) 1 P) 2 (1) S. aureus 0.5 (S) 0.5 (S) 1 P) 2 (1)
P. aeruginosa 0.25 (S) 0.5 (S) 1 (1) 2 (1) C. albicans 0,25 (S) 0.25 (S) 2 (1) 1 (I) A. baum.annii 0.25 (S) 0.25 (S) 1 (i) 1 (I) r. P. aeruginosa 0.25 (S) 0.5 (S) 1 (1) 2 (1) C. albicans 0.25 (S) 0.25 (S) 2 (1) 1 (I) A. baum.annii 0.25 (S) 0.25 (S) 1 (i) 1 (I) r.
0.25 (S) 0.5 (S) 2 (1) 1 (I) rn.entagrop hytes 0.25 (S) 0.5 (S) 2 (1) 1 (I) rn.entagrop hytes
(S)= sinergia, (l)=indifferenza (S) = synergy, (l) = indifference
L’alluminio acetato utilizzato per il test era stato ottenuto per opportuna diluizione di una soluzione madre preparata sciogliendo 0,991 g di acetato di calcio monoidrato e 1,403 g di solfato d’alluminio tetradecaidrato in 0,5 1 di acqua. The aluminum acetate used for the test was obtained by diluting a stock solution prepared by dissolving 0.991 g of calcium acetate monohydrate and 1.403 g of aluminum sulphate tetradecahydrate in 0.5 1 of water.
Come si nota dalla Tabella 1, la combinazione di acetato d’alluminio e permanganato di potassio così come la combinazione di acetato d’alluminio e cloramina T hanno dimostrato un’azione antimicrobica chiaramente sinergica nei confronti dei microrganismi saggiati laddove nessuna azione sinergica è stata riscontrata per le combinazioni acetato d’alluminio/benzalconio cloruro e acetato d’alluminio / clorexidina. As can be seen from Table 1, the combination of aluminum acetate and potassium permanganate as well as the combination of aluminum acetate and chloramine T demonstrated a clearly synergistic antimicrobial action against the microorganisms tested where no synergistic action was found. for the combinations aluminum acetate / benzalkonium chloride and aluminum acetate / chlorhexidine.
Tabella 2 Table 2
Specie Indice FIC di permanganato di potassio più -<.. ..>“m Species FIC index of potassium permanganate plus - <.. ..> “m
Benzalconio Benzalkonium
Cloramina T Clorexidina Cloruro Chloramine T Chlorhexidine Chloride
S. aureus 0.25 (S) 2 (1) 1 (i) S. aureus 0.25 (S) 2 (1) 1 (i)
P. aeruginosa 0.5 (S) 1 (i) 1 (1) P. aeruginosa 0.5 (S) 1 (i) 1 (1)
C. albicane 0.5 (S) 2 (1) 2 (1) A. baumannii 0.25 (S) MI) 1 (I) C. albicane 0.5 (S) 2 (1) 2 (1) A. baumannii 0.25 (S) MI) 1 (I)
T. mentagrophytes 0.5 (S) 1 (I) 1 (I) Anche in questo caso è stata dimostrata una chiara azione antimicrobica sinergica per la combinazione permanganato di potassio /cloramina T ma non per le combinazioni permanganato di potassio /benzalconio cloruro e permanganato di potassio/ clorexidina. T. mentagrophytes 0.5 (S) 1 (I) 1 (I) Also in this case a clear synergistic antimicrobial action has been demonstrated for the potassium permanganate / chloramine T combination but not for the potassium permanganate / benzalkonium chloride and permanganate combinations of potassium / chlorhexidine.
Esempio 12 Example 12
Le composizioni secondo la presente invenzione sono state studiate in vivo per valutare il loro effetto sui tempi di riparazione di ferite cutanee. Per questa valutazione è stato utilizzato il modello descrìtto in Dovi JV et al<9>che prevede la valutazione della percentuale di ri-epitelizzazione, in funzione del tempo, dopo rasatura. The compositions according to the present invention have been studied in vivo to evaluate their effect on the repair times of skin wounds. For this evaluation, the model described in Dovi JV et al <9> was used which provides for the evaluation of the percentage of re-epithelialization, as a function of time, after shaving.
Oltre al trattamento descritto dagli autori, dopo la rasatura, sono state utilizzate le seguenti formulazioni, mediante 5 lavaggi al giorno della durata di 3 minuti: In addition to the treatment described by the authors, after shaving, the following formulations were used, with 5 washes per day lasting 3 minutes:
AC = soluzione di acetato d'alluminio alla minima concentrazione inibente, ottenuta mediante diluizione di una soluzione di 0,991 g di acetato di calcio monoidrato e 1,403 g di solfato d’alluminio tetradecaidrato in 0,5 1 di acqua. AC = aluminum acetate solution at the minimum inhibitory concentration, obtained by diluting a solution of 0.991 g of calcium acetate monohydrate and 1.403 g of aluminum sulfate tetradecahydrate in 0.5 1 of water.
PP = soluzione di permanganato di potassio alla MIC, ottenuta mediante diluizione di una soluzione di 0,040 g di permanganato di potassio in 0,5 1 di acqua. PP = MIC solution of potassium permanganate, obtained by diluting a solution of 0.040 g of potassium permanganate in 0.5 1 of water.
CT = soluzione di cloramina T alla MIC, ottenuta mediante diluizione di una soluzione di 0,300 g di cloramina T in 0,5 1 dì acqua. CT = MIC solution of chloramine T, obtained by diluting a solution of 0.300 g of chloramine T in 0.5 1 of water.
El = soluzione ottenuta miscelando (parti in volume) 1 parte di soluzione AC con 1 parte di soluzione PP e diluendo il tutto con 3 parti di acqua. E2 = soluzione ottenuta miscelando {parti in volume) 1 parte di soluzione AC con 1 parte di soluzione CT e diluendo il tutto con 3 parti di acqua. El = solution obtained by mixing (parts by volume) 1 part of AC solution with 1 part of PP solution and diluting everything with 3 parts of water. E2 = solution obtained by mixing {parts by volume) 1 part of solution AC with 1 part of solution CT and diluting the whole with 3 parts of water.
E3 = soluzione ottenuta miscelando (parti in volume) 1 parte di soluzione PP con 1 parte di soluzione CT e diluendo il tutto con 3 parti di acqua. E3 = solution obtained by mixing (parts by volume) 1 part of PP solution with 1 part of CT solution and diluting everything with 3 parts of water.
I risultati sono mostrati nella Tabella 3. The results are shown in Table 3.
Tabella 3 Table 3
Tempo Time
Giorno 1 Giorno 2 Giorno 3 Giorno 4 Giorno 5 AC 10% 40% 60% 75% 100% PP 12% 38% 58% 76% 100% CT 9% 41% 63% 74% 100% El 20% 65% 100% 100% 100% E2 18% 63% 100% 100% 100% E3 20% 59% 100% 100 100% Day 1 Day 2 Day 3 Day 4 Day 5 AC 10% 40% 60% 75% 100% PP 12% 38% 58% 76% 100% CT 9% 41% 63% 74% 100% El 20% 65% 100% 100% 100% E2 18% 63% 100% 100% 100% E3 20% 59% 100% 100 100%
L’applicazione delle soluzioni El, E2 ed E3 ha permesso una più rapida ri-epitelizzazione della cute dopo rasatura rispetto all’applicazione delle soluzioni AC, PP e CT. The application of the El, E2 and E3 solutions allowed a faster re-epithelialization of the skin after shaving compared to the application of the AC, PP and CT solutions.
Riferimenti bibliografici: Bibliographical references:
1. Thorp MA, Gardiner IB, Prescott CA. Burow's solution in thè treatment of active muco sai chronic suppurative otitis media: determining an effective diìution. J Laryngol Otol. 2000 Jun:l 14(6):432-6 1. Thorp MA, Gardiner IB, Prescott CA. Burow's solution in the treatment of active muco sai chronic suppurative otitis media: determining an effective diìution. J Laryngol Otol. 2000 Jun: L 14 (6): 432-6
2. Thorp MA, Oliver SP, Kruger J, Prescott CA. Determination of thè lowest dilution of aluminium acetate solution able to inhibit in vitro growth of organisms commonly found in chronic suppurative otitis media. J Laryngol Otol. 2000 Nov; 114(1 1):830-1. 2. Thorp MA, Oliver SP, Kruger J, Prescott CA. Determination of the lowest dilution of aluminum acetate solution able to inhibit in vitro growth of organisms commonly found in chronic suppurative otitis media. J Laryngol Otol. 2000 Nov; 114 (1 1): 830-1.
3. Food and Drug Administration, HHS. Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; te eh nicol amendment. Final ruie; te chili cal amendment. Fed Regist. 2009 Mar 6:74(43): 9759-65 3. Food and Drug Administration, HHS. Astringent drug products that produce aluminum acetate; skin protectant drug products for over-the-counter human use; te eh nicol amendment. Final ruie; te chili cal amendment. Fed Regist. 2009 Mar 6:74 (43): 9759-65
4. Hsieh MH, Yu CM, Yu VL, Chow JW. Synergy assessed by checkerboard. A criticai analysis. Diagn Micro biol Infect Dis. 1993 May-Jun;16(4):343-9. 4. Hsieh MH, Yu CM, Yu VL, Chow JW. Synergy assessed by checkerboard. I criticized analysis. Diagn Micro biol Infect Dis. 1993 May-Jun; 16 (4): 343-9.
5. White RL, Burgess DS, Manduru M, Bosso JA. Comparison of three different in vitro methods of detecting synergy: time-kill, checkerboard, and E test. Antimicrob Agents Chemother. 5. White RL, Burgess DS, Manduru M, Bosso JA. Comparison of three different in vitro methods of detecting synergy: time-kill, checkerboard, and E test. Antimicrob Agents Chemother.
1996 Aug;40(8}:1914-8. 1996 Aug; 40 (8}: 1914-8.
6. Chen YL, Lehman VN, Averette AF, Pcrfect JR, Heitman «J. Posaconazole exhibits in vitro and in vivo syn ergi stia antifungal activity with easpofungin or FK506 against. Candida albicans. 6. Chen YL, Lehman VN, Averette AF, Pcrfect JR, Heitman «J. Posaconazole exhibits in vitro and in vivo syn ergi stia antifungal activity with easpofungin or FK506 against. Candida albicans.
7. Perrins N, Howell SA, Moore M, Bond R. Inhibition of thè growth in vitro of Trichophyton mentagropliytes, Trichophyton erinacei and Microsporum persicolor by miconazole and chlorhexidine. Vet Dermatol. 2005 Oct;16(5):330-3. 7. Perrins N, Howell SA, Moore M, Bond R. Inhibition of the growth in vitro of Trichophyton mentagropliytes, Trichophyton erinacei and Microsporum persicolor by miconazole and chlorhexidine. Vet Dermatol. 2005 Oct; 16 (5): 330-3.
8. Sopirala MM, Mangino JE, Gebreyes WA, Biller B, Bannerman T, Balada-Llasat JM, Pancholi P. Synergj<1>' testing by Etest, microdilution checkerboard, and time-kill methods for pan-drugresistant Acinetobacter baumannii. Antimicrob Agents Chemother. 8. Sopirala MM, Mangino JE, Gebreyes WA, Biller B, Bannerman T, Balada-Llasat JM, Pancholi P. Synergj <1> 'testing by Etest, microdilution checkerboard, and time-kill methods for pan-drugresistant Acinetobacter baumannii. Antimicrob Agents Chemother.
2010 Nov;54{l l):4678-83. 2010 Nov; 54 {l l): 4678-83.
9. Dovi JV. He LK, DiPietro LA. Accelerated wound closure in neutrophil-depleted mice. J Leukoc Biol. 2003 Apr;73{4):448-55. 9. Dovi JV. He LK, DiPietro LA. Accelerated wound closure in neutrophil-depleted mice. J Leukoc Biol. 2003 Apr; 73 {4): 448-55.
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US4840798A (en) * | 1988-07-27 | 1989-06-20 | Theon, Inc. | Astringent gel composition and method for use |
CN101474421A (en) * | 2008-10-31 | 2009-07-08 | 宋培荣 | Moisture paper tissue for disinfection, anti-inflammation and sterilization |
US7790771B1 (en) * | 1999-07-23 | 2010-09-07 | Engelhard Arzneimittel GmbH & Co. | Use of tosylchloramide(s) for treating disease of the skin, mucous membrane, organs and tissues |
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Publication number | Priority date | Publication date | Assignee | Title |
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US4840798A (en) * | 1988-07-27 | 1989-06-20 | Theon, Inc. | Astringent gel composition and method for use |
US7790771B1 (en) * | 1999-07-23 | 2010-09-07 | Engelhard Arzneimittel GmbH & Co. | Use of tosylchloramide(s) for treating disease of the skin, mucous membrane, organs and tissues |
CN101474421A (en) * | 2008-10-31 | 2009-07-08 | 宋培荣 | Moisture paper tissue for disinfection, anti-inflammation and sterilization |
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