ITNA20110020A1 - NAC AND MSM PHARMACEUTICAL PREPARATION IN SOLUTION FOR THE TREATMENT OF RINOFARINGEAL AFFECTIONS - Google Patents
NAC AND MSM PHARMACEUTICAL PREPARATION IN SOLUTION FOR THE TREATMENT OF RINOFARINGEAL AFFECTIONS Download PDFInfo
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- ITNA20110020A1 ITNA20110020A1 IT000020A ITNA20110020A ITNA20110020A1 IT NA20110020 A1 ITNA20110020 A1 IT NA20110020A1 IT 000020 A IT000020 A IT 000020A IT NA20110020 A ITNA20110020 A IT NA20110020A IT NA20110020 A1 ITNA20110020 A1 IT NA20110020A1
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- rhinological
- acetylcysteine
- treatment
- solution
- Prior art date
Links
- 238000011282 treatment Methods 0.000 title claims description 8
- 239000000825 pharmaceutical preparation Substances 0.000 title description 2
- PWKSKIMOESPYIA-BYPYZUCNSA-N L-N-acetyl-Cysteine Chemical compound CC(=O)N[C@@H](CS)C(O)=O PWKSKIMOESPYIA-BYPYZUCNSA-N 0.000 claims description 14
- 229960004308 acetylcysteine Drugs 0.000 claims description 14
- 229940016409 methylsulfonylmethane Drugs 0.000 claims description 11
- HHVIBTZHLRERCL-UHFFFAOYSA-N sulfonyldimethane Chemical compound CS(C)(=O)=O HHVIBTZHLRERCL-UHFFFAOYSA-N 0.000 claims description 11
- 239000000243 solution Substances 0.000 claims description 7
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 6
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 6
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 4
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 3
- 239000003755 preservative agent Substances 0.000 claims description 3
- 230000002335 preservative effect Effects 0.000 claims description 3
- 239000011780 sodium chloride Substances 0.000 claims description 3
- CHHHXKFHOYLYRE-UHFFFAOYSA-M 2,4-Hexadienoic acid, potassium salt (1:1), (2E,4E)- Chemical compound [K+].CC=CC=CC([O-])=O CHHHXKFHOYLYRE-UHFFFAOYSA-M 0.000 claims description 2
- 239000003109 Disodium ethylene diamine tetraacetate Substances 0.000 claims description 2
- 201000010099 disease Diseases 0.000 claims description 2
- 235000019301 disodium ethylene diamine tetraacetate Nutrition 0.000 claims description 2
- 239000006193 liquid solution Substances 0.000 claims description 2
- 239000008368 mint flavor Substances 0.000 claims description 2
- 235000010241 potassium sorbate Nutrition 0.000 claims description 2
- 239000004302 potassium sorbate Substances 0.000 claims description 2
- 229940069338 potassium sorbate Drugs 0.000 claims description 2
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 2
- 235000010234 sodium benzoate Nutrition 0.000 claims description 2
- 239000004299 sodium benzoate Substances 0.000 claims description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 2
- 239000001488 sodium phosphate Substances 0.000 claims description 2
- 229910000162 sodium phosphate Inorganic materials 0.000 claims description 2
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 claims description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 2
- 239000000203 mixture Substances 0.000 claims 10
- -1 Ascorbyl Disodium EDTA Chemical compound 0.000 claims 1
- 239000000443 aerosol Substances 0.000 claims 1
- 239000007923 nasal drop Substances 0.000 claims 1
- 229940100662 nasal drops Drugs 0.000 claims 1
- 239000007922 nasal spray Substances 0.000 claims 1
- 230000001580 bacterial effect Effects 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000000047 product Substances 0.000 description 5
- 239000003963 antioxidant agent Substances 0.000 description 4
- 230000003078 antioxidant effect Effects 0.000 description 4
- 230000000420 mucociliary effect Effects 0.000 description 4
- 210000003097 mucus Anatomy 0.000 description 4
- 210000002850 nasal mucosa Anatomy 0.000 description 4
- 230000001681 protective effect Effects 0.000 description 4
- 230000003115 biocidal effect Effects 0.000 description 3
- 244000005700 microbiome Species 0.000 description 3
- 210000004877 mucosa Anatomy 0.000 description 3
- 230000002195 synergetic effect Effects 0.000 description 3
- 241000894006 Bacteria Species 0.000 description 2
- 230000009471 action Effects 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 230000000845 anti-microbial effect Effects 0.000 description 2
- 230000002225 anti-radical effect Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000001413 cellular effect Effects 0.000 description 2
- 230000008260 defense mechanism Effects 0.000 description 2
- 210000002919 epithelial cell Anatomy 0.000 description 2
- 230000013632 homeostatic process Effects 0.000 description 2
- 239000011159 matrix material Substances 0.000 description 2
- 210000003928 nasal cavity Anatomy 0.000 description 2
- 244000052769 pathogen Species 0.000 description 2
- 230000007170 pathology Effects 0.000 description 2
- 210000002345 respiratory system Anatomy 0.000 description 2
- 230000028327 secretion Effects 0.000 description 2
- 238000013112 stability test Methods 0.000 description 2
- 230000004083 survival effect Effects 0.000 description 2
- 108010065152 Coagulase Proteins 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical compound [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 description 1
- 206010028916 Neologism Diseases 0.000 description 1
- 208000031481 Pathologic Constriction Diseases 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 241000295644 Staphylococcaceae Species 0.000 description 1
- 241000191963 Staphylococcus epidermidis Species 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 230000037446 allergic sensitization Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 125000003289 ascorbyl group Chemical group [H]O[C@@]([H])(C([H])([H])O*)[C@@]1([H])OC(=O)C(O*)=C1O* 0.000 description 1
- 244000052616 bacterial pathogen Species 0.000 description 1
- 210000004556 brain Anatomy 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 210000004081 cilia Anatomy 0.000 description 1
- 230000001886 ciliary effect Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 230000001143 conditioned effect Effects 0.000 description 1
- 231100000263 cytotoxicity test Toxicity 0.000 description 1
- 230000007123 defense Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000005684 electric field Effects 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 210000002615 epidermis Anatomy 0.000 description 1
- 230000005713 exacerbation Effects 0.000 description 1
- 210000000416 exudates and transudate Anatomy 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- 230000003284 homeostatic effect Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002458 infectious effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 244000000010 microbial pathogen Species 0.000 description 1
- 230000000510 mucolytic effect Effects 0.000 description 1
- 210000004400 mucous membrane Anatomy 0.000 description 1
- 231100000017 mucous membrane irritation Toxicity 0.000 description 1
- 201000009240 nasopharyngitis Diseases 0.000 description 1
- 238000006386 neutralization reaction Methods 0.000 description 1
- 231100000344 non-irritating Toxicity 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000008506 pathogenesis Effects 0.000 description 1
- 230000001575 pathological effect Effects 0.000 description 1
- 230000002688 persistence Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 230000004962 physiological condition Effects 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000000306 recurrent effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000000241 respiratory effect Effects 0.000 description 1
- 206010039083 rhinitis Diseases 0.000 description 1
- 230000001235 sensitizing effect Effects 0.000 description 1
- 230000000087 stabilizing effect Effects 0.000 description 1
- 230000036262 stenosis Effects 0.000 description 1
- 208000037804 stenosis Diseases 0.000 description 1
- OTVAEFIXJLOWRX-NXEZZACHSA-N thiamphenicol Chemical compound CS(=O)(=O)C1=CC=C([C@@H](O)[C@@H](CO)NC(=O)C(Cl)Cl)C=C1 OTVAEFIXJLOWRX-NXEZZACHSA-N 0.000 description 1
- 229960003053 thiamphenicol Drugs 0.000 description 1
- 230000032258 transport Effects 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/095—Sulfur, selenium, or tellurium compounds, e.g. thiols
- A61K31/10—Sulfides; Sulfoxides; Sulfones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid, pantothenic acid
- A61K31/198—Alpha-aminoacids, e.g. alanine, edetic acids [EDTA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
Description
DESCRIZIONE dell'invenzione avente per TITOLO: DESCRIPTION of the invention having as TITLE:
"PREPARATO FARMACEUTICO A BASE NAC E MSM IN SOLUZIONE PER IL "PHARMACEUTICAL PREPARATION BASED ON NAC AND MSM IN SOLUTION FOR THE
TRATTAMENTO DI AFFEZIONI RINOFARINGEE". TREATMENT OF RHINOPHARYNGAL AFFECTIONS ".
La presente invenzione si riferisce a una composizione farmaceutica liquida che contenga una quantità appropriata di N-acetylcisteina e di metil sulfonil metano in una soluzione acquosa per il trattamento delle affezioni rinofaringee. The present invention relates to a liquid pharmaceutical composition which contains an appropriate quantity of N-acetylcysteine and methyl sulfonyl methane in an aqueous solution for the treatment of nasopharyngeal affections.
La presente invenzione è impostata sull’azione sinergica tra l’N-acetylcisteina che ha la capacità di rompere i biofilm batterici presenti nelle cavità nasali ed il metil sulfonil metano che ha elevate capacità antiossidanti, una buona attività protettiva delle mucose nasali nonché una discreta attività antimicrobica. The present invention is based on the synergistic action between N-acetylcysteine which has the ability to break the bacterial biofilms present in the nasal cavities and methyl sulfonyl methane which has high antioxidant capacities, a good protective activity of the nasal mucosa as well as a good activity antimicrobial.
La presenza del metil sulfonil metano permette, quindi, di stabilizzare la N’Acetyl cisteina ovvero di ridurre la tendenza di questa a degradarsi (grazie alle sue capacità antiossidanti), di aumentare la capacità conservante del prodotto e, nel contempo, di avere un’attività protettiva delle mucose nasali grazie alla sua attività antiradicalica e di adesione alle mucose stesse (Jacob, S.W. - The miracle of MSM: thè naturai solution for pain. G.P. Putnam’s Sons, New York, 1999, p.4-233) nonché alla sua discrete attività antimicrobica e biofilmolitica. The presence of methyl sulfonyl methane allows, therefore, to stabilize the N'Acetyl cysteine or to reduce its tendency to degrade (thanks to its antioxidant capacity), to increase the preservative capacity of the product and, at the same time, to have a protective activity of the nasal mucosa thanks to its antiradical activity and adhesion to the mucous membranes themselves (Jacob, S.W. - The miracle of MSM: the naturai solution for pain. G.P. Putnam's Sons, New York, 1999, p.4-233) as well as its fair antimicrobial and biofilmolytic activity.
Tale invenzione, quindi, permette la contemporaneità delle seguenti azioni • la rottura del biofilm batterico a livello rinofaringeo This invention, therefore, allows the following actions to be taken at the same time: • the rupture of the bacterial biofilm at the nasopharyngeal level
• un’attività antmicrobica locale • a local antmicrobial activity
• un’azione meccanica di eliminazionedelle secrezioni della mucosa • una detersione della mucosa • a mechanical action of elimination of mucosal secretions • a cleansing of the mucosa
• una maggiore capacità protettiva della mucosa nasale • a greater protective capacity of the nasal mucosa
• una migliore capacità conservante del prodotto • a better preservative capacity of the product
• una migliore capacità stabilizzante della N-acetylcisteina. • a better stabilizing capacity of N-acetylcysteine.
La principale funzione delle vie aeree superiori è quella di permettere un corretto passaggio dell’aria verso i tratti più lontani dell’albero respiratorio. Per un’adeguata funzionalità della mucosa nasale sono necessari: il buon drenaggio delle secrezioni e la ventilazione che richiede la pervietà delle vie aeree (Catalano G.B., Serra A., 1986). The main function of the upper airways is to allow proper passage of air to the farthest reaches of the respiratory tree. For adequate functionality of the nasal mucosa, the following are necessary: good drainage of secretions and ventilation that requires a patent airway (Catalano G.B., Serra A., 1986).
La patogenesi delle affezioni dell’apparato rinosinusale contempla tutta una serie di cause dipendenti dall’alterazione dei meccanismi fisiologici di difesa delle alte vie respiratorie. The pathogenesis of diseases of the rhinosinus system includes a whole series of causes dependent on the alteration of the physiological defense mechanisms of the upper respiratory tract.
Esse possono essere in stretta correlazione tra di loro innescando, pertanto, dei meccanismi di reciproco mantenimento e progressione in senso patologico producendo patologie acute, ad andamento ricorrente e recidivante e che, frequentemente, assumono caratteri di cronicità (Stenosi, Flogosi). They can be in close correlation with each other triggering, therefore, mechanisms of reciprocal maintenance and progression in a pathological sense, producing acute pathologies, with a recurrent and relapsing course and which frequently take on chronic characteristics (Stenosis, Phlogosis).
In condizioni fisiologiche, l’attività mucociliare ed il complesso neurovascolare mantengono e regolano i fattori essenziali per l’instaurarsi e per il perpetuarsi dell’equilibrio omeostatico del sistema rino-sinusale e della mucosa . In physiological conditions, the mucociliary activity and the neurovascular complex maintain and regulate the essential factors for establishing and perpetuating the homeostatic balance of the rhino-sinus system and the mucosa.
Lo strato di muco fluido impedisce il contatto diretto dei patogeni alla superficie della cellule epiteliali, mentre il trasporto mucociliare permette, grazie all’adesione allo strato gel di polvere ed altre particelle più fini, la detersione della superficie delle cavità nasali e paranasali. Le ciglia delle cellule epiteliali sono proiettate nel "blanket" di muco nasale; il muco viene sospinto in senso antero-posteriore grazie all’attività ciliare, con una propulsione rapida seguita da un lento ritorno delle ciglia nella posizione iniziale. (Mackay I., Brain D.,1989). The layer of fluid mucus prevents direct contact of pathogens with the surface of the epithelial cells, while the mucociliary transport allows, thanks to the adhesion to the gel layer of powder and other finer particles, the cleansing of the surface of the nasal and paranasal cavities. The cilia of the epithelial cells are projected into the "blanket" of nasal mucus; the mucus is pushed antero-posteriorly thanks to the ciliary activity, with a rapid propulsion followed by a slow return of the lashes to their initial position. (Mackay I., Brain D., 1989).
In caso di alterata omeostasi nasale, di origine intrinseca o estrinseca, la mucosa non riesce più a sopperire al normale flusso muco-ciliare, e quindi è necessaria una detersione tale da ripristinare un continuo lavaggio delle fosse nasali. In case of altered nasal homeostasis, of intrinsic or extrinsic origin, the mucosa is no longer able to make up for the normal muco-ciliary flow, and therefore a cleansing is necessary to restore a continuous washing of the nasal passages.
La funzionalità delle fosse nasali, fortemente condizionata dallo stato di pervietà degli osti della parete laterale, è una condizione fondamentale per l’omeostasi rinosinusale (Passali D., Biagini C., Pedace E., 1996). In corso di rinite acuta si osserva una riduzione dell’attività degli elementi ciliati che può rendere difficoltoso il drenaggio muco-ciliare e favorire il ristagno di secrezioni sierose e di essudato, inducendo un’ulteriore alterazione deN’ecosistema nasale e offrendo migliori condizioni per la sopravvivenza di microorganismi patogeni (Staffieri A., Miani C. 1996) che creano un biofilm batterico a difesa della loro persistenza nell’apparato. The functionality of the nasal cavities, strongly conditioned by the state of patency of the ostia of the lateral wall, is a fundamental condition for rhinosinus homeostasis (Passali D., Biagini C., Pedace E., 1996). In the course of acute rhinitis, a reduction in the activity of the ciliated elements is observed which can make mucociliary drainage difficult and favor the stagnation of serous secretions and exudate, inducing a further alteration of the nasal ecosystem and offering better conditions for survival of pathogenic microorganisms (Staffieri A., Miani C. 1996) which create a bacterial biofilm to defend their persistence in the apparatus.
Il termine “biofilm” è un neologismo, corrispondente ad un fenomeno che si riferisce alle strategie selezionate dai microrganismi allo scopo di incrementare le possibilità di sopravvivenza neN’ambiente e all’interno dell’organismo umano. The term "biofilm" is a neologism, corresponding to a phenomenon that refers to the strategies selected by microorganisms in order to increase the chances of survival in the environment and within the human organism.
I microrganismi tendono a non rimanere isolati, ma ad aggregarsi in colonie, confermando quella tendenza alla “socializzazione”, che appare propria della materia vivente fin dalle forme più elementari, con rarissime eccezioni. Microorganisms tend not to remain isolated, but to aggregate in colonies, confirming that tendency to "socialization", which appears to be typical of living matter from the most elementary forms, with very rare exceptions.
II biofilm non è un semplice aggregato nel quale la prossimità tra i germi rende più difficile la loro neutralizzazione. The biofilm is not a simple aggregate in which the proximity between the germs makes their neutralization more difficult.
Tra le motivazioni della refrattarietà delle patologie infettive merita un posto di qualche rilievo il fenomeno della formazione dei biofilm batterici. Queste complesse organizzazioni tridimensionali rappresentano una modalità di crescita protetta, che rende i batteri altamente resistenti ai meccanismi di difesa messi in atto dall’organismo umano così come ai trattamenti antibiotici. Dai biofilm si distaccano microrganismi isolati, determinanti per le riacutizzazioni delle patologie infettive delle prime vie respiratorie. Among the reasons for the refractoriness of infectious pathologies, the phenomenon of the formation of bacterial biofilms deserves a place of some importance. These complex three-dimensional organizations represent a protected growth mode, which makes bacteria highly resistant to the defense mechanisms implemented by the human body as well as to antibiotic treatments. Isolated microorganisms detach from the biofilms, determining the exacerbations of infectious diseases of the upper respiratory tract.
In termini generali è intuitivo comprendere che la disgregazione della matrice sottragga un fondamentale fattore di protezione e resistenza agli elementi cellulari del biofilm, esponendoli ad una ritrovata efficacia tanto delle difese dell’ospite quanto dei trattamenti antibiotici. In general terms, it is intuitive to understand that the disintegration of the matrix removes a fundamental factor of protection and resistance to the cellular elements of the biofilm, exposing them to a newfound effectiveness both of the host's defenses and of antibiotic treatments.
La N-acetylcisteina è un efficace mucolitico con un riconosciuto potere antiossidante: probabilmente alla combinazione di tali caratteristiche va ascritta la capacità di interferire nelle diverse fasi di formazione dei biofilm batterici, composti da Staphylococcus epidermidis (S. epidermis), stafilococchi coagulasi negativi e S. aureus. Particolarmente interessante è l’effetto disgregante nei confronti di biofilm anche consolidati. N-acetylcysteine is an effective mucolytic with a recognized antioxidant power: the ability to interfere in the various stages of formation of bacterial biofilms, composed of Staphylococcus epidermidis (S. epidermis), coagulase negative staphylococci and S. . aureus. Particularly interesting is the disintegrating effect against even consolidated biofilms.
L’attività battericida di un antibiotico uso rinologico quale il tiamfenicolo risulta significativamente potenziata, fino al 90%, dall’azione sinergica della N-acetylcisteina. The bactericidal activity of a rhinological antibiotic such as thiamphenicol is significantly enhanced, up to 90%, by the synergistic action of N-acetylcysteine.
La matrice cellulare potrebbe risultare alterata dalla manipolazione dei campi elettrici, che circondano i biofilm (ACTA Volume II - Numero 1 - Marzo 2008). The cellular matrix could be altered by the manipulation of the electric fields surrounding the biofilms (ACTA Volume II - Issue 1 - March 2008).
Come precedentemente enunciato, nella presente invenzione, l’azione sinergica tra ΓΝ-acetylcisteina e il metyl sulfonil metano è dovuta alla capacità dell’una di agire sul biofilm batterico ed all’altra di aumentare la potenza antiossidante ed antiradicalica del preparato migliorando la capacità biofilmolitica e protettiva del composto. As previously stated, in the present invention, the synergistic action between ΓΝ-acetylcysteine and methyl sulfonyl methane is due to the ability of one to act on the bacterial biofilm and to the other to increase the antioxidant and antiradical power of the preparation by improving the biofilmolytic capacity and protective of the compound.
La sinergia si ha quando la N-acetylcisteina è presente in una concentrazione in peso compresa tra lo 0,1 % e il 10% e il metil sulfonil metano (msm) è presente in una concentrazione in peso compresa tra lo 0,1 % e il 30 %. Synergy occurs when N-acetylcysteine is present in a concentration by weight between 0.1% and 10% and methyl sulfonyl methane (msm) is present in a concentration by weight between 0.1% and 30%.
Secondo una forma preferita relativa il dispositivo medico, oggetto della presente invenzione, contiene per 100 grammi di prodotto finale. According to a relative preferred embodiment, the medical device object of the present invention contains per 100 grams of final product.
Acqua 94.897 g Water 94,897 g
Cloruro di sodio 0,9 g Sodium chloride 0.9 g
di N-acetil cisteina 1 g of N-acetyl cysteine 1 g
Metil sulfonil metano 1g Methyl sulfonyl methane 1g
Bicarbonato di Sodio 0,5 g Sodium bicarbonate 0.5 g
Fosfato di sodio 0,5 g Ascorbyl Sodium phosphate 0.5 g Ascorbyl
Disodio EDTA 0,5 g Disodium EDTA 0.5 g
Idrossido di sodio al 30% 0,5 g 30% sodium hydroxide 0.5 g
Sorbato di potassio 0,1 g Potassium sorbate 0.1 g
Benzoato di sodio 0,1 g Sodium benzoate 0.1 g
Aroma Menta 0,003 g Mint flavor 0.003 g
Il dispositivo medico della presente invenzione viene preparato sotto forma di soluzione liquida. The medical device of the present invention is prepared in the form of a liquid solution.
Su questo vengono eseguiti test di biocompatibilità e test di stabilità. Biocompatibility tests and stability tests are performed on this.
1. I test di biocompatibilità atti a determinare la sicurezza del dispositivo sono: 1. The biocompatibility tests to determine the safety of the device are:
• Test di Irritazione della mucosa nasale • Nasal mucosal irritation test
• Test di Citotossicità • Cytotoxicity test
• Test di Sensibilizzazione allergica • Allergic Sensitization Test
Tutti i test di biocompatibilità sono risultati positivi, ovvero il prodotto è risultato innocuo, non irritante, non sensibilizzante. All biocompatibility tests were positive, i.e. the product was found to be harmless, non-irritating, non-sensitizing.
I test di stabilità eseguiti per determinare la stabilità della N-acetylcisteina e dell’intero prodotto sono stati: The stability tests performed to determine the stability of N-acetylcysteine and of the entire product were:
• challenge test da Farmacopea Ufficiale Italiana XII ed. • challenge test from the Official Italian Pharmacopoeia XII ed.
• Determinazione della N-AcetyCisteina mediante determinazione cromatografica. • Determination of N-AcetyCysteine by chromatographic determination.
• Determinazione del PH • Determination of the PH
• Determinazione di batteri, muffe, lievfi e patogeni come richiesto dalla Farmacopea Ufficiale Italiana XII ed. Categorie 2 e 3°. • Determination of bacteria, molds, yeasts and pathogens as required by the Official Italian Pharmacopoeia XII ed. Categories 2 and 3 °.
La stabilità ha evidenziato un prodotto stabile. The stability showed a stable product.
Claims (2)
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000020A ITNA20110020A1 (en) | 2011-05-03 | 2011-05-03 | NAC AND MSM PHARMACEUTICAL PREPARATION IN SOLUTION FOR THE TREATMENT OF RINOFARINGEAL AFFECTIONS |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT000020A ITNA20110020A1 (en) | 2011-05-03 | 2011-05-03 | NAC AND MSM PHARMACEUTICAL PREPARATION IN SOLUTION FOR THE TREATMENT OF RINOFARINGEAL AFFECTIONS |
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| Publication Number | Publication Date |
|---|---|
| ITNA20110020A1 true ITNA20110020A1 (en) | 2012-11-04 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT000020A ITNA20110020A1 (en) | 2011-05-03 | 2011-05-03 | NAC AND MSM PHARMACEUTICAL PREPARATION IN SOLUTION FOR THE TREATMENT OF RINOFARINGEAL AFFECTIONS |
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| Country | Link |
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| IT (1) | ITNA20110020A1 (en) |
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| WO1996020700A1 (en) * | 1994-12-30 | 1996-07-11 | Jacob Stanley W | Pharmacologic management of snoring |
| US5580577A (en) * | 1990-01-11 | 1996-12-03 | Herzenberg; Leonard A. | Method of treating the symptoms of human rhinovirus infection |
| WO2001007019A2 (en) * | 1999-07-27 | 2001-02-01 | Zambon Group S.P.A. | Use of n-acetyl-cysteine in the treatment of allergic pathologies of the respiratory tract |
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| US5580577A (en) * | 1990-01-11 | 1996-12-03 | Herzenberg; Leonard A. | Method of treating the symptoms of human rhinovirus infection |
| WO1996020700A1 (en) * | 1994-12-30 | 1996-07-11 | Jacob Stanley W | Pharmacologic management of snoring |
| WO2001007019A2 (en) * | 1999-07-27 | 2001-02-01 | Zambon Group S.P.A. | Use of n-acetyl-cysteine in the treatment of allergic pathologies of the respiratory tract |
| EP2251016A2 (en) * | 2008-11-11 | 2010-11-17 | Farma-Derma S.R.L. | Topical use of hyaluronic acid with folmogenic action for the treatment and prophylaxys of pathologies of the respiratory tract. |
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