ITMI20132103A1 - NASAL TOPIC COMPOSITIONS CONTAINING XILOGLUCANS FOR USE AS DECONGESTANTS - Google Patents
NASAL TOPIC COMPOSITIONS CONTAINING XILOGLUCANS FOR USE AS DECONGESTANTSInfo
- Publication number
- ITMI20132103A1 ITMI20132103A1 IT002103A ITMI20132103A ITMI20132103A1 IT MI20132103 A1 ITMI20132103 A1 IT MI20132103A1 IT 002103 A IT002103 A IT 002103A IT MI20132103 A ITMI20132103 A IT MI20132103A IT MI20132103 A1 ITMI20132103 A1 IT MI20132103A1
- Authority
- IT
- Italy
- Prior art keywords
- nasal
- rhinitis
- decongestants
- topical
- xiloglucans
- Prior art date
Links
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- 239000000850 decongestant Substances 0.000 title claims description 9
- 229940124581 decongestants Drugs 0.000 title description 6
- 206010028735 Nasal congestion Diseases 0.000 claims description 15
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- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 1
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- 229960001802 phenylephrine Drugs 0.000 description 1
- SONNWYBIRXJNDC-VIFPVBQESA-N phenylephrine Chemical compound CNC[C@H](O)C1=CC=CC(O)=C1 SONNWYBIRXJNDC-VIFPVBQESA-N 0.000 description 1
- 230000000379 polymerizing effect Effects 0.000 description 1
- 229960003908 pseudoephedrine Drugs 0.000 description 1
- KWGRBVOPPLSCSI-WCBMZHEXSA-N pseudoephedrine Chemical compound CN[C@@H](C)[C@@H](O)C1=CC=CC=C1 KWGRBVOPPLSCSI-WCBMZHEXSA-N 0.000 description 1
- 230000001739 rebound effect Effects 0.000 description 1
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- 208000017022 seasonal allergic rhinitis Diseases 0.000 description 1
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- MNQYNQBOVCBZIQ-JQOFMKNESA-A sucralfate Chemical compound O[Al](O)OS(=O)(=O)O[C@@H]1[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](COS(=O)(=O)O[Al](O)O)O[C@H]1O[C@@]1(COS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)[C@H](OS(=O)(=O)O[Al](O)O)[C@@H](OS(=O)(=O)O[Al](O)O)O1 MNQYNQBOVCBZIQ-JQOFMKNESA-A 0.000 description 1
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- QURCVMIEKCOAJU-UHFFFAOYSA-N trans-isoferulic acid Natural products COC1=CC=C(C=CC(O)=O)C=C1O QURCVMIEKCOAJU-UHFFFAOYSA-N 0.000 description 1
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Engineering & Computer Science (AREA)
- Otolaryngology (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Description
Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:
“COMPOSIZIONI TOPICHE NASALI CONTENENTI XILOGLUCANI PER USO COME DECONGESTIONANTI” "NASAL TOPICAL COMPOSITIONS CONTAINING XYLOGLUCANS FOR USE AS DECONGESTANTS"
L’invenzione si riferisce a composizioni topiche nasali comprendenti xiloglucani o estratti che li contengono per uso nel trattamento della congestione nasale, in particolare congestione nasale associata alla rinite o sinusite. The invention refers to nasal topical compositions comprising xyloglucans or extracts containing them for use in the treatment of nasal congestion, in particular nasal congestion associated with rhinitis or sinusitis.
Stato della tecnica State of the art
La congestione nasale è il risultato dell'infiammazione e del gonfiore dei tessuti di rivestimento delle vie nasali e può avere molteplici cause quali per esempio infezioni, allergie o anche cause strutturali quali la deviazione del setto nasale. In particolare la congestione nasale è associata alla rinite e alla sinusite. Nasal congestion is the result of inflammation and swelling of the lining tissues of the nasal passages and can have multiple causes such as infections, allergies or even structural causes such as deviation of the nasal septum. In particular, nasal congestion is associated with rhinitis and sinusitis.
La rinite è una a infiammazione delle mucose nasali causata, ad esempio, da raffreddore, influenza o allergie. La rinite può essere caratterizzata da uno o più sintomi quali rinorrea, starnuti, congestione nasale, e aumento della secrezione nasale. La rinite può includere rinite acuta, rinite, rinite allergica, rinite allergica stagionale, rinite allergica cronica, rinite vasomotoria, rinite infettiva e rinite atrofica. La sinusite è una infiammazione dei seni paranasali, che può essere il risultato di infezione (ad esempio, batterica, micotica o virale), o avere cause allergiche o autoimmuni. Rhinitis is an inflammation of the nasal mucosa caused, for example, by colds, flu or allergies. Rhinitis can be characterized by one or more symptoms such as runny nose, sneezing, nasal congestion, and increased nasal discharge. Rhinitis can include acute rhinitis, rhinitis, allergic rhinitis, seasonal allergic rhinitis, chronic allergic rhinitis, vasomotor rhinitis, infectious rhinitis, and atrophic rhinitis. Sinusitis is inflammation of the sinuses, which can be the result of infection (for example, bacterial, fungal, or viral), or have allergic or autoimmune causes.
I farmaci più utilizzati nella rinite e congestione nasale sono gli antistaminici anti-H1, che inibiscono l’azione dell’istamina bloccando il legame dell’istamina con i recettori H1 o gli antistaminici atipici che inibiscono l’attività enzimatica della istidina decarbossilasi che catalizza la trasformazione di istidina a istamina. Gli antistaminici sono efficaci contro i sintomi mediati da istamina, quali rinorrea, starnuti, prurito nasale e sintomi oculari, ma sono meno efficaci sulla congestione nasale. Gli effetti collaterali degli antistaminici orali anti-H1 di prima generazione comprendono sedazione e compromissione del sistema nervoso centrale, (disturbi della vigilanza, sonnolenza, effetti sulla guida di veicoli). Questi disturbi possono essere potenziati da alcol e altri farmaci sedativi. Inoltre gli antistaminici anti-H1 possono interagire con alcuni farmaci, prodotti vegetali, supplementi nutrizionali o dietetici. The drugs most used in rhinitis and nasal congestion are anti-H1 antihistamines, which inhibit the action of histamine by blocking the binding of histamine with H1 receptors or atypical antihistamines that inhibit the enzymatic activity of histidine decarboxylase which catalyzes the transformation of histidine to histamine. Antihistamines are effective against histamine-mediated symptoms such as runny nose, sneezing, itchy nose, and eye symptoms, but are less effective on nasal congestion. Side effects of first generation anti-H1 oral antihistamines include sedation and impaired central nervous system (disturbances in alertness, drowsiness, effects on vehicle driving). These disorders can be potentiated by alcohol and other sedative medications. In addition, anti-H1 antihistamines can interact with some drugs, plant products, nutritional or dietary supplements.
I corticosteroidi per via intranasale rimangono il trattamento di scelta della congestione nasale ma in circa il 5% di pazienti possono verificarsi effetti secondari quali formazione di croste, secchezza e epistassi minore che possono essere motivo di interruzione del trattamento. I bambini regolarmente trattati per un anno con beclometasone per via nasale mostrano un lieve ritardo nella crescita. Intranasal corticosteroids remain the treatment of choice for nasal congestion but secondary effects such as crusting, dryness and minor nosebleeds may occur in approximately 5% of patients and may be grounds for discontinuation of treatment. Babies regularly treated with nasal beclomethasone for one year show mild growth retardation.
Un altro gruppo di farmaci utilizzato nel caso di congestione nasale sono i decongestionanti quali pseudo efedrina e fenilefrina. Decongestionanti orali e intranasali possono essere utilizzati nel trattamento della congestione nasale associata con rinite allergica. Tuttavia, l’uso di decongestionanti per os o come spray nasali è limitato da effetti collaterali quali un effetto rebound sulla congestione, la possibilità di indurre una ipertrofia tissutale irreversibile, e una diminuzione della durata dell’ effetto dopo 10 giorni di utilizzo. Per esempio la rhinitis medicamentosa è indotta o aggravata dall’uso eccessivo di decongestionanti topici con o senza conservanti. Gli antileukotrieni sono una nuova classe di farmaci per il trattamento della rinite allergica e asma. Hanno un efficacia paragonabile a quella degli antistaminici orali sebbene sembrino avere un maggiore effetto sulla ostruzione nasale. Gli altri prodotti utilizzati nella rinite, come gli antibiotici, anticolinergici e cromoni non hanno un azione decongestionante. E’ pertanto sempre sentita l’esigenza di ulteriori presidi terapeutici che possano sostituire o affiancare quelli ad oggi disponibili. Another group of drugs used in the case of nasal congestion are decongestants such as pseudo ephedrine and phenylephrine. Oral and intranasal decongestants can be used in the treatment of nasal congestion associated with allergic rhinitis. However, the use of oral decongestants or nasal sprays is limited by side effects such as a rebound effect on congestion, the possibility of inducing irreversible tissue hypertrophy, and a decrease in the duration of the effect after 10 days of use. For example, rhinitis medicamentosa is induced or aggravated by the excessive use of topical decongestants with or without preservatives. Antileukotrienes are a new class of drugs for the treatment of allergic rhinitis and asthma. They have comparable efficacy to that of oral antihistamines although they appear to have a greater effect on nasal obstruction. The other products used in rhinitis, such as antibiotics, anticholinergics and chromones, do not have a decongestant action. The need is therefore always felt for further therapeutic aids that can replace or complement those currently available.
Descrizione dell’invenzione Description of the invention
L’invenzione ha pertanto per oggetto composizioni topiche nasali comprendenti come ingredienti attivi xiloglucani o estratti che li contengono per uso nel trattamento della congestione nasale, in particolare la congestione nasale associata rinite e/o sinusite. The invention therefore relates to nasal topical compositions comprising as active ingredients xyloglucans or extracts containing them for use in the treatment of nasal congestion, in particular nasal congestion associated with rhinitis and / or sinusitis.
Gli xiloglucani sono molecole costituite da uno scheletro lineare di β-1,4-glucani con corte ramificazioni laterali. Queste si legano grazie allo xilosio legato all’ossigeno in posizione 6 dello zucchero. Tali catene laterali possono inoltre contenere altri zuccheri come arabinosio e fucosio. Xyloglucans are molecules consisting of a linear skeleton of β-1,4-glucans with short lateral branches. These bind thanks to xylose bound to oxygen in position 6 of the sugar. These side chains may also contain other sugars such as arabinose and fucose.
Gli xiloglucani appartengono alla famiglia delle emicellulose che si associano alla cellulosa all’interno della parete cellulare delle piante superiori. Una fonte particolarmente ricca di xiloglucano è il seme del tamarindo (Tamarindus indica), un albero tropicale originario dell’Africa Orientale. Xyloglucans belong to the family of hemicelluloses which are associated with cellulose within the cell wall of higher plants. A particularly rich source of xyloglucan is the seed of the tamarind (Tamarindus indica), a tropical tree native to East Africa.
Estratti di semi di tamarindo ricchi in xiloglucani sono noti e sono stati usati in campo medico per lo più come agenti viscosizzanti in composizioni oftalmiche (US 6 056 950), come agenti muco adesivi (WO2006131262), come sostituti lacrimali (WO2009/044423), come agenti anti-infettivi (WO2011147767) e come agenti anti-infiammatori (WO2011147768). Tamarind seed extracts rich in xyloglucans are known and have been used in the medical field mostly as thickening agents in ophthalmic compositions (US 6 056 950), as mucus adhesive agents (WO2006131262), as tear substitutes (WO2009 / 044423), as anti-infective agents (WO2011147767) and as anti-inflammatory agents (WO2011147768).
Gli Xiloglucani estratti da Tamarindus indica sono disponibili in commercio, ad esempio da Indena (Italia) (Xilogel®) e da DSP Gokyo Food & Chemical (Giappone) (Glyloid®). Xyloglucans extracted from Tamarindus indica are commercially available, for example from Indena (Italy) (Xilogel®) and DSP Gokyo Food & Chemical (Japan) (Glyloid®).
Le composizione topiche nasali dell’invenzione possono comprendere inoltre uno o più ingredienti attivi e/o eccipienti. Ad esempio le composizioni dell’invenzione possono comprendere come ulteriori principi attivi antibiotici, antivirali, antinfiammatori, decongestionanti. The topical nasal compositions of the invention may also comprise one or more active ingredients and / or excipients. For example, the compositions of the invention may include antibiotic, antiviral, anti-inflammatory, decongestant active ingredients as further active ingredients.
Inoltre le composizioni secondo l’invenzione possono contenere eccipienti quali sucralfato, polisaccaridi naturali e sintetici come ad esempio pectine, chitosano (animale o vegetale), acido ialuronico, gomma di Guar, gomma di xantano, gelatine animali, proteine vegetali come ad esempio la proteina di pisello, cellulose ed emicellulose e derivati come ad esempio idrossipropilcellulosa, carragenine, carbomeri, composti reticolanti/polimerizzanti come acido ferulico; polifenoli, come ad esempio polifenoli da galle, polifenoli da semi d’uva. Furthermore, the compositions according to the invention can contain excipients such as sucralfate, natural and synthetic polysaccharides such as pectins, chitosan (animal or vegetable), hyaluronic acid, Guar gum, xanthan gum, animal jellies, vegetable proteins such as protein pea, cellulose and hemicellulose and derivatives such as hydroxypropylcellulose, carrageenans, carbomers, cross-linking / polymerizing compounds such as ferulic acid; polyphenols, such as gall polyphenols, grape seed polyphenols.
Inoltre le composizioni della presente invenzione possono contenere acqua, conservanti, tamponi, agenti che modificano la viscosità, agenti sospendenti, agenti per la regolazione del pH e aromi. Furthermore, the compositions of the present invention may contain water, preservatives, buffers, viscosity modifying agents, suspending agents, pH regulating agents and flavors.
Le composizioni dell’invenzione sono preferibilmente somministrate come spray nasale. The compositions of the invention are preferably administered as a nasal spray.
Nelle composizioni dell’invenzione gli xiloglucani possono essere presenti in un ampio intervallo di concentrazione che dipende dal tipo di composizione e dalla indicazione terapeutica a cui sono destinati. In the compositions of the invention, xyloglucans can be present in a wide range of concentration which depends on the type of composition and the therapeutic indication for which they are intended.
L’intervallo della concentrazione di xiloglucano riferita alla singola dose di somministrazione è comunque compreso tra 0,1 e 10 mg/dose, preferibilmente tra 0,5 mg/dose e 2,5 mg/dose. The range of the concentration of xyloglucan referred to the single dose of administration is in any case between 0.1 and 10 mg / dose, preferably between 0.5 mg / dose and 2.5 mg / dose.
Gli esempi che seguono illustrano l’invenzione in maggior dettaglio. The following examples illustrate the invention in greater detail.
Sono state preparate le seguenti soluzioni per spray nasale: The following nasal spray solutions have been prepared:
Esempio 1 Example 1
diente g/100 g ILSULFONILMETANO 1,00000 ZIONE FISIOLOGICA-sodio cloruro 0,9% q.b. 100 ARINDO Semi polisaccaridi (GLYLOID 3S) 1,00000 O EDTA 0,07500 O BORICO (sol. 3%) 10,00000 diente g / 100 g ILSULFONILMETANO 1,00000 PHYSIOLOGICAL ZION-sodium chloride 0,9% q.s. 100 ARINDO Semi polysaccharides (GLYLOID 3S) 1.00000 OR EDTA 0.07500 OR BORIC (sol. 3%) 10.00000
0,19000 ZIONE NaOH 14% 0.19000 ZION NaOH 14%
(pH=6,8) LE 100,00 (pH = 6.8) LE 100.00
Esempio 2 Example 2
diente g/100 g ILSULFONILMETANO 1,00000 ZIONE FISIOLOGICA-sodio cloruro 0,9% q.b. 100 GLUCANO 0,5000 TINA 0,5000 O EDTA 0,07500 O BORICO (sol. 3%) 10,00000 LE 100,00 diente g / 100 g ILSULFONILMETANO 1,00000 PHYSIOLOGICAL ZION-sodium chloride 0,9% q.s. 100 GLUCAN 0.5000 TINA 0.5000 OR EDTA 0.07500 OR BORIC (sol. 3%) 10.00000 LE 100.00
Esempio 3 Example 3
iente g/100 g LSULFONILMETANO 1,00000 ZIONE FISIOLOGICA-sodio cloruro 0,9% q.b. 100 GLUCANO 0,5000 TINA 0,5000 O EDTA 0,07500 O BORICO 10,00000 iente g / 100 g LSULPHONYLMETHANE 1.00000 PHYSIOLOGICAL ZION-sodium chloride 0.9% q.s. 100 GLUCAN 0.5000 TINA 0.5000 OR EDTA 0.07500 OR BORIC 10.00000
0,19000 ZIONE NaOH 14% 0.19000 ZION NaOH 14%
(pH=6,8) LE 100,00 (pH = 6.8) LE 100.00
Claims (5)
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WO2006131262A1 (en) * | 2005-06-06 | 2006-12-14 | Alfa Wassermann S.P.A. | Mucoadhesive xyloglucan-containing formulations useful in medical devices and in pharmaceutical formulations |
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WO2006131262A1 (en) * | 2005-06-06 | 2006-12-14 | Alfa Wassermann S.P.A. | Mucoadhesive xyloglucan-containing formulations useful in medical devices and in pharmaceutical formulations |
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