IT201800005002A1 - COMPOSITIONS INCLUDING BOSWELLIA EXTRACTS AND BUTYRATES - Google Patents

COMPOSITIONS INCLUDING BOSWELLIA EXTRACTS AND BUTYRATES Download PDF

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IT201800005002A1
IT201800005002A1 IT102018000005002A IT201800005002A IT201800005002A1 IT 201800005002 A1 IT201800005002 A1 IT 201800005002A1 IT 102018000005002 A IT102018000005002 A IT 102018000005002A IT 201800005002 A IT201800005002 A IT 201800005002A IT 201800005002 A1 IT201800005002 A1 IT 201800005002A1
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boswellia
butyric acid
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incensol
butyrate
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IT102018000005002A
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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)
    • A61K36/32—Burseraceae (Frankincense family)
    • A61K36/324—Boswellia, e.g. frankincense
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Description

Descrizione del brevetto per invenzione industriale avente per titolo: Description of the patent for industrial invention entitled:

“COMPOSIZIONI COMPRENDENTI ESTRATTI DI BOSWELLIA E BUTIRRATI” "COMPOSITIONS INCLUDING BOSWELLIA EXTRACTS AND BUTYRATES"

La presente invenzione ha per oggetto composizioni comprendenti come ingredienti attivi acidi boswellici, incensolo e incensolo acetato o estratti che li contengono in combinazione con acido butirrico o suoi sali dieteticamente accettabili. The present invention relates to compositions comprising as active ingredients boswellic acids, incensol and incensol acetate or extracts containing them in combination with butyric acid or its dietetically acceptable salts.

Le composizioni dell'invenzione sono utili per il trattamento di infiammazioni croniche dell’intestino. The compositions of the invention are useful for the treatment of chronic inflammation of the intestine.

STATO DELLA TECNICA STATE OF THE TECHNIQUE

L’ecosistema intestinale regola numerose funzioni gastrointestinali. Ne fanno parte le cellule della mucosa, le cellule del sistema immunitario, neuroni, la microflora batterica che contiene circa 400-500 specie batteriche e i nutrienti ingeriti con gli alimenti. Si è compreso che alterazioni delle relazioni tra i vari componenti dell’ecosistema possono contribuire all’insorgenza di alcune patologie umane. The intestinal ecosystem regulates numerous gastrointestinal functions. It includes the cells of the mucosa, the cells of the immune system, neurons, the bacterial microflora which contains about 400-500 bacterial species and the nutrients ingested with food. It is understood that alterations in the relationships between the various components of the ecosystem can contribute to the onset of some human pathologies.

Ad esempio, una scorretta alimentazione o trattamenti farmacologici possono alterare l’equilibrio della flora intestinale, portando ad una crescita incontrollata di microrganismi patogeni. Se questa condizione si protrae nel tempo le mucose intestinali si infiammano e si manifestano episodi di colite e disturbi intestinali riconosciuti come sintomi del colon irritabile (IBS). For example, an incorrect diet or drug treatments can alter the balance of the intestinal flora, leading to an uncontrolled growth of pathogenic microorganisms. If this condition continues over time, the intestinal mucous membranes become inflamed and episodes of colitis and intestinal disorders recognized as symptoms of irritable bowel (IBS) occur.

Dalla fermentazione attuata dagli enzimi batterici si formano acidi carbossilici a corta catena, in particolare acido propionico (C3), butirrico (C4), valerico (C5) oltre a metano, anidride carbonica e idrogeno. From the fermentation carried out by bacterial enzymes, short-chain carboxylic acids are formed, in particular propionic (C3), butyric (C4), valeric (C5) acids as well as methane, carbon dioxide and hydrogen.

La formazione degli acidi carbossilici porta ad una riduzione del pH nel tratto prossimale del colon che favorisce la crescita dei batteri che producono acido butirrico. The formation of carboxylic acids leads to a reduction in pH in the proximal tract of the colon which favors the growth of bacteria that produce butyric acid.

Studi condotti in vitro hanno dimostrato che l’acido butirrico regola il trasporto di fluidi, protegge i colonociti dalla stress ossidativo, influenza la motilità lungo il tratto gastrointestinale, modula la proliferazione cellulare e il differenziamento cellulare. Studies conducted in vitro have shown that butyric acid regulates the transport of fluids, protects colonocytes from oxidative stress, influences motility along the gastrointestinal tract, modulates cell proliferation and cell differentiation.

E’ stato dimostrato che il butirrato può avere effetti positivi sia sugli animali che negli esseri umani con il diabete di tipo 2. It has been shown that butyrate can have positive effects on both animals and humans with type 2 diabetes.

E’ inoltre noto che pazienti affetti da malattie infiammatorie intestinali presentano ridotta produzione di butirrato a livello intestinale. It is also known that patients with inflammatory bowel diseases have a reduced production of butyrate in the intestine.

Furusawa Y1, et al. in “Commensal microbe-derived butyrate induces colonic regulatory T cells", Nature, 2013 Dec 19;504(7480):446-50 hanno identificato un meccanismo mediante il quale i batteri intestinali influenzano i processi messi in atto dal sistema immunitario per ridurre l’infiammazione. Il butirrato, un prodotto di scarto della digestione delle fibre alimentari ad opera dei batteri intestinali, fungerebbe da “interruttore” epigenetico in grado di stimolare il sistema immunitario attraverso l’induzione della produzione di cellule T regolatorie nell’intestino. Furusawa Y1, et al. in "Commensal microbe-derived butyrate induces colonic regulatory T cells", Nature, 2013 Dec 19; 504 (7480): 446-50 have identified a mechanism by which intestinal bacteria influence the processes put in place by the immune system to reduce the Inflammation Butyrate, a waste product of the digestion of dietary fibers by intestinal bacteria, would act as an epigenetic "switch" capable of stimulating the immune system by inducing the production of regulatory T cells in the intestine.

Lo studio ha mostrato che i topi sofferenti di colite presentavano un innalzamento dei livelli di cellule T regolatorie e un miglioramento della sintomatologia dopo somministrazione di butirrato come parte della loro dieta. L'acido butirrico svolge un ruolo di messaggero primario tra i batteri commensali e il sistema immunitario umano. In questa comprensione, la presenza di acido butirrico ad una appropriata concentrazione fisiologica nel colon viene interpretata dal corpo come informazione che l'equilibrio batterico non è disturbato, che riduce la risposta immunitaria e la tolleranza a migliaia di antigeni che rappresentano batteri commensali e, di conseguenza, impedisce l'inizio del processo infiammatorio (Louis P et al., Life in the gut: microbial responses to stress in the gastrointestinal tract. Sci Prog. 2010; 93:7-36). The study showed that the mice suffering from colitis had increased levels of regulatory T cells and improved symptoms after administration of butyrate as part of their diet. Butyric acid plays a primary messenger role between commensal bacteria and the human immune system. In this understanding, the presence of butyric acid at an appropriate physiological concentration in the colon is interpreted by the body as information that the bacterial balance is not disturbed, which reduces the immune response and tolerance to thousands of antigens representing commensal bacteria and, of consequently, it prevents the onset of the inflammatory process (Louis P et al., Life in the gut: microbial responses to stress in the gastrointestinal tract. Sci Prog. 2010; 93: 7-36).

L’acido butirrico aiuta il proliferare dei batteri buoni della flora batterica, e mantiene salubre la nostra mucosa intestinale; è un potente antinfiammatorio gastrico, e secondo Stephane Guyenet, uno dei maggiori esperti di obesità, l’acido butirrico riduce lo stress e spinge il corpo a bruciare i grassi, mantenendo viva e attiva la massa magra (Borycka-Kiciaket al., Butyric acid - a well-known molecule revisited, Prz Gastroenterol. 2017; 12(2): 83-89.). Butyric acid helps the proliferation of good bacteria in the bacterial flora, and keeps our intestinal mucosa healthy; is a potent gastric anti-inflammatory, and according to Stephane Guyenet, a leading obesity expert, butyric acid reduces stress and prompts the body to burn fat while keeping lean mass alive and active (Borycka-Kiciaket al., Butyric acid - a well-known molecule revisited, Prz Gastroenterol. 2017; 12 (2): 83-89.).

Il butirrato di sodio è stato introdotto nel protocollo di trattamento dietetico nei pazienti con stoma (Krokowicz L et al., A prospective, descriptive study to assess the effectiveness of dietary and pharmacological strategies to manage constipation in patients with a stoma . Ostomy Wound Manage. 2015; 61:14-22). Sodium butyrate has been introduced in the dietary treatment protocol in patients with stoma (Krokowicz L et al., A prospective, descriptive study to assess the effectiveness of dietary and pharmacological strategies to manage constipation in patients with a stoma. Ostomy Wound Manage. 2015; 61: 14-22).

La ricerca in un modello animale ha dimostrato che l'acido butirrico ha aumentato l'efficacia della peristalsi migliorando la contrattività del muscolo liscio del colon e regolando la neurotrasmissione, in particolare nei casi di peristalsi compromessa che accompagna la costipazione funzionale negli anziani (Bajka BH et al., Butyrylated starch increases large bowel butyrate levels and lowers colonic smooth muscle contractility in rats . Nut Res. 2010; 30:427-34). Research in an animal model has shown that butyric acid increased the efficacy of peristalsis by improving colonic smooth muscle contraction and regulating neurotransmission, particularly in cases of impaired peristalsis accompanying functional constipation in the elderly (Bajka BH et al., Butyrylated starch increases large bowel butyrate levels and lowers colonic smooth muscle contractility in rats. Nut Res. 2010; 30: 427-34).

L'acido butirrico influenza i meccanismi che regolano la peristalsi dello stomaco, la gravità dei processi infiammatori e i meccanismi di regolazione dell'asse del cervello-intestino (Marchesi JR et al., The gut microbiota and host health: a new clinical frontier , Gut. 2016;65:330-9). Butyric acid influences the mechanisms that regulate stomach peristalsis, the severity of inflammatory processes and the mechanisms of regulation of the brain-gut axis (Marchesi JR et al., The gut microbiota and host health: a new clinical frontier, Gut 2016; 65: 330-9).

La Boswellia, un vegetale appartenente alla famiglia delle Burseraceae, è una nota fonte di principi attivi naturali prevalentemente, ma non esclusivamente, antinfiammatori. La Boswellia è utilizzata in medicina tradizionale e ayurvedica per il trattamento del diabete e di alcune patologie cardiovascolari, dermatologiche e neurologiche. Agli acidi boswellici, i principali principi attivi della Boswellia, sono attribuite proprietà antinfiammatorie, antireumatiche e antidolorifiche: estratti di Boswellia sono stati per esempio proposti per il trattamento di artrosi e artrite reumatoide. Boswellia, a vegetable belonging to the Burseraceae family, is a well-known source of natural active ingredients mainly, but not exclusively, anti-inflammatory. Boswellia is used in traditional and Ayurvedic medicine for the treatment of diabetes and some cardiovascular, dermatological and neurological diseases. Boswellic acids, the main active ingredients of Boswellia, are attributed anti-inflammatory, antirheumatic and pain-relieving properties: Boswellia extracts have for example been proposed for the treatment of osteoarthritis and rheumatoid arthritis.

Numerosi studi scientifici hanno dimostrato che gli acidi boswellici possono essere utili nel trattamento sia del morbo di Crohn che nella colite ulcerosa. (Ren J et al., J Nat Prod. 2015 Oct 23;78(10):2322-31; Cembranoids from the Gum Resin of Boswellia car ter ii as Potential Antiulcerative Colitis Agents; Hartmann RM et al., Phytother Res. 2014 Sep; 28(9):1392-8; Boswellia serra ta has beneficial anti-inflammatory and antioxidant properties in a model of experimental colitis; Hartmann RM et al., Dig Dis Sci. 2012 Aug; 57(8):2038-44; Effect of Boswellia serra ta on antioxidant sta tus in an experimental model of colitis ra ts induced by acetic acid; Latella G et al., Eur J Clin Invest. 2008 Jun; 38(6):410-20; Prevention of colonic fibrosis by Boswellia and Scutellar ia extracts in ra ts with colitis induced by 2,4,5-tr initrobenzene sulphonic acid. Al-Yasiry AR et al.,Postepy Hig Med Dosw 2016 Jan 4;70:380-91; Frankincense--therapeutic properties). Numerous scientific studies have shown that boswellic acids can be useful in the treatment of both Crohn's disease and ulcerative colitis. (Ren J et al., J Nat Prod. 2015 Oct 23; 78 (10): 2322-31; Cembranoids from the Gum Resin of Boswellia car ter ii as Potential Antiulcerative Colitis Agents; Hartmann RM et al., Phytother Res. 2014 Sep; 28 (9): 1392-8; Boswellia serra ta has beneficial anti-inflammatory and antioxidant properties in a model of experimental colitis; Hartmann RM et al., Dig Dis Sci. 2012 Aug; 57 (8): 2038-44 ; Effect of Boswellia serra ta on antioxidant sta tus in an experimental model of colitis ra ts induced by acetic acid; Latella G et al., Eur J Clin Invest. 2008 Jun; 38 (6): 410-20; Prevention of colonic fibrosis by Boswellia and Scutellar ia extracts in ra ts with colitis induced by 2,4,5-tr initrobenzene sulphonic acid. Al-Yasiry AR et al., Postepy Hig Med Dosw 2016 Jan 4; 70: 380-91; Frankincense - therapeutic properties).

L’efficacia dei farmaci convenzionalmente utilizzati in queste patologie è stata confrontata con quella di estratti standardizzati di Boswellia. Nel caso specifico del morbo di Crohn il farmaco di riferimento è la mesalazina, un farmaco antinfiammatorio non steroideo (FANS) che esercita un’azione localizzata a livello dell’apparato gastrointestinale. Madisch A et al. (Int J Colorectal Dis. 2007 Dec;22(12):1445-51:Boswellia serra ta extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter tria l) hanno messo in evidenza che gli estratti di Boswellia hanno un’efficacia paragonabile a quella della mesalazina. The effectiveness of the drugs conventionally used in these pathologies was compared with that of standardized Boswellia extracts. In the specific case of Crohn's disease, the reference drug is mesalazine, a non-steroidal anti-inflammatory drug (NSAID) that exerts a localized action at the level of the gastrointestinal system. Madisch A et al. (Int J Colorectal Dis. 2007 Dec; 22 (12): 1445-51: Boswellia serra ta extract for the treatment of collagenous colitis. A double-blind, randomized, placebo-controlled, multicenter tria l) have shown that Boswellia extracts have an efficacy comparable to that of mesalamine.

Descrizione dell’invenzione Description of the invention

Si è ora trovato che l’associazione dei componenti attivi della Boswellia sacra , acidi boswellici, incensolo acetato ed incensolo, con acido butirrico o suoi sali determina effetti sinergici; gli acidi boswellici e gli incensoli controllano infatti l’infiammazione, mentre l’acido butirrico favorisce il ripristino delle condizioni fisiologiche ideali per il proliferare della flora batterica intestinale simbiotica dell’intestino. It has now been found that the association of the active components of Boswellia sacra, boswellic acids, incensol acetate and incensol, with butyric acid or its salts determines synergistic effects; boswellic acids and incensoles control inflammation, while butyric acid promotes the restoration of ideal physiological conditions for the proliferation of the symbiotic intestinal bacterial flora of the intestine.

L’invenzione ha pertanto per oggetto composizioni comprendenti acidi boswellici, incensolo ed incensolo acetato o estratti che li contengono in combinazione con acido butirrico o suoi sali dieteticamente accettabili, utili per il trattamento di infiammazioni croniche dell’intestino. The invention therefore relates to compositions including boswellic acids, incensol and incensol acetate or extracts that contain them in combination with butyric acid or its dietetically acceptable salts, useful for the treatment of chronic inflammation of the intestine.

L’estratto di Boswellia sacra , disponibile in commercio da più fonti, è la fonte preferita di acidi boswellici ed incensoli. E’ un estratto fluido di gommoresine di Boswellia sacra contenente ≥40 g/Kg di acido acetil-11-cheto-β-boswellico (AKBA) e ≥ 30 g/Kg di acido β-boswellico (β-BA), acido α-boswellico (α-BA) e acido cheto-β-boswellico (KBA). La frazione volatile contiene i diterpeni cembranici incensolo e incensolo acetato in quantità ≥ 65 g/Kg. Boswellia sacra extract, commercially available from multiple sources, is the preferred source of boswellic acids and incensoles. It is a fluid extract of Boswellia sacra gum resin containing ≥40 g / kg of acetyl-11-keto-β-boswellic acid (AKBA) and ≥ 30 g / kg of β-boswellic acid (β-BA), α- acid boswellic (α-BA) and keto-β-boswellic acid (KBA). The volatile fraction contains the cembrane diterpenes incensole and incensol acetate in quantities ≥ 65 g / kg.

Detti componenti dell’estratto di Boswellia agiscono in modo selettivo sui recettori dell’infiammazione e sul sistema immunitario: l'incensolo acetato (tipico della B. sacra) è un agonista selettivo di TRPV3 in grado di stimolare l’influsso di calcio mediato da TRPV3, mentre l’incensolo è un potente inibitore di STAT3 indotta da IL-6 e un potente attivatore di NF-kB. These components of the Boswellia extract act selectively on the inflammation receptors and on the immune system: incensol acetate (typical of B. sacra) is a selective TRPV3 agonist able to stimulate the calcium influx mediated by TRPV3 , while incensole is a potent inhibitor of STAT3 induced by IL-6 and a potent activator of NF-kB.

Gli acidi boswellici AKBA, α-BA, β-BA e KBA hanno una dimostrata attività sulla 5-lipossigenasi e sulle PGE. The boswellic acids AKBA, α-BA, β-BA and KBA have demonstrated activity on 5-lipoxygenase and PGE.

Gli effetti del butirrato sul sistema immunitario sono mediati dall'inibizione dell'istone deacetilasi di classe I e dall'attivazione dei suoi bersagli recettori accoppiati a proteine G: NIACR1 (GPR109A), FFAR2 (GPR43) e FFAR3 (GPR41). The effects of butyrate on the immune system are mediated by the inhibition of class I histone deacetylase and the activation of its target G protein-coupled receptors: NIACR1 (GPR109A), FFAR2 (GPR43) and FFAR3 (GPR41).

L'attività antiinfiammatoria degli acidi boswellici e dell’AKBA in particolare, l'interazione con TRPV3 dell'incensolo acetato e con STAT3 dell'incensolo unite all'inibizione dell'istone deacetilasi e all'attivazione delle proteine G da parte del butirrato determinano effetti sinergici utili ai fini della riduzione e del controllo dei processi infiammatori intestinali. The anti-inflammatory activity of boswellic acids and AKBA in particular, the interaction with TRPV3 of incensol acetate and STAT3 of incensol combined with the inhibition of histone deacetylase and the activation of G proteins by butyrate determine effects synergists useful for the reduction and control of intestinal inflammatory processes.

Le composizioni dell’invenzione sono preferibilmente adatte alla somministrazione orale, ad esempio in forma di compresse, capsule o granulati gastroresistenti. The compositions of the invention are preferably suitable for oral administration, for example in the form of gastro-resistant tablets, capsules or granulates.

L’estratto di Boswellia è tipicamente presente in quantità da 100 a 800 mg, mentre l’acido butirrico, preferibilmente butirrato di sodio , è presente in quantità da 100 a 1000 mg. Le composizioni dell’invenzione possono essere somministrate da una a tre volte al giorno, preferibilmente due volte al giorno. Le composizioni dell’invenzione potranno essere preparate secondo metodi convenzionali, come quelli descritti in “Remington’s Pharmaceutical Handbook”, Mack Publishing Co., N.Y., USA, utilizzando eccipienti quali solubilizzanti, disgreganti, stabilizzanti, diluenti, regolatori di pH, polimeri gastro-resistenti, conservanti, aromi, coloranti. Boswellia extract is typically present in quantities from 100 to 800 mg, while butyric acid, preferably sodium butyrate, is present in quantities from 100 to 1000 mg. The compositions of the invention can be administered from one to three times a day, preferably twice a day. The compositions of the invention can be prepared according to conventional methods, such as those described in "Remington's Pharmaceutical Handbook", Mack Publishing Co., N.Y., USA, using excipients such as solubilizers, disintegrants, stabilizers, diluents, pH regulators, gastro-resistant polymers , preservatives, flavors, dyes.

Si riportano di seguito, a titolo di esempio, le composizioni quantitative di compresse e capsule gastroresistenti. The quantitative compositions of gastro-resistant tablets and capsules are reported below by way of example.

ESEMPIO N°1 EXAMPLE N ° 1

Forma Farmaceutica: Compresse Pharmaceutical form: Tablets

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco): 200 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract): 200 mg

Butirrato di sodio: 375 mg corrispondente a 307 mg di acido butirrico. Agenti di carica: Sodium butyrate: 375 mg corresponding to 307 mg of butyric acid. Bulking agents:

Cellulosa microcristallina, Sorbitolo Microcrystalline cellulose, Sorbitol

Agenti di rivestimento: Coating agents:

Gomma lacca, idrossipropilmetilcellulosa, Cellulosa microcristallina, Acidi grassi Shellac, hydroxypropylmethylcellulose, microcrystalline cellulose, fatty acids

Antiagglomeranti: Anti-caking agents:

Biossido di silicio, Sali di magnesio degli acidi grassi, Acidi grassi Stabilizzante: Silicon dioxide, Magnesium salts of fatty acids, Fatty acids Stabilizer:

Glicerolo Glycerol

Colorante: Dye:

Biossido di titanio Titanium dioxide

Aroma: Aroma:

vario varied

ESEMPIO N°2 EXAMPLE N ° 2

Forma Farmaceutica: Compresse Pharmaceutical form: Tablets

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco): 400 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract): 400 mg

Butirrato di sodio: 750 mg corrispondente a 614 mg di acido butirrico. Agenti di carica: Sodium butyrate: 750 mg corresponding to 614 mg of butyric acid. Bulking agents:

Cellulosa microcristallina, Sorbitolo Microcrystalline cellulose, Sorbitol

Agenti di rivestimento: Coating agents:

Gomma lacca, idrossipropilmetilcellulosa, Cellulosa microcristallina, Acidi grassi Shellac, hydroxypropylmethylcellulose, microcrystalline cellulose, fatty acids

Antiagglomeranti: Anti-caking agents:

Biossido di silicio, Sali di magnesio degli acidi grassi, Acidi grassi Stabilizzante: Silicon dioxide, Magnesium salts of fatty acids, Fatty acids Stabilizer:

Glicerolo Glycerol

Colorante: Dye:

Biossido di titanio Titanium dioxide

Aroma: Aroma:

vario varied

ESEMPIO N°3 EXAMPLE N ° 3

Forma Farmaceutica: Compresse Pharmaceutical form: Tablets

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco); 100 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract); 100 mg

Butirrato di sodio: 187 mg corrispondente a 153 mg di acido butirrico. Agenti di carica: Sodium butyrate: 187 mg corresponding to 153 mg of butyric acid. Bulking agents:

Cellulosa microcristallina, Sorbitolo Microcrystalline cellulose, Sorbitol

Agenti di rivestimento: Coating agents:

Gomma lacca, idrossipropilmetilcellulosa, Cellulosa microcristallina, Acidi grassi Shellac, hydroxypropylmethylcellulose, microcrystalline cellulose, fatty acids

Antiagglomeranti: Anti-caking agents:

Biossido di silicio, Sali di magnesio degli acidi grassi, Acidi grassi Stabilizzante: Silicon dioxide, Magnesium salts of fatty acids, Fatty acids Stabilizer:

Glicerolo Glycerol

Colorante: Dye:

Biossido di titanio; Titanium dioxide;

Aroma: Aroma:

vario varied

ESEMPIO N°4 EXAMPLE N ° 4

Forma Farmaceutica: Capsule Gastroresistenti Pharmaceutical Form: Gastroresistant Capsules

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco): 400 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract): 400 mg

Butirrato di sodio: 750 mg corrispondente a 614 mg di acido butirrico Antiagglomeranti: Sodium butyrate: 750 mg corresponding to 614 mg of butyric acid Anti-caking agents:

Biossido di silicio Silicon dioxide

Magnesio stearato Magnesium stearate

ESEMPIO N°5 EXAMPLE N ° 5

Forma Farmaceutica: Capsule Gastroresistenti Pharmaceutical Form: Gastroresistant Capsules

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco): 200 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract): 200 mg

Butirrato di sodio: 375 mg corrispondente a 307 mg di acido butirrico. Sodium butyrate: 375 mg corresponding to 307 mg of butyric acid.

Antiagglomeranti: Anti-caking agents:

Biossido di silicio Silicon dioxide

Magnesio stearato Magnesium stearate

ESEMPIO N°6 EXAMPLE N ° 6

Forma Farmaceutica: Capsule Gastroresistenti Pharmaceutical Form: Gastroresistant Capsules

Ingredienti: Ingredients:

Boswellia sacra (Boswellia Carter i Birdw., resina, gummi estratto secco); 100 mg Boswellia sacra (Boswellia Carter i Birdw., Resin, gummi dry extract); 100 mg

Butirrato di sodio: 187 mg corrispondente a 153 mg di acido butirrico. Sodium butyrate: 187 mg corresponding to 153 mg of butyric acid.

Antiagglomeranti: Anti-caking agents:

Biossido di silicio Silicon dioxide

Magnesio stearato Magnesium stearate

Claims (5)

RIVENDICAZIONI 1. Composizioni comprendenti acidi boswellici, incensolo, incensolo acetato, o estratti che li contengono in combinazione con acido butirrico o suoi sali dieteticamente accettabili. CLAIMS 1. Compositions comprising boswellic acids, incensol, incensol acetate, or extracts containing them in combination with butyric acid or its dietetically acceptable salts. 2. Composizioni secondo la rivendicazione 1 comprendenti estratto di Boswellia sacra e acido butirrico o suoi sali dieteticamente accettabili. 2. Compositions according to claim 1 comprising Boswellia sacra extract and butyric acid or dietetically acceptable salts thereof. 3. Composizioni secondo la rivendicazione 1 o 2 in forma di compresse, capsule o granulati gastroresistenti. 3. Compositions according to claim 1 or 2 in the form of gastro-resistant tablets, capsules or granulates. 4. Composizioni secondo una o più delle rivendicazioni da 1 a 3 comprendenti da 100 a 800 mg di estratto di Boswellia e da 100 a 1000 mg di acido butirrico o i suoi sali dieteticamente accettabili. 4. Compositions according to one or more of claims 1 to 3 comprising from 100 to 800 mg of Boswellia extract and from 100 to 1000 mg of butyric acid or its dietetically acceptable salts. 5. Composizioni delle rivendicazioni 1-4 per uso nel trattamento di infiammazioni croniche dell’intestino. 5. Compositions of claims 1-4 for use in the treatment of chronic inflammation of the intestine.
IT102018000005002A 2018-05-02 2018-05-02 COMPOSITIONS INCLUDING BOSWELLIA EXTRACTS AND BUTYRATES IT201800005002A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1790333A1 (en) * 2005-10-21 2007-05-30 Promefarm s.r.l. Gastroresistant tablet comprising a butyric acid compound
WO2008065666A2 (en) * 2006-11-29 2008-06-05 Yissum Research Development Company Of The Hebrew University Of Jerusalem, Ltd. Uses of incensole, incensole acetate and derivatives thereof
WO2012013495A1 (en) * 2010-07-29 2012-02-02 Cosmo Technologies Ltd. Pharmaceutical and/or dietary compositions based on short chain fatty acids
EP2444081A1 (en) * 2010-10-19 2012-04-25 Parenteral, A.S. A composition for the treatment of inflammatory diseases comprising boswellic acids and cannabidiol
WO2015048395A1 (en) * 2013-09-26 2015-04-02 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Tolerogenic dendritic cells to treat inflammatory bowel disease

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1790333A1 (en) * 2005-10-21 2007-05-30 Promefarm s.r.l. Gastroresistant tablet comprising a butyric acid compound
WO2008065666A2 (en) * 2006-11-29 2008-06-05 Yissum Research Development Company Of The Hebrew University Of Jerusalem, Ltd. Uses of incensole, incensole acetate and derivatives thereof
WO2012013495A1 (en) * 2010-07-29 2012-02-02 Cosmo Technologies Ltd. Pharmaceutical and/or dietary compositions based on short chain fatty acids
EP2444081A1 (en) * 2010-10-19 2012-04-25 Parenteral, A.S. A composition for the treatment of inflammatory diseases comprising boswellic acids and cannabidiol
WO2015048395A1 (en) * 2013-09-26 2015-04-02 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Tolerogenic dendritic cells to treat inflammatory bowel disease

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