ITMI20091142A1 - ASSOCIATIONS INCLUDING EXTRACTS FROM VALERIANA, ESCHSCHOLZIA AND BIANCOSPINO AND THEIR FORMULATIONS FOR THE TREATMENT AND PREVENTION OF THE DISORDERS RELATED TO SLOW / MODERATE INSOMNIA, ASSOCIATED WITH ANXIETY, TACHYCARDY AND VISCERAL SIZING - Google Patents
ASSOCIATIONS INCLUDING EXTRACTS FROM VALERIANA, ESCHSCHOLZIA AND BIANCOSPINO AND THEIR FORMULATIONS FOR THE TREATMENT AND PREVENTION OF THE DISORDERS RELATED TO SLOW / MODERATE INSOMNIA, ASSOCIATED WITH ANXIETY, TACHYCARDY AND VISCERAL SIZING Download PDFInfo
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- ITMI20091142A1 ITMI20091142A1 IT001142A ITMI20091142A ITMI20091142A1 IT MI20091142 A1 ITMI20091142 A1 IT MI20091142A1 IT 001142 A IT001142 A IT 001142A IT MI20091142 A ITMI20091142 A IT MI20091142A IT MI20091142 A1 ITMI20091142 A1 IT MI20091142A1
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 description 1
- 235000020769 valeriana extract Nutrition 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Classifications
-
- 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)
- A61K36/73—Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
- A61K36/734—Crataegus (hawthorn)
-
- 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)
- A61K36/66—Papaveraceae (Poppy family), e.g. bloodroot
-
- 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)
- A61K36/84—Valerianaceae (Valerian family), e.g. valerian
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Medicinal Chemistry (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
Description
- - anc ett racco no a s.r.. - - also racco no to s.r ..
Bianchetti Giuseppe ed altri 8856 M Descrizione del brevetto per invenzione industriale avente per titolo: Bianchetti Giuseppe and others 8856 M Description of the patent for industrial invention entitled:
MaB/mg “ASSOCIAZIONI COMPRENDENTI ESTRATTI DI VALERIANA, MaB / mg "ASSOCIATIONS INCLUDING VALERIANA EXTRACTS,
ESCHSCHOLZIA E BIANCOSPINO E RELATIVE FORMULAZIONI ESCHSCHOLZIA AND HAWTHORN AND RELATED FORMULATIONS
PER IL TRATTAMENTO E LA PREVENZIONE DEI DISTURBI FOR THE TREATMENT AND PREVENTION OF DISORDERS
LEGATI AD INSONNIA LIEVE/MODERATA, ASSOCIATA AD RELATED TO Mild / MODERATE INSOMNIA, ASSOCIATED WITH
ANSIA, TACHICARDIA E SOMATIZZAZIONI VISCERALI” a nome : AXIOMA s.r.l. ANXIETY, TACHY AND VISCERAL SOMATIZATIONS "in the name: AXIOMA s.r.l.
con sede in : Torino based in: Turin
* * * * * *
La presente invenzione ha per oggetto associazioni comprendenti estratti di valeriana, eschscholzia e biancospino e relative formulazioni per il trattamento e la prevenzione dei disturbi legati ad insonnia lieve/moderata, associata ad ansia, tachicardia e somatizzazioni viscerali. The present invention relates to combinations comprising extracts of valerian, eschscholzia and hawthorn and relative formulations for the treatment and prevention of disorders related to mild / moderate insomnia, associated with anxiety, tachycardia and visceral somatization.
BACKGROUND TECNICO TECHNICAL BACKGROUND
I disturbi del sonno sono frequentissimi ed arrivano a manifestarsi, a vario grado, nel 75% dei soggetti adulti e nel 30% circa dei soggetti sotto i 12 anni d’età. Sleep disorders are very frequent and occur, to varying degrees, in 75% of adults and in about 30% of subjects under 12 years of age.
La terapia farmacologica classica da sempre propone l’impiego delle benzodiazepine da sole o formulate con altri ansiolitici e/o spasmolitici e/o miorilassanti. Classic drug therapy has always proposed the use of benzodiazepines alone or formulated with other anxiolytics and / or spasmolytics and / or muscle relaxants.
Il massiccio ricorso a questi composti, giustificabile in termini di risultati clinico ottenuti (successo terapeutico intorno all’85-90% dei casi trattati), ha comunque messo in luce la comparsa di evidenti effetti collaterali: dipendenza, sonnolenza al mattino, effetti rebound alla sospensione, impossibilità di impiego in gravidanza. The massive use of these compounds, justifiable in terms of clinical results obtained (therapeutic success around 85-90% of cases treated), has however highlighted the appearance of evident side effects: addiction, sleepiness in the morning, rebound effects at the suspension, impossibility of use during pregnancy.
Molto spesso inoltre il disturbo del sonno è più complesso e, soprattutto se non eccessivamente severo, si accompagna ad altri fenomeni diurni come la tachicardia, il senso di oppressione al torace, manifestazioni di colite addominale di tipo spastico, ansia. Very often, sleep disturbance is more complex and, especially if not excessively severe, is accompanied by other diurnal phenomena such as tachycardia, a sense of oppression in the chest, manifestations of spastic abdominal colitis, anxiety.
Per contrastare tale complessità di disturbi è opportuno formulare servendosi di ingredienti capaci di contrastare la molteplicità di tali aspetti. To counteract this complexity of disturbances it is appropriate to formulate using ingredients capable of counteracting the multiplicity of these aspects.
Valeriana officinalis Valeriana officinalis
L’uso dell’estratto di Valeriana officinalis per il trattamento dell’insonnia da lieve a moderata e dell’ansia è assolutamente consolidato. Ma non sempre il responso clinico ne ha avvalorato però l’uso. The use of Valeriana officinalis extract for the treatment of mild to moderate insomnia and anxiety is absolutely consolidated. But the clinical response has not always supported its use.
Questo in relazione e dipendenza di almeno 3 parametri che vanno considerati come obbligatori e che, se non rispettati, inficiano l’attività clinica del prodotto: This is in relation to and depending on at least 3 parameters which must be considered as mandatory and which, if not respected, affect the clinical activity of the product:
- la qualità dell’estratto usato; - the quality of the extract used;
- il dosaggio impiegato; - the dosage used;
- l’assorbimento dei composti attivi. - the absorption of active compounds.
In termini di qualità, l’estratto più documentato risponde alla standardizzazione e titolazione presente in molte Farmacopee Europee (0,8% acidi valerenici). In terms of quality, the most documented extract responds to the standardization and titration present in many European Pharmacopoeias (0.8% valerenic acids).
In termini di dosaggio (efficaci quanto una benzodiazepina ma senza effetti collaterali evidenti) sono inoltre necessari almeno 300 mg/dose di estratto. Alcuni preparati di grado farmaceutico impiegano addirittura 2 compresse da 300 mg al giorno. In terms of dosage (as effective as a benzodiazepine but with no obvious side effects) at least 300 mg / dose of extract is also needed. Some pharmaceutical grade preparations even use 2 tablets of 300 mg per day.
Il terzo parametro è senza dubbio più complesso. La frazione attiva dell’estratto risiede nella quota di acidi valerenici. Questi, somministrati senza modifiche galeniche di rilascio, devono essere assunti fino a 2 ore prima di coricarsi. The third parameter is undoubtedly more complex. The active fraction of the extract resides in the amount of valerenic acids. These, administered without galenic release changes, should be taken up to 2 hours before bedtime.
Inoltre, in quanto acidi il loro assorbimento è comunque anche, e soprattutto, gastrico. L’assorbimento gastrico, se rispettato, consente grande rapidità (ad esempio analgesici/antinfiammatori) d’azione: infatti la quota in acidi valerenici raggiunge la circolazione plasmatica nell’arco dei 15-20 minuti (se il prodotto viene assunto a stomaco vuoto, a partire da 60 min dopo la fine del pasto). Furthermore, as they are acids, their absorption is also, and above all, gastric. Gastric absorption, if respected, allows great rapidity (for example analgesics / anti-inflammatories) of action: in fact the amount of valerenic acids reaches the plasma circulation within 15-20 minutes (if the product is taken on an empty stomach, starting from 60 min after the end of the meal).
Per ottenere il rilascio degli acidi valerenici in area gastrica è necessario impiegare uno sviluppo galenico di prodotto a matrice (con opportuni eccipienti) con conseguenti tempi di rilascio non inferiori ai 2 minuti (la rapida disgregazione della compressa determinerebbe disgusto nel soggetto per l’odore di zolfo caratteristico dell’estratto) e non superiori ai 5 minuti circa (per ottenere il 100% dell’assorbimento gastrico). To obtain the release of valerenic acids in the gastric area it is necessary to use a galenic development of a matrix product (with suitable excipients) with consequent release times of not less than 2 minutes (the rapid disintegration of the tablet would cause disgust in the subject for the smell of characteristic sulfur of the extract) and no longer than about 5 minutes (to obtain 100% gastric absorption).
Eschscholtzia californica Eschscholtzia californica
La Eschscholtzia californica, pianta di origine californiana comunemente nota come eschscholzia, è caratterizzata chimicamente per il suo contenuto in flavonoidi e alcaloidi ad azione sedante, antinevralgica ed antispastica. Eschscholtzia californica, a plant of Californian origin commonly known as eschscholzia, is chemically characterized by its content in flavonoids and alkaloids with sedating, antineuralgic and antispastic action.
L’uso tradizionale come miorilassante ed antispastico, confermato dai risultati ottenuti in farmacologia e in clinica, e la ben dimostrata azione sedante (centrale) dell’eschscholzia fanno di questa pianta un elemento fondamentale nel trattamento dell’ansia e dei disturbi ad essa correlabili (spasmi addominali, tachicardia, etc.). The traditional use as a muscle relaxant and antispasmodic, confirmed by the results obtained in pharmacology and in the clinic, and the well-demonstrated sedating action (central) of eschscholzia make this plant a fundamental element in the treatment of anxiety and related disorders ( abdominal spasms, tachycardia, etc.).
Crataegus oxyacantha Crataegus oxyacantha
E’ una pianta – il biancospino - utilizzata da sempre in medicina tradizionale come ansiolitico, anti-tachicardico e nel trattamento dell’insonnia. It is a plant - hawthorn - which has always been used in traditional medicine as an anxiolytic, anti-tachycardic and in the treatment of insomnia.
DESCRIZIONE DELL’INVENZIONE DESCRIPTION OF THE INVENTION
Oggetto della presente invenzione è di fornire una associazione che risulti efficace nella prevenzione e nel trattamento dei disturbi legati ad insonnia lieve/moderata, associata ad ansia, tachicardia e somatizzazioni viscerali. The object of the present invention is to provide an association which is effective in the prevention and treatment of disorders related to mild / moderate insomnia, associated with anxiety, tachycardia and visceral somatization.
Un ulteriore oggetto dell’invenzione è di fornire una forma orale per la somministrazione di tali associazioni. A further object of the invention is to provide an oral form for the administration of such associations.
È stato ora trovato che una associazione comprendente estratti di valeriana, eschscholzia e biancospino risulta estremamente efficace per la prevenzione e il trattamento dei disturbi legati ad insonnia lieve/moderata, associata ad ansia, tachicardia e somatizzazioni viscerali. It has now been found that a combination comprising extracts of valerian, eschscholzia and hawthorn is extremely effective for the prevention and treatment of disorders related to mild / moderate insomnia, associated with anxiety, tachycardia and visceral somatization.
Pertanto, la presente invenzione ha per oggetto associazioni comprendenti estratti di valeriana, eschscholzia e biancospino, e le relative forme orali. Therefore, the present invention relates to combinations comprising extracts of valerian, eschscholzia and hawthorn, and the related oral forms.
Secondo aspetto preferito, la presente invenzione ha per oggetto compresse a rilascio rapido o multi-strato, dove almeno lo strato contenente valeriana sia a rapido rilascio, per la prevenzione e il trattamento dei disturbi legati ad insonnia lieve/moderata, associata ad ansia, tachicardia e somatizzazioni viscerali. According to preferred aspect, the present invention relates to fast-release or multi-layer tablets, where at least the layer containing valerian is fast-release, for the prevention and treatment of disorders related to mild / moderate insomnia, associated with anxiety, tachycardia and visceral somatizations.
Più particolarmente, la presente invenzione ha per oggetto associazioni comprendenti: More particularly, the present invention relates to associations comprising:
a) estratto di Valeriana officinalis; a) Valeriana officinalis extract;
b) estratto di Eschscholtzia californica; b) Eschscholtzia californica extract;
c) estratto di Crataegus oxyacantha; c) Crataegus oxyacantha extract;
per la prevenzione e il trattamento dei disturbi legati ad insonnia lieve/moderata, associata ad ansia, tachicardia e somatizzazioni viscerali. for the prevention and treatment of disorders related to mild / moderate insomnia, associated with anxiety, tachycardia and visceral somatization.
Secondo un aspetto preferito, le associazioni della presente invenzione comprenderanno i vari componenti entro le seguenti quantità espresse come mg/unità di dosaggio: According to a preferred aspect, the combinations of the present invention will comprise the various components within the following amounts expressed as mg / dosage unit:
a) estratto di Valeriana officinalis: tra 10 e 2000 mg; a) Valeriana officinalis extract: between 10 and 2000 mg;
b) estratto di Eschscholtzia californica: tra 5 e 1000 mg; b) Eschscholtzia californica extract: between 5 and 1000 mg;
c) estratto di Crataegus oxyacantha: tra 10 e 2000 mg. c) Crataegus oxyacantha extract: between 10 and 2000 mg.
Secondo un aspetto particolarmente preferito, le associazioni della presente invenzione comprenderanno i vari componenti nelle seguenti quantità espresse come mg/unità di dosaggio: According to a particularly preferred aspect, the combinations of the present invention will comprise the various components in the following quantities expressed as mg / dosage unit:
a) estratto di Valeriana officinalis: 100 mg; a) Valeriana officinalis extract: 100 mg;
b) estratto di Eschscholtzia californica: 80 mg; b) Eschscholtzia californica extract: 80 mg;
c) estratto di Crataegus oxyacantha: 100 mg. c) Crataegus oxyacantha extract: 100 mg.
Le associazioni dell’invenzione si dimostrano dotate di un’efficacia ottimale in termini di attività clinica dimostrata, grazie all’inattesa azione sinergica tra i vari componenti. The associations of the invention prove to be endowed with optimal efficacy in terms of demonstrated clinical activity, thanks to the unexpected synergistic action between the various components.
A questo riguardo è in particolare noto (Hanus et al.; 2004; Curr Med Res Opin; 20(1): 63-71) che l’associazione di 20 mg/dose di escolzia con 75 mg/dose di biancospino, associati inoltre a 75 mg/dose di magnesio, riduce del 40-60% i segni clinici di ansia e delle somatizzazioni ad essa associate (valori di riduzione ottenuti tramite somministrazione di placebo: 30-40%) senza influenzare, in maniera terapeutica, le problematiche legate all’insonnia e ai tempi di addormentamento. E’ altresì noto che l’impiego di valeriana, assolutamente non ipno-inducente (cioè non in grado di provocare addormentamento), è in grado invece di modificare, in termini terapeutici, la qualità del sonno riducendo il numero di risvegli possibili del 30-50% (valori ottenuti con placebo tra il 20-30%; Autori vari). In this regard it is known in particular (Hanus et al .; 2004; Curr Med Res Opin; 20 (1): 63-71) that the association of 20 mg / dose of escolzia with 75 mg / dose of hawthorn, also associated at 75 mg / dose of magnesium, it reduces the clinical signs of anxiety and associated somatizations by 40-60% (reduction values obtained by administering placebo: 30-40%) without affecting, in a therapeutic way, the related problems insomnia and times of falling asleep. It is also known that the use of valerian, which is absolutely not hypno-inducing (i.e. not capable of causing sleep), is instead able to modify, in therapeutic terms, the quality of sleep by reducing the number of possible awakenings by 30- 50% (values obtained with placebo between 20-30%; Various authors).
Abbiamo invece rilevato che l’associazione descritta, con formula galenica a rapido rilascio, dei 3 attivi (con incremento dei dosaggi di biancospino ed escolzia rispettivamente a 100 e 80 mg/dose e senza la presenza del magnesio) incrementa di un ulteriore 25% l’azione contro i parametri di ansia e somatizzazioni ad essa correlati (i valori del placebo invece non si modificano) e consente di incidere anche sui tempi di addormentamento, agendo come ipno-inducente, che vengono ridotti del 75% (valori ottenuti placebo: 0-5%). Inoltre l’azione terapeutica in favore della qualità del sonno misurata come numero di risvegli notturni viene ad essere ulteriormente favorita e nell’85% dei soggetti testati si assiste alla totale scomparsa (0) del numero di risvegli notturni (valore placebo da 2 a 4). On the other hand, we found that the described association, with a quick-release galenic formula, of the 3 active ingredients (with an increase in the dosages of hawthorn and escolzia respectively at 100 and 80 mg / dose and without the presence of magnesium) increases by a further 25%. action against anxiety parameters and related somatizations (the values of the placebo instead do not change) and allows you to also affect the times of falling asleep, acting as a hypno-inducer, which are reduced by 75% (values obtained placebo: 0 -5%). Furthermore, the therapeutic action in favor of the quality of sleep measured as the number of nocturnal awakenings is further favored and in 85% of the tested subjects there is a total disappearance (0) of the number of nocturnal awakenings (placebo value from 2 to 4 ).
Secondo un aspetto preferito dell’invenzione, i vari componenti possono essere presenti in forma di estratto o come ingredienti attivi in esso contenuti. According to a preferred aspect of the invention, the various components can be present in the form of an extract or as active ingredients contained therein.
Secondo un aspetto preferito dell’invenzione, gli estratti presenti nelle associazioni della presente invenzione saranno presenti in forma di complessi con un fosfolipide di soia, come lecitine, fosfatidilcolina, fosfatidiletanolammina, fosfatidilserina e simili, in particolare distearoilfosfatidilicolina di soia. Questi complessi, noti come fitosomi, sono descritti, per esempio, in EP 441 279 e disponibili commercialmente sotto la denominazione commerciale di Fitosoma®. According to a preferred aspect of the invention, the extracts present in the associations of the present invention will be present in the form of complexes with a soy phospholipid, such as lecithins, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and the like, in particular soy distearoylphosphatidylcholine. These complexes, known as phytosomes, are described, for example, in EP 441 279 and commercially available under the trade name of Fitosoma®.
La porzione lipofila di tale complesso, il fosfolipide della soia, permette una migliore interazione dell’ingrediente attivo con gli acidi colici preposti all’emulsione e alla cattura delle sostanze da veicolare, per assorbimento, alla circolazione sistemica. Studi tossicologici eseguiti sull’animale e farmacocinetici sull’uomo hanno in effetti dimostrato la mancanza di tossicità e il maggiore assorbimento dell’ingrediente somministrato come fitosoma rispetto all’ingrediente somministrato in forma libera. The lipophilic portion of this complex, the soy phospholipid, allows a better interaction of the active ingredient with the cholic acids responsible for emulsifying and capturing the substances to be conveyed, by absorption, to the systemic circulation. Toxicological studies performed on animals and pharmacokinetics on humans have in fact demonstrated the lack of toxicity and greater absorption of the ingredient administered as a phytosome compared to the ingredient administered in free form.
Inoltre, la presente invenzione ha per oggetto formulazioni solide orali, in forma di compresse interamente a rapido rilascio, o multi-strato dove lo strato con valeriana sia a rapido rilascio, secondo i dosaggi sopra descritti e gli esempi in seguito riportati. Furthermore, the present invention relates to solid oral formulations, in the form of fully rapid-release or multi-layer tablets where the layer with valerian is rapid-release, according to the dosages described above and the examples reported below.
Secondo un aspetto preferito della presente invenzione, le composizioni in oggetto potranno contenere componenti addizionali, ad azione curativa, o complementare, o comunque utile ai fini che l’invenzione si propone. According to a preferred aspect of the present invention, the compositions in question may contain additional components, with a curative or complementary action, or in any case useful for the purposes of the invention.
Componenti addizionali potranno essere oligoelementi come magnesio, manganese, potassio, selenio, cromo, boro, calcio, fluoro, iodio, rame e ferro. Oppure vitamine (gruppo B oppure A, C, E, K, F, PP); donatori di metili come la betaina, il SAMe o la dimetil-glicina; estratti da piante alimentari o medicinali come quelle ad elevato contenuto in polifenoli (vite, mirtillo, tè, cardo mariano, picnogenolo). Additional components could be trace elements such as magnesium, manganese, potassium, selenium, chromium, boron, calcium, fluorine, iodine, copper and iron. Or vitamins (group B or A, C, E, K, F, PP); methyl donors such as betaine, SAMe or dimethyl-glycine; extracts from food or medicinal plants such as those with a high content of polyphenols (grapevine, blueberry, tea, milk thistle, pycnogenol).
Sebbene le compresse a rapido rilascio o multi-strato costituiscano uno specifico oggetto della presente invenzione, le associazioni in oggetto potranno eventualmente essere formulate in una qualunque forma adatta alla somministrazione orale, ad esempio come capsule di gelatina dura o molle, compresse, compresse effervescenti o masticabili, granulari o polveri in bustina, forme solide a rilascio controllato, gomme da masticare e simili; e saranno preparate secondo metodi convenzionali ben noti in tecnica farmaceutica, come quelli descritti in “Remington’s Pharmaceutical Handbook”, Mack Publishing Co., N.Y., USA, utilizzando eccipienti, diluenti, agenti di carica, antiagglomeranti accettabili per il loro uso finale. Although the fast-release or multi-layer tablets constitute a specific object of the present invention, the combinations in question may optionally be formulated in any form suitable for oral administration, for example as hard or soft gelatin capsules, tablets, effervescent tablets or chewable, granular or powder sachets, controlled release solid forms, chewing gums and the like; and will be prepared according to conventional methods well known in the pharmaceutical technique, such as those described in "Remington's Pharmaceutical Handbook", Mack Publishing Co., N.Y., USA, using acceptable excipients, diluents, bulking agents, anti-caking agents for their final use.
Esempi di eccipienti convenzionali, adatti al rilascio immediato sono agenti leganti, quali polivinilpirrolidone, carbossimetilcellulosa, cellulosa micro-cristallina, lattosio, saccarosio, mannitolo, gomma arabica, pectina, gelatina e simili; agenti disintegranti, quali sodio croscarmellosio, amido, sorbitolo, sodio amido glicolato, alginati, polivinilpirrolidone e simili; lubrificanti, quali talco, magnesio stearato, acido stearico, gel di silice e simili; diluenti e glidanti, quali fosfato di calcio, biossido di silicio, amido, talco e simili; agenti di rivestimento, quali sodio carbossilmetilcellulosa, cere, gelatina, shellac, biossido di titanio e simili; aromi e agenti edulcoranti, quali acesulfame potassio e simili. Examples of conventional excipients suitable for immediate release are binding agents, such as polyvinylpyrrolidone, carboxymethylcellulose, micro-crystalline cellulose, lactose, sucrose, mannitol, gum arabic, pectin, gelatin and the like; disintegrating agents, such as croscarmellose sodium, starch, sorbitol, sodium starch glycolate, alginates, polyvinylpyrrolidone and the like; lubricants, such as talc, magnesium stearate, stearic acid, silica gel and the like; diluents and glidants, such as calcium phosphate, silicon dioxide, starch, talc and the like; coating agents, such as sodium carboxylmethylcellulose, waxes, gelatin, shellac, titanium dioxide and the like; flavorings and sweetening agents, such as acesulfame potassium and the like.
Esempi di eccipienti convenzionali, adatti al rilascio prolungato sono agenti ritardanti, quali etilcellulosa, metilcellulosa, polivinilacetato, esteri dell’acido metacrilico, cellulosa acetato, alcoli grassi, esteri glicerici di acidi grassi, paraffina, gomme naturali e oli vegetali idrogenati, oltre agli eccipienti convenzionali sopra menzionati. Examples of conventional excipients suitable for prolonged release are retarding agents, such as ethylcellulose, methylcellulose, polyvinyl acetate, esters of methacrylic acid, cellulose acetate, fatty alcohols, glyceric esters of fatty acids, paraffin, natural gums and hydrogenated vegetable oils, in addition to excipients conventional ones mentioned above.
ESEMPI FORMULATIVI (mg/dose) FORMULATIVE EXAMPLES (mg / dose)
ESEMPIO 1 - COMPRESSE A RILASCIO RAPIDO Valeriana estratto: 100 mg EXAMPLE 1 - QUICK RELEASE TABLETS Valerian extract: 100 mg
Biancospino estratto: 100 mg Hawthorn extract: 100 mg
Escolzia estratto: 80 mg Escolzia extract: 80 mg
ESEMPIO 2 - COMPRESSE BISTRATO EXAMPLE 2 - TWO-LAYER TABLETS
1° strato a rilascio rapido (2-4 min) 1st layer quick release (2-4 min)
Valeriana estratto: 100 mg Valerian extract: 100 mg
2° strato a rilascio normale (30-45 min) Biancospino estratto 100 mg 2nd layer normal release (30-45 min) Hawthorn extract 100 mg
Escolzia estratto 80 mg Escolzia extract 80 mg
ESEMPIO 3 - BUSTINE ORO-SOLUBILI Valeriana estratto: 100 mg EXAMPLE 3 - GOLD-SOLUBLE SACHETS Valerian extract: 100 mg
Biancospino estratto: 100 mg Hawthorn extract: 100 mg
Escolzia estratto: 80 mg Escolzia extract: 80 mg
Magnesio (forma organica): 150% RDA Vitamina B6: 150% RDA ESEMPIO 4 – CAPSULE DI GELATINA MOLLE Valeriana estratto: 50 mg Magnesium (organic form): 150% RDA Vitamin B6: 150% RDA EXAMPLE 4 - SOFT JELLY CAPSULES Valerian extract: 50 mg
Biancospino Fitosoma estratto: 150 mg Hawthorn Phytosome extract: 150 mg
Escolzia estratto: 40 mg Escolzia extract: 40 mg
Magnesio (forma organica): 150% RDA Magnesium (organic form): 150% RDA
Selenio (forma organica): 150% RDA Selenium (organic form): 150% RDA
Vitamina B6: 150% RDA Vitamin B6: 150% RDA
ESEMPIO 5 - DISCOIDE GOMMOSO EXAMPLE 5 - RUBBER DISC
Valeriana estratto: 25 mg Valerian extract: 25 mg
Biancospino estratto: 20 mg Hawthorn extract: 20 mg
Escolzia estratto: 10 mg Escolzia extract: 10 mg
Magnesio (forma organica): 150% RDA Magnesium (organic form): 150% RDA
Vitamina B6: 150% RDA Vitamin B6: 150% RDA
ESEMPIO 6 - BUSTINE DA SCIOGLIERE IN ACQUA Valeriana estratto: 100 mg EXAMPLE 6 - SACHETS TO BE MELTED IN WATER Valerian extract: 100 mg
Biancospino estratto: 100 mg Hawthorn extract: 100 mg
Escolzia estratto: 80 mg Escolzia extract: 80 mg
Vitamina B6: 150% RDA Dimetilglicina: 250 mg Vitamin B6: 150% RDA Dimethylglycine: 250 mg
Claims (11)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001142A ITMI20091142A1 (en) | 2009-06-29 | 2009-06-29 | ASSOCIATIONS INCLUDING EXTRACTS FROM VALERIANA, ESCHSCHOLZIA AND BIANCOSPINO AND THEIR FORMULATIONS FOR THE TREATMENT AND PREVENTION OF THE DISORDERS RELATED TO SLOW / MODERATE INSOMNIA, ASSOCIATED WITH ANXIETY, TACHYCARDY AND VISCERAL SIZING |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT001142A ITMI20091142A1 (en) | 2009-06-29 | 2009-06-29 | ASSOCIATIONS INCLUDING EXTRACTS FROM VALERIANA, ESCHSCHOLZIA AND BIANCOSPINO AND THEIR FORMULATIONS FOR THE TREATMENT AND PREVENTION OF THE DISORDERS RELATED TO SLOW / MODERATE INSOMNIA, ASSOCIATED WITH ANXIETY, TACHYCARDY AND VISCERAL SIZING |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ITMI20091142A1 true ITMI20091142A1 (en) | 2010-12-30 |
Family
ID=41478980
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT001142A ITMI20091142A1 (en) | 2009-06-29 | 2009-06-29 | ASSOCIATIONS INCLUDING EXTRACTS FROM VALERIANA, ESCHSCHOLZIA AND BIANCOSPINO AND THEIR FORMULATIONS FOR THE TREATMENT AND PREVENTION OF THE DISORDERS RELATED TO SLOW / MODERATE INSOMNIA, ASSOCIATED WITH ANXIETY, TACHYCARDY AND VISCERAL SIZING |
Country Status (1)
| Country | Link |
|---|---|
| IT (1) | ITMI20091142A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2143275C1 (en) * | 1999-05-06 | 1999-12-27 | Общество с ограниченной ответственностью "Доктор Н" | Homeopathic drug "valeriana-plus multigran" for treatment of patients with insomnia and increased nervous excitability |
| FR2878163A1 (en) * | 2004-11-25 | 2006-05-26 | R & D Pharma | Compositions, useful to treat anxiety, comprise active ingredients of Eschscholtzia extract with Valerian extract, in association with a vehicle for oral administration of distinct dosages and for day or night administration |
-
2009
- 2009-06-29 IT IT001142A patent/ITMI20091142A1/en unknown
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2143275C1 (en) * | 1999-05-06 | 1999-12-27 | Общество с ограниченной ответственностью "Доктор Н" | Homeopathic drug "valeriana-plus multigran" for treatment of patients with insomnia and increased nervous excitability |
| FR2878163A1 (en) * | 2004-11-25 | 2006-05-26 | R & D Pharma | Compositions, useful to treat anxiety, comprise active ingredients of Eschscholtzia extract with Valerian extract, in association with a vehicle for oral administration of distinct dosages and for day or night administration |
Non-Patent Citations (1)
| Title |
|---|
| ABASCAL K ET AL: "Nervine herbs for treating anxiety", ALTERNATIVE AND COMPLEMENTARY THERAPIES, MARY ANN LIEBERT, LARCHMONT, NY, US, vol. 10, no. 6, 1 December 2004 (2004-12-01), pages 309 - 315, XP009110219, ISSN: 1076-2809 * |
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