ITGE20060013A1 - preparation based on á-lactalbumin - Google Patents
preparation based on á-lactalbumin Download PDFInfo
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- ITGE20060013A1 ITGE20060013A1 ITGE20060013A ITGE20060013A1 IT GE20060013 A1 ITGE20060013 A1 IT GE20060013A1 IT GE20060013 A ITGE20060013 A IT GE20060013A IT GE20060013 A1 ITGE20060013 A1 IT GE20060013A1
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- lactalbumin
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- tryptophan
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Description
DESCRIZIONE del brevetto per invenzione industriale avente per titolo: “Preparazioni a base di a-lactalbumina”, DESCRIPTION of the patent for industrial invention entitled: "Preparations based on a-lactalbumin",
TESTO DELLA DESCRIZIONE TEXT OF THE DESCRIPTION
La presente invenzione riguarda l’uso di alactalbumina in delle preparazioni, sia di tipo farmaceutico che non farmaceutico, ed in particolare riguarda l’uso di alactalbumina per la fabbricazione di un farmaco per il trattamento di patologie neurologiche e psichiatriche. The present invention relates to the use of alactalbumin in preparations, both pharmaceutical and non-pharmaceutical, and in particular concerns the use of alactalbumin for the manufacture of a drug for the treatment of neurological and psychiatric diseases.
Diversi disturbi neuropsichiatrici sono connessi a squilibri nella produzione cerebrale di serotonina, un importante mediatore molecolare della neurotrasmissione cerebrale nella zona limbica paramediana del cervello, al quale è riconosciuta una importante azione nella zona extrapiramidale, e che è responsabile di numerosi processi fisiologici e comportamentali. Several neuropsychiatric disorders are connected to imbalances in the cerebral production of serotonin, an important molecular mediator of cerebral neurotransmission in the paramedian limbic zone of the brain, which is recognized as having an important action in the extrapyramidal zone, and which is responsible for numerous physiological and behavioral processes.
Le recenti conoscenze della neurofarmacologia della serotonina nel sistema nervoso centrale hanno portato allo sviluppo di agenti farmacologici e farmaci (inibitori selettivi del reuptake della serotonina: SSRI) in grado di interagire con il sistema serotoninergico: bloccando il reuptake cellulare tali farmaci aumentano la disponibilità della serotonina nelle sinapsi. Recent knowledge of the neuropharmacology of serotonin in the central nervous system has led to the development of pharmacological agents and drugs (selective serotonin reuptake inhibitors: SSRIs) capable of interacting with the serotonergic system: by blocking cellular reuptake these drugs increase the availability of serotonin in the synapses.
La serotonina è implicata nei disturbi neuropsichiatrici tipici del Parkinson, della Corea di Huntington e in alcune forme di malattie cerebrovascolari. Gli SSRI sono usati in queste patologie per curare la depressione, l’ansia, la psicosi dopaminamimetica, l’instabilità emozionale, i disturbi compulsivi-ossessivi ed il suicido. Si sono dimostrati efficaci anche nell’emotività in seguito ad infarto cerebrale. Serotonin is implicated in neuropsychiatric disorders typical of Parkinson's, Huntington's and some forms of cerebrovascular disease. SSRIs are used in these pathologies to treat depression, anxiety, dopaminamimetic psychosis, emotional instability, compulsive-obsessive disorders and suicide. They have also been shown to be effective in emotionality following a cerebral infarction.
Nonostante gli SSRI fossero considerati come favorenti crisi epilettiche, recentemente sono stati utilizzati con successo nell’epilessie, dimostrando il coinvolgimento del sistema serotoninergico nella patogenesi dell’epilessia. Although SSRIs were considered as favoring epileptic seizures, they have recently been successfully used in epilepsies, demonstrating the involvement of the serotonergic system in the pathogenesis of epilepsy.
La serotonina viene sintetizzata nel cervello esclusivamente dal triptofano, amminoacido essenziale che viene assunto con la dieta. Il triptofano compete con gli altri amminoacidi neutri (Large Neutral Amino Acids: LNAA), che sono tirosina, vaiina, metionina, isoleucina, leucina e fenilalanina, per il passaggio della barriera emato-encefalica, pertanto la capacità del triptofano di entrare nel sistema nervoso centrale dipenderà dal rapporto tra la sua concentrazione e quella degli altri LNAA competitori. Serotonin is synthesized in the brain exclusively from tryptophan, an essential amino acid that is consumed in the diet. Tryptophan competes with the other neutral amino acids (Large Neutral Amino Acids: LNAA), which are tyrosine, goine, methionine, isoleucine, leucine and phenylalanine, for the passage of the blood-brain barrier, therefore the ability of tryptophan to enter the nervous system central will depend on the relationship between its concentration and that of other competing LNAAs.
In base ai valori di concentrazione plasmatici di questi amminoacidi, con i dati di studio cinetici su animali, è possibile stimare la velocità di uptake cerebrale dei singoli LNAA. Based on the plasma concentration values of these amino acids, with the kinetic study data on animals, it is possible to estimate the cerebral uptake rate of the individual LNAAs.
Da uno studio dei ricercatori che hanno realizzato la presente invenzione risulta che la velocità di uptake cerebrale del triptofano nei pazienti epilettici esaminati è di circa un terzo rispetto a quella dei controlli. La minor disponibilità di triptofano cerebrale porta ad una minore disponibilità di serotonina cerebrale, pertanto una causa dismetabolica nell’assorbimento intestinale delle proteine porterebbe ad una patologia cerebrale. From a study by the researchers who carried out the present invention it appears that the cerebral uptake rate of tryptophan in the epileptic patients examined is about one third compared to that of the controls. The lower availability of cerebral tryptophan leads to a lower availability of cerebral serotonin, therefore a dysmetabolic cause in the intestinal absorption of proteins would lead to brain disease.
Nel processo di assimilazione degli amminoacidi liberi a livello della membrana intestinale è presente la stessa competizione tra gli LNAAs, per tanto il triptofano libero verrà assorbito in funzione della concentrazione degli altri LNAAs. Inoltre un amminoacido libero, assunto con la dieta, non viene facilmente assimilato dal tratto digerente, in quanto non riconosciuto come alimento, e quindi eliminato. In the process of assimilation of free amino acids at the level of the intestinal membrane there is the same competition between the LNAAs, therefore the free tryptophan will be absorbed according to the concentration of the other LNAAs. Furthermore, a free amino acid, taken with the diet, is not easily assimilated by the digestive tract, as it is not recognized as a food, and therefore eliminated.
Scopo della presente invenzione è dunque fornire una preparazione che consenta di incrementare il bilancio del triptofano nell’organismo, in modo da prevenire l’insorgenza di patologie legate al sistema serotoninergico. Una possibile soluzione a questo problema è l’individuazione di una proteina di facile assimilazione da parte dell’organismo, contenente una elevata quantità di triptofano ed un ridotto contenuto degli altri LNAA. The purpose of the present invention is therefore to provide a preparation that allows to increase the balance of tryptophan in the body, in order to prevent the onset of pathologies related to the serotoninergic system. A possible solution to this problem is the identification of a protein that is easily assimilated by the body, containing a high amount of tryptophan and a reduced content of the other LNAAs.
Sorprendentemente si è rilevato che la a-lactalbumina, una sieroproteina del latte, ed in particolare la subunità regolatoria del complesso enzimatico lattosio sintasi, presenta un rilevante contenuto di triptofano ed un contenuto proporzionalmente più basso degli altri LNAA. Surprisingly, it has been found that a-lactalbumin, a whey protein, and in particular the regulatory subunit of the lactose synthase enzyme complex, has a relevant tryptophan content and a proportionally lower content than the other LNAAs.
Oggetto della presente invenzione è pertanto la alactalbumina per l’uso quale farmaco. Un ulteriore oggetto dell’invenzione è la α-lactalbumina per l’uso quale integratore alimentare. The object of the present invention is therefore alactalbumin for use as a drug. A further object of the invention is α-lactalbumin for use as a food supplement.
Un altro oggetto dell’invenzione è l’uso di alactalbumina nella fabbricazione di un farmaco per il trattamento di patologie neuropsichiatriche, quali il morbo di Parkinson, le patologie depressive, l’epilessia e simili. Another object of the invention is the use of alactalbumin in the manufacture of a drug for the treatment of neuropsychiatric diseases, such as Parkinson's disease, depressive diseases, epilepsy and the like.
Un ulteriore oggetto della presente invenzione è una composizione farmaceutica comprendente α-lactalbumina quale principio attivo. A further object of the present invention is a pharmaceutical composition comprising α-lactalbumin as the active principle.
Ulteriori vantaggi e caratteristiche della presente invenzione risulteranno in modo più evidente da quanto segue. Come già detto in precedenza, alla base della ricerca che portato alla presente invenzione vi è lo studio relativo alla correlazione tra l’assunzione di triptofano ed il bilancio della serotonina. Come si può notare dalla sequenza primaria dell’a-lactalbumina bovina qui allegata a titolo di esempio, (all. 1) nel formato che utilizza il codice ad una lettera per indicare ciascuno degli aminoacidi, questa proteina esibisce una notevole presenza di triptofano rispetto agli altri LNAA. Further advantages and features of the present invention will become more apparent from the following. As already mentioned above, the research that led to the present invention is based on the study relating to the correlation between the intake of tryptophan and the serotonin balance. As can be seen from the primary sequence of bovine a-lactalbumin attached here as an example, (Annex 1) in the format that uses the one-letter code to indicate each of the amino acids, this protein exhibits a significant presence of tryptophan compared to other LNAA.
Questa proteina è presente nel siero di latte vaccino, ed quindi considerabile come un sottoprodotto dell’industria lattiero-casearia. L’ α-lactalbumina viene ottenuta di norma per purificazione tramite cromatografia separativa, anche se possono essere utilizzate con successo le tecniche comunemente citate come “cromatografia flash”. This protein is present in cow's milk whey, and therefore can be considered as a by-product of the dairy industry. Α-lactalbumin is usually obtained by purification by separative chromatography, although the techniques commonly referred to as "flash chromatography" can be successfully used.
Possono essere utilizzate anche α-lactalbumine di origine diversa, tuttavia è preferibile l’utilizzazione della proteina di origine bovina, sia per la sua maggiore abbondanza sul mercato, sia per il fatto che è quella con il maggiore contenuto in triptofano rispetto alle altre più comunemente disponibili. Α-lactalbumins of different origin can also be used, however it is preferable to use protein of bovine origin, both for its greater abundance on the market, and for the fact that it is the one with the highest content of tryptophan compared to the others more commonly available.
La somministrazione può avvenire in diverse maniere, tuttavia risulta preferibile la somministrazione per via orale; tra le forme di somministrazione per via orale possono essere previsti sciroppi, polveri solubili, compresse, capsule, confetti e simili. Administration can take place in various ways, however oral administration is preferable; among the forms of oral administration, syrups, soluble powders, tablets, capsules, dragees and the like can be provided.
Esempio di preparazione Preparation example
750 mg di a-lactalbumina bovina purificata, prodotta dalla DAVISCO FOOD INTERNATIONAL, sono miscelati a 300 mg di fruttosio, 45 mg di cellulosa microcristallina, 15 mg di stearato di magnesio e 15 mg di agente aromatizzante. E’ stata preparata una compressa con le usuali tecniche di preparazione. 750 mg of purified bovine alpha-lactalbumin, produced by DAVISCO FOOD INTERNATIONAL, are mixed with 300 mg of fructose, 45 mg of microcrystalline cellulose, 15 mg of magnesium stearate and 15 mg of flavoring agent. A tablet was prepared with the usual preparation techniques.
Esempio di applicazione terapeutica Example of therapeutic application
Ad un panel di pazienti soggetti a crisi epilettiche sono state somministrate 3 dosi giornaliere di circa 0,5 g di alactalbumina per un dato periodo di tempo. Nella tabella 1 qui di seguito allegata sono riportati i tempi di trattamento, l’eventuale raddoppio dei dosaggi di terapia, da 2 g a 3 g al giorno, ed un valore di autovalutazione dell’efficacia della terapia, basato su di una scala da 0 a 10, dove con 0 si identifica la mancanza di efficacia della terapia, con la conseguente immutata frequenza delle crisi, e con 10 si identifica il totale controllo delle crisi. Nella tabella, la definizione del tipo di crisi riportata come “PC II gen.” È da intendersi come “crisi parziali con generalizzazione secondaria”. A panel of patients with seizures was given 3 daily doses of approximately 0.5 g of alactalbumin for a given period of time. Table 1 attached below shows the treatment times, any doubling of the therapy dosages, from 2 g to 3 g per day, and a self-assessment value of the efficacy of the therapy, based on a scale from 0 to 10, where 0 identifies the lack of efficacy of the therapy, with the consequent unchanged frequency of the seizures, and with 10 identifies the total control of the seizures. In the table, the definition of the type of crisis reported as "PC II gen." It is to be understood as "partial seizures with secondary generalization".
TABELLA 1 TABLE 1
Come si può rilevare dai dati riportati nella tabella, in sette casi su dieci il livello di autovalutazione della terapia è da considerare decisamente accettabile (maggiore od uguale a 5), ed addirittura in tre casi su dieci il livello è decisamente eccellente, con le crisi pressoché scomparse o del tutto scomparse (vedere pazienti 6 e 9). As can be seen from the data shown in the table, in seven out of ten cases the level of self-assessment of the therapy is to be considered decidedly acceptable (greater than or equal to 5), and even in three out of ten cases the level is decidedly excellent, with crises almost disappeared or completely disappeared (see patients 6 and 9).
L’uso dell’ α-lactalbumina nei termini sopra descritti costituisce un notevole progresso nel trattamento delle patologie legate al sistema serotoninergico; tale progresso viene conseguito utilizzando una molecola di larga diffusione, di semplice purificazione, dal costo sostanzialmente contenuto e generalmente priva di effetti collaterali dannosi. The use of α-lactalbumin in the terms described above constitutes a significant progress in the treatment of pathologies related to the serotoninergic system; this progress is achieved by using a molecule of wide diffusion, of simple purification, of substantially contained cost and generally free of harmful side effects.
Claims (8)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITGE20060013 ITGE20060013A1 (en) | 2006-02-03 | 2006-02-03 | preparation based on á-lactalbumin |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ITGE20060013 ITGE20060013A1 (en) | 2006-02-03 | 2006-02-03 | preparation based on á-lactalbumin |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ITGE20060013A1 true ITGE20060013A1 (en) | 2007-08-04 |
Family
ID=40242881
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ITGE20060013 ITGE20060013A1 (en) | 2006-02-03 | 2006-02-03 | preparation based on á-lactalbumin |
Country Status (1)
| Country | Link |
|---|---|
| IT (1) | ITGE20060013A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2656855A3 (en) * | 2008-12-16 | 2013-11-27 | Kolfarma S.r.L. | Pharmaceutical preparation for the treatment of depressive pathologies, comprising a protein with a high tryptophan-LNAAs (Large Neutral Amino Acids) ratio |
| IT202100019613A1 (en) | 2021-07-23 | 2023-01-23 | Kolfarma S R L | Pharmaceutical or dietary supplement formulation containing alpha-lactalbumin and butyric acid or a salt thereof |
-
2006
- 2006-02-03 IT ITGE20060013 patent/ITGE20060013A1/en unknown
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2656855A3 (en) * | 2008-12-16 | 2013-11-27 | Kolfarma S.r.L. | Pharmaceutical preparation for the treatment of depressive pathologies, comprising a protein with a high tryptophan-LNAAs (Large Neutral Amino Acids) ratio |
| EP2218462B1 (en) * | 2008-12-16 | 2015-04-29 | Kolfarma S.r.L. | Pharmaceutical preparation for the treatment of depressive pathologies, comprising a protein with a high tryptophan/LNAAs (Large Neutral Amino Acids) ratio |
| IT202100019613A1 (en) | 2021-07-23 | 2023-01-23 | Kolfarma S R L | Pharmaceutical or dietary supplement formulation containing alpha-lactalbumin and butyric acid or a salt thereof |
| WO2023001883A1 (en) | 2021-07-23 | 2023-01-26 | Kolfarma S.R.L. | Pharmaceutical or food supplement formulation containing alpha-lactalbumin and butyric acid or a salt thereof |
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