ITMI960112A1 - GASTRO-RESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA - Google Patents
GASTRO-RESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA Download PDFInfo
- Publication number
- ITMI960112A1 ITMI960112A1 IT96MI000112A ITMI960112A ITMI960112A1 IT MI960112 A1 ITMI960112 A1 IT MI960112A1 IT 96MI000112 A IT96MI000112 A IT 96MI000112A IT MI960112 A ITMI960112 A IT MI960112A IT MI960112 A1 ITMI960112 A1 IT MI960112A1
- Authority
- IT
- Italy
- Prior art keywords
- colostrum
- insomnia
- gastro
- treatment
- pharmaceutical formulations
- Prior art date
Links
- 210000003022 colostrum Anatomy 0.000 title claims abstract description 23
- 235000021277 colostrum Nutrition 0.000 title claims abstract description 23
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 title claims abstract description 15
- 206010022437 insomnia Diseases 0.000 title claims abstract description 15
- 239000008194 pharmaceutical composition Substances 0.000 title claims description 7
- 238000009472 formulation Methods 0.000 claims abstract description 10
- 239000000203 mixture Substances 0.000 claims abstract description 10
- 241000283073 Equus caballus Species 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 5
- 239000007788 liquid Substances 0.000 claims description 4
- 241000283690 Bos taurus Species 0.000 claims description 3
- 239000011049 pearl Substances 0.000 claims description 3
- 239000000843 powder Substances 0.000 claims description 3
- 235000008476 powdered milk Nutrition 0.000 claims 1
- 241001465754 Metazoa Species 0.000 abstract description 2
- 230000007958 sleep Effects 0.000 description 7
- 229940079593 drug Drugs 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 206010041349 Somnolence Diseases 0.000 description 2
- 229940125717 barbiturate Drugs 0.000 description 2
- 208000002173 dizziness Diseases 0.000 description 2
- 230000000147 hypnotic effect Effects 0.000 description 2
- 230000001939 inductive effect Effects 0.000 description 2
- 239000000932 sedative agent Substances 0.000 description 2
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 206010010144 Completed suicide Diseases 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 206010012373 Depressed level of consciousness Diseases 0.000 description 1
- 208000027534 Emotional disease Diseases 0.000 description 1
- JMBQKKAJIKAWKF-UHFFFAOYSA-N Glutethimide Chemical compound C=1C=CC=CC=1C1(CC)CCC(=O)NC1=O JMBQKKAJIKAWKF-UHFFFAOYSA-N 0.000 description 1
- 208000004044 Hypesthesia Diseases 0.000 description 1
- NPPQSCRMBWNHMW-UHFFFAOYSA-N Meprobamate Chemical compound NC(=O)OCC(C)(CCC)COC(N)=O NPPQSCRMBWNHMW-UHFFFAOYSA-N 0.000 description 1
- SIDLZWOQUZRBRU-UHFFFAOYSA-N Methyprylon Chemical compound CCC1(CC)C(=O)NCC(C)C1=O SIDLZWOQUZRBRU-UHFFFAOYSA-N 0.000 description 1
- 206010027590 Middle insomnia Diseases 0.000 description 1
- 208000028017 Psychotic disease Diseases 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- -1 barbiturates Chemical class 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- RNFNDJAIBTYOQL-UHFFFAOYSA-N chloral hydrate Chemical compound OC(O)C(Cl)(Cl)Cl RNFNDJAIBTYOQL-UHFFFAOYSA-N 0.000 description 1
- 229960002327 chloral hydrate Drugs 0.000 description 1
- 239000003959 coumarin anticoagulant Substances 0.000 description 1
- 230000002996 emotional effect Effects 0.000 description 1
- 229960002972 glutethimide Drugs 0.000 description 1
- 239000003326 hypnotic agent Substances 0.000 description 1
- 208000034783 hypoesthesia Diseases 0.000 description 1
- 239000000411 inducer Substances 0.000 description 1
- 208000013433 lightheadedness Diseases 0.000 description 1
- 229960004815 meprobamate Drugs 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229960000316 methyprylon Drugs 0.000 description 1
- 235000013336 milk Nutrition 0.000 description 1
- 239000008267 milk Substances 0.000 description 1
- 210000004080 milk Anatomy 0.000 description 1
- 231100000862 numbness Toxicity 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000036385 rapid eye movement (rem) sleep Effects 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 230000001624 sedative effect Effects 0.000 description 1
- 230000035807 sensation Effects 0.000 description 1
- 230000004620 sleep latency Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- HFFLGKNGCAIQMO-UHFFFAOYSA-N trichloroacetaldehyde Chemical class ClC(Cl)(Cl)C=O HFFLGKNGCAIQMO-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/20—Milk; Whey; Colostrum
Abstract
Formulazioni farmaceutiche gastroresistenti a base di colostro animale per il trattamento dell'insonnia, e l'uso del colostro per il trattamento dell'insonnia.Pharmaceutical gastro-resistant formulations based on animal colostrum for the treatment of insomnia, and the use of colostrum for the treatment of insomnia.
Description
Descrizione dell'invenzione industriale avente per titolo: "FORMULAZIONI FARMACEUTICHE GASTRORESISTENTI CONTENENTI COLOSTRO E USO DEL COLOSTRO PER IL TRATTAMENTO DELL'INSONNIA" Description of the industrial invention entitled: "GASTRORESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA"
La presente invenzione ha per oggetto formulazioni farmaceutiche gastroresistenti a base di colostro animale per il trattamento dell'insonnia,e l'uso del colostro per il trattamento dell'insonnia. The present invention relates to gastro-resistant pharmaceutical formulations based on animal colostrum for the treatment of insomnia, and the use of colostrum for the treatment of insomnia.
L'insonnia è un disturbo frequente,che affligge una notevole parte della popolazione adulta dei Paesi industrializzati. Tra i responsabili noti dell'insonnia si possono citare,oltre a cause di origine organica, lo stress, l'ansia, la depressione e in generale i disturbi emotivi e psicotici, e l'uso improprio di farmaci ipnotici e sedativi. Tuttavia, in numerosi casi l’eziologia dell'insonnia resta sconosciuta. Insomnia is a frequent ailment that afflicts a large part of the adult population of industrialized countries. Among the known responsible for insomnia, in addition to organic causes, stress, anxiety, depression and in general emotional and psychotic disorders, and the improper use of hypnotic and sedative drugs can be mentioned. However, in many cases the etiology of insomnia remains unknown.
La terapia dipende principalmente dall'origine dell'insonnia: in generale, il trattamento consiste per lo più nella somministrazione di ipnotici o sedativi, quali benzodiazepine, barbiturici, derivati del cloralio,etclorvinolo,glutetimide,metiprilone,meprobamato,ecc. The therapy mainly depends on the origin of the insomnia: in general, the treatment mostly consists in the administration of hypnotics or sedatives, such as benzodiazepines, barbiturates, chloral derivatives, etchlorvinol, glutethimide, metiprilone, meprobamate, etc.
Tutti questi farmaci presentano, in misura variabile, rischi di tolleranza, dipendenza, assuefazione, overdose e effetti "rebound", oltre a effetti collaterali quali sonnolenza, stordimento e torpore (dovuti a una residua depressione del SNC) nelle ore successive al risveglio. Un altro aspetto da tenere in considerazione, al momento della prescrizione di tali farmaci, è il cosiddetto rischio suicidarlo. Inoltre i barbiturici, il cloralio idrato e la glutetimide sono controindicati in caso di trattamento con anticoagulanti cumarinici o di insufficienza polmonare grave. All these drugs present, to varying degrees, risks of tolerance, dependence, addiction, overdose and "rebound" effects, as well as side effects such as drowsiness, lightheadedness and numbness (due to a residual CNS depression) in the hours following awakening. Another aspect to take into consideration when prescribing these drugs is the so-called risk of committing suicide. Furthermore, barbiturates, chloral hydrate and glutethymide are contraindicated in case of treatment with coumarin anticoagulants or severe pulmonary insufficiency.
Pertanto è fortemente sentita l'esigenza di un farmaco che, oltre a indurre il sonno,non provochi gli effetti collaterali sopra indicati. Therefore, there is a strong need for a drug which, in addition to inducing sleep, does not cause the side effects indicated above.
La presente invenzione ha lo scopo di superare i problemi sopra indicati, mediante l'uso di formulazioni farmaceutiche gastroresistenti contenenti colostro equino o bovino o comunque di mammifero, ma preferibilmente equino,per indurre sonno fisiologico. The present invention has the purpose of overcoming the problems indicated above, through the use of gastro-resistant pharmaceutical formulations containing equine or bovine or in any case mammalian, but preferably equine colostrum, to induce physiological sleep.
La presente invenzione, inoltre, ha per oggetto l'uso di colostro equino o bovino o comunque di mammifero, ma preferibilmente equino,come induttore di sonno fisiologico. Furthermore, the present invention relates to the use of equine or bovine or in any case mammalian colostrum, but preferably equine, as inducer of physiological sleep.
E' stato sorprendentemente trovato che il colostro, somministrato a pazienti affetti da insonnia,agisce favorevolmente inducendo il sonno. It has been surprisingly found that colostrum, administered to patients suffering from insomnia, acts favorably by inducing sleep.
E' opportuno sottolineare che il sonno indotto dalla somministrazione delle formulazioni gastroresistenti a base di colostro secondo l'invenzione,ha carattere fisiologico, con sonno profondo senza risvegli notturni e senza riduzione del periodo di sonno REM. Inoltre viene ridotto anche il periodo di latenza del sonno. It should be emphasized that the sleep induced by the administration of the colostrum-based gastro-resistant formulations according to the invention has a physiological character, with deep sleep without nocturnal awakenings and without a reduction in the REM sleep period. In addition, the sleep latency period is also reduced.
Nella sperimentazione clinica, infatti, si è osservato che su 12 pazienti affetti da insonnia trattati, 11 rispondevano positivamente al trattamento con colostro, ottenendo un sonno profondo e fisiologico, accompagnato da un'ottima attività onirica, senza risentire di sensazioni quali stordimento o sonnolenza dopo il risveglio. In fact, in the clinical trial, it was observed that out of 12 treated insomnia patients, 11 responded positively to colostrum treatment, obtaining a deep and physiological sleep, accompanied by excellent dream activity, without being affected by sensations such as dizziness or drowsiness after the awakening.
Le formulazioni farmaceutiche gastroresistenti dell'invenzione contengono colostro in polvere o liquido in quantità da 500 mg a 5 g per dose unitaria. The gastro-resistant pharmaceutical formulations of the invention contain colostrum in powder or liquid form in quantities ranging from 500 mg to 5 g per unit dose.
Più particolarmente, le formulazioni dell'invenzione conprendono compresse gastroresistenti contenenti colostro in polvere, liofilizzato o sprayzzato,oppure perle gastroresistenti contenenti colostro liquido. More particularly, the formulations of the invention comprise gastro-resistant tablets containing powdered, freeze-dried or sprayed colostrum, or gastro-resistant pearls containing liquid colostrum.
Le compresse o perle gastroresistenti dell'invenzione vengono preparate secondo le tecniche farmaceutiche convenzionali per la preparazione di formulazioni gastroresistenti. The gastro-resistant tablets or pearls of the invention are prepared according to conventional pharmaceutical techniques for the preparation of gastro-resistant formulations.
Le formulazioni dell'invenzione ·saranno assunte dal paziente affetto da insonnia la sera,prima di coricarsi. The formulations of the invention will be taken by the patient suffering from insomnia in the evening, before going to bed.
Secondo un ulteriore aspetto dell'invenzione, le formulazioni possono contenere colostro miscelato a latte. According to a further aspect of the invention, the formulations can contain colostrum mixed with milk.
Claims (7)
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT96MI000112A IT1282951B1 (en) | 1996-01-24 | 1996-01-24 | GASTRO-RESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA |
| AU15445/97A AU1544597A (en) | 1996-01-24 | 1997-01-22 | Gastro-resistant pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of insomnia |
| PCT/EP1997/000295 WO1997026898A1 (en) | 1996-01-24 | 1997-01-22 | Gastro-resistant pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of insomnia |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT96MI000112A IT1282951B1 (en) | 1996-01-24 | 1996-01-24 | GASTRO-RESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| ITMI960112A0 ITMI960112A0 (en) | 1996-01-24 |
| ITMI960112A1 true ITMI960112A1 (en) | 1997-07-24 |
| IT1282951B1 IT1282951B1 (en) | 1998-04-02 |
Family
ID=11372997
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| IT96MI000112A IT1282951B1 (en) | 1996-01-24 | 1996-01-24 | GASTRO-RESISTANT PHARMACEUTICAL FORMULATIONS CONTAINING COLOSTRUM AND USE OF COLOSTRUM FOR THE TREATMENT OF INSOMNIA |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU1544597A (en) |
| IT (1) | IT1282951B1 (en) |
| WO (1) | WO1997026898A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20012319A1 (en) * | 2001-11-06 | 2003-05-06 | Mario Baraldi | USE OF MILK SERUM CONTAINING SUBSTANCES IN BENZODIAZEPINO-SIMILE ACTIVITIES |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ATE151278T1 (en) * | 1993-01-26 | 1997-04-15 | Horse Vitality Ltd | PHARMACEUTICAL AND DERMOCOSMETIC PRODUCTS CONTAINING HORSE ECOLOSTRUM |
| EP0711171B1 (en) * | 1993-06-23 | 2002-09-04 | Novatreat Oy | A pharmaceutical or cosmetic composition comprising a colostrum fraction and its medical use |
-
1996
- 1996-01-24 IT IT96MI000112A patent/IT1282951B1/en active IP Right Grant
-
1997
- 1997-01-22 WO PCT/EP1997/000295 patent/WO1997026898A1/en active Application Filing
- 1997-01-22 AU AU15445/97A patent/AU1544597A/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO1997026898A1 (en) | 1997-07-31 |
| AU1544597A (en) | 1997-08-20 |
| IT1282951B1 (en) | 1998-04-02 |
| ITMI960112A0 (en) | 1996-01-24 |
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| Date | Code | Title | Description |
|---|---|---|---|
| 0001 | Granted |