WO1997026898A1 - Gastro-resistant pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of insomnia - Google Patents
Gastro-resistant pharmaceutical formulations containing colostrum and the use of colostrum for the treatment of insomnia Download PDFInfo
- Publication number
- WO1997026898A1 WO1997026898A1 PCT/EP1997/000295 EP9700295W WO9726898A1 WO 1997026898 A1 WO1997026898 A1 WO 1997026898A1 EP 9700295 W EP9700295 W EP 9700295W WO 9726898 A1 WO9726898 A1 WO 9726898A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- colostrum
- gastro
- insomnia
- treatment
- pharmaceutical formulations
- Prior art date
Links
- 210000003022 colostrum Anatomy 0.000 title claims abstract description 30
- 235000021277 colostrum Nutrition 0.000 title claims abstract description 30
- 208000013738 Sleep Initiation and Maintenance disease Diseases 0.000 title claims abstract description 14
- 206010022437 insomnia Diseases 0.000 title claims abstract description 14
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 6
- 239000000203 mixture Substances 0.000 claims description 12
- 238000009472 formulation Methods 0.000 claims description 11
- 239000000843 powder Substances 0.000 claims description 7
- 241000283073 Equus caballus Species 0.000 claims description 6
- 239000003814 drug Substances 0.000 claims description 4
- 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
- 235000008476 powdered milk Nutrition 0.000 claims description 2
- 238000002360 preparation method Methods 0.000 claims description 2
- 241001465754 Metazoa Species 0.000 abstract description 4
- 230000007958 sleep Effects 0.000 description 7
- 239000011248 coating agent Substances 0.000 description 5
- 238000000576 coating method Methods 0.000 description 5
- 239000002702 enteric coating Substances 0.000 description 5
- 238000009505 enteric coating Methods 0.000 description 5
- BXWNKGSJHAJOGX-UHFFFAOYSA-N hexadecan-1-ol Chemical compound CCCCCCCCCCCCCCCCO BXWNKGSJHAJOGX-UHFFFAOYSA-N 0.000 description 5
- -1 barbiturates Chemical class 0.000 description 4
- 239000002775 capsule Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 229960000541 cetyl alcohol Drugs 0.000 description 3
- 229920003134 Eudragit® polymer Polymers 0.000 description 2
- JMBQKKAJIKAWKF-UHFFFAOYSA-N Glutethimide Chemical compound C=1C=CC=CC=1C1(CC)CCC(=O)NC1=O JMBQKKAJIKAWKF-UHFFFAOYSA-N 0.000 description 2
- 235000017309 Hypericum perforatum Nutrition 0.000 description 2
- 244000141009 Hypericum perforatum Species 0.000 description 2
- 240000008415 Lactuca sativa Species 0.000 description 2
- 235000003228 Lactuca sativa Nutrition 0.000 description 2
- 206010024264 Lethargy Diseases 0.000 description 2
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 2
- 206010041349 Somnolence Diseases 0.000 description 2
- 229940125717 barbiturate Drugs 0.000 description 2
- 239000002662 enteric coated tablet Substances 0.000 description 2
- 229960002972 glutethimide Drugs 0.000 description 2
- 230000001939 inductive effect Effects 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- XNGIFLGASWRNHJ-UHFFFAOYSA-L phthalate(2-) Chemical compound [O-]C(=O)C1=CC=CC=C1C([O-])=O XNGIFLGASWRNHJ-UHFFFAOYSA-L 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 description 2
- ZEHYJZXQEQOSON-AATRIKPKSA-N (e)-1-chloro-3-ethylpent-1-en-4-yn-3-ol Chemical compound CCC(O)(C#C)\C=C\Cl ZEHYJZXQEQOSON-AATRIKPKSA-N 0.000 description 1
- 208000019901 Anxiety disease Diseases 0.000 description 1
- 229920000623 Cellulose acetate phthalate Polymers 0.000 description 1
- 206010012335 Dependence Diseases 0.000 description 1
- 206010012373 Depressed level of consciousness Diseases 0.000 description 1
- 206010052804 Drug tolerance Diseases 0.000 description 1
- 206010019133 Hangover Diseases 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 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
- CERQOIWHTDAKMF-UHFFFAOYSA-N Methacrylic acid Chemical compound CC(=C)C(O)=O CERQOIWHTDAKMF-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
- 239000004480 active ingredient Substances 0.000 description 1
- 230000036506 anxiety Effects 0.000 description 1
- 229940049706 benzodiazepine Drugs 0.000 description 1
- 150000001557 benzodiazepines Chemical class 0.000 description 1
- 229940081734 cellulose acetate phthalate Drugs 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
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid group Chemical group C(CC(O)(C(=O)O)CC(=O)O)(=O)O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 1
- 239000003959 coumarin anticoagulant Substances 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 230000002996 emotional effect Effects 0.000 description 1
- 229960004447 ethchlorvynol Drugs 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 235000013773 glyceryl triacetate Nutrition 0.000 description 1
- 239000001087 glyceryl triacetate Substances 0.000 description 1
- 230000026781 habituation Effects 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 229940031704 hydroxypropyl methylcellulose phthalate Drugs 0.000 description 1
- 239000003326 hypnotic agent Substances 0.000 description 1
- 230000000147 hypnotic effect Effects 0.000 description 1
- 229940005535 hypnotics and sedatives Drugs 0.000 description 1
- 239000005554 hypnotics and sedatives Substances 0.000 description 1
- 239000000411 inducer Substances 0.000 description 1
- 239000008101 lactose Substances 0.000 description 1
- 229960004815 meprobamate Drugs 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
- 150000003022 phthalic acids Chemical class 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- 208000020016 psychiatric disease Diseases 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 230000036385 rapid eye movement (rem) sleep Effects 0.000 description 1
- 230000001739 rebound effect Effects 0.000 description 1
- 230000004044 response Effects 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- HFFLGKNGCAIQMO-UHFFFAOYSA-N trichloroacetaldehyde Chemical class ClC(Cl)(Cl)C=O HFFLGKNGCAIQMO-UHFFFAOYSA-N 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-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
Definitions
- the present invention relates to gastro-resi ⁇ tant pharmaceutical formulations containing animal colostrum for the treatment of insomnia, and the use of colostrum for the treatment of insomnia.
- Insomnia is a common disturbance which affects a great number of persons in industrialized countries. Stress, anxiety, depression and generally emotional and psychic disturbances, as well as the incorrect use of hypnotics and sedatives, besides causes of organic origin, can be mentioned among the known factors responsible for insomnia.
- insomnia etiology is unexplained.
- the treatment mainly depends on the origin of insomnia: in general, the treatment mainly consists in the administration of hypnotics or sedatives, such as benzodiazepines, barbiturates, chloral derivatives, ethchlorvynol, glutethimide, methyprylon, meprobamate , etc.. All of these medicaments involve to a varying extent risks of tolerance, addiction, habituation, overdosage and rebound effects, as well as side-effects such as drowsiness, hangover and lethargy (due to a residual CNS depression) in the hours subsequent awakening. Another aspect which should be considered, when prescribing these medicaments, is the suicidal risk. Moreover, barbiturates, chloral hydrate and glutethimide are contraindicated in case of treatment with coumarin anticoagulants or in severe pulmonary insufficiency.
- the present invention aims at overcoming the above cited problems, by the use of gastro-resistant pharma ⁇ ceutical formulations containing equine, bovine or anyhow animal, but preferably equine, colostrum, to in ⁇ cute a physiological sleep.
- the present invention further relates to the use of equine, bovine or anyhow animal, but preferably equine, colostrum, as a physiological sleep inducer. It has surprisingly been found that colostrum, ad ⁇ ministered to patients suffering from insomnia, acts fa ⁇ vourably inducing sleep.
- the sleep induced by the gastro-resistant formulations containing colostrum, ac- cording to invention has a physiological pattern, with normal depths, no awakenings during the night and no re ⁇ ductions in the REM sleep time. Moreover, the sleep la ⁇ tency time is reduced.
- the gastro-resistant pharmaceutical formulations of invention contain powder or liquid colostrum in amounts of 10 mg to 5 g per unitary dose. More particularly, the formulations of the inven ⁇ tion comprise gastro-resistant tablets containing powde ⁇ red, freeze-dried or sprayzed colostrum, or gastro-resi ⁇ stant pearls containing liquid colostrum.
- the gastro-resistant tablets or pearls of invention are prepared according to the conventional pharmaceuti ⁇ cal techniques for the preparation of gastro-resistant formulations, for example an enteric coating can be ap ⁇ plied to a colostrum core by means of fluidized bed coa- ting or pan coating techniques.
- the enteric coating is used to protect colostrum against the gastric acid environment, such a coating can consist of copolymerized methacrylic acid/methacrylic acid methyl esters, such as those known under the names Eudragit R (commercialized by Rohm Pharma), polymers such as cellulose acetate phthalate, hydroxypropyl methylcel- lulose phthalate, water-based polymer dispersions, such as Eudragit R (by Rohm Pharma), Aquateric R (FMC Corp.).
- the enteric coating can optionally contain plasticizers such as triacetin, cetanol, citric and phthalic acids esters.
- the formulations of the invention can optionally contain other active ingredients known to have a benefi ⁇ cial effect on the condition to treat, particularly ve- getable extracts.
- the formulations of invention will be administered to the patient suffering from insomnia at night, before going to bed.
- the formulations can contain colostrum mixed with milk.
- Example 1 The following examples further illustrate the in- vention.
- Example 1 The following examples further illustrate the in- vention.
- One enteric-coated tablet contains:
- Example 2 One enteric-coated tablet contains:
- One 300 mg capsule contains:
- Example 4 One 300 mg capsule contains:
- the whole mass is mixed thoroughly, then placed into a gastro-resistant capsule.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Biotechnology (AREA)
- Cell Biology (AREA)
- Developmental Biology & Embryology (AREA)
- Immunology (AREA)
- Virology (AREA)
- Zoology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Fodder In General (AREA)
- Medicinal Preparation (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| 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 |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| IT96MI000112A IT1282951B1 (it) | 1996-01-24 | 1996-01-24 | Formulazioni farmaceutiche gastroresistenti contenenti colostro e uso del colostro per il trattamento dell'insonnia |
| ITMI96A000112 | 1996-01-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO1997026898A1 true WO1997026898A1 (en) | 1997-07-31 |
Family
ID=11372997
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| 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 |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU1544597A (enrdf_load_stackoverflow) |
| IT (1) | IT1282951B1 (enrdf_load_stackoverflow) |
| WO (1) | WO1997026898A1 (enrdf_load_stackoverflow) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003039565A1 (en) * | 2001-11-06 | 2003-05-15 | Mario Baraldi | Use of milk serum containing substances with benzodiazepine-like activity as adjuvants to therapy of anxiety and insomnia |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994016675A1 (en) * | 1993-01-26 | 1994-08-04 | Horse Vitality Ltd. | Pharmaceutical and dermocosmetic compositions containing equine colostrum |
| WO1995000155A1 (en) * | 1993-06-23 | 1995-01-05 | Viable Bioproducts Ltd. | Method for the improvement of wound healing and compositions therefor |
-
1996
- 1996-01-24 IT IT96MI000112A patent/IT1282951B1/it 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
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1994016675A1 (en) * | 1993-01-26 | 1994-08-04 | Horse Vitality Ltd. | Pharmaceutical and dermocosmetic compositions containing equine colostrum |
| WO1995000155A1 (en) * | 1993-06-23 | 1995-01-05 | Viable Bioproducts Ltd. | Method for the improvement of wound healing and compositions therefor |
Non-Patent Citations (2)
| Title |
|---|
| DATABASE BIOSIS BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; Z. ZHOU ET AL: "A study on the anti-aging effect of bovine colostrum extract in the elderly", XP002031211 * |
| MARKUS V. GRAF ET AL: "Presence of Delta-Sleep-Inducing Peptide-Like Material in Human Milk", JOURNAL OF CLINICAL ENDOCRINOLOGY AND METABOLISM, vol. 59, no. 1, July 1984 (1984-07-01), USA, pages 127 - 132, XP000197371 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2003039565A1 (en) * | 2001-11-06 | 2003-05-15 | Mario Baraldi | Use of milk serum containing substances with benzodiazepine-like activity as adjuvants to therapy of anxiety and insomnia |
Also Published As
| Publication number | Publication date |
|---|---|
| ITMI960112A1 (it) | 1997-07-24 |
| IT1282951B1 (it) | 1998-04-02 |
| ITMI960112A0 (enrdf_load_stackoverflow) | 1996-01-24 |
| AU1544597A (en) | 1997-08-20 |
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