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.

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• 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)
• Medicinal Preparation (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Fodder In General (AREA)

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Publications (1)

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Cited By (1)

Citations (2)

• 1996
  • 1996-01-24 IT IT96MI000112A patent/IT1282951B1/it active IP Right Grant
• 1997
  • 1997-01-22 AU AU15445/97A patent/AU1544597A/en not_active Abandoned
  • 1997-01-22 WO PCT/EP1997/000295 patent/WO1997026898A1/en not_active Ceased

Patent Citations (2)

Non-Patent Citations (2)

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