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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
  • A61P1/10—Laxatives

Definitions

• the present invention relates to gastro-resistant pharmaceutical formulations containing animal colostrum for the treatment of constipation, and the use of colostrum for the treatment of constipation.
• Constipation is a widespread problem in adults and children, consisting in the difficult or infrequent passage of the stool mass through the colon, which mass accumulates becoming hard following water reasdorption. Constipation can be acute or chronic, due to organic, traumatic, functional, neurogenic conditions and the like.
• saline or osmotic laxatives such as salts (magnesium; sodium and potassium sulfates, phosphates and tartrates); lactulose, sorbitol: they transit rapidly in the bowel, where they cause an increase in osmotic pressure and therefore an increase in water adsorption in the feces and the peristalsis stimulation.
• This laxatives act rapidly and are generally used to empty the bowel prior to diagnostic procedures and surgery; they are contraindicated in case of renal failure and heart failure.
• stimulant laxatives phenolphthalein, castor oil, anthraquinone derivatives such as senna and cascara
• They can cause a remarkable irritation of bowel and electrolyte balance disturbances.
• the present invention aims at overcoming the above cited problems, by the use of gastro-resistant pharmaceutical formulations containing equine, bovine or anyhow animal, but preferably equine, colostrum, for the treatment of constipation.
• the present invention further relates to the use of equine, bovine or anyhow animal, but preferably equine, colostrum, as a laxative.
• colostrum administered to patients suffering from constipation, acts favourably inducing elimination of stool mass without causing irritation, cramps or electrolyte disturbances.
• colostrum exerts and effective action in the treatment of women suffering from pregnancy or post-partum constipation, which are delicate conditions difficult to treat, as the response to the treatment with both bulking agents and common laxatives is poor, and contraindications to pharmacological treatment are remarkable, since drugs can induce uterus contractions in the pregnant woman (as is the case with castor oil) or they can be present in breast milk in amounts adversely affecting the breast ⁇ fed infant (particularly anthraquinone laxatives).
• the colostrum treated patients obtained an effective, physiological laxative effect without any side-effects.
• the gastro-resistant pharmaceutical formulations of invention contain powder or liquid colostrum in amounts of 10 mg to 5 g per unitary dose.
• the formulations of the invention comprise gastro-resistant tablets containing powdered, freeze-dried or sprayzed colostrum, or gastro- resistant pearls containing liquid colostrum.
• gastro-resistant tablets or pearls of invention are prepared according to the conventional pharmaceutical techniques for the preparation of gastro- resistant formulations, for example an enteric coating can be applied to a colostrum core by means of fluidized bed coating 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 methylcellulose phthalate, water-based polymer dispersions, such as Eudragit* (by Rohm Pharma), Aquateric R (PMC 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 beneficial effect on the condition to treat, particularly vegetable extracts.
• the formulations can contain colostrum mixed with milk.
• One enteric-coated tablet contains:
• the enteric coating solution is applied on the colostrum core by fluidized bed coating.
• One enteric-coated tablet contains: Powder colostrum 64 mg
• the enteric coating solution is applied on the colostrum core by fluidized bed coating.
• One 400 mg capsule contains:
• One 400 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)
• Chemical & Material Sciences (AREA)
• Engineering & Computer Science (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Pharmacology & Pharmacy (AREA)
• Medicinal Chemistry (AREA)
• Developmental Biology & Embryology (AREA)
• Biomedical Technology (AREA)
• Virology (AREA)
• Epidemiology (AREA)
• Immunology (AREA)
• Cell Biology (AREA)
• Biotechnology (AREA)
• Zoology (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Medicinal Preparation (AREA)
• Magnetic Treatment Devices (AREA)
• Medicines Containing Plant Substances (AREA)

Priority Applications (4)

Applications Claiming Priority (2)

Publications (1)

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ID=11372999

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Cited By (3)

Citations (3)

• 1996
  • 1996-01-24 IT IT96MI000113A patent/IT1282952B1/it active IP Right Grant
• 1997
  • 1997-01-23 DE DE69714424T patent/DE69714424D1/de not_active Expired - Lifetime
  • 1997-01-23 AU AU15943/97A patent/AU1594397A/en not_active Abandoned
  • 1997-01-23 EP EP97902204A patent/EP0886522B1/en not_active Expired - Lifetime
  • 1997-01-23 WO PCT/EP1997/000300 patent/WO1997026899A1/en not_active Ceased

Patent Citations (3)

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