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-resistant pharmaceutical formulations containing animal colostrum for the treatment of erectile dysfunctions, and the use of colostrum for the treatment of erectile dysfunctions.
• Impotence is a dysfunction consisting in the inability to attain or sustain the erection of penis.
• Etiological factors of impotence can be either physical (androgen low levels; diseases of the genito ⁇ urinary tract; diabetes mellitus; drug dependency and alcoholism; local or neurogenic vascular disturbances; use of antihypertensives, amphetamines, tranquillizers and sedatives), or psychic (emotional and psychotic disturbances, stress, anxiety, depression).
• the treatment can be surgical (penile prosthesis are implanted in the penis or in the testicular bag to electrically stimulate erigentes nerves) or pharmacological (injection of vasodilators, such as papaverine, or ⁇ -blockers, such as phentolamine, in the cavernous bodies; topical administration of vasodilators, such as inoxidil).
• penile prosthesis are implanted in the penis or in the testicular bag to electrically stimulate erigentes nerves
• pharmacological injection of vasodilators, such as papaverine, or ⁇ -blockers, such as phentolamine, in the cavernous bodies
• topical administration of vasodilators such as inoxidil
• the patient is not particularly in favour of the surgical approach; on the other hand, the pharmacological treatment also is not particularly attractive, in view of both the site of the injection (which is effected by the physician or by the patient himself) and the disagreeable side-effects (risk of prolonged, painful erection or overdose).
• 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, to induce erection.
• the present invention further relates to the use of equine, bovine or anyhow animal, but preferably equine, colostrum, in the treatment of erectile dysfunctions.
• the gastro-resistant pharmaceutical formulations of invention contain powder or liquid colostrum in amounts of 10 mg to 5 g per unitary dose.
• 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 copoly erized 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 R (by Rohm Pharma),
• 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 of invention will be administered to the patient suffering from erectile dysfunctions at night, before the sexual intercourse.
• the formulations can contain colostrum mixed with milk.
• Example 1 One enteric-coated tablet contains:
• the enteric coating solution is applied on the colostrum core by fluidized bed coating.
• One enteric-coated tablet contains:
• the enteric coating solution is applied on the colostrum core by fluidized bed coating.

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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)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Medicines Containing Material From Animals Or Micro-Organisms (AREA)
• Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
• Medicinal Preparation (AREA)

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

Family

ID=11373032

Family Applications (1)

Country Status (3)

Citations (2)

• 1996
  • 1996-01-26 IT IT96MI000133A patent/IT1282953B1/it active IP Right Grant
• 1997
  • 1997-01-24 WO PCT/EP1997/000331 patent/WO1997026900A1/en not_active Ceased
  • 1997-01-24 AU AU14450/97A patent/AU1445097A/en not_active Abandoned

Patent Citations (2)

Non-Patent Citations (1)

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