Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/557—Eicosanoids, e.g. leukotrienes or prostaglandins
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P17/00—Drugs for dermatological disorders
  • A61P17/04—Antipruritics

Definitions

• the present invention relates to misoprostol-based pharmaceutical preparations for the topical treatment of skin lesions from stings and superficial burns.
• Misoprostol i.e., methyl 7- [3-hydroxy-2 (4- hydroxy-4-methyloct-l-enyl) -5-oxocyclopentyl] heptanoate, is a synthetic prostaglandin of formula C22H38O5 and with a molecular weight of 382.5 g/mol. Its metabolism and bioavailability are at the moment unknown. When it is assumed by traditional routes, i.e., oral, sublingual or vaginal, its half-life in the organism is 20-40 minutes and 80% thereof is eliminated through the kidneys .
• Prostaglandins are fatty acids that act where they are produced and at extremely low concentrations. Arachidonic acid from which they originate is present in the phospholipids of the cell membranes, from which it is released by the action of hydrolases and phospholipases .
• Prostaglandins form part of a class of biochemical mediators, the intimate mechanisms and interactions of which have for some time been the subject of study.
• prostaglandins can express in the biological field different effects not only in a guantitative sense but also in a qualitative sense, frequently acting in opposite ways with respect to one another on one and the same organ.
• the effect of one and the same prostaglandin can vary according to the dose, the organ to which the reactive tissue belongs, and the physiological or pathological state of said organ.
• prostaglandins amongst which misoprostol, or of pharmaceutically acceptable salts of prostaglandins themselves, as active principles in pharmaceutical preparations that can be administered by oral, rectal, and topical route, and that are effective in combating pruritis as symptom of inflammations of the skin, such as knettle rash, eczema, psoriasis, dermatosis, as likewise atopical symptoms, such as atopical dermatites and atopical conjunctivites .
• the dosages indicated are comprised between 0.1 ⁇ g and 100 ⁇ g per administration, which may even be repeated many a day.
• prostaglandins have a very short life in the organism because they are metabolized. If, however, they are used in the form of ointments, they enable a continuous and gradual release of the substance.
• prostaglandins can be very conditioned by the dosage and by the habitat where they act, and by the interaction with other prostaglandins.
• the inventor has assessed the possibility of applying high concentrations of a synthetic analogue of prostaglandins, such as misoprostol, over a prolonged time, into the area of the skin involved by superficial burns and lesions deriving from insect bytes and stings, verifying the effects and tolerability thereof.
• a synthetic analogue of prostaglandins such as misoprostol
• misoprostol used by topical route in the form of ointment has proven capable of controlling rapidly the typical burning pain and of speeding up healing of skin lesions from burns, guaranteeing in a high percentage of patients with second- degree burns a complete healing without leaving any signs.
• Misoprostol once again at a high dose, has also proven able to reduce the times of healing of skin lesions from insect bytes and stings, guaranteeing in a high percentage of patients the immediate disappearance of the symptoms.
• an object of the present invention is a pharmacological preparation of misoprostol for the treatment of skin lesions from stings and burns in the form of ointment, cream, gel, and paste, wherein misoprostol is present in an amount comprised between 10 and 25 mg per gram of preparation.
• Topical treatment envisages the application on the surface of the skin involved by the lesion of an amount of ointment, cream, gel or paste, according to the cases, comprising an effective amount of misoprostol for the use according to the present invention comprised between 300 and 750 mg, to be repeated three times a day.
• the purpose of the research was to assess the effectiveness in terms of time and after effects of healing (including the disappearance of the symptoms) of misoprostol for topical use in the treatment of first-degree and second- degree superficial burns.
• PATIENTS AND METHODS thirty patients were enrolled who presented consecutively at a first- aid unit with superficial burns. All the patients recruited granted their written informed consent to participate in the study. Ten patients were male and twenty female. The age range was from 20 to 67 years old. Working activities: 7 cooks, 20 ironers, 3 mechanics. Of the patients 40% presented first-degree superficial burns, the remainder second-degree burns (the lesions were substancially located on the hands: only 30% on the back) .
• the wounds were cleaned and medicated.
• the patients received a misoprostol-based preparation (600 mg of misoprostol dissolved in 30 g of base cream) to be applied three times a day for ten days .
• Disappearance of the symptoms was assessed at two hours, at three days, and at ten days, and healing of the lesions, understood as disappearance of the erythema in the first-degree burns and of the blisters in the second-degree burns, at three and ten days.
• the evaluation of the lesions was always made by the same physician both at the first examination and at the subsequent ones.
• misoprostol for topical use has proven able to reduce the times of healing of superficial burns, also guaranteeing a complete healing without leaving any sign in a high percentage of patients with second-degree burns.
• the purpose of the research was to assess the effectiveness in terms of time and after effects of healing (including the disappearance of the symptoms) of misoprostol for topical use in the treatment of skin lesions from insect bytes and stings.
• PATIENTS AND METHODS thirty patients were enrolled who presented for observation at a first-aid unit consecutively with skin lesions from insect bytes and stings.
• the patients received a misoprostol-based preparation for topical use (600 mg of misoprostol dissolved in 30 g of base cream) to be applied three times a day for two days.
• Misoprostol for topical use has proven able to reduce the times of healing of skin lesions from insect bytes and stings, guaranteeing in a high percentage of patients immediate disappearance of the symptoms.

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• Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Chemical & Material Sciences (AREA)
• Medicinal Chemistry (AREA)
• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Dermatology (AREA)
• Engineering & Computer Science (AREA)
• Bioinformatics & Cheminformatics (AREA)
• Chemical Kinetics & Catalysis (AREA)
• General Chemical & Material Sciences (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Organic Chemistry (AREA)
• Epidemiology (AREA)
• Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
• Cosmetics (AREA)

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Citations (3)

• 2007
  • 2007-04-02 IT IT000007A patent/ITCE20070007A1/it unknown
• 2008
  • 2008-04-01 WO PCT/IT2008/000217 patent/WO2008120264A1/en active Application Filing

Patent Citations (3)

Non-Patent Citations (2)

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