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WO2013115759A1 - Médicaments topiques destinés à contrôler des symptômes épidermiques - Google Patents

Médicaments topiques destinés à contrôler des symptômes épidermiques Download PDF

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Publication number
WO2013115759A1
WO2013115759A1 PCT/US2012/000226 US2012000226W WO2013115759A1 WO 2013115759 A1 WO2013115759 A1 WO 2013115759A1 US 2012000226 W US2012000226 W US 2012000226W WO 2013115759 A1 WO2013115759 A1 WO 2013115759A1
Authority
WO
WIPO (PCT)
Prior art keywords
medications
symptoms
skin
lotions
creams
Prior art date
Application number
PCT/US2012/000226
Other languages
English (en)
Inventor
Branimir L. Horvat
Nevenka Horvat
Michael I. PASS
Original Assignee
Horvat Branimir L
Nevenka Horvat
Pass Michael I
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Horvat Branimir L, Nevenka Horvat, Pass Michael I filed Critical Horvat Branimir L
Publication of WO2013115759A1 publication Critical patent/WO2013115759A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles

Definitions

  • the proposed creams and lotions treat the epidermal symptoms in four to five days or, in more severe skin diseases, in two to three weeks.
  • the topical medications are composed of Aloe Vera, vanishing cream, water and different concentrations of Salicylic Acid and certain glucocorticoids dispersed in the form of extremely small micelles. Some strengths of the medications may be sold over-the-counter (OTC), while some will require physicians' prescription.
  • Photographs 5., 6. and 7. These photographs illustrate the skin of the leg of a young woman with Eczema previously treated unsuccessfully. Notice the dry and scaly lesions of her skin.
  • Photographs 16. through 19. illustrate the patient's appearance after fifteen days of treatment. With the exception of his neck which showed some residual scarring, the remaining photographs exhibit normal skin of the areas which were previously involved. Photographs 20. through 23. The same patient seen in photographs 12. through 15. and 16. through 19., came six weeks later with recurrence of his skin symptoms on the back (20.,), flexor side of his legs (21.) and his ankles (22. and 23.).
  • Photographs 24. through 27 The same areas are shown after four days of treatment with our creams. All skin symptoms were essentially resolved. Photograph 24. exhibits the back of the aforementioned patient ten days after treatment was stopped. The skin appears completely normal.
  • Photographs 28. through 30 The same patient came again five weeks later with recurrence of his symptoms. He shows involvement of the skin of the face (#28), back (#29) and frontal part of his abdomen (#30).
  • Photographs 31. through 33 This same patient was treated for four days and skin of the face is totally normal (#31.) and the skin of the frontal part of his abdomen is without any abnormality (#32.) and his back is now clear (#33.). He did not receive any more treatment for this recurrence.
  • Photographs 34. and 35 This patient came sixteen weeks after the resolution of his Topical Medications for Controlling Epidermal Symptoms last symptoms. He presented with the scaly symptoms and erythema of his scalp (#34) and the back of his ear (#35.).
  • Photographs 36. and 37 The appearance of the patient's scalp (#36.) treated with our lotion and ear (#37) treated with our cream after seven days of treatment.
  • Photographs 38. through 41 The appearance of the same patient two months after the resolution of his previous symptoms. The patient was not treated after the initial seven days of treatment.
  • Photographs 42. through 43 This patient exhibited skin symptoms on her left hand. She suffered from Eczematoid Neurodermatitis. She had been treated previously by numerous physicians without any results.
  • Photograph 44 Appearance of the hand after eight days of treatment.
  • Photograph 45 Patient with Eczema of the left fourth finger. The patient was seen in the past by numerous physicians without any significant improvement.
  • Photograph 46 Appearance of the finger seven days after treatment. No treatment was administered after first three days.
  • Photograph 47 The same patient experienced a recurrence of Eczema five weeks after the resolution of his initial symptoms.
  • Photograph 48 Appearance of the finger seven days later with no treatment after the initial four days.
  • Photographs 49. through 52 Patient with Solar keratoses of his left shoulder (#49.), back (50.), right side of his abdomen (51.) and lower arms (52.).
  • Photographs 53. through 56 Appearance of the skin after twelve days of treatment Topical Medications for Controlling Epidermal Symptoms of left shoulder (#53.), back (#54.), right side of the abdomen (#55.) and lower arms (#56.).
  • Photographs 57. through 64 Appearance of the patient with fulminant Psoriasis Vulgaris. The pictures show the back of his neck (#57.), left arm (#58.), upper head (59.) and lateral side of his face (#60.), frontal side of his neck (#61.), left ear (#62.), chest (#63.) and his back (#64.).
  • Photographs 65. through 72 Appearance of the patient's skin and scalp after fifteen days of treatment. The skin was treated with our cream and the scalp with our lotion.
  • Photograph 73 The same patient showed recurrence of the scalp symptoms after two years without any symptoms.
  • Photograph 74 The same patient after seven days of treatment with our lotion. The scalp symptoms are completely resolved.
  • Photographs 75 and 76 Patient with Rosacea treated unsuccessfully by numerous physicians.
  • the diseases mentioned above are caused by many diverse pathophysiologic conditions many of which are unknown.
  • the medications described in this patent do not address the etiology of these various diseases and do not cure these conditions but provide temporary relief of the epidermal symptoms of the patients.
  • the proposed creams and lotions will give patients suffering from these conditions periods of symptomatic relief of their epidermal symptoms more effectively than other currently available products. Photographic examples of patients treated with the proposed medications are presented in this patent application and show that some of the patients had several recurrences of skin symptoms.
  • the first patent we found is "Method of Treating Acne Vulgaris and Composition" by Joel Bernstein (US Patent 4,505, 896) submitted in December 1995.
  • This patent deals with a combination of several oral medications (nicotinic acid or nicotinamide) and topical solutions of similar compounds dissolved in various organic vehicles (not specifically identified) combined with several substances (sulfur, benzoyl peroxide, Topical Medications for Controlling Epidermal Symptoms vitamin A, erythromycin, clindamycin, and tetracycline) as well as Salicylic Acids.
  • the proposed creams and lotions contain substances that will promote the necessary moisture of the skin, prepare the dermis to accept the newly grown epidermis, desquamate the damaged epidermis, and promote the growth of the new healthy epidermis. Bacterial, fungal and viral inflammations may need to be treated in addition to the treatments of the damaged epidermis.
  • the first problem we addressed was maintaining the moisture level of the skin, which must be addressed if any medication will be successful.
  • Damaged skin commonly exhibits drying of the skin surfaces due to nonspecific inflammation and specific infections damaging the skin. Dry epidermis has a tendency to crack, resulting in further loss of integrity of the epidermal surface. Outside irritants, allergens and noxious substances cause damage to the underlying skin layers, further damaging the weakened epidermis as well as the skin layers under it. This also exposes the damaged areas to the specific bacterial, fungal or viral infections.
  • the medications we use have to be emulsified as very finely dispersed micelles in the aqueous milieu to act positively on skin symptoms. We have found several substances that are effective in the resolution of such problems. Due to common problems with dry skin, we always suggest that patients use a good, commercially available moisturizing cream after we finish treating their skin symptoms.
  • the other problem in addressing epidermal skin symptoms is the inflammatory effect that negates the effect of the first class of substances.
  • External substances such as irritants, allergens and infections result in damage to the sub-epidermal areas of the skin. This causes either nonspecific or specific inflammatory presentations of the affected skin.
  • Most of these specific and nonspecific inflammatory effects are the result of the interruption of the integrity of the epidermis, which has an inflammatory effect on the underlying sub-epidermal layers of the skin.
  • the substances used to deal with nonspecific inflammatory conditions of the skin are various corticoid medications.
  • corticoid medications are used as the only method of treating the skin, they offer only a very temporary relief to the patients because they do not cause re- epithelialization of the interrupted and damaged skin from the surrounding normal epidermal surfaces.
  • the next issues are various concurrent infections of the skin due to the interrupted integrity of the epidermis as well as a decrease of the basic immunologic resistance of the skin due to the loss of the epidermal integrity and the underlying primary diseases. These underlying primary causes of the skin diseases damage the epidermis and decrease the patients' general immunity. These factors allow infections to start and progress. Bacterial, fungal and viral infections also have to be addressed while the epidermis is being repaired. Clinical signs, cytologic manifestations and cultures of the surface of the skin are used to diagnose the presence of such additional problems. These conditions have to be properly addressed in affected patients.
  • a patient may show shows symptoms of hypo-nutrition or other Topical Medications for Controlling Epidermal Symptoms debilitation.
  • additional substances like vitamins may be included in the proposed creams and lotions.
  • patients may have to be systemically treated. For details, refer to the composition of various proposed creams and lotions in this paper. The prescribing physician must make a decision when examining the patient and determine the proper composition of the medication to be added for each patient.
  • the active medications had to be usable in workable concentrations in the aqueous milieu to be effective, whether they were dissolved or functioned as minute globules (micelles) emulsified in the aqueous milieu.
  • Aloe Vera cream was one of the ideal substances for that purpose and we were able to use it to moisturize the patients' skins.
  • the active medications were also incorporated into the Aloe Vera and commercially available vanishing cream.
  • Other moisturizing agents could be used for this purpose.
  • the vanishing cream contains varying amounts of purified water.
  • the entire composite is placed in an EMP (electronic mortor pastle) resulting in extremely fine emulsified creams and lotions containing effective medication.
  • EMP electronic mortor pastle
  • These finely emulsified creams and lotions provide us with a medication that exhibits surprisingly effective treatment of skin symptoms in patients with a variety of skin conditions.
  • the active substances we selected work together during the therapeutic application.
  • the Topical Medications for Controlling Epidermal Symptoms pharmacodynamics of the creams and lotions are presented in the later text.
  • Creams and lotions have several similarities and differences.
  • Creams may be oil-in-water or water-in-oil.
  • Our creams are oil-in-water. They are soft-solid and contain active substances to be applied externally for therapeutic purposes.
  • the lotions are mainly aqueous.
  • the main difference between the creams and lotions is that lotions are less viscous, meaning the medium meets with less resistance, allowing the patient to spread it thinly over larger areas than is possible with a cream.
  • the lotions contain insoluble materials in the form of suspension or emulsion intended for external application without excessive rubbing. Lotions usually have soothing, cleansing, and antiseptic properties.
  • Thymol Crystals for preservation of the creams under room temperature (usually 0.02 grams per 100 grams of cream) was also added.
  • the nonspecific inflammatory symptoms of the skin are due to the exposure of Topical Medications for Controlling Epidermal Symptoms the subepidermal areas of the skin to outside irritants or allergens because of the lack of epidermal integrity. This is also due to a general decrease of the patients' immunity because of their primary diseases.
  • corticoids may be used in prescription strength or in strengths suitable to be sold for over-the-counter (OTC) use. Because we were dealing with different levels of presentations of nonspecific skin inflammations, we decided to use both of these groups of corticoid medications rather than experiment with other, less tested compounds.
  • OTC over-the-counter
  • over-the counter (OTC) medications we used up to one percent of Hydrocortisone Mic powder 99.34 in our creams and lotions. Other such glucocorticoids may also be used. In the creams for more severe cases requiring prescription medications, we used Triamcinolone Acetonide micronized powder. However, other cortisone medications may be used for making these creams and lotions. More potent medications may require prescription and other less potent medications could be incorporated in the OTC medications.
  • Glucocorticoids were incorporated in the creams and lotions as separate micelles in the emulsions.
  • Topical Medications for Controlling Epidermal Symptoms were incorporated in the creams and lotions as separate micelles in the emulsions.
  • Skins of patients with different dermatologic ailments are often affected by secondary bacterial, fungal or viral infections.
  • the skin which is weakened by the lack of a protective epidermis and decreased immunity due to the patient's primary disease, allows bacteria, fungi and viruses to attack the skins of these patients.
  • Salicylic Acid acts as a desquamative agent at certain higher concentrations and promotes the growth of the epidermis in lower concentrations.
  • the inflammatory effects were ameliorated with the glucocorticoids.
  • This new epidermis provided continuity of the epidermal layer of the skin and thus protected the immediate subepidermal areas of the skin against negative outside influences.
  • the application of our creams and lotions caused this new epidermis to reach normal thickness in a very short period of time (see photographs of the treated patients).
  • the new skin was able to protect patients from irritative, allergic and infectious agents.
  • Lotions were usually prepared using higher concentrations than were used in creams for the same patients because of the scaly presentation of the patients' hairy areas. Proper further clinical Protocols will determine the upper ranges in such extreme cases.
  • glucocorticoids of the creams and lotions decrease nonspecific inflammation and prepare the subcutaneous area of the skin for re-growth of the new basilar epidermal cells from the surrounding unaffected skin after the desquamated cells are removed.
  • OTC oxygen-driven oxidant
  • Both glucocorticoids and Salicylic Acid must be dispersed in the creams and lotions in the form of very fine micelles to be effective.
  • the active medications are finely suspended in the basic creams and lotions. Aloe Vera and other adjuvants such as the vanishing cream consisting of Polysorbate 80 and Krisgel 100 are placed in EMP (electronic mortor pastle). This results in extremely fine emulsified creams and lotions containing appropriate concentrations of Salicylic Acid and glucocorticoids in the form of Topical Medications for Controlling Epidermal Symptoms extremely small micelles. These simple compositions gave us results that have not been achieved previously by other medications for these skin diseases. They allow us to achieve proper skin moisturization and proper dispersion of our active substances.
  • the young patient in the pictorial presentation in this paper showed several recurrences of symptoms.
  • the third and fifth patients in the pictorial presentation exhibited recurrences of symptoms after two weeks, three months, and over two years, respectively, after the initial treatments. They were treated again and the epidermal Topical Medications for Controlling Epidermal Symptoms symptoms were resolved after eight to ten days. Thus, when symptoms recur, we established that a short application of four to ten days is sufficient.
  • the base cream is composed as follows:
  • the base lotion is composed as follows:
  • glucocorticoids were added. They were emulsified for five to ten minutes in the Base Creams or Lotions to achieve the finest micelles possible.
  • Salicylic Acid was also emulsified for five to ten minutes.
  • the amount of Salicylic Acid was determined based on the severity of the symptoms, age of the patient and, if the patient was previously treated with our creams or lotions, the clinical response to the treatment. Generally speaking, the more severe the symptoms, the higher the Topical Medications for Controlling Epidermal Symptoms concentration of Salicylic Acid used in the medication. However, we always started w a lower percentage of Salicylic Acid. Typically we started with 3% to 5%.
  • antibiotic, anti-funj medication or anti viral compound may be added or patient may be treated separat from incorporating such agents in the creams and lotions.

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Abstract

La présente invention concerne une méthode de traitement de symptômes épidermiques de diverses maladies cutanées allant de l'eczéma au psoriasis, la rosacée, etc. Selon l'invention, les crèmes et lotions proposées traitent les symptômes épidermiques en quatre à cinq jours ou, pour des symptômes cutanés plus graves, en deux à trois semaines. Les médicaments topiques sont composés d'Aloe Vera, de crèmes de jour, d'eau et de différentes concentrations d'acide salicylique et de certains glucocorticoïdes. Pour l'action appropriée des médicaments, l'acide salicylique et les glucocorticoïdes doivent être dispersés dans des micelles extrêmement petites dans les émulsions des crèmes et lotions. Certains dosages des médicaments peuvent être obtenus en vente libre (OTC), tandis que certains nécessiteront la prescription d'un médecin.
PCT/US2012/000226 2012-02-01 2012-04-30 Médicaments topiques destinés à contrôler des symptômes épidermiques WO2013115759A1 (fr)

Applications Claiming Priority (2)

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US201213385066A 2012-02-01 2012-02-01
US13/385,066 2012-02-01

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WO2013115759A1 true WO2013115759A1 (fr) 2013-08-08

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Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5063049A (en) * 1990-06-11 1991-11-05 Calvert Billings Disinfectant nail polish remover
US5733572A (en) * 1989-12-22 1998-03-31 Imarx Pharmaceutical Corp. Gas and gaseous precursor filled microspheres as topical and subcutaneous delivery vehicles
US6146639A (en) * 1999-07-26 2000-11-14 Merich Nick Arthritis, muscle pain, and dry skin remedy
US6375942B1 (en) * 1999-08-31 2002-04-23 Michael C. Rico Skin healing ointment
US20030104016A1 (en) * 2001-09-17 2003-06-05 Gendimenico Gerard J. Method for treating skin disorders
US20080113037A1 (en) * 2006-11-10 2008-05-15 Green Barbara A Topical Compositions Comprising Polyhydroxy Acids and/or Lactones for Improved Cutaneous Effects of Oxidative Therapeutic Drugs
US20090087407A1 (en) * 2004-03-22 2009-04-02 Celgene Corporation Methods for the treatment of scleroderma using 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-methylisoindoline
US20100040561A9 (en) * 2002-10-25 2010-02-18 Foamix Ltd. Penetrating pharmaceutical foam
US20110178177A1 (en) * 2008-09-27 2011-07-21 Taraxos Inc. Topical formulations for treatment of neuropathy

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5733572A (en) * 1989-12-22 1998-03-31 Imarx Pharmaceutical Corp. Gas and gaseous precursor filled microspheres as topical and subcutaneous delivery vehicles
US5063049A (en) * 1990-06-11 1991-11-05 Calvert Billings Disinfectant nail polish remover
US6146639A (en) * 1999-07-26 2000-11-14 Merich Nick Arthritis, muscle pain, and dry skin remedy
US6375942B1 (en) * 1999-08-31 2002-04-23 Michael C. Rico Skin healing ointment
US20030104016A1 (en) * 2001-09-17 2003-06-05 Gendimenico Gerard J. Method for treating skin disorders
US20100040561A9 (en) * 2002-10-25 2010-02-18 Foamix Ltd. Penetrating pharmaceutical foam
US20090087407A1 (en) * 2004-03-22 2009-04-02 Celgene Corporation Methods for the treatment of scleroderma using 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-methylisoindoline
US20080113037A1 (en) * 2006-11-10 2008-05-15 Green Barbara A Topical Compositions Comprising Polyhydroxy Acids and/or Lactones for Improved Cutaneous Effects of Oxidative Therapeutic Drugs
US20110178177A1 (en) * 2008-09-27 2011-07-21 Taraxos Inc. Topical formulations for treatment of neuropathy

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
"The Salon Healing Red", DERMILLUME PHOTOTHERAPY, 5 November 2006 (2006-11-05) *
TERRY LABS, 15 September 2010 (2010-09-15), pages 1 - 2, Retrieved from the Internet <URL:http://www.terrylabs.com/pure-products> [retrieved on 20120827] *

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