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WO2007067347A2 - Compositions destinees a la regression sure et efficace de pustules spongiformes - Google Patents

Compositions destinees a la regression sure et efficace de pustules spongiformes Download PDF

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Publication number
WO2007067347A2
WO2007067347A2 PCT/US2006/045065 US2006045065W WO2007067347A2 WO 2007067347 A2 WO2007067347 A2 WO 2007067347A2 US 2006045065 W US2006045065 W US 2006045065W WO 2007067347 A2 WO2007067347 A2 WO 2007067347A2
Authority
WO
WIPO (PCT)
Prior art keywords
safe
topical composition
effective regression
amount
present
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2006/045065
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English (en)
Other versions
WO2007067347A3 (fr
Inventor
N. B . Baktha Reddy
Senthil Kumar
Vilambi Nrk Reddy
Anil Torgalkar
N. R. Murugan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Apptec Inc
Original Assignee
Apptec Inc
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
Priority claimed from US11/288,923 external-priority patent/US20070122498A1/en
Priority claimed from US11/395,944 external-priority patent/US20070231415A1/en
Application filed by Apptec Inc filed Critical Apptec Inc
Publication of WO2007067347A2 publication Critical patent/WO2007067347A2/fr
Publication of WO2007067347A3 publication Critical patent/WO2007067347A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/24—Apocynaceae (Dogbane family), e.g. plumeria or periwinkle
    • 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)
    • A61K36/889—Arecaceae, Palmae or Palmaceae (Palm family), e.g. date or coconut palm or palmetto
    • 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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite

Definitions

  • the present invention relates to compositions for Safe and Effective regression of Spongiform Pustule.
  • the present invention relates to compositions for safe and effective regression of Spongiform Pustule in Psoriatic Lesions.
  • the epidermis of the skin is a non-vascularized layer of the skin.
  • Different factors can result in increased blood vessel formation in the papillary dermis and these blood vessels may sometimes extend into the epidermis resulting in clinically significant skin manifestations.
  • over activated keratinocytes actively producing and secreting pro-angiogenic factors in the form of growth factors or cytokines can result in increased blood vessel formation in the papillary dermis which may sometime extend into the epidermis.
  • Epidermal microvascular proliferation ultimately leads to epidermal keratinocyte hyperproliferation, thickening of the epidermis with parakeratosis of the stratum corneum and inflammatory infiltrate around the blood vessels in the papillary dermis [see Figure 1].
  • microvascular changes are also characterized by increased tortuosity of dermal capillary loops which precedes the development of epidermal hyperplasia.
  • Mitotic activity in the basal and suprabasal cells are greatly increased [Dr. George Jacob, Seminar on Psoriasis, Dubai, Jan 2001].
  • Cellular invasion takes place, particularly in the suprapapillary region to form the Munro 'micro abscess' which are extruded in the horny layer or they may collect in disintegrated malphigian cells, the cytoplasm of which had been lysed to form the multilocular or spongiform pustule of Kogoj [see Figure 2].
  • Spongiform pustules of Kagoj are multilocular pustules in the upper stratum malpighii within a sponge-like network made up of flattened keratinocytes [M.S. Stone and T.L. Ray, DermPath Tutor, Department of Dermatology, Iowa College of Medicine, September 1995]. They are seen in psoriasis, Reiter's disease, geographical tongue and rarely in candidiasis.
  • compositions for Safe and Effective regression of Spongiform Pustule in the form of ointment, cream, oil, soap and shampoo which comprise non aqueous herbal extract of Wrightia Tinctoria, cocos nucifera, and suitable pharmaceutically / cosmetically accepted excipients for dermal use.
  • Figure 1 Illustration of epidermal microvascular proliferation.
  • Figure 2 Example of spongiform pustules of Kagoj.
  • FIG. 3 Micro Graphs of Spongiform Pustule- Before and after Treatment
  • the present invention relates to novel Herbal formulations which unexpectedly provide statistically superior efficacy to allopathy control formulations in reduction of Spongiform
  • the Novel Herbal formulations for the Safe and Effective regression of Spongiform Pustule are designed specifically for topical use in the form of ointment, shampoo, oil and soap. These compositions typically contain non-aqueous Herbal extract of Wrightia Tinctoria and Herbal extract of Cocos nucifera and pharmaceutically or cosmetically accepted excipients for dermal use in ointment, oil, soap and shampoo
  • the non aqueous medium of the present invention for Herbal extract is non-volatile oil, wherein non-volatile oil is preferably vegetable oil such as coconut oil, gingely oil, sunflower oil, corn oil, or refined vegetable oil.
  • non-volatile oil in the extract of the present invention generally comprises from about 80% to 99% weight percent of the extract.
  • the Herbal extract in the topical composition for Safe and Effective regression of Spongiform Pustule is derived from Wrightia Tinctoria and is from either or combination of leaves, leafy stems and other cut portions of Wrightia Tinctoria plant. It is an apocynaceae tree growing throughout India. Its flowers are white and fragrant.
  • Non aqueous extracts of Wrightia Tinctoria are prepared at ambient temperature and compounded with the other ingredients mentioned herein to prepare the different topical formulations for Ointment, Oil, Liquid soap and Shampoo.
  • Other Herbal extracts in the formulation may include Melia Azardirachta Linn oils documented to have beneficial skin effects [Nair et al., 1978].
  • the topical composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of extract of active Herbal ingredient mentioned above in the extraction medium in the amount from 1% to 20% weight percent.
  • the Herbal extract of Cocos Nucifera in the topical composition for Safe and Effective regression of Spongiform Pustule is derived from the copra of the coconut. Copra of the coconut is dried and processed to extract oil which is purified and stabilized.
  • the topical composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of Herbal extract of cocos nucifera from the copra of the coconut present in the amount of 40% to 80%.
  • the topical ointment composition for Safe and Effective regression of Spongiform Pustule described above include pharmaceutically accepted excipients such as Bees Wax, Paraffin (liquid, soft and hard), and other standard ointment bases or equivalents to optimize use characteristics (such as consistency, spreadability, ..) manufacturability and stability.
  • the topical ointment composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of excipients such as Bees Wax present in the amount of 1 to 5%, Paraffin present in the amount of 5 to 40 % and / or standard ointment bases present in the amount of 5 to 50 %.
  • the topical oil composition for Safe and Effective regression of Spongiform Pustule described above include pharmaceutically accepted excipients such as Vegetable oil, animal oil, and synthetic oils such as mineral oil and liquid paraffin or equivalents to optimize use
  • the topical oil composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of excipients such as coconut oil present in the amount of 70 to 95%.
  • the topical liquid soap composition for Safe and Effective regression of Spongiform Pustule described above include pharmaceutically accepted excipients such as water, surface active agents, thickeners or viscosity enhancers, foam boosters, and stabilizers or equivalents to optimize use characteristics (such as consistency, cleaning, spreadability, foaming, ..) manufacturability and stability.
  • pharmaceutically accepted excipients such as water, surface active agents, thickeners or viscosity enhancers, foam boosters, and stabilizers or equivalents to optimize use characteristics (such as consistency, cleaning, spreadability, foaming, ..) manufacturability and stability.
  • the topical liquid soap composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of excipients such as water present in the amount of 60 to 85%, surface active agents present in the amount of 5 to 40%, thickeners or viscosity enhancers present in the amount of 0.5 to 8 %, foam boosters present in the amount of 1 to 4 % and stabilizers present in the amount of 0.5 to 2 %.
  • the topical shampoo composition for Safe and Effective regression of Spongiform Pustule described above include pharmaceutically accepted excipients such as water, surface active agents, thickeners or viscosity enhancers, foam boosters, and stabilizers or equivalents to optimize use characteristics (such as consistency, cleaning, spreadability, foaming, ..) manufacturability and stability.
  • pharmaceutically accepted excipients such as water, surface active agents, thickeners or viscosity enhancers, foam boosters, and stabilizers or equivalents to optimize use characteristics (such as consistency, cleaning, spreadability, foaming, ..) manufacturability and stability.
  • the topical shampoo composition of the present invention for Safe and Effective regression of Spongiform Pustule generally comprises of excipients such as water present in the amount of 50 to 85%, surface active agents present in the amount of 10 to 30%, thickeners or viscosity enhancers present in the amount of 2 to 8 %, foam boosters present in the amount of 2 to 6 % and stabilizers present in the amount of 0.5 to 2 %.
  • topical composition for Safe and Effective regression of Spongiform Pustule described above wherein Pharmaceutically or cosmetically accepted excipients in ointment, oil, liquid soap and shampoo formulations may include preservatives, coloring agents and fragrances as needed wherein preservatives, coloring agents and fragrances in ointment, oil, liquid soap and shampoo formulations is present in the amount of 0 - 5 total weight %.
  • Group I was treated with the Herbal formulation (see Table 1 for details) once daily and Group Il was treated with Allopathy control formulation (see Table 2 for details) once daily. All patients recruited were screened to be suffering from Spongiform Pustule problems (Psoriasis patients).
  • Randomization was done as per standard statistical methods to minimize bias in the study. Patients were enrolled into the study on a first come first served basis and assigned a subject number sequentially. The assignment of each patient to the treatment group was determined by the randomization list provided by the statistician.
  • Spongiform Pustule parameter represents the Severity of Infiltration in the epidermal cells. More active the disease more severe the degree of infiltration.
  • FIG. 3 presents photos of micrographs observed before and after treatment with patients treated for 8 weeks with the Herbal formulation presented in this invention. It is clear from the photographs that the treatment with The Herbal formulation is very effective in regressing the Spongiform Pustules and clearing of the dermal infiltrate as compared to prior to the start of treatment.
  • TC Total count of White blood cells
  • DC-P Polymorphonuclear neutrophil
  • DC-L Lymphocytes
  • DC-E Eosinophils
  • Hb Haemoglobin
  • DC-P which stands for the percentage of P- Polymorphonuclear neutrophil, was measured using Neubauer Counting Chamber and the normal range for DC-P
  • DC-L which is the percentage of
  • Lymphocytes present was measured using Neubauer Counting chamber and the normal range for DC-L Measurements is 30-40% of the total white cell count.
  • DC-L was measured.
  • DC-E which is the percentage of Eosinophils, was measured using the Neubauer Counting Chamber and the normal range for DC-E measurements is 1-7% of the total white blood cell count.
  • DC-E was measured.
  • HB which is Haemoglobin measurements was measured using RA 50 Biochemical analyzer and the normal range is 12 - 14 gms. Table 5: Statistical Analysis of Haemogram Measurements for Herbal treatment.
  • Glutamic Oxalo acetic Transaminase (SGOT), Serum Glutamic Pyruvic Transaminase (SGPT) and Serum Bilirubin] are presented in Table 6.
  • SGOT serum glutamic - oxalo acetic transaminase (international unit per liter), was measured at visits T 0 and T 8 w. And the normal range is 0 - 46 LU / L.
  • SGPT Serum glutamic pyruvic transaminase (international units / liter) was measured at visits T 0 and T 8W . And the normal SGPT ranges from 0 to 49 IU/L.
  • Serum Bilirubin was measured at visits T 0 and T 8 w and the normal Serum Bilirubin ranges from 0,0 to 1.0 mg/dl.
  • Serum Creatinine was measured at visits T 0 and T 8W . And the normal Serum Creatinine value ranges from 0.8 to 1.4mg/dl. Serum Urea was measured at visits T 0 and T 8 w. And the normal Serum Urea value ranges from 10 to 50mg/dl.

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Biotechnology (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

L'invention concerne des compositions topiques destinées à la régression sûre et efficace de pustules spongiformes, se présentant sous la forme d'un onguent, d'une crème, d'une huile, d'un savon ou d'un shampooing. Les compositions selon l'invention contiennent un extrait d'herbes non aqueux de Wrightia Tinctoria, cocos nucifera, et des excipients pharmaceutiques/cosmétiques adaptés pour une utilisation cutanée.
PCT/US2006/045065 2005-11-28 2006-11-20 Compositions destinees a la regression sure et efficace de pustules spongiformes Ceased WO2007067347A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US11/288,923 2005-11-28
US11/288,923 US20070122498A1 (en) 2005-11-28 2005-11-28 Compositions for safe and effective regression of dermal vessel tortuosity
US11/395,944 2006-03-31
US11/395,944 US20070231415A1 (en) 2006-03-31 2006-03-31 Compositions for safe and effective regression of spongiform pustule

Publications (2)

Publication Number Publication Date
WO2007067347A2 true WO2007067347A2 (fr) 2007-06-14
WO2007067347A3 WO2007067347A3 (fr) 2008-04-24

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PCT/US2006/045065 Ceased WO2007067347A2 (fr) 2005-11-28 2006-11-20 Compositions destinees a la regression sure et efficace de pustules spongiformes

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010127396A1 (fr) * 2009-05-04 2010-11-11 Cimtech Pty Limited Un ou plusieurs extraits de vigna marina, cocos nucifera l. ou terminalia catappa l. destinés au traitement de plaies, de troubles cutanés et de la perte des cheveux

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5858372A (en) * 1997-09-12 1999-01-12 Jacob; George Herbal medication for the treatment of psoriasis

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2010127396A1 (fr) * 2009-05-04 2010-11-11 Cimtech Pty Limited Un ou plusieurs extraits de vigna marina, cocos nucifera l. ou terminalia catappa l. destinés au traitement de plaies, de troubles cutanés et de la perte des cheveux
CN104138487A (zh) * 2009-05-04 2014-11-12 库克岛医学技术有限公司 用于处理伤口、皮肤疾病和脱发的滨豇豆、椰子树或榄仁树提取物中的一种或多种
US9649512B2 (en) 2009-05-04 2017-05-16 Cimtech Pty Limited One or more of Vigna marina, Cocos nucifera L. or Terminalia catappa L. extracts for treating wounds, skin disorders and hair loss
KR101798665B1 (ko) * 2009-05-04 2017-11-16 씨아이엠테크 피티와이 리미티드 상처, 피부 질환 및 모발 상실을 치유하기 위한 비그나 마리나 (Ｖｉｇｎａｍａｒｉｎａ), 종려나무과 (Ｃｏｃｏｓ ｎｕｃｉｆｅｒａ Ｌ.), 또는 인디안 아몬드 (Ｔｅｒｍｉｎａｌｉａ ｃａｔａｐｐａ Ｌ.)중에서 한 가지 이상의 추출물

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