US3137622A - Topical therapeutic composition - Google Patents
Topical therapeutic composition Download PDFInfo
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- US3137622A US3137622A US704277A US70427757A US3137622A US 3137622 A US3137622 A US 3137622A US 704277 A US704277 A US 704277A US 70427757 A US70427757 A US 70427757A US 3137622 A US3137622 A US 3137622A
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- United States
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- resorcinol
- attapulgite
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- liquid
- composition
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- 239000000203 mixture Substances 0.000 title claims description 60
- 230000001225 therapeutic effect Effects 0.000 title claims description 18
- 230000000699 topical effect Effects 0.000 title claims description 13
- GHMLBKRAJCXXBS-UHFFFAOYSA-N resorcinol Chemical compound OC1=CC=CC(O)=C1 GHMLBKRAJCXXBS-UHFFFAOYSA-N 0.000 claims description 58
- 229960000892 attapulgite Drugs 0.000 claims description 39
- 229910052625 palygorskite Inorganic materials 0.000 claims description 39
- 239000007788 liquid Substances 0.000 claims description 26
- 208000002874 Acne Vulgaris Diseases 0.000 claims description 18
- 206010000496 acne Diseases 0.000 claims description 18
- 239000000463 material Substances 0.000 claims description 16
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 13
- ZZPKZRHERLGEKA-UHFFFAOYSA-N resorcinol monoacetate Chemical compound CC(=O)OC1=CC=CC(O)=C1 ZZPKZRHERLGEKA-UHFFFAOYSA-N 0.000 claims description 9
- TUJKJAMUKRIRHC-UHFFFAOYSA-N hydroxyl Chemical class [OH] TUJKJAMUKRIRHC-UHFFFAOYSA-N 0.000 claims 2
- KFZMGEQAYNKOFK-YZRHJBSPSA-N (214C)propan-2-ol Chemical compound [14CH](C)(C)O KFZMGEQAYNKOFK-YZRHJBSPSA-N 0.000 claims 1
- XLYOFNOQVPJJNP-PWCQTSIFSA-N Tritiated water Chemical compound [3H]O[3H] XLYOFNOQVPJJNP-PWCQTSIFSA-N 0.000 claims 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 16
- 239000011707 mineral Substances 0.000 description 16
- 235000010755 mineral Nutrition 0.000 description 16
- 238000009472 formulation Methods 0.000 description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 15
- XLOMVQKBTHCTTD-UHFFFAOYSA-N Zinc monoxide Chemical compound [Zn]=O XLOMVQKBTHCTTD-UHFFFAOYSA-N 0.000 description 14
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 14
- 239000000499 gel Substances 0.000 description 14
- 210000003491 skin Anatomy 0.000 description 12
- 208000035475 disorder Diseases 0.000 description 11
- 230000000694 effects Effects 0.000 description 11
- -1 hydroxy aromatic compounds Chemical class 0.000 description 10
- 239000003814 drug Substances 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 8
- 229910052901 montmorillonite Inorganic materials 0.000 description 7
- 239000011787 zinc oxide Substances 0.000 description 7
- 229960001296 zinc oxide Drugs 0.000 description 7
- 235000014692 zinc oxide Nutrition 0.000 description 7
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 6
- GUJOJGAPFQRJSV-UHFFFAOYSA-N dialuminum;dioxosilane;oxygen(2-);hydrate Chemical compound O.[O-2].[O-2].[O-2].[Al+3].[Al+3].O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O GUJOJGAPFQRJSV-UHFFFAOYSA-N 0.000 description 6
- 230000008901 benefit Effects 0.000 description 5
- 239000004927 clay Substances 0.000 description 5
- 239000006185 dispersion Substances 0.000 description 5
- IDGUHHHQCWSQLU-UHFFFAOYSA-N ethanol;hydrate Chemical compound O.CCO IDGUHHHQCWSQLU-UHFFFAOYSA-N 0.000 description 5
- 238000000034 method Methods 0.000 description 5
- 208000017520 skin disease Diseases 0.000 description 5
- 150000001491 aromatic compounds Chemical class 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 4
- 239000000470 constituent Substances 0.000 description 4
- 239000012535 impurity Substances 0.000 description 4
- 229940124597 therapeutic agent Drugs 0.000 description 4
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 3
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 3
- 229910052782 aluminium Inorganic materials 0.000 description 3
- IXWIAFSBWGYQOE-UHFFFAOYSA-M aluminum;magnesium;oxygen(2-);silicon(4+);hydroxide;tetrahydrate Chemical compound O.O.O.O.[OH-].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[O-2].[Mg+2].[Al+3].[Si+4].[Si+4].[Si+4].[Si+4] IXWIAFSBWGYQOE-UHFFFAOYSA-M 0.000 description 3
- 239000000084 colloidal system Substances 0.000 description 3
- 239000000645 desinfectant Substances 0.000 description 3
- 201000010099 disease Diseases 0.000 description 3
- 238000009826 distribution Methods 0.000 description 3
- 239000012530 fluid Substances 0.000 description 3
- 229910000286 fullers earth Inorganic materials 0.000 description 3
- 241000894007 species Species 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- 230000008961 swelling Effects 0.000 description 3
- 239000003981 vehicle Substances 0.000 description 3
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 2
- ISWSIDIOOBJBQZ-UHFFFAOYSA-N Phenol Chemical compound OC1=CC=CC=C1 ISWSIDIOOBJBQZ-UHFFFAOYSA-N 0.000 description 2
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 229910052783 alkali metal Inorganic materials 0.000 description 2
- 150000001340 alkali metals Chemical class 0.000 description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 2
- 239000002585 base Substances 0.000 description 2
- 239000000440 bentonite Substances 0.000 description 2
- 229910000278 bentonite Inorganic materials 0.000 description 2
- SVPXDRXYRYOSEX-UHFFFAOYSA-N bentoquatam Chemical compound O.O=[Si]=O.O=[Al]O[Al]=O SVPXDRXYRYOSEX-UHFFFAOYSA-N 0.000 description 2
- 239000002537 cosmetic Substances 0.000 description 2
- 230000002939 deleterious effect Effects 0.000 description 2
- 239000010433 feldspar Substances 0.000 description 2
- 210000003780 hair follicle Anatomy 0.000 description 2
- ACGUYXCXAPNIKK-UHFFFAOYSA-N hexachlorophene Chemical compound OC1=C(Cl)C=C(Cl)C(Cl)=C1CC1=C(O)C(Cl)=CC(Cl)=C1Cl ACGUYXCXAPNIKK-UHFFFAOYSA-N 0.000 description 2
- 229960004068 hexachlorophene Drugs 0.000 description 2
- 239000003906 humectant Substances 0.000 description 2
- 239000004615 ingredient Substances 0.000 description 2
- 239000002198 insoluble material Substances 0.000 description 2
- 230000000622 irritating effect Effects 0.000 description 2
- 239000006210 lotion Substances 0.000 description 2
- 239000003921 oil Substances 0.000 description 2
- 239000002674 ointment Substances 0.000 description 2
- 239000010453 quartz Substances 0.000 description 2
- 230000000246 remedial effect Effects 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N silicon dioxide Inorganic materials O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 230000001954 sterilising effect Effects 0.000 description 2
- 238000004659 sterilization and disinfection Methods 0.000 description 2
- NCKMMSIFQUPKCK-UHFFFAOYSA-N 2-benzyl-4-chlorophenol Chemical compound OC1=CC=C(Cl)C=C1CC1=CC=CC=C1 NCKMMSIFQUPKCK-UHFFFAOYSA-N 0.000 description 1
- QTWJRLJHJPIABL-UHFFFAOYSA-N 2-methylphenol;3-methylphenol;4-methylphenol Chemical compound CC1=CC=C(O)C=C1.CC1=CC=CC(O)=C1.CC1=CC=CC=C1O QTWJRLJHJPIABL-UHFFFAOYSA-N 0.000 description 1
- WFJIVOKAWHGMBH-UHFFFAOYSA-N 4-hexylbenzene-1,3-diol Chemical compound CCCCCCC1=CC=C(O)C=C1O WFJIVOKAWHGMBH-UHFFFAOYSA-N 0.000 description 1
- 206010000503 Acne cystic Diseases 0.000 description 1
- 241000894006 Bacteria Species 0.000 description 1
- HWSISDHAHRVNMT-UHFFFAOYSA-N Bismuth subnitrate Chemical compound O[NH+]([O-])O[Bi](O[N+]([O-])=O)O[N+]([O-])=O HWSISDHAHRVNMT-UHFFFAOYSA-N 0.000 description 1
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 206010048768 Dermatosis Diseases 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 229940124091 Keratolytic Drugs 0.000 description 1
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 description 1
- 206010054107 Nodule Diseases 0.000 description 1
- 206010033733 Papule Diseases 0.000 description 1
- 239000004264 Petrolatum Substances 0.000 description 1
- 206010037888 Rash pustular Diseases 0.000 description 1
- 206010039509 Scab Diseases 0.000 description 1
- 239000004113 Sepiolite Substances 0.000 description 1
- 241000934136 Verruca Species 0.000 description 1
- 208000000260 Warts Diseases 0.000 description 1
- YKTSYUJCYHOUJP-UHFFFAOYSA-N [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] Chemical compound [O--].[Al+3].[Al+3].[O-][Si]([O-])([O-])[O-] YKTSYUJCYHOUJP-UHFFFAOYSA-N 0.000 description 1
- 239000013543 active substance Substances 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 229910052784 alkaline earth metal Inorganic materials 0.000 description 1
- 150000001342 alkaline earth metals Chemical class 0.000 description 1
- 229940009868 aluminum magnesium silicate Drugs 0.000 description 1
- WMGSQTMJHBYJMQ-UHFFFAOYSA-N aluminum;magnesium;silicate Chemical compound [Mg+2].[Al+3].[O-][Si]([O-])([O-])[O-] WMGSQTMJHBYJMQ-UHFFFAOYSA-N 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 125000003118 aryl group Chemical group 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 229960001482 bismuth subnitrate Drugs 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 239000002734 clay mineral Substances 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- OTGAHJPFNKQGAE-UHFFFAOYSA-N cresatin Chemical compound CC(=O)OC1=CC=CC(C)=C1 OTGAHJPFNKQGAE-UHFFFAOYSA-N 0.000 description 1
- 229930003836 cresol Natural products 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 229910001649 dickite Inorganic materials 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 230000008020 evaporation Effects 0.000 description 1
- 238000004299 exfoliation Methods 0.000 description 1
- 230000001747 exhibiting effect Effects 0.000 description 1
- 210000000416 exudates and transudate Anatomy 0.000 description 1
- 239000003925 fat Substances 0.000 description 1
- 230000009969 flowable effect Effects 0.000 description 1
- 210000004907 gland Anatomy 0.000 description 1
- 210000004209 hair Anatomy 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 229960003258 hexylresorcinol Drugs 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 description 1
- 229910052622 kaolinite Inorganic materials 0.000 description 1
- 230000001530 keratinolytic effect Effects 0.000 description 1
- 239000003410 keratolytic agent Substances 0.000 description 1
- 239000007791 liquid phase Substances 0.000 description 1
- 229910052749 magnesium Inorganic materials 0.000 description 1
- 239000011777 magnesium Substances 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 231100000344 non-irritating Toxicity 0.000 description 1
- 230000001473 noxious effect Effects 0.000 description 1
- 150000002894 organic compounds Chemical class 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 230000035515 penetration Effects 0.000 description 1
- 235000019271 petrolatum Nutrition 0.000 description 1
- 229940066842 petrolatum Drugs 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 150000002989 phenols Chemical class 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- BDERNNFJNOPAEC-UHFFFAOYSA-N propan-1-ol Chemical compound CCCO BDERNNFJNOPAEC-UHFFFAOYSA-N 0.000 description 1
- 208000029561 pustule Diseases 0.000 description 1
- 150000003242 quaternary ammonium salts Chemical class 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 201000004700 rosacea Diseases 0.000 description 1
- 210000001732 sebaceous gland Anatomy 0.000 description 1
- 235000019355 sepiolite Nutrition 0.000 description 1
- 229910052624 sepiolite Inorganic materials 0.000 description 1
- 229910052604 silicate mineral Inorganic materials 0.000 description 1
- 235000012239 silicon dioxide Nutrition 0.000 description 1
- 201000010153 skin papilloma Diseases 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 238000003756 stirring Methods 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000011593 sulfur Substances 0.000 description 1
- 229910052717 sulfur Inorganic materials 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 239000000375 suspending agent Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000000454 talc Substances 0.000 description 1
- 229910052623 talc Inorganic materials 0.000 description 1
- 239000002562 thickening agent Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Classifications
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth 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)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
Description
United States Patent 3,137,622 TGPICAL THERAPEUTIC COMPOSITION Albert J. Mueller, Princeton, N.J., and Paul R. Kline, 30 Lafayette Road W., Princeton, NJ; said Mueller assignor, by mesne assignments, to said Kline No Drawing. Filed Dec. 23, 1957, Ser. No. 704,277 7 Claims. (Cl. 167-58) This invention relates to improved topical therapeutic compositions and particularly to compositions useful in treatment of disorders of the pilosebaceous apparatus. The invention also relates to a method of making such compositions.
Certain dermatoses, such as for example acne, involve disorders in the oil glands associated with hair follicles, the so called pilosebaceous apparatus. These diseases are characterized by inflammation of the hair follicles and/ or sebaceous glands and in some instances are marked by disfiguring papules, pustules, nodules or crusts. These diseases are frequently chronic and in many individuals are highly resistant to cure,
Many medicinals have been used in the treatment of such disorders of the pilosebaceous apparatus. Among the most effective remedial agents are resorcinol and resorcinol monoacetate which function by virtue of their keratolytic and/ or keratoplastic effect, the particular effect depending principally on the concentration of the active ingredient. Dermatological preparations including resorcinol, resorcinol monoacetate or other phenolic compounds are frequently supplied as ointments in oleaginous bases, usually petrolatum with or without fats and waxes and may or may not include anodynes, such as for example bismuth subnitrate, zinc oxide, tale, etc. The effectiveness of resorcinol or other hydroxy aromatic compounds in treatment of disorders of the pilosebaceous system is reduced by the presence of oleaginous material therewith since such oleaginous material interferes with the activity of the therapeutic component of the composition. Accordingly, resorcinol is frequently employed in the form of a dilute solution or lotion when used to treat certain dermatoses. However, the use of flowable preparations for the purpose is highly undesirable particularly when the face is the site of the disorder treated because drippings of the medicament from said site can be unpleasant if not noxious, particularly to the hair, eyes, mouth or clothing of the patient. Hence, hydroxy aromatic therapeutic agents are advantageously applied in thickened systems. Ideally the therapeutic agent is incorporated in a hydrophilic base whereby the composition resists flow unless sufficient mechanical force is applied thereto. An advantage inherent in the use of a gel is that the total quantity of treating material topically applied to any cutaneous site is susceptible to control. Resorcinol preparations including a variety of hydrophilic colloids as the vehicle have been used in medicinals. However, the efiicacy of resorcinol in such preparations as have been heretofore available is essentially that of the resorcinol in the absence of said colloid.
Accordingly, it is a principal object of the subject invention to provide a novel therapeutic composition. of matter suitable for topical application to the skin in treatment of acne which combines in improved and more efiicacious form the remedial and soothing effects of certain known therapeutic materials whereby the individual effects of each of those materials are enhanced and unexpectedly improved by the combination and conjoint application thereof.
Another object of the instant invention is to provide novel therapeutic compositions and techniques for the treatment of acne with a view to avoiding disadvantages of medicaments or modes of treatment heretofore employed.
3,137,622 Patented June 16, 1964 A more particular object of the invention is the provision of a thickened hydrophilic therapeutic composition in which the thickening agent improves the ability of the principal medicament to combat certain skin disorders.
Still another object is the provision of a composition of the character described which is characterized by a remarkable degree of efficacy in the treatment of acne; that is substantially free of adverse side effect when used by the patient in the prescribed manner.
The invention combines in synergistic form and effect certain therapeutic materials which in combination effectively heal, sooth and improve acne, which is a disease involving disorders of the pilosebaceous apparatus. Preferred compositions of the invention have the property of existing as stable gels or highly thickened systems which turn to a dry composition after a period of controlled residence on the skin. The dry mass, and particularly the 'mineral component of said powder, has the property, inter alia, of permitting the primary active agent to function for prolonged periods without introduction to the site of the disorder of deleterious foreign matter, such as for example certain body oils. Said compositions have numerous advantages over ointments, lotions, or solutions heretofore suggested for use in treatment of acne.
Briefly, the subject invention is the result of our surprising discovery that the clay mineral attapulgite, and particularly colloidal attapulgite, has the ability to cooperate with certain hydroxylated aromatic compounds to effectively arrest acne when said attapulgite and said hydroxylated aromatic compound in intimate association with each other, and preferably in the absence of oleaginous material, are applied to the site of such a disorder. When the mineral has colloidal properties liquid dispersions thereof provide suitable hydrophilic thickened or gelled systems which function as ideal carriers for the hydroxylated aromatic compound and such other auxiliary therapeutic agents as may be included in formulations. We are cognizant of the fact that various clays have been topically applied by primitive peoples and that healing qualities have been imputed to the clays. Nevertheless it is recognized by competent dermatologists that the acute inflammatory cutaneous disorders with which We are concerned fail to respond to topical application of attapulgite or other clays, sorptive or non-sorptive. Furthermore, in vivo observations show that bentonitic clays used in lieu of attapulgitein compositions of our invention fail to enhance the therapeutic value of the hydroxy aromatic compound when used therewith in the treatment of acne.
Clays are naturally-occurring crystalline or semi-crystalline hydrous aluminum silicates frequently associated in nature with minor amounts of impurities such as feldspar, quartz or other impurities. In some clays aluminum is replaced in the lattice of the crystal by magnesium, calcium and/ or small amounts of alkali metals. Clay species vary considerably in such physical characteristics as lattice orientation, substitution of aluminum by alkaline earth or alkali metal constituents, quantity and physical state of water associated with the clay and imponderables such as origin of the clay. Kaolinitic clay, for example, is a hydrous aluminum silicate which in its raw state comprises as the chief mineral constituent hexagonal platelets of kaolinite, nacrite or dickite. Kaolinitic clays have very low sorptivity for water or other fluids and fail to gel in water or other fluids or otherwise exhibit colloidal properties. On the other hand, clays having as the chief constituent a montmorillonite mineral have layer-like structures and exhibit physical characteristics markedly different from those of kaolinitic clays. Furthermore, the properties of individual species of montmorillonite minerals or clays including a substantial portion of such minerals differ considerably inter se. For example, bentonite,
of which the major component is montmorillonite, exists as a sodium-type montmorillonite which swells in water and as a calcium-type which is non-swelling.
. Montmorillonite is a layer-like mineral in which th bonding between sheets is weak so that water or other polar molecules can penetrate between sheets and be sorbed.
In the case of sodium montmorillonites, .the'
that in the treatment of disordersin someindividuals less than 2 percent and more than aboutv percent of resorcinol or resorcinol monoacetate is indicated.
sheets can be swelled apart to the point where the sheets can be colloidally dispersed in the swelling medium. The
I term fullers earth usually refers to non-swelling sorptive clays and encompasses both calcium-montmorillonitesand clays comprising the mineral attapulgite. Attapulgus clay, sometimes called Attapulgus fullers earth, contains in addition to a majorportion of attapulgite minor amounts 'of montmorillonit minerals, sepiolite, quartz or feldspar. The morphology of attapulgite, an aluminummagnesium silicate mineral, differs considerably from that of the layer-like,montmorillonite minerals and from the ened gelatinous systems exhibiting a high degree of thixo-' tropy. High shear is required to bring out the colloidal properties of attapulgite particularly when associated with small quantities of non-colloidal impurities.
More specifically, our invention is practiced by preparing a thickened system including a vaporizable innoxious liquid having attapulgite dispersed therein and incorpo rating into the thickened system 'aihydroxy aromatic comi The carrier for the hydroxy aromatic compound is a thickened system, preferably 'sufiiciently bodied to be a gel, and which is formed by the dispersion of colloidal attapulgite in an innoxious liquid which issubstan'tially vaporizable under ambient conditions of temperature and humidity.
It will be understood that the term attapulgite as used herein refers to the pure mineral .or to a clay'in :which attapulgite is the" chief mineral constituent, such as so called .Attapulgus clay. A typical chemical analysis ofan' Attapulgus clay expressed inrterms of theoxides "present is tabulated belowon a'volatile-free basis sit) 67.0 A1203 -.V- MgO v a 11.0 7 F6 0;; ..l v i ,CaO a 2.5 Others l 3.0
pound which when applied to the site of certain dermai toses has a kerotolytic or keretoplastic effect. Compositions of our invention comprise a hydroxy aromatic compound, preferably resorcinol or resorcinol monoacetate, in a liquid thickened by dispersion of attapulgite therein,
to and preferably at least double that of the hydroxy aromatic compound. Auxiliary therapeutic agents such as for example certain anodynes, humectants, antiseptic and antibiotics may be included in the. composition. Pursuant Percent The liquid or liquid mixture ispreferably one injwhich 'the hydroxy aromatic compound has good solubility so thatuniform distribution of that compound in the formulation and into the interstices of the attapulgite is facilitated. Furthermore, the liquid'should be sufficiently polarto permit satisfactory dispersion ofthe attapu-lgi'te therein. Particularly useful liquids include water (preferably distilled), ethanol, isopropanol, and mixtures thereof. However, propanol and C-4 alcohols may be-used. T he .ultimate, choicerin liquid composition will be predicated on the determination of desirable rateofevaporation of liquid from the composition: after topical applica -tion.- A particularly useful liquid mixture when resor:
cinol is usedis a -50 mixture of water ethanol. When the evaporation of theliquid is tobe restricted,a humectant, such as for example glycerol, ethylene glycol or sorbitol may be added to'. the liquid. f The total liquid is ordinarily about 50 percent byweight of the ultimate v formulation, althoughthe quantity will vary somewhat said attapulgite being present inramount at least equal to a preferred embodiment of the" invention, the thickened system is a gel whereby particulate insoluble material may be included in stable formulations by being suspended'by the gel.
Hydroxy aromatic compounds capable of effectively influencing the cure of pilosebaceous disorders include resorcinol, resorcinolmonoacetate, hexylresorcinol, cresol and'metacresyl acetate. 1 Resorcinol and resorcinol'monoacetate are preferred species because of' their'outstanding eflicacy. Phenol has been used as a desquamating agent, however, the toxicity and irritating effects of phenol make it less desirable for the purpose of treating pilosebaceous disorders than resorcinol. An important advantage of resorcinol, particularly when the resorcinolattapulgite ratio is low, is that its high water solubility promotes homogeneous distribution of the compound throughout the composition. Resorcinol monoacetate, on'
V the other hand, is only slightly soluble in water, although readily soluble in alcohol. Accordingly, distribution of resorcinol monoacetate in the composition is facilitated by use of alcohol as the principal fluid in whichsthe attapulgite is dispersed or in admixture with the Water used for the purpose. In general, from about 2to 10 percent byweight of resorcinol or the monoacetate there of is used in formulations of the invention. At lower levels the benefits are minimal. At levels higher than about 10 percent the irritating effect of the ingredient will usually be excessive. However, it will be" understood with variations in. consistency of the composition and use, if' any, of a particulate insolubleanodyne such as for example, zinc oxide, sulfur or talc.
Colloidal attapulgite is used in the formulation' and servesat least a tri-fold function. First, by virtue of its colloidal properties, the attapulgite forms the gel or thickened systemand provides a suitable flow-resistant vehicle for the hydroxy, aromatic compound; 1 'Secondly,
the attapulgite-bodied vehicle is a suspending agent for any materials present in the formulation in excess of their solubility or which are totally insoluble; 'Thirdly, and of utmost importance, the attapulgite enhances the ability of :the medicinal tocomb'a't the dermatosi's. The reason underlying the'remarkable ability of the attapulgite to cooperate in such a manner with the medicinal ingredient is unknown. Although we do not wish to be bound in any manner to the hypothesis herein set forth, it is felt that theunusual sorptivity and ultimate particl shape of the attapulgite is responsible. Sincethe hydroxy aromatic: compound is associated with the minute particlesofatta pulgit e the penetration characteristics of the compound into the skin is probably profoundly different from what it would be in the absence of the attapulgite. Furthermore, after all or' a substantial portion (of theliquidis evaporated from the formulation subsequent to topical application, the attapulgite resident at the diseased site is available to sorb bacteria originating therein, deleterious foreign sebaceous matter or sebaceous exudate ofwhich' the inflamed area is the precursor.
attapulgite exerts" a soothing cooling effect when present I "on the 'skin because of its hygroscopic nature.
From about 0.5 to about-5.0 percent by weight of the liquid phase of attapulgi'te is required for thickenin'g'the' Furthermore, 'the 1 v liquid whereas from about 5.0 to 20.0 percent by weight will produce gellation. For satisfactory formulations the weight ratio of attapulgite to hydroxyl aromatic material should be at least 1/1 and is more preferably about 2/1 or higher. When the quantity of attapulgite is more than can be satisfactorily dispersed in the liquid by high shear it may be agitated into the previously thickened system. The attapulgite may be used in its raw state after removal of grit. Preferably the mineral is washed to remove impurities and classified as wet or dry methods wellknown to those skilled in the art. The attapulgite may be heat treated to effect sterilization although this step may be omitted when a disinfectant, suitably a halogenated organic compound is included in minor proportion in the formulation. Sterilization should be carried out at temperatures not to exceed about 400 F., and usually I from about 225-400 F., since the gel-forming properties of the material will be reduced.
Pursuant to an embodiment of the invention, zinc oxide or other anodynes is included in the formulation in relatively large proportions. Colloidal sulfur may be used in lieu of or as a supplement to the zinc oxide. Particulate water-insoluble anodynes are especially desirable because they are retained at the site of application. The waterinsoluble anodyne should be used in finely-divided form so that its retention on the skin is adequate and so that it is non-irritating when applied to the skin. Although relatively large quantities of insoluble anodynes may be used, they should not be used in amounts exceeding that capable of being stably suspended by the thickened system.
Small amounts of other active ingredients such as disinfectants, particularly halogenated disinfectants as exemplified by hexachlorophene and quaternary ammonium salts, may be included in formulations where their use is indicated. These additives may be soluble or insoluble in the liquid component in the system.
A preferred method of preparing the compositions of the instant invention includes the preliminary step of forming a thickened or gelled system comprising attapulgite in liquid by use of high shear technique. When the total quantity of mineral called for in a particular formulation exceeds that which is capable of being colloidally dispersed in the liquid only a fraction of the total may be preliminarily dispersed. Suitable high shear equipment includes colloid mills, kinetic energy mills, 3-roll mills and ball mills. The resorcinol or other hydroxy aromatic compound is incorporated into the formulations by high shear technique, suitable by addition in the presence of additional quantities of liquid. The balance of the attapulgite, up to a total of 35 parts by weight, and any other comminuted insoluble material is then blended into the thickened system using a conventional mechanical mixing device.
The following examples are given only for the sake of further illustrating the invention and are not to be construed as limiting the scope thereof.
Example I A pharmaceutical preparation demonstrated to be highly effective in the cure of acne was prepared. The composition of the preparation is as follows:
Attagel 20 is a purified colloidal form of attapulgite mined in Georgia and sold by Minerals & Chemicals Corporation of America. It can be dispersed to an average particle size of less than 0.1 micron. In the preparation of the composition, the Attagel may be dispersed in the water and the alcohol and sheared in a Waring Blendor for about 10 minutes with intermittent stirring to prevent formation of shear planes. The resultant dispersion is a very stiff homogeneous gel. Hexachlorophene and resorcinol are incorporated into' the stiff gel and homogenized therein in the Blendor. The resultant stiff gel is transferred to a low-speed mixer. The zinc oxide is then added to the mass and stirred into the composition at increasing rates of speed for about 30 minutes. The resultant product is a smooth creamy unctuous-feeling suspension. Example 11 The preparation of the composition of Example I is repeated except that resorcinol isused in the amount of 2.5 percent, based on the total weight of the composition. Such a preparation is preferred to a, 10 percent resorcinol composition when the latter produces in a particular patient severe exfoliation or other adverse effects.
One hundred patients were treated with compositions of Example I or II over a period of from one to eight months in private practice and in institutions under the supervision of competent dermatologists. Over ninety percent of these patients, many of whom failed to respond to competent treatment with various commonly used modalities, showed satisfactory improvement, with remarkable improvement being noted in many of the cases of acne. Disorders treated comprised severe cystic acne, congestive nodular acne, rosacea, verruca plana juvenilis. Bentonite used in lieu of attapulgite in formulations otherwise identical did not produce the outstanding benefits when used as a control.
It will be understood that the invention is susceptible to variation without departing from the spirit and scope thereof.
We claim:
1. A thickened hydrophilic therapeutic composition suitable for topical application to the skin in treatment of acne consisting essentially of at least one liquid selected from the group consisting of water, ethanol and isopropanol, from 2 to 10 percent by weight of a hydroxyl aromatic material selected from the group consisting of resorcinol and resorcinol monoacetate, and colloidal attapulgite dispersed in said liquid in an amount at least substantially equal to the weight of said hydroxyl aromatic material, said composition being substantially devoid of oleaginous matter.
2. A thickened hydrophilic therapeutic composition suitable for topical application to the skin in treatment of acne consisting essentially of water, from 2 to 10 percent by weight of resorcinol, and colloidal attapulgite dispersed in said water in an amount within the range of from 2 to 35 percent by weight and at least substantially equal to the weight of said resorcinol, said composition bieng substantially devoid of oleaginous matter.
3. A thickened hydrophilic therapeutic composition suitable for topical application to the skin in treatment of acne consisting essentially of a liquid consisting of water and ethanol, from 2 to 10 percent by weight of resorcinol, and colloidal attapulgite dispersed in said liquid in an amount within the range of from 2 to 35 percent by weight and at least substantially equal to the weight of said resorcinol, said composition being substantially devoid of oleaginous matter.
4. A hydrophilic therapeutic gel suitable for topical application to the skin in treatment of acne consisting essentially of at least one material selected from the group consisting of water, ethanol and isopropanol, from 2 to 10 percent by 'weight of resorcinol, and colloidal attapulgite dispersed in said liquid in an amount within the range of from about 5 to 20 percent by weight and at least substantially equal to the weight of said resorcinol, said composition being substantially devoid of oleaginous matter.
5. A hydrophilic therapeutic gel suitable for topical application to the skin in treatmentof acne consisting" of about 50 percent by weight of a water-ethanol mixture,
I from 2- to 10 percent by weight of resorcinol, and about 20 percent .by weight of colloidal attapulgite dispersed in said water-ethanol'mixture, the balance being finely divided zincoxide. f
6. A hydrophilic therapeutic gel. suitable fortopical application to the skin in'treatmen't of acne consisting of about 50 percent by weight of a 50-50 water-ethanol mix- .ture, from 2 to 10 percent by weight of resorcinol, about 20 percent by weight of colloidal attapulgite dispersed in said water-ethanol mixture, and about 1 percent of heXa- 3 chlorophene, the balance being finely divided zinc oxide.
7. A hydrophilic therapeutic gel suitable for topical ber1956 ,pp.1111- 1 112.
I References Cited in the file of this patent Kulchar: Arch. Dermatologyand Syphilology, vol. 44
Perrnagel, Bulletin Chemicals Corp, Philadelphia, Pa., 7 pp No. P53, Attapulgus Mineral and brochure. v Franburg: Drug and Cosmetic Industry, vol. 66,"No. 5, May 1950, pp. 580-581. 5 I 7 .Harry: Cosmetic Materials,Leonard Hill Ltd., London Registered Us. Trademark 561,218 (for 1 0w volatile fullers earth), July.8, 1952.
US. Dispensatory, 25th ed, Lippincott Co Philadelv phia,Pa. (1955),pp. 734-736.
- Harry; 'Modern Cosmeticology,
Ltd., London (1955); pp. 273-274.
Malkinson: Clinical VMedicine, vol. 3,
o. 1 1', Nove 4m ed;, I ;eonard Hill I
Claims (1)
1. A THICKENED HYDROPHILIC THERAPEUTIC COMPOSITOR SUITABLE FOR TOPICAL APPLICATION TO THE SKIN IN TREATMENT OF ACNE CONSISTING ESSENTIALLY OF AT LEAST ONE LIQUID SELECTED FROM THE GROUP CONSISTING OF WATER, ETHANOL AND ISOPROPANOL, FROM 2 TO 10 PERCENT BY WEIGHT OF A HYDROXYL AROMATIC MATERIAL SELECTED FROM THE GROUP CONSISTING OF RESORCINOL AND RESORCINOL MONOACETATE, AND COLLOIDAL ATTAPULGITE DISPERSED IN SAID LIQUID IN AN AMOUNT AT LEAST SUBSTANTIALLY EQUAL TO THE WEIGHT OF SAID HYDROXYL AROMATIC MATERIAL, SAID COMPOSITION BEING SUBSTANTIALLY DEVOID OF OLEAGINOUS MATTER.
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US704277A US3137622A (en) | 1957-12-23 | 1957-12-23 | Topical therapeutic composition |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US704277A US3137622A (en) | 1957-12-23 | 1957-12-23 | Topical therapeutic composition |
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US3137622A true US3137622A (en) | 1964-06-16 |
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US704277A Expired - Lifetime US3137622A (en) | 1957-12-23 | 1957-12-23 | Topical therapeutic composition |
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Cited By (17)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3258398A (en) * | 1965-02-24 | 1966-06-28 | Vienna Beauty Products Co | Acidic aqueous alkali metal alginate and lanolin acne vulgaris preparation |
US3322621A (en) * | 1962-01-16 | 1967-05-30 | Hollichem Corp | Thixotropic quaternary ammonium aromatic cyclic imides |
US3337434A (en) * | 1964-01-15 | 1967-08-22 | Mc Donnell Douglas Corp | Method of electrolytic etching metals using a gel electrolyte |
US4005191A (en) * | 1974-06-04 | 1977-01-25 | Clark Mary G | Topical ointment composition |
US4704280A (en) * | 1986-12-19 | 1987-11-03 | Bates Harry L | Cosmetic lotion |
US4810496A (en) * | 1985-02-19 | 1989-03-07 | Jensen Charles A | Treatment of skin and inflammatory disorders |
US4968510A (en) * | 1985-02-19 | 1990-11-06 | Jensen Charles A | Method of treating arthritis |
US5069912A (en) * | 1985-02-19 | 1991-12-03 | Jensen Charles A | Method of treating spastic colitis |
US20050187129A1 (en) * | 2004-02-06 | 2005-08-25 | Unilever Home & Personal Care Usa, Division Of Conopco, Inc. | Detergent composition |
US20060269504A1 (en) * | 2003-04-15 | 2006-11-30 | James Alexander G | Use of alkyl resorcinols in the treatment of acne |
US7687650B2 (en) | 2006-02-03 | 2010-03-30 | Jr Chem, Llc | Chemical compositions and methods of making them |
US7867522B2 (en) | 2006-09-28 | 2011-01-11 | Jr Chem, Llc | Method of wound/burn healing using copper-zinc compositions |
US7897800B2 (en) | 2006-02-03 | 2011-03-01 | Jr Chem, Llc | Chemical compositions and methods of making them |
US7927614B2 (en) | 2006-02-03 | 2011-04-19 | Jr Chem, Llc | Anti-aging treatment using copper and zinc compositions |
US8273791B2 (en) | 2008-01-04 | 2012-09-25 | Jr Chem, Llc | Compositions, kits and regimens for the treatment of skin, especially décolletage |
US8952057B2 (en) | 2011-01-11 | 2015-02-10 | Jr Chem, Llc | Compositions for anorectal use and methods for treating anorectal disorders |
US9427397B2 (en) | 2009-01-23 | 2016-08-30 | Obagi Medical Products, Inc. | Rosacea treatments and kits for performing them |
-
1957
- 1957-12-23 US US704277A patent/US3137622A/en not_active Expired - Lifetime
Non-Patent Citations (1)
Title |
---|
None * |
Cited By (20)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3322621A (en) * | 1962-01-16 | 1967-05-30 | Hollichem Corp | Thixotropic quaternary ammonium aromatic cyclic imides |
US3337434A (en) * | 1964-01-15 | 1967-08-22 | Mc Donnell Douglas Corp | Method of electrolytic etching metals using a gel electrolyte |
US3258398A (en) * | 1965-02-24 | 1966-06-28 | Vienna Beauty Products Co | Acidic aqueous alkali metal alginate and lanolin acne vulgaris preparation |
US4005191A (en) * | 1974-06-04 | 1977-01-25 | Clark Mary G | Topical ointment composition |
US4810496A (en) * | 1985-02-19 | 1989-03-07 | Jensen Charles A | Treatment of skin and inflammatory disorders |
US4968510A (en) * | 1985-02-19 | 1990-11-06 | Jensen Charles A | Method of treating arthritis |
US5069912A (en) * | 1985-02-19 | 1991-12-03 | Jensen Charles A | Method of treating spastic colitis |
US4704280A (en) * | 1986-12-19 | 1987-11-03 | Bates Harry L | Cosmetic lotion |
US20060269504A1 (en) * | 2003-04-15 | 2006-11-30 | James Alexander G | Use of alkyl resorcinols in the treatment of acne |
US7285521B2 (en) | 2004-02-06 | 2007-10-23 | Unilever Home & Personal Care Usa, Division Of Conopco, Inc. | Detergent composition comprising predominantly soap and palygorskite clay |
US20050187129A1 (en) * | 2004-02-06 | 2005-08-25 | Unilever Home & Personal Care Usa, Division Of Conopco, Inc. | Detergent composition |
US7687650B2 (en) | 2006-02-03 | 2010-03-30 | Jr Chem, Llc | Chemical compositions and methods of making them |
US7897800B2 (en) | 2006-02-03 | 2011-03-01 | Jr Chem, Llc | Chemical compositions and methods of making them |
US7927614B2 (en) | 2006-02-03 | 2011-04-19 | Jr Chem, Llc | Anti-aging treatment using copper and zinc compositions |
US8148563B2 (en) | 2006-02-03 | 2012-04-03 | Jr Chem, Llc | Chemical compositions and methods of making them |
US7867522B2 (en) | 2006-09-28 | 2011-01-11 | Jr Chem, Llc | Method of wound/burn healing using copper-zinc compositions |
US8273791B2 (en) | 2008-01-04 | 2012-09-25 | Jr Chem, Llc | Compositions, kits and regimens for the treatment of skin, especially décolletage |
US8505730B2 (en) | 2008-01-04 | 2013-08-13 | Jr Chem, Llc | Compositions, kits and regimens for the treatment of skin, especially décolletage |
US9427397B2 (en) | 2009-01-23 | 2016-08-30 | Obagi Medical Products, Inc. | Rosacea treatments and kits for performing them |
US8952057B2 (en) | 2011-01-11 | 2015-02-10 | Jr Chem, Llc | Compositions for anorectal use and methods for treating anorectal disorders |
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