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(12) United States Patent (10) Patent No.: US 6,471,971 B1 Wollenweber Et Al

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(12) United States Patent (10) Patent No.: US 6,471,971 B1 Wollenweber Et Al USOO6471971B1 (12) United States Patent (10) Patent No.: US 6,471,971 B1 Wollenweber et al. (45) Date of Patent: Oct. 29, 2002 (54) CELLULOSE-ETHER-STABILIZED OIL-IN- 6,046,022 A * 11/1997 Zhang et al. ................. 435/41 WATER EMULSIONS AS A VEHICLE FOR 6,074,652. A 1/1998 Ishiwatari et al. .......... 424/401 HOMEOPATHIC AND HERBALACTIVE 5,804,168 A 9/1998 Murad ......................... 424/59 INGREDIENTS FOREIGN PATENT DOCUMENTS (75) Inventors: Christian Wollenweber, Karlsruhe JP WO994O887 * 8/1999 (DE); Rainer Oschmann, Landau (DE); Marianne Heger, St. Leon-Rot OTHER PUBLICATIONS (DE); Rolf Daniels, Salzgitter (DE) Rimpler S. and R. Daniels, “Effect of oil content on the properties of emulsions containing HPMC as polymeric (73) Assignee: Deutsche Homoeopathic-Union, emulsifier.” Proc. 1st World Meeting APGI/APV, Budapest, Karlsruhe (DE) 9/11, May. 651–652, (1995). (*) Notice: Subject to any disclaimer, the term of this Ashton P, et al., “Effects of Surfactants in percutaneous patent is extended or adjusted under 35 adsorption,” pharm. Acta Helv. 61 (8), 228-235, 1986. U.S.C. 154(b) by 0 days. Barta A. and Daniels R., “Pharmacopoeial cellulose ethers as O/w emulsifiers-I. Interfacial properties,” Eur. J. Pharm. (21) Appl. No.: 09/695,938 Biopharm., 40, 128-133. (1994). (22) Filed: Oct. 25, 2000 * cited by examiner (30) Foreign Application Priority Data Primary Examiner Jose' G. Dees Assistant Examiner Mina Haghighatian Oct. 26, 1999 (DE) ......................................... 19951474 (74) Attorney, Agent, or Firm-Davidson, Davidson & (51) Int. Cl. ............................. A61K 7/00; A61K 7/48 Kappel, LLC (52) U.S. Cl. ......................... 424/400; 424/401; 424/59; (57) ABSTRACT 424/70.6 (58) Field of Search ......................... 424/401, 59, 70.6, An oil-in-water emulsion preparation comprises oil, water, 424/400, 450; 435/41 alcohol, at least one of an homeopathic active ingredient and an herbal active ingredient, and a cellulose ether. A method (56) References Cited of preparing an emulsion and a use of the emulsion are also provided. U.S. PATENT DOCUMENTS 5,466,443 A 11/1995 Ho et al. ................... 424/70.6 19 Claims, No Drawings US 6,471,971 B1 1 2 CELLULOSE-ETHER-STABILIZED OIL-IN 1st World Meeting APGI/APV, Budapest, 9/11 May WATER EMULSIONS AS A VEHICLE FOR 651–652, (1995)). HOMEOPATHIC AND HERBALACTIVE In addition to the problem of satisfactory stabilization, INGREDIENTS another problem with O/W emulsion preparations is that water-containing preparations tend to be Susceptible to microbial attack. Germs can be introduced during manufac BACKGROUND OF THE INVENTION ture and during use by the patient. The use of preservatives 1. Field of the Invention in Such preparations is therefore appropriate, but preserva The present invention concerns an oil-in-water emulsion tives can trigger incompatibility reactions in patients and are preparation containing alcoholic, homeopathic and/or herbal preferably avoided for this reason. active ingredients. SUMMARY OF THE INVENTION 2. Background Information Preparations applied to the skin (dermatics) with homeo An object of the present invention is to present well pathic or herbal active ingredients are distinguished in that tolerated and Sufficiently preserved emulsion preparations as they only contain a few adjuvants that are natural in origin. 15 a base for homeopathic mother tinctures and dilutions, liquid No stabilizers, antioxidants and preservatives should be plant extracts and ethanolic tinctures. The vehicles should used. The creation and composition of Such preparations are have very few adjuvants that are preferably described in the described in detail in the Homeopathic Pharmacopoeia pharmacopoeias (Pharmacopoia Europa (Ph Eur), German (HAB). For example in regard to ointments, it prescribes Pharmacopoeia (DAB), Homeopathic Pharmacopoeia (according to specification 13) that water-containing wool (HAB), United States Pharmacopoeia (USP)) in a mono wax alcohol ointment as per the German pharmacopoeia graph and are hence judged harmless, it should be easy to (DAB) is to be used as a base, i.e., a vehicle for the active prepare and incorporate the active ingredient(s) in a labo ingredient(s). If other bases are used, they must be stated. ratory and on a mass-production Scale. The present invention provides an O/W emulsion prepa The homeopathic active ingredient(s) are incorporated into 25 the base. Such water-in-oil or oil-in-water emulsion ration containing an alcohol and an homeopathic and/or preparations, termed “W/O” and “O/W emulsion prepara other herbal active ingredient, the preparation being char tions” in the following are frequently physically instable acterized in that it contains cellulose ether as an additive. when the homeopathic active ingredients are added in the The cellulose-ether-stabilized, oil-in-water emulsion form of mother tinctures and/or dilutions due to the alcohol preparations containing active ingredient in alcohol (i.e.: content (especially ethanol content) of the mother tinctures/ containing alcohol and homeopathic and herbal active dilutions. There hence exists a need for other preparations ingredient(s)) are distinguished primarily in that they are that have a Sufficiently high alcohol and especially ethanol Surprisingly very stable in Storage. This Storage Stability is tolerance and are permitted by the HAB. clearly greater than would be expected based on State-of the-art professional knowledge on hypromellose-stabilized Normally, emulsifiers are used to stabilize O/W emulsion 35 preparations. These usually low-molecular Substances can emulsions. The present invention is based on the Surprising interact with the skin due to their amphiphile Structure insight that adding alcohol and especially ethanol Substan Ashton P., et al., “Effects of Surfactants in percutaneous tially improves the Storage Stability of hypromellose Stabilized emulsions. This insight contrasts with the pre adsorption,” pharm. Acta Helv. 61 (8), 228-235, 1986 and dominant opinion of the professional world up to now that hence generate incompatibility reactions Such as toxic 40 irritating reactions or contact allergies. asserts that O/W emulsions become unstable with the addi State-of-the-art Suitable adjuvants for Stabilizing certain tion of alcohol-containing liquids Such as liquid homeo Specific emulsions are in particular cellulose ethers, pathic tinctures and dilutions, or plant extracts in alcohol. so-called polymer emulsifiers. They are suitable for stabi In addition, the O/W emulsion preparations according to lizing these certain emulsions Since they are adsorbed at 45 the present invention have the advantage that the emulsion O/W interfaces, lower the interface tension between the is Sufficiently preserved, and other preservatives do not need outer and inner phase, and form stabile interface films Barta to be added at a correspondingly high alcohol concentration A. and Daniels R., “Pharmacopoeial cellulose ethers as o/w (especially ethanol concentration) of e.g. 15 mass percent emulsifiers-I. Interfacial properties,” Eur. J. Pharm. (% m/m). Biopharm., 40, 128-133. (1994)). Cellulose ethers enjoy 50 Another advantage of the O/W emulsion preparations widespread use as adjuvants in certain pharmacy and foods according to the present invention is that they are Substan technology. In Solid drug forms, they are used as a binder for tially easier to prepare in contrast to conventional alcohol granules, a matrix former for the delayed release of active free and ethanol-free emulsions, the polymer emulsifiers can ingredients, and as a film former that is dissolved by disperse without being heated to high temperatures by Stomach and intestinal juices. In liquid preparations, they 55 adding alcohol-containing or ethanol-containing active primarily Serve to increase Viscosity of eye drops, at higher ingredient to the preparation and/or the adding pure ethanol. concentrations, they also serve as a hydrogel former. It has The problem on which the present invention is based is been determined that cellulose-ether-containing prepara also Solved by the presentation of a procedure to create a tions are well-tolerated in eyes. There are no known unde cellulose-ether-containing O/W emulsion preparation con Sirable Side-effects on the skin for this class of Substances. 60 taining homeopathic and/or herbal active ingredients in The use of various cellulose ethers to stabilize alcohol alcohol that is characterized by the number and series of the free O/W emulsions has been investigated in recent years procedural Steps below: where particularly positive results were obtained with 1. The cellulose ether(s) is/are dissolved in the alcoholic hypromellose-stabilized O/W emulsions that contain aqueous emulsion phase, and medium-chain triglycerides as an oil phase Rimpler S. and 65 2. The cellulose-ether-containing alcoholic-acqueous R. Daniels, “Effect of oil content on the properties of emulsion phase obtained in this manner is then homog emulsions containing HPMC as polymeric emulsifier,” Proc. enized with the oil (oil phase). US 6,471,971 B1 3 4 This preparation procedure according to the present inven 3. The aqueous phase and oil phase are heated to 40 C. tion has advantages over conventional procedures: It is 4. The oil phase is worked into the aqueous phase. The much faster Since only two procedural Steps are required phases are homogenized with a rotor-Stator homogenizer. whereas the conventional procedure has four Steps, and leSS A homogenous emulsion
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