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Methods and related compositions for the non-surgical removal of fatRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Cyclopentanohydrophenanthrene Ring System DoaiMethods and related compositions for the non-surgical removal of fat description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060154906, Methods and related compositions for the non-surgical removal of fat. Brief Patent Description - Full Patent Description - Patent Application Claims
RELATED APPLICATIONS [0001] The present application is a continuation of U.S. patent application Ser. No. 11/054,171, filed Feb. 8, 2005 which claims priority under 35 U.S.C. 119(e) to U.S. Provisional Application Ser. No. 60/572,879 filed May 19, 2004. FIELD OF THE INVENTION [0002] The present invention is related to compositions and methods useful for the non-surgical removal of localized fat accumulation. Specifically, the present invention is related to pharmacologically active detergent compositions than are suitable for injection directly into a treatment site of a patient in need of fat removal without the need for surgical intervention. BACKGROUND OF THE INVENTION [0003] Numbers appearing in parentheses at the end of a sentence refer to specific references cited at the conclusion of this specification immediately before the claims. [0004] Formulations containing phosphatidylcholine and bile salts (phosphatidylcholine bile salt formulations, PBF) are increasingly being utilized to treat localized fat accumulation (1-8). Several open label clinical studies have reported promising results using injections of PBFs for the treatment of localized fat accumulation, including lower eyelid fat herniation and "buffalo hump" lipodystrophy (1-3). [0005] Phosphatidylcholine is a natural phospholipid that is an essential component of cell membranes and is important for normal cellular membrane composition and repair. Phosphatidylcholine is also the major delivery form of the essential nutrient choline. Choline itself is a precursor in the synthesis of the neurotransmitter acetylcholine, the methyl donor betaine and phospholipids, including phosphatidylcholine and sphingomyelin among others. Phosphatidylcholine is also involved in the hepatic export of very-low-density lipoproteins. [0006] Bile salts have been used to improve the aqueous solubility of phosphatidylcholine and more recently, medications like amphotericin B, Taxol.RTM., and diazepam (9-14). Highly purified phosphatidylcholine can be combined with the secondary bile salt sodium deoxycholate, an anti-microbial, benzyl alcohol, and water to form a stable, mixed micelle preparation that can be rapidly sterilized and used for intravenous administration (12). Pharmaceutical preparations of this mixture, known as Essentiale.RTM. and Lipostabil.RTM., are marketed in other countries for treatment of liver disease and hyperlipidemia, respectively (12,15). [0007] Rittes first reported that injections of a PBF into subcutaneous fat reduced infraorbital fat herniation (1). Since then, physicians have been using the pharmaceutical preparations or similar, compounded PBFs, to treat lower eyelid fat herniation, as well as fat deposits on the thighs, abdomen, upper back, chin, and arms (2,3,5). These PBFs often lack the dl-alpha-tocopherol (vitamin E), B-vitamins, and adenosine monophosphate variably found in Essentiale.RTM. and Lipostabile (2,16). [0008] Phosphatidylcholine formulations are associated with localized burning sensations, erythema, transient urticaria and variable degrees of pruritus all of which usually resolve within a few days. More serious sequelae of ulceration and pain have also been seen. An infectious granulomatous reaction has been reported in the thigh of a patient at the site of multiple phosphatidylcholine injections (7). Increased dosages of injected phosphatidylcholine have paralleled side effects seen with large doses of oral and intravenous formulations of Lipostabil.RTM. and include nausea, diarrhea, abdominal pain and syncope. [0009] The mechanism whereby phosphatidylcholine-containing formulation cause reduction of subcutaneous fat deposits is unknown but several mechanisms have been proposed (4). The first is that phosphatidylcholine could reduce the size of lipocytes by stimulating lipase activity. Alternatively, the PBFs have been postulated to function as a detergent that emulsifies lipocyte cell membranes. Detergents have been used in medicine for decades, specifically, as sclerosing agents commonly used in sclerotherapy (American College of Phlebology, 2003). Detergents possess unique polar and non-polar chemical properties which facilitates emulsification of insoluble substances by reducing surface tension at their interface (17). In fact, laboratory detergents like Triton.RTM.X-100 and Empigen.RTM. BB are commonly used to disrupt the lipid bilayer of cell membranes (10,18-21). Two major components of the PBFs, phosphatidylcholine and sodium deoxycholate, have these unique chemical properties and therefore have been used independently as detergents or emulsifying agents (9,18,20-25). [0010] Surgical and non-surgical procedures for improving appearance have increased in prevalence as populations age and gain weight. Liposuction is one of the most popular cosmetic surgery procedures and involves the surgical removal of fat deposits using suction and optionally assisted by solutions to assist in fat removal. Liposuction, also known as lipoplasty or suction lipectomy, is a surgical procedure that removes fat through an incision in the skin through which a cannula is inserted. The cannula is connected to a suction source and the unwanted fat is aspirated through the cannula and discarded. Liposuction is performed under general or local anesthesia, depending on the amount and location of the fat to be removed. [0011] The most commonly used forms of liposuction additionally use fluid injection methodologies wherein a medicated solution containing a mixture of salts, an anesthetic and a vasoconstrictor, is infused into the treatment site prior to aspiration of the fat tissue. The medicated solution helps the fat be removed more easily, reduces blood loss and provides anesthesia both during and after surgery. [0012] In an example of adjuvant solutions for liposuction, a United States patent filed on Apr. 22, 1997 and issued as U.S. Pat. No. 5,891,083 on Apr. 6, 1999 by Capella and Capella teaches liposuction and a carrier solution containing a compound for an improved surgical procedure for removing subcutaneous fat. In one embodiment the Capella patent discloses the compound is an enzyme, particularly lipase or colipase. The enzyme is added to a carrier such as saline solution to provide a lipolysis solution. In another embodiment of the invention, Capella teaches emulsifying agents such as bile salts may also be beneficial in combination or as the primary active compound added to the solution. In every embodiment of the Capella invention, the lipolysis solution is administered for a period of time before liposuction to allow for the solution to infiltrate the fat tissue. Nowhere in Capella is the use of a lipolysis solution alone disclosed as a non-surgical means for removing fat from the body. In all examples and specific embodiments disclosed in Capella, liposuction is used as a surgical procedure for fat removal and lipase and bile salts are provided as an adjuvant to liposuction. [0013] However, liposuction and other surgical methods of fat removal are associated with significant adverse events including temporary bruising, swelling, numbness, soreness and burning sensation, risk of infection, pigmentation changes; the formation of fat clots or blood clots which can migrate to the lungs and cause death, excessive fluid loss, which can lead to shock or fluid accumulation that must be drained, friction burns or other damage to the skin or nerves or perforation injury to the vital organs. Additionally, liposuction requires a recovery time of one to two weeks wherein the patient cannot work or perform certain daily activities. Moreover, because surgical procedures such as liposuction require local and occasionally general anesthesia, significant anesthesia-related risks are associated with surgical fat removal. [0014] Therefore it would be desirable to have a method of removing localized fat accumulations that does not require surgery or prolonged recovery time and has fewer adverse side effects than currently available methods. SUMMARY OF THE INVENTION [0015] The present invention provides a method for the non-surgical removal of localized fat deposits in patients by administration of fat-solubilizing concentrations of phosphatidylcholine-free detergent compositions in pharmaceutically acceptable formulations. Prior to the discovery of the present invention, prior art formulations (hereinafter referred to as phosphatidylcholine bile salt formulations (PBFs)), containing phosphatidylcholine (PC) and bile salts used to reduce localized fat deposits were thought to function through the activity of phosphatidylcholine alone. Detergents such as bile salts were merely added in small quantities to disperse the PC. However, the present invention unexpectedly demonstrates that bile salts alone are the active agents responsible for the reduction of localized fat deposits, and possess detergent effects on muscle and connective tissue. [0016] For the purposes of the present invention, a non-surgical method of fat removal does not include liposuction, llipoplasty or suction lipectomy. [0017] In one embodiment of the present invention, a medical composition for the non-surgical removal of localized fat deposits in a patient is provided which comprises at least one pharmacologically active detergent, optionally at least one pharmaceutically acceptable excipient and optionally at least one additional active ingredient wherein the medical composition does not include phosphotidylcholine. The pharmacologically active detergent can be an ionic detergent, a non-ionic detergent or a zwitterionic detergent. [0018] In one embodiment of the present invention the ionic detergent is at least one pharmacologically active bile salt. The bile salt can be at least one of deoxycholic, cholic, chenodeoxycholic, 7-alpha-dehydroxylate, chenodeoxycholic, lithocholic, ursodeoxycholic, dihydroxy- and trihydroxy-bile salts. The bile salts can be in the taurine or glycine conjugate forms. [0019] In an embodiment of the present invention, the pharmacologically active detergent can be a non-ionic detergent such as alkylaryl polyether alcohol. In another embodiment of the present invention, the pharmacologically active detergent can be zwitterionic detergent such as lauryldimethylbetaine. [0020] In yet another embodiment of the present invention the medical composition contains one or more additional active ingredients. One or more additional active ingredients can include anti-inflammatory agents such as a steroidal anti-inflammatory agent or a non-steroidal anti-inflammatory agent; analgesics and dispersion agents such as hyaluronidase or collagenase. Continue reading about Methods and related compositions for the non-surgical removal of fat... Full patent description for Methods and related compositions for the non-surgical removal of fat Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Methods and related compositions for the non-surgical removal of fat patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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