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Oral compositions containing a salivation inducing agentRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Preparations Characterized By Special Physical Form, Tablets, Lozenges, Or Pills, Sustained Or Differential Release Type, Layered Unitary Dosage FormsOral compositions containing a salivation inducing agent description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070077300, Oral compositions containing a salivation inducing agent. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] This invention relates to oral compositions containing an active ingredient and a salivation inducing agent. These compositions may be used to make dosage forms that conveniently may be administered without water. BACKGROUND OF THE INVENTION [0002] Pharmaceuticals intended for oral administration are typically provided in solid form as tablets, capsules, pills, lozenges, or granules. Tablets are swallowed whole, chewed in the mouth, or dissolved in the oral cavity. Chewable tablets are typically made from a mixture including active drug particles, and other inactive ingredients (excipients), and are often employed for the administration of pharmaceuticals where it is impractical to provide a tablet for swallowing whole. With chewable tablets, the act of chewing helps to break up the tablet particles as the tablet disintegrates and may increase the rate of absorption by the digestive tract. Chewable tablets are often utilized to improve drug administration in pediatric and geriatric patients. [0003] Various attempts have been made to enhance the texture of drug particles in order to prevent their adhesion to the oral mucosa upon ingestion. For example, WO88/06893 discloses an oral composition comprised of an active substance and a gelling or swelling agent capable of forming a viscous medium around the particles in an aqueous carrier. Disadvantageously, such compositions must be disintegrated in water to form a liquid suspension before ingestion for purposes of facilitating the ease of quickly swallowing the composition without chewing. U.S. Pat. No. 6,709,678 has overcome the need to suspend the formulation in an aqueous vehicle before administration by coating its particles with a hydratable polymer and a salivation-promoting agent. [0004] It would be desirable to have an oral dosage form that effectively increases saliva production during ingestion, which thereby obviates the need for consumption with water and thereby improves the swallowability of such dosage forms. SUMMARY OF THE INVENTION [0005] The present invention provides for pharmaceutical compositions as disclosed in the claims. [0006] In accordance with this invention, various forms of pharmaceutical formulations having an immediate release profile may be made using a salivation inducing agent. The initiation of an increased amount of saliva not only facilitates the swallowing of the dosage form, but it also provides for convenient ingestion without the need for water. DETAILED DESCRIPTION OF THE INVENTION [0007] It is believed that one skilled in the art can, based upon the description herein, utilize the present invention to its fullest extent. The following specific embodiments are to be construed as merely illustrative, and not limitative of the remainder of the disclosure in any way whatsoever. [0008] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Also, all publications, patent applications, patents, and other references mentioned herein are incorporated by reference. As used herein, all percentages are by weight unless otherwise specified. [0009] Unless defined otherwise, all ranges provided herein also explicitly include all range combinations that may be formed by all numbers within the endpoints of the range. [0010] As used herein, "injection molding" shall mean a process of forming a dosage form in a desired shape and size wherein a flowable material, which is in a fluid or flowable state form, enters a mold, then is solidified in the mold via a change in temperature (either positive or negative) before being removed therefrom. By contrast, "compression," as used herein, shall mean a process of forming a dosage form in a desired shape and size wherein a material is compacted into a tablet between the surfaces of punches via an increase in pressure before being removed therefrom. [0011] As used herein, an "exterior surface" of a portion is a surface that comprises part of the exterior surface of the finished dosage form. [0012] As used herein, the term "substantially covers" or "substantially continuous" means that the coating is generally continuous and generally covers the entire surface of the core or underlying layer, so that little to none of the active ingredient or underlying layer is exposed. [0013] As used herein, the term "salivation inducing agent" shall mean a tasteless compound that has a salivation-inducing value of at least about 10%, e.g. at least about 12% or at least about 16% or at least about 18%, and which substantially excludes the following water soluble components: a) water-soluble acids such as tartaric acid, citric acid, malic acid, fumaric acid, and ascorbic acid; b) water-soluble salts such as sodium or potassium chloride, sodium or potassium hydrogen tartarate, sodium hydrogen citrate or sodium ascorbate; and c) water-soluble substances having an osmotic action such as glucose, fructose, sucrose, xylitol, mannitol; sorbitol, maltitol and mixtures thereof. By "substantially excludes," it means that the resulting formulation contains less than about 0.1 percent, e.g. less than about 0.5 percent or less than about 0.01 percent or less than 0.001 percent of such water soluble components. [0014] Examples of suitable salivation inducing agents include, but are not limited to, those tasteless muscarinic acetylcholine receptor agonists such as pilocarpine and the compound that is commercially available from IFF under the tradename, "SN12011;" sigma sigma binders such as arylalkylamines wherein the alkyl group has from about 1 to about 8 carbons, i.e., e.g., N,N-disubstituted phenylalkylamines wherein the alkyl has from about 1 to about 8 carbons and N,N disubstituted-2-phenylcyclopropylamines; spirooxathiolane-quinnuclidine; Heliopsis longpipes root; cholinesterase inhibitors; and mixtures thereof. [0015] As used herein, "tasteless" shall mean the substantial absent of or not substantially contributing to a sense of flavor, sweetness, saltiness, bitterness or sourness. [0016] As used herein, "salivation inducing value" is the amount of additional saliva, expressed in percentage terms, secreted in the mouth of a user who consumes a dosage form containing a compound that may be a salivation inducing agent in accordance with the test method set forth in Example 3, relative to the amount of saliva secreted in the mouth of a user who similarly consumes a tablet containing the same ingredients but without that compound, after a period of about 30 seconds, e.g. after about 1 minute or about 3 minutes or about 5 minutes, after either swallowing the tablet or removing the tablet from the user's mouth. [0017] As used herein, "sweetness index" is a term used to describe the level of sweetness of the dosage form relative to sucrose. Sucrose, defined as the standard, has a sweetness index of 1. For example, the sweetness indices of several known sweetener compounds are listed below: TABLE-US-00001 Sorbitol 0.54-0.7 Dextrose 0.6 Mannitol 0.7 Sucrose 1.0 High Fructose Corn Syrup 55% 1.0 Xylitol 1.0 Fructose 1.2-1.7 Cyclamate 30 Aspartame 180 Acesulfame K 200 Saccharin 300 Sucralose 600 Talin 2000-3000 [0018] In one embodiment, the dosage form of the present invention may be provided with a sweetness index less than about 0.6. The addition of sweetening agent may increase the sweetness of the dosage form to at least about 0.9, e.g. at least about 1.0, say at least about 1.5, or at least about 2.0. [0019] As used herein, the term "dosage form" applies to any ingestible forms that are designed to be chewed or remain in the mouth of a user, as opposed to those forms that are designed to be immediately swallowed upon ingestion. Examples of suitable ingestible forms include, but are not limited to solid, dosage forms having a liquid, powder or solid core; chewable or oral disintegrating tablets; thin strips; gummi tablets; foam tablet; and coated particles having the salivation inducing agent in the coating and/or granulation matrix. In one embodiment, dosage forms are solid, semi-solid, or liquid compositions designed to contain a specific pre-determined amount (i.e. dose) of a certain ingredient, for example an active ingredient as defined below. Suitable dosage forms may be pharmaceutical drug delivery systems, including those for oral administration, buccal administration, or mucosal delivery; or compositions for delivering minerals, vitamins and other nutraceuticals, oral care agents, flavorants, and the like. In one embodiment, the dosage forms of the present invention may be considered to be solid; however, they may contain liquid or semi-solid components. In another embodiment, the dosage form is an orally administered system for delivering a pharmaceutical active ingredient to the gastro-intestinal tract of a human. In yet another embodiment, the dosage form is an orally administered "placebo" system containing pharmaceutically inactive ingredients, and the dosage form is designed to have the same appearance as a particular pharmaceutically active dosage form, such as may be used for control purposes in clinical studies to test, for example, the safety and efficacy of a particular pharmaceutically active ingredient. "Active ingredients," as used herein, includes, for example, pharmaceuticals, minerals, vitamins and other nutraceuticals, oral care agents, flavorants and mixtures thereof. Suitable pharmaceuticals include analgesics, anti-inflammatory agents, antiarthritics, anesthetics, antihistamines, antitussives, antibiotics, anti-infective agents, antivirals, anticoagulants, antidepressants, antidiabetic agents, antiemetics, antiflatulents, antifungals, antispasmodics, appetite suppressants, bronchodilators, cardiovascular agents, central nervous system agents, central nervous system stimulants, decongestants, diuretics, expectorants, gastrointestinal agents, migraine preparations, motion sickness products, mucolytics, muscle relaxants, osteoporosis preparations, polydimethylsiloxanes, respiratory agents, sleep-aids, urinary tract agents and mixtures thereof. Suitable oral care agents include breath fresheners, tooth whiteners, antimicrobial agents, tooth mineralizers, tooth decay inhibitors, topical anesthetics, mucoprotectants, and the like. Suitable flavorants include menthol, peppermint, mint flavors, fruit flavors, chocolate, vanilla, bubblegum flavors, coffee flavors, liqueur flavors and combinations and the like. Examples of suitable gastrointestinal agents include antacids such as calcium carbonate, magnesium hydroxide, magnesium oxide, magnesium carbonate, aluminum hydroxide, sodium bicarbonate, dihydroxyaluminum sodium carbonate; stimulant laxatives, such as bisacodyl, cascara sagrada, danthron, senna, phenolphthalein, aloe, castor oil, ricinoleic acid, and dehydrocholic acid, and mixtures thereof; H2 receptor antagonists, such as famotadine, ranitidine, cimetadine, nizatidine; proton pump inhibitors such as omeprazole or lansoprazole; gastrointestinal cytoprotectives, such as sucraflate and misoprostol; gastrointestinal prokinetics, such as prucalopride, antibiotics for H. pylori, such as clarithromycin, amoxicillin, tetracycline, and metronidazole; antidiarrheals, such as diphenoxylate and loperamide; glycopyrrolate; antiemetics, such as ondansetron, analgesics, such as mesalamine. In one embodiment of the invention, the active ingredient may be selected from bisacodyl, famotadine, ranitidine, cimetidine, prucalopride, diphenoxylate, loperamide, lactase, mesalamine, bismuth, antacids, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof. In another embodiment, the active ingredient may be selected from analgesics, anti-inflammatories, and antipyretics: e.g. non-steroidal anti-inflammatory drugs (NSAIDs), including propionic acid derivatives: e.g. ibuprofen, naproxen, ketoprofen and the like; acetic acid derivatives: e.g. indomethacin, diclofenac, sulindac, tolmetin, and the like; fenamic acid derivatives: e.g. mefanamic acid, meclofenamic acid, flufenamic acid, and the like; biphenylcarbodylic acid derivatives: e.g. diflunisal, flufenisal, and the like; and oxicams: e.g. piroxicam, sudoxicam, isoxicam, meloxicam, and the like. In one embodiment, the active ingredient is selected from propionic acid derivative NSAID: e.g. ibuprofen, naproxen, flurbiprofen, fenbufen, fenoprofen, indoprofen, ketoprofen, fluprofen, pirprofen, carprofen, oxaprozin, pranoprofen, suprofen, and pharmaceutically acceptable salts, derivatives, and combinations thereof. In another embodiment of the invention, the active ingredient may be selected from acetaminophen, acetyl salicylic acid, ibuprofen, naproxen, ketoprofen, flurbiprofen, diclofenac, cyclobenzaprine, meloxicam, rofecoxib, celecoxib, and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof. [0020] In another embodiment of the invention, the active ingredient may be selected from pseudoephedrine, phenylepherine, phenylpropanolamine, chlorpheniramine, dextromethorphan, diphenhydramine, guaifenesin, astemizole, terfenadine, fexofenadine, loratadine, desloratidine, doxilamine, norastemizole, cetirizine, benzocaine, mixtures thereof and pharmaceutically acceptable salts, esters, isomers, and mixtures thereof. Continue reading about Oral compositions containing a salivation inducing agent... Full patent description for Oral compositions containing a salivation inducing agent Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Oral compositions containing a salivation inducing agent 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. 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