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Oral dosage form comprising an antimisuse systemRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Identification Or Warning Feature, Printed Or Embossed Unitary Dosage FormOral dosage form comprising an antimisuse system description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070202049, Oral dosage form comprising an antimisuse system. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The present invention relates to an oral solid dosage forms containing one or several active principle(s) having analgesic properties, the composition of said dosage form being such that it prevents the intentional or unintentional misuse of said dosage form through the liquid extraction of the active principle(s) contained therein, using commonly available solvents. [0002] More specifically, the analgesic active principle (AAP) is present in the oral solid dosage form is a pharmaceutically acceptable salt. In the present disclosure, the mention analgesic active principle means a pharmaceutically acceptable salt of analgesic active principle. BACKGROUND OF THE INVENTION [0003] Analgesics, and more particularly opioid or morphine derivatives, are often misused. Such misuse can be intentional or unintentional consumption of a solid oral drug containing an analgesic active principle, for a purpose other than that which is officially approved by the competent health authorities. This is a very complex and difficult problem to solve. The reason is that drug abuses and unfortunately now even teenagers have found way to recover the drug from tablets quite easily. [0004] For example, today, teenagers prepare for parties on Saturday, a cocktail of vodka with Oxycodon that they extract easily from tablets, with water or alcohol. The process consists in crushing the tablet and pouring the powder into a glass of vodka or water and then, to wait long enough to extract almost completely all the morphines derivative. They use to do the preparation of the drug before they take it. This practice is widespread in US but also in Europe. This is becoming a real social concern addressed by social agencies but also by the Food and Drug Administration in US and European Agencies, who wish that dosage forms preventing misuse be developed. [0005] There are other ways to misuse the type of opioid such as extracting the drug as described above and make an intra-venous injection or dry the drug in order to obtain a powder which can be inhaled. [0006] There is a prior art describing different solution to avoid the misusage of opioids contained into a delivery systems. [0007] Our understanding is that patent application US-A-2003/0224051 describes osmotic delivery dosage forms for the modified release of oxycodone. The dosage form comprises an oxycodone core or acceptable salts thereof, a semi-permeable membrane at least partially surrounding the core, an exit orifice through the membrane allowing the release of oxycodone. This type of tablet allows an easy extraction by water for example after 12 hours or more and consequently does not provide i.a. a satisfactory solution against misuse. [0008] Another way to avoid misuse of an opioid is to combine the opioid with its antagonist such as naltrexone. Our understanding is that patent application WO-A-03/013479 patent describes an oral dosage form comprising a therapeutically effective amount of an opioid analgesic; an opioid antagonist (naltrexone); and a bittering agent. When the drug abuser crushes the tablet, the opioid and its antagonist are released and the opioid effect is neutralised. [0009] This system does not prevent i.a extraction by water because, without crushing, the opioid can be extracted, contrary to naltrexone. [0010] Our understanding is that published European patent application EP-A-1293209 describes a solid oral pharmaceutical dosage form with reduced potential for drug abuse. The oral dosage form of the invention is a sustained release dosage form based on an ion exchange resin which contains an opioid derivative. However, this dosage form does not prevent solvent extraction with an extraction time longer than the normal release time of the drug. If said oral dosage form is left in a glass of water during 24 hours, most of the drug will be extracted. [0011] As can be seen from the foregoing presentation of the prior art, different solutions are provided to prevent misuse of pharmaceutical opioids in modified release solid dosage forms. [0012] However, our understanding is that none of the solutions can prevent i.a. the extraction by water, alcohol or any other type of drinkable solvent. OBJECTIVES OF THE INVENTION [0013] In these circumstances, one of the main objects of the instant invention is to fill in the prior art. [0014] Thus, according to one aspect of the invention it is an object of the invention to provide a new solid oral analgesic medicine/dosage form, allowing for the prevention of oral misuse after liquid extraction such as a "long" liquid extraction of the analgesic active principle, in one aspect without resorting to antagonists of the analgesic active principle. [0015] By "long liquid extraction", it is meant that the liquid extraction is planned by the drug abuser to last longer than 10 minutes. [0016] According to further aspects of the invention, it is an objective of the invention to provide a solid oral dosage form containing an analgesic active principle, said dosage form having the following features: [0017] Under normal prescribed condition of administration, the dosage form should have the desired therapeutic effect, for example during 12 hours or 24 hours; [0018] Under any attempt of improper extraction of the analgesic by a misuser, the oral dosage form will not be able to provide fast absorption of the analgesic into the blood circulation. Another objective of the invention is to provide a new solid oral dosage form that prevents misuse by a long liquid extraction as well as a brief liquid extraction and/or by crushing. Another objective of the invention is to provide a new solid oral analgesic dosage form: [0019] which can be administered easily to patients having difficulties to swallow large tablets, among which infants, children and the elderly; [0020] which permits the association of several analgesic active principles, or even other Continue reading about Oral dosage form comprising an antimisuse system... Full patent description for Oral dosage form comprising an antimisuse system Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Oral dosage form comprising an antimisuse system 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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