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NEW Patent CD for Use of O desmethyl N mono desmethyl tramadol




Following is a sample of the information contained on this CD: BACKGROUND OF THE INVENTION This invention relates to the use of O-desmethyl-N-mono-desmethyl-tramadol for the production of pharmaceutical compositions for the treatment of pain and various related indications as well as pharmaceuticals comprising O-desmethyl-N-mono-desmethyl-tramadol. The treatment of pain conditions is of great importance in medicine. There is currently a world-wide need for additional pain therapy. The pressing requirement for a target-oriented treatment of pain conditions which is right for the patient which is to be understood as the successful and satisfactory treatment of pain for the patients is documented in the large number of scientific works which have recently and over the years appeared in the field of applied analgesics or on basic research on nociception. SUMMARY OF THE INVENTION The underlying object of the present invention was to provide a substance useful in the treatment of pain and also related indications, as well as pharmaceutical compositions for such treatment. It has now been found that O-desmethyl-N-mono-desmethyl-tramadol is useful in the treatment of pain and also related indications. One main aspect of the invention is therefore the use of O-desmethyl-N-mono-desmethyl-tramadol as a racemate, a mixture of its enantiomers or a single enantiomer in the form of its base or salts of physiologically acceptable acids for the production of a pharmaceutical composition for the treatment of pain. O-desmethyl-N-mono-desmethyl-tramadol (sometimes referred to as MS in the literature and in the following text) is known as one of the in vivo metabolites of Tramadol (1RS,2RS)-2[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol; Lintz et al. Arzneim.-Forsch./Drug Res. 31(11), 1932-1943, 1981). Tramadol assumes a special position amongst centrally acting analgesics. Since this active ingredient acts as a strong inhibitor of pain without the

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    NEW Patent CD for Controlled release tramadol

    NEW Patent CD for Controlled release tramadol




    Following is a sample of the information contained on this CD: The present invention relates to a controlled release preparation for oral administration, to processes for its preparation and to its medical use. In particular, (lie invention relates to a controlled release preparation comprising tramadol or a pharmaceutically acceptable salt thereof. Tramadol, which has the chemical name (+)-trans-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol, is an orally active opioid analgesic. Conventional release preparations in the form of capsules, drops and suppositories containing tramadol, or more particularly its hydrochloride salt, have been commercially available for many years for use in the treatment of moderate to severe pain; Such preparations, however, do not provide a controlled release of the tramadol. Moreover, despite tramadol’s long-standing use, controlled release preparations for oral administration containing tramadol as active ingredient have not even previously been described in the literature. It is an object of the present invention to provide an oral controlled release tramadol preparation suitable for at least twelve-hourly (e.g. up to twenty-four hourly) administration for the treatment of pain. The present invention therefore provides a controlled release preparation comprising tramadol or a pharmaceutically acceptable salt thereof for oral administration. Suitable pharmaceutically acceptable salts of tramadol for use according to the present invention are those conventionally known in the art such as pharmaceutically acceptable acid addition salts. The hydrochloride salt is particularly preferred. A controlled release preparation according to the present invention is one that achieves slow release of a drug over an extended period of time, thereby extending the duration of drug action over that achieved by conventional delivery. Preferably such a preparation maintains a drug concentration in the blood within the

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      NEW Patent CD for Sustained release formulations containing acetaminophen and tramadol




      Following is a sample of the information contained on this CD: FIELD OF THE INVENTION The present invention is directed to a sustained release formulation of Acetaminophen and tramadol. Particularly, this invention is related to a formulation and dissolution specifications from a sustained release dosage form of acetaminophen tramadol in connection with an improved dose segment for a better patient compliance. BACKGROUND OF THE INVENTION Acetaminophen with Codeine Phosphate (Tylenol.RTM. with Codeine) or Hydrocodone Bitartrate (Vicodin.RTM.) or Oxycodone (Tylox.RTM.) is commonly used analgesic drugs, indicated for the relief of moderate to moderately severe pain. Acetaminophen with Codeine or Hydrocodone combines the analgesic effects of a centrally acting analgesic, codeine or hydrocodone, with a peripherally analgesic, acetaminophen. Opioids have for many years been used as analgesics to treat severe pain. They, however, produce undesirable side effects and as a result cannot be given repeatedly or at high doses. The side effect problems are well documented in the literature (J. Jaffe and W. Martin in chapter 15, The Pharmacological Basis of Therapeutics , editors L. Goodman and A. Gilman, 5th Edition, 245, 1975), which discloses that morphine and its congeners, e.g., codeine, hydrocodone and oxycodone, are opioid agonist analgesics that exhibit side effects such as respiratory depression, constipation, tolerance and abuse liability. As alternatives to using opioids, non-opioids such as acetaminophen (APAP) and aspirin are used as analgesics. APAP, like aspirin, is not subject to the tolerance, addiction and toxicity of the opioid analgesics. However, APAP and aspirin are only useful in relieving pain of moderate intensity, whereas the opioid analgesics are useful in relieving more intense pain; See Woodbury, D. and Fingl, E. in The Pharmacological Basis of Therapeutics , 5th Ed.; Goodman, L. and Gilman, A., Chapter 15, pages 325 (1975).

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        NEW Patent CD for Stabilized sustained release tramadol formulations




        Following is a sample of the information contained on this CD: BACKGROUND OF THE INVENTION The present invention relates to sustained release matrix preparations containing tramadol or a pharmaceutically acceptable salt thereof as the therapeutically active agent. Sustained release preparations are known to those skilled in the art to achieve a slow release of a drug over an extended period of time, thereby extending the duration of drug action over that achieved by conventional delivery. Preferably such a preparation maintains a drug concentration in the blood within the therapeutic range for 12 hours or more. An important aspect of the manufacture, regulatory review and approval of all dosage forms concerns their stability over extended periods of time. The stability data obtained with regard to a particular dosage form directly affects its shelf-life. The stability of a pharmaceutical dosage form is related to maintaining its physical, chemical, microbiological, therapeutic, and toxicological properties when stored, i.e., in a particular container and environment. Stability study requirements are covered, e.g., in the Good Manufacturing Practices (GMPs), the U.S.P., as well as in the regulatory requirements of the country where approval to market a dosage form is being sought. In the United States, a request to test, and eventually market, a drug or a drug formulation may be made via a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA) or an Investigational New Drug Applications (IND). The agents used in sustained release dosage formulations often present special problems with regard to their physical stability during storage. For example, waxes which have been used in such formulations are known to undergo physical alterations on prolonged standing. Precautions may be taken to stabilize waxes at the time of manufacture or to prevent the change from occurring. Fats and waxy materials when used in purified states are

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          NEW Patent CD for Pharmaceutical compositions containing tramadol for migraine




          Following is a sample of the information contained on this CD: FIELD OF THE INVENTION The present invention relates to a new process for using pharmaceutical compositions containing tramadol, and an antiemetic-antinauseant substance for the treatment of migraines and migraine-like headaches. BACKGROUND Migraine is a disease with recurring attacks of headaches, which last between 4 and 72 hours. Migraine attacks predominantly are unilateral, dull at the beginning and then pulsing headaches occur with moderate to severe intensity. Typical accompanying symptoms of migraines are hypersensitivity towards light and sound, pallor, nausea and vomiting and without neurological focal attack, as a prodromal stage. The (usual) migraine without aura is differentiated from the (classical) migraine with aura, which always commences with a characteristic scintillating scotoma. A complicated migraine exists if the visual disorders last for days or other neurological focal symptoms occur with the known special forms of the retinal, basilar, ophthal-moplegic, aphasic or hemiplegic migraine. There are different ideas concerning the pathomechanism of the migraine. Earlier hemodynamic ideas, according to which the initial neurological attacks are triggered by regional, intracranial vasoconstriction and the subsequent pulsing headache by extracranial vasodilation with pain conduction over the nervus opththalmicus and nervus trigeminus, explain the processes during the migraine only inadequately. The regional cerebral blood flow is reduced during a migraine with aura occipital, the slow migration of the cortical oligemia with crossing over of the supply regions of individual arteries suggesting that not only vasomotor, but also electrophysiological phenomena corresponding to the so-called spreading depression participating (Spierings ELH (1988); Recent advances in understanding of migraine. Headache 28; 655-658). Other findings suggest that the accompanying

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