Patent application serial number 699699 has not been assigned to a company or institution.
The following quote was obtained by the news editors from the background information supplied by the inventors: "Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), effective for major depressive disorder and it is as effective as venlafaxine in generalized anxiety disorder.
"Duloxetine is chemically (+)-(S)-N-methyl-.gamma.-(1-naphthyloxy)-2-thiophene propylamine, and commonly used as its hydrochloride salt. In this document, the term 'duloxetine' will refer to the hydrochloride salt of the S-enantiomer unless otherwise specified. Duloxetine hydrochloride has the following formula.
"Duloxetine is commercially available as capsules containing delayed release pellets under the trade name CYMBALTA.TM. in
"Duloxetine, being an acid-labile substance is very much susceptible to degradation in the acidic environment of the stomach. Therefore duloxetine is formulated as an enteric coated dosage form to protect it from acid degradation.
"U.S. Pat. No. 5,508,276 discloses an enteric duloxetine pellet comprising hydroxypropylmethyl cellulose acetate succinate (HPMCAS) as an enteric coating polymer. The '276 patent also discloses that the HPMCAS should be neutralized, for example, with ammonia to facilitate its dissolution. The '276 patent also discloses that duloxetine was found to react with many enteric coatings to form a slowly soluble or insoluble coating. This may lead to a disadvantageous drug-releasing profile and/or low bioavailability.
"US patent application no. 2006/0165776 describes an oral pharmaceutical composition comprising a core comprising duloxetine or its pharmaceutically acceptable derivative thereof and the said core comprised of pharmaceutically inert nuclei and duloxetine or its pharmaceutically acceptable derivative thereof mixed and compressed together, an intermediate layer and an enteric layer comprising one or more enteric polymers; wherein the said composition is free of alkaline reacting compounds.
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