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AssigneeOrion Corporation
InventorsKaija Af Ursin, Jukka Salmia, Heikki Niskanen, Pirjo Kortesuo, Mikko Kananen, Gunilla Örn, Juha Kiesvaara
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Aqueous compositions of nonsteroidal triphenylethylene antiestrogens for pharmaceutical use comprising as a solubility enhancing agent a pharmaceutically acceptable mono- or dicarboxylic acid having 1-5 carbon atoms, wherein the carbon chain may further contain 1-4 hydroxyl, 1-3 oxo, or one or several halogen a substituents, or a corresponding anion thereof, or methanesulfonic acid or its corresponding anion, in molar excess with respect to the triphenylethylene antiestrogen, optionally together with an organic water miscible co-solvent such as polyethylene glycol (PEG), propylene glycol, ethanol or isopropanol.
An aqueous solution of a nonsteroidal triphenylethylene antiestrogen or a pharmaceutically acceptable salt thereof, comprising the nonsteroidal triphenylethylene antiestrogen toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene, or pharmaceutically acceptable salt of toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene and, as a solubility enhancing agent,
A method for preparing an aqueous solution of a nonsteroidal triphenylethylene antiestrogen or a pharmaceutically acceptable salt thereof, comprising contacting the nonsteroidal triphenylethylene antiestrogen toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene, or pharmaceutically acceptable salt of toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene, with aqueous media and
A method for preparing an aqueous solution of a nonsteroidal triphenylethylene antiestrogen or a pharmaceutically acceptable salt thereof comprising contacting the nonsteroidal triphenylethylene antiestrogen toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene, or pharmaceutically acceptable salt of toremifene, tamoxifen, droloxifene, 4-hydroxytamoxifen or clomiphene, with aqueous media, an organic water miscible co-solvent and the solubility enhancing agent lactic acid, or a corresponding anion thereof, in molar excess with respect to the triphenylethylene antiestrogen, with the proviso that the nonsteroidal triphenylethylene antiestrogen or a pharmaceutically acceptable salt thereof is not in the form of cyclodextrin inclusion complex.
Dependencies are inferred from the claim text.