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Publication Date: 2016-Feb-01
Document File: 2 page(s) / 91K

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The Prior Art Database

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    (2S,3R,4R,5S,6R)-2-[4-chloro-3-[[4-[(3S)-oxolan-3-yl]oxyphenyl]methyl]phenyl]-6- (hydroxymethyl)oxane-3,4,5-triol is known as empagliflozin. Reportedly, empagliflzoin is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), apparently reported for the treatment or improvement in glycemic control in patients with type 2 diabetes. A pharmaceutical composition with empagliflozin, preferably crystalline form of empagliflozin was found suitable for formulation of a finished dosage form.

    The pharmaceutical composition may be suitable for oral administration such as tablets, caplets, capsules, or any other form suitable for oral administration. Preferably the pharmaceutical composition is a solid dosage form, more preferably a compressible dosage form such as a tablet.

    It was found that stable formulations may be obtained without the presence of a binder nor a disintegrant. These formulations may contain a filler, optionally a surfactant, optionally a glidant and a lubricant.

    Binders are for example naturally occurring or partially or totally synthetic polymers selected from acacia, agar, alginic acid, carbomers, carmellose sodium, carrageenan, cellulose acetate phthalate, ceratonia, chitosan, confectionar's sugar, copovidone, povidone, cottonseed oil, dextrate, dextrin, dextrose, polydextrose, maltodextrin, maltose, cellulose and derivatives thereof such as microcrystalline cellulose, methylcellulose, ethylcellulose, hydroxyethyl cellulose, hydroxyethyl methylcellulose, hydroxypropyl celluloses, carboxymethylcelluloses, hypromelloses (cellulose hydroxypropyl methyl ether), starch and derivatives thereof, such as pregelatinized starch, hydroxypropylstarch, corn starch, gelatin, glyceryl behenate, tragacanth, guar gum, hydrogenated vegetable oils, inulin, poloxamer, polycarbophils, polyethylene...