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Pharmaceutical compositions of 8-Cyano-1-cyclopropyl-7-(1S,6S)-2,8-diazabicyclo-(4.3.0)nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinoline carboxylic acid

IP.com Disclosure Number: IPCOM000234658D
Publication Date: 2014-Jan-27
Document File: 3 page(s) / 667K

Publishing Venue

The IP.com Prior Art Database

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Pharmaceutical compositions of 8-Cyano-1-cyclopropyl-7-(1S,6S)-2,8-diazabicyclo-(4.3.0)nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinoline carboxylic acid

Suspension

The composition 2.5% Oral Suspension was prepared in accordance with Examples disclosed in EP1513500, and includes, in addition to the active substance, 8-Cyano-1-cyclopropyl-7-(1S,6S)-2,8-diazabicyclo-(4.3.0)nonan-8-yl)-6-fluoro-1,4-dihydro-4-oxo-3-quinoline carboxylic acid, excipients commonly used in oral suspensions: an Amberlite ion

exchange resin (taste masking); xanthan gum (thickener); propylene glycol (humectant); ascorbic acid(antioxidant); sorbic acid (preservative); purified water (vehicle); and, a vanilla flavour (to improve palatability to the target species, cats).

Optical microscopy photographs of the prepared compositions are shown in the following figures:

Figure 1

  

Figure 2

The average particle size of the primary particles measured as the longest dimension using a microscope in a suspension shown in Figure 1 is approximately 30μm, and in suspension shown in Figure 2 approximately 25μm. The visible particles are present in amorphous form consisting of complex of Amberlite with active ingredient.

Tablets

The composition of the Tablets is prepared in accordance with Examples disclosed in EP1682144 and include, in addition to the active substance, conventional tablet excipients: lactose (filler); microcrystalline cellulose (filler/dry binder); povidone (wet binder); colloidal anhydrous silic...