Bausch-lomb Incorporated

Mohannad Shawer

Eric Phillips

Martin J Coffey

Harry M King, Jr

A suspension includes an ophthalmic active ingredient suspended in a formulation vehicle including a suspending agent and a non-ionic cellulose derivative. The ophthalmic active agent is present as particles having D&#x3c;5 &#x3bc;m and D&#x3c;1 &#x3bc;m. The suspension may be administered to a patient for treating an ophthalmic inflammatory condition.

Ophthalmic suspension composition

Amorphous solid-state form of (R)-(+)-7-(3-amino-2,3,4,5,6,7-hexahydro-1H-azepin-1-yl)-1,4-dihydro-4-oxoquinoline-3-carboxylic acid is characterized by at least one of: (a) an X-ray powder diffraction ('XRPD') spectrum that comprises peaks at 2&#x3b8; angles of 6.9-7.1, 9.4, 10.6-10.7, and 13.4-13.7&#xb0;&#xb1;0.2&#xb0;, and a diffuse halo pattern at 11-30&#xb0;; and (b) a DSC (differential scanning calorimetry) melting peak at about 267-272&#xb0; C. The amorphous solid is prepared by rapid precipitation from a saturated or supersaturated solution of besifloxacin free base in a solvent comprising at least benzyl alcohol.

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Lexington, MA, United States of America

Mohannad Shawer