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US 9,694,010 B2Granted
Therapeutic formulation and methods of treatment
AssigneeMacuCLEAR, Inc.
InventorsPamela A. Lewis, William H. Woller
Life of this patent
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Abstract
The present disclosure relates pharmaceutical formulations comprising hydralazine in the treatment of eye diseases and conditions with the formulations. The present disclosure also related to methods of preparing the pharmaceutical formulations.
Claims23
An ophthalmic composition, comprising:
- a pharmaceutically active drug comprising hydralazine in an amount between about 0.02-2 wt %;
- an acetate buffer solution having pH of between 3.9-4.5 in an amount between 8-12 wt %;
- propylene glycol in an amount between 0.5-2 wt %;
- sodium chloride in an amount between 0.25-1 wt %;
- methylparaben in an amount between 0.015-0.06 wt %;
- benzalkonium chloride in the form of a 50% solution, present in an amount between 0.01-0.04 wt %;
- and
- edetate disodium in an amount between 0.008-0.030 wt %;
- wherein said composition has a pH of between 4.0-4.4.
6 more elements
A method for preparing an ophthalmic formulation, comprising:
- mixing water and an acetate buffer solution having a pH 3.9-4.5 to form a first interim mixture, the acetate buffer solution added in an amount to provide between about 8-12 wt % of acetate buffer solution in the formulation;
- adding to the first interim mixture edetate disodium, to form a second interim mixture, the edetate disodium added in an amount to provide between about 0.008-0.030 wt % of edetate disodium in the formulation;
- adding to the second interim mixture propylene glycol to form a third interim mixture, the propylene glycol added in an amount to provide between about 0.5-2 wt % of propylene glycol in the formulation;
- adding to the third interim mixture sodium chloride to form a fourth interim mixture, the sodium chloride added in an amount to provide between about 0.25-1 wt % of sodium chloride in the formulation;
- adding to the fourth interim mixture benzalkonium chloride to form a fifth interim mixture, the benzalkonium chloride added in an amount to provide between about 0.01-0.04 wt % of benzalkonium chloride in the formulation;
- and
- adding to the fifth interim mixture methylparaben to form a sixth interim mixture, the methylparaben added in an amount to provide between about 0.015-0.06 wt % of methylparaben in the formulation;
- adding to the sixth interim mixture to form said formulation, a pharmaceutically active drug comprising hydralazine.
5 more elements
Dependencies are inferred from the claim text.