Temperature-stable formulations, and methods of development thereof
First Claim
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1. An aqueous formulation, comprising:
- water;
a therapeutic agent, selected from the group consisting of anti-inflammatory steroids and steroidal hormones, in an amount between about 0.001% and about 2.0% (w/v);
propylene glycol in an amount between about 13% and about 20% (w/v);
polyethylene glycol (PEG) in an amount between about 10% and about 50% (w/v);
a preservative;
a stabilizer; and
a pH buffering agent sufficient to maintain the pH of the aqueous formulation at between about 3.5 and about 8.0.
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Abstract
One embodiment of the present invention relates to a method of preparing a concentrated pharmaceutical formulation, comprising the steps of: combining in a container a therapeutic agent, a solvent and at least one pharmaceutically acceptable excipient to give a solution; adding to said solution a seed crystal of said compound to give a heterogeneous mixture; and observing the stability of said heterogeneous mixture.
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Citations
20 Claims
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1. An aqueous formulation, comprising:
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water;
a therapeutic agent, selected from the group consisting of anti-inflammatory steroids and steroidal hormones, in an amount between about 0.001% and about 2.0% (w/v);
propylene glycol in an amount between about 13% and about 20% (w/v);
polyethylene glycol (PEG) in an amount between about 10% and about 50% (w/v);
a preservative;
a stabilizer; and
a pH buffering agent sufficient to maintain the pH of the aqueous formulation at between about 3.5 and about 8.0. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 17, 18, 19, 20)
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15. An aqueous formulation, comprising:
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water;
triamcinolone acetonide in an amount between about 0.01% and about 0.05% (w/v);
propylene glycol in an amount of about 14% (w/v);
PEG in an amount between about 35% and 45% (w/v);
benzalkonium chloride in an amount of about 0.05% (w/v);
disodium EDTA in an amount of about 0.05% (w/v);
citric acid in an amount of about 0.72% (w/v);
sodium citrate dihydrate in an amount of about 0.74% (w/v); and
an amount of a pH buffering agent sufficient to maintain the pH of the aqueous formulation between about 5 and 7.
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Specification