Suspension of loteprednol etabonate for ear, eye, or nose treatment
First Claim
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1. A composition for ophthalmic or otolaryngological anti-inflammatory use comprising:
- (A) a corticosteroid in an amount of 0.01 to about 2% by weight and having a particle size of about 0.1 to 30 microns in diameter to substantially prevent discomfort upon use of the composition for said ophthalmic or otolaryngological anti-inflammatory treatment;
(B) a nonionic polymer in an aqueous medium;
(C) a nonionic tonicity agent in an amount sufficient to achieve isotonicity; and
(D) a nonionic surface active agent in an amount sufficient to retain the corticosteroid, the nonionic tonicity agent and the nonionic polymer in a suspension.
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Abstract
The invention provides novel compositions of matter for delivering water-insoluble steroid drugs suitable for therapeutic use. The invention also provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of ≦30 μm which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.
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Citations
30 Claims
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1. A composition for ophthalmic or otolaryngological anti-inflammatory use comprising:
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(A) a corticosteroid in an amount of 0.01 to about 2% by weight and having a particle size of about 0.1 to 30 microns in diameter to substantially prevent discomfort upon use of the composition for said ophthalmic or otolaryngological anti-inflammatory treatment; (B) a nonionic polymer in an aqueous medium; (C) a nonionic tonicity agent in an amount sufficient to achieve isotonicity; and (D) a nonionic surface active agent in an amount sufficient to retain the corticosteroid, the nonionic tonicity agent and the nonionic polymer in a suspension. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29)
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2. A composition for ophthalmic or otolaryngological anti-inflammatory use comprising:
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(A) a corticosteroid in an amount of about 0.01% to about 2% by weight, said corticosteroid having a particle size of about 0.1 to 30 microns diameter to substantially prevent discomfort upon use of the composition for said ophthalmic or otolaryngological anti-inflammatory applications; (B) a nonionic polymer in an aqueous medium; (C) a nonionic tonicity agent in an amount sufficient to achieve isotonicity; and (D) a nonionic surface active agent in an amount sufficient to retain the corticosteroid, the nonionic tonicity agent and the nonionic polymer in suspension, wherein the molar ratio of (A);
(B);
(D) is about 1;
0.01;
0.05 to about 1;
20;
1. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 20)
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18. A method for treating ophthalmic or otolaryngological inflammation which comprises applying to inflamed tissue a composition comprising:
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(A) a corticosteroid in an amount of 0.01 to about 2% by weight and having a particle size of about 0.1 to 30 microns in diameter to substantially prevent discomfort upon use of the composition for said ophthalmic or otolaryngological anti-inflammatory treatment; (B) a nonionic polymer in an aqueous medium; (C) a nonionic tonicity agent in an amount sufficient to achieve isotonicity; and (D) a nonionic surface active agent in an amount sufficient to retain the corticosteroid, the nonionic tonicity agent and the nonionic polymer in a suspension, wherein said composition is applied in an amount effective to treat said inflammation. - View Dependent Claims (19, 30)
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Specification