OPHTHALMIC FORMULATIONS AND PROCESSES FOR THEIR PREPARATION
First Claim
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1. A process for preparing an ophthalmic formulation for topical application comprising:
- (i) an ophthalmic drug,(ii) at least one wetting agent, and(iii) an aqueous vehiclewherein the ophthalmic drug is in aqueous suspension in the formulation, said process comprising;
(a) subjecting a suspension of the ophthalmic drug in an aqueous solution of wetting agent to high pressure homogenization, and(b) combining the mixture in step (a) with the aqueous vehicle.
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Abstract
The invention relates to a process for preparing ophthalmic formulations and to formulations containing a suspension of an ophthalmic drug in an aqueous vehicle. The invention further relates to the production of stable ophthalmic formulations that have a minimal propensity to form drug aggregates.
22 Citations
52 Claims
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1. A process for preparing an ophthalmic formulation for topical application comprising:
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(i) an ophthalmic drug, (ii) at least one wetting agent, and (iii) an aqueous vehicle wherein the ophthalmic drug is in aqueous suspension in the formulation, said process comprising; (a) subjecting a suspension of the ophthalmic drug in an aqueous solution of wetting agent to high pressure homogenization, and (b) combining the mixture in step (a) with the aqueous vehicle. - View Dependent Claims (2, 3, 8, 11, 12, 13, 17, 20, 34, 35, 36, 37, 38, 41)
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4-7. -7. (canceled)
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9-10. -10. (canceled)
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14. A process according to 1 claim wherein the ophthalmic drug is selected from the group consisting of brimonidine, brinzolamide, dorzolamide, natamycin, ofloxacin, bimatoprost, travoprost, latanoprost, nepafenac, ketoconazole, fluconazole, voriconazole, hydrocortisone, prednisolone, dexamethasone, timolol, levobunolol, betaxolol, or pharmaceutically acceptable salts, and combinations thereof.
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15-16. -16. (canceled)
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18-19. -19. (canceled)
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21-33. -33. (canceled)
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39-40. -40. (canceled)
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42. An ophthalmic formulation for topical application comprising:
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(i) an ophthalmic drug, (ii) at least one wetting agent, and (iii) an aqueous vehicle wherein the ophthalmic drug is in aqueous suspension in the formulation, and the formulation is substantially free of drug particles having a particle size of over 10 μ
m.
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43-50. -50. (canceled)
- 51. A method of preventing the formation of drug aggregates in an ophthalmic formulation containing an ophthalmic drug suspended in an aqueous vehicle containing at least one wetting agent by the use of high pressure homogenization.
Specification