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US 11,229,596 B2Granted
Preservative free pharmaceutical ophthalmic compositions
AssigneePharmathen S.A.
InventorsEvangelos Karavas, Efthymios Koutris, Vasiliki Samara, Ioanna Koutri, Anastasia Kalaskani, Andreas Kakouris, Manolis Fousteris
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Abstract
The present invention relates to a preservative-free ophthalmic composition for the reduction of elevated intraocular pressure containing Latanoprost or a combination of Latanoprost and Timolol and to a process for preparing such compositions.
Claims13
A preservative-free ophthalmic pharmaceutical composition consisting of:
- Latanoprost or a combination of Latanoprost and Timolol;
- at least one Latanoprost solubilizing agent having an hydrophilic-lipophilic balance (HLB) value >10 selected from the group consisting of polyoxyl 40 hydrogenated castor oil, polyoxyl 35, castor oil poloxamer 407, and mixtures thereof, wherein said solubilizing agent is present in the composition in an amount from 1.5% to 5% w/v;
- at least one buffering agent selected from the group consisting of sodium dihydrogen phosphate dihydrate, anhydrous disodium phosphate, and mixtures thereof;
- at least one tonicity agent which is sodium chloride;
- at least one chelating agent which is disodium edetate dehydrate,
- water, and
- optionally at least one pH adjusting agent;
- wherein Latanoprost is present in the composition in an amount of 0.005% w/v, wherein when present, Timolol is present in the composition in an amount of 0.500% w/v.
5 more elements
A preservative-free ophthalmic pharmaceutical composition consisting of one of the following:
- Ingredients
- % w/v
- Latanoprost
- 0.005
- 0.005
- 0.005
- Timolol
- 0.500
- 0.500
- 0.500
- Timolol Maleate
- 0.683
- 0.683
- 0.683
- polyoxyl 40 hydrogenated
- 1,.00-5.000
- 1.500-5.000
- 2.500
- castor oil or polyoxyl 35
- castor oil
- Poloxamer 407
- —
- 1.500-3.000
- —
- Disodium edetate dehydrate
- —
- —
- 0.111
- NaCl
- 0.300-0.450
- 0.300-0.400
- 0.360
- NaH2PO4•2H2O
- 0.650-0.800
- 0.600-0.750
- 0.800
- Na2HPO4
- 0.250-0.350
- 0.200-0.300
- 0.250
- NaOH/HCl 1N
- q.s pH 6.00
- Water for injections
- q.s 100.
41 more elements
A preservative-free ophthalmic pharmaceutical composition consisting of one of the following:
- Ingredients
- % w/v
- Latanoprost
- 0.005
- 0.005
- 0.005
- polyoxyl 40 hydrogenated
- 1.500-5.000
- 1.500-5.000
- 2.500
- castor oil or polyoxyl 35
- castor oil
- Poloxamer 407
- —
- 1.500-3.000
- —
- Disodium edetate dehydrate
- —
- —
- 0.111
- NaCl
- 0.350-0.500
- 0.250-0.400
- 0.370
- NaH2PO4•2H2O
- 0.600-0.950
- 0.600-0.950
- 0.900
- Na2HPO4
- 0.100-0.200
- 0.100-0.200
- 0.130
- NaOH/HCl 1N
- q.s pH 6.00
- Water for injections
- q.s 100.
33 more elements
Dependencies are inferred from the claim text.