Pharmaceutical composition for oral administration
AssigneeSanofi-Synthelabo
InventorsClaude Aleman, Philippe Bastard, Marielle Bonnel, Thierry Breul
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Abstract
The present invention relates to an aqueous solution containing 1-[2-(2-naphthyl)ethyl]-4-(3- trifluoromethylphenyl)-1,2,3,6-tetrahydropyridine hydrochloride (hydrochloride of SR 57746), also comprising β-cyclodextrin (β-CD) and a pharmaceutically acceptable acid or buffer to give a pH of less than or equal to 3.
Claims21
Aqueous solution containing 1-[2-(2-naphthyl)ethyl]-4-(3-trifluoromethylphenyl)-1,2,3,6-tetrahydropyridine hydrochloride (hydrochloride of SR 57746), characterized in that it comprises:
- a non-zero amount of β-CD of less than or equal to 50 mg/ml:
- a non-zero amount of SR 57746 hydrochloride (in mg/ml) of less than or equal to one-tenth of the amount of β-CD expressed in mg/ml;
- a pharmaceutically acceptable acid or buffer to give a pH of less than or equal to 3;
- with the proviso that, for an amount of β-CD ranging from 30 to 50 mg/ml, the amount of SR 57746 hydrochloride fits the equation:
- amount of SR 57746
- hydrochloride ( mg / ml ) ≥ [ amount of β - CD ( mg / ml ) 10 - 3 ] .
An aqueous solution which comprises:
- a non-zero amount of β-cyclodextrin of less than or equal to 50 mg/ml:
- a non-zero amount of 1-[2-(2-naphthyl)ethyl]-4-(3-trifluoromethylphenyl)-1,2,3,6-tetrahydropyridine hydrochloride (in mg/ml) of less than or equal to one-tenth of the amount of β-cyclodextrin expressed in mg/ml;
- a pharmaceutically acceptable acid or buffer to give a pH of less than or equal to 3;
- with the proviso that, for an amount of β-cyclodextrin ranging from 30 to 50 mg/ml, the amount of 1-[2-(2-naphthyl)ethyl]-4-(3-trifluoromethylphenyl)-1,2,3,6-tetrahydropyridine hydrochloride is greater than or equal to [ amount of β - cyclodextrin ( mg / ml ) 10 - 3 ]
A complex formed between a molecule 1-[2-(2-naphthyl)ethyl]-4-(3-trifluoromethylphenyl)-1,2,3,6-tetrahydropyridine and two molecules of β-cyclodextrin.
Dependencies are inferred from the claim text.