Stable hyperbaric composition comprising prilocaine HCl, use of said new composition for intrathecal anaethesia, and method for manufacturing said composition
AssigneeSintetica S.A.
InventorsAugusto Mitidieri, Elisabetta Donati
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Abstract
The present invention concerns new preservative-free hyperbaric compositions of prilocaine HCI intended for use in intrathecal narcosis, characterized by high stability at ambient temperature (15° C. -27° C.). The present invention also concerns a method for manufacturing said compositions.
Claims8
A pharmaceutical composition, which is stable and has a shelf-life, at ambient temperature, of at least 5 years, wherein the composition comprises prilocaine HCl and glucose in a hyperbaric solution of water for injection and has a 2-methylaniline content, throughout the entire shelf-life duration, of less than 0.10% relative to the quantity of prilocaine HCl contained,
- wherein the prilocaine HCl content is from 1.8% to 2.2% (w/V), the glucose content, expressed as anhydrous glucose, is from 5.4% to 6.6% (w/V) and the osmolarity is in the range from 490 to 540 mOsm/kg.
Dependencies are inferred from the claim text.