Stable pharmaceutical system (kit) for the preparation of oral solution of levothyroxine or pharmaceutically acceptable salt thereof

摘要

The present invention relates to a stable pharmaceutical system (kit) for the preparation of oral solution of levothyroxine or pharmaceutically acceptable salt thereof, which consists of a solid for reconstitution in the form of powder or granules and of a reconstitution liquid. The solid for reconstitution further comprises at least one excipient - carrier of the active ingredient, preferably water soluble, more preferably sorbitol or maltodextrin or a mixture thereof. The reconstitution liquid is aqueous and comprises at least one excipient for the solubilization of the active ingredient, preferably polyvinylpyrrolidone and optionally at least one preservative.