This invention belongs to the field of pharmaceutical preparation technology, and particularly relates to
ketorolac tromethamine biphasic controlled-release tablets and their preparation method. The
ketorolac tromethamine biphasic controlled-release tablets include a controlled-release layer and an immediate-release layer. The controlled-release layer includes a double-layer tablet core containing a
drug-containing layer and a semi-permeable membrane disposed outside the double-layer tablet core. The semi-permeable membrane allows water molecules to pass through, and has release pores on its side facing the
drug-containing layer. After the double-layer tablet core absorbs water molecules passing through the semi-permeable membrane, the
ketorolac tromethamine containing the
drug-containing layer is released. The immediate-release layer includes a therapeutically effective amount of
ketorolac tromethamine and pharmaceutically acceptable immediate-release excipients. This invention combines the effects of
immediate release and zero-order release with
controlled release, achieving both rapid and long-lasting
drug action. It can continuously and stably release the drug within 24 hours, which is beneficial for maintaining a stable
blood drug concentration in patients during medication, reducing the frequency of dosing to once daily, and providing a
safer, more stable, and longer-lasting
analgesic drug formulation for clinical use.