Transdermal drug delivery patch system for controlled and sustained delivery of tizanidine base

Abstract

A transdermal drug delivery patch system for controlled and sustained delivery of tizanidine base. The patch includes an adhesive matrix containing a pressure-sensitive adhesive and tizanidine base, dispersed together with at least one permeation enhancer. The patch includes a release liner and a backing film. Configured for titratable dosing, each patch delivers tizanidine base transdermally over a period of time, achieving content uniformity, process controls, and impurity limits suitable for commercial use. The delivery system provides steady-state plasma levels, reduced Cmax, minimized gastrointestinal side effects, and bypasses first-pass metabolism, offering improved therapy options for patients intolerant or unable to take oral muscle relaxants. Kits and methods for individualized dosing and safe application in clinical or home settings are provided.

Dependencies are inferred from the claim text.