申请人:ExxPharma Therapeutics LLC
公开号:US10010620B2
公开(公告)日:2018-07-03
A process for the preparation of an erodible tamper-resistant dosage form that comprises a therapeutic agent-substrate complex embedded in a thermo-formable matrix, such that the complex includes at least one therapeutic agent bound to at least one substrate to form the therapeutic agent-substrate complex. The at least one substrate is being selected from a polyelectrolyte, an organic counter-ion, a pharmacologically inert organic component of a prodrug, an inclusion compound and an inorganic adsorbent; and the thermo-formable matrix includes one or more thermoplastic polymers and optionally at least one pharmaceutical additive. The dosage form provides resistance to intentional or unintentional tampering such as chewing, crushing and grinding, and volatilization.
一种用于制备可侵蚀防篡改剂型的工艺,该剂型包括嵌入热成型基质中的治疗剂-基质复合物,该复合物包括至少一种治疗剂与至少一种基质结合以形成治疗剂-基质复合物。至少一种基质选自聚电解质、有机反离子、原药的药理学惰性有机成分、包涵化合物和无机吸附剂;热成型基质包括一种或多种热塑性聚合物,以及可选的至少一种药物添加剂。该剂型可防止有意或无意的篡改,如咀嚼、粉碎和研磨以及挥发。