SPL Set ID: a4f21b1a-5691-4b14-a56d-651962d06f39

PERSERIS contains risperidone, an atypical antipsychotic. Risperidone belongs to the chemical class of benzisoxazole derivatives. The chemical designation 3-[2-[4-(6-fluoro-1,2-benzoxazol-3-yl) piperidin-1-yl] ethyl]-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a] pyrimidin-4-one. Its molecular formula is C 23 H 27 FN 4 O 2 and its molecular weight is 410.5 g/mol. The structural formula is: Risperidone is a white to off-white powder. It is practically insoluble in water and soluble in methanol and 0.1 N HCl. PERSERIS is available as a sterile two-syringe mixing system: a liquid syringe prefilled with the delivery system (colorless to yellow solution), and a powder syringe prefilled with risperidone (white to yellow). PERSERIS for extended release injectable suspension, for subcutaneous use, is available in 90 mg and 120 mg risperidone strengths. The quantitative composition is provided below ( Table 6 ). Table 6 PERSERIS Constituted Product Delivered Mass *PLGH poly D,L(lactide co-glycolide); 80:20 molar ratio of lactide to glycolide Component PERSERIS 90 mg PERSERIS 120 mg Risperidone 90 mg 120 mg PLGH* 228 mg 304 mg N -methyl-pyrrolidine 282 mg 376 mg Total mass 600 mg 800 mg Total volume 0.6 mL 0.8 mL Structural Formula