MEHTA, Kamal Surendrakumar,SRIVASTAVA, Saurabh,KUMAR, Dinesh,JHA, Amit Kumar,MOHANTA, Subash Chandra,PANDA, Sunil Kumar,GAT, Ganesh Vinayak
申请号:
EP17857957
公开号:
EP3522889A4
申请日:
2017.10.06
申请国别(地区):
EP
年份:
2020
代理人:
摘要:
The present invention discloses stable delayed release multiparticulate powder for oral suspension of proton pump inhibitor compounds comprising: a) a core with an effective amount of proton pump inhibitor and at least one or more pharmaceutical excipients, b) at least one water-soluble seal coating over core c) at least one enteric coating layer over the seal coat wherein the said core comprises disintegrant (0-10%) and/or surfactant (0-2%) w/w of core. The prior art discloses restrictive formulation technique and suggest high amount of various excipients to achieve desired technical attributes. The prepared test formulations exhibited desired pharmaceutical technical attributes like drug release, assay, stability, no polymorphic change, reduced sticking to nasogastric and gastronomy tubes, and packaging material.