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Methods for Superdisintegrant-Based Composite Particles for Dispersion and Dissolution of Active Pharmaceutical Agents
专利权人:
发明人:
Ecevit Bilgili,Rajesh Dave,Anagha Bhakay,Mohammad Azad
申请号:
US15235397
公开号:
US20160346209A1
申请日:
2016.08.12
申请国别(地区):
US
年份:
2016
代理人:
摘要:
The present disclosure provides improved systems and methods utilizing colloidal/ultrafine superdisintegrant-based composite particles for dispersion and/or dissolution of active pharmaceutical agents. In general, the present disclosure utilizes a surfactant-free or near surfactant-free formulation by incorporating a wet milled SDI as a dispersant in the formulation. As such, the present disclosure provides for the preparation of surfactant-free or substantially surfactant-free formulations (e.g., nano-composite micro-particle formulations) by incorporating a wet-milled superdisintegrant (SDI) as the dispersant in the formulations. The advantageous SDI particles (e.g., colloidal/ultrafine SDI particles) of the present disclosure can be used to break-up the aggregates (e.g., nanoparticle aggregates) of the active agents (e.g. poorly water-soluble drugs) in the formulations (e.g., micro-particle formulations) and enhance the recovery of the nanoparticles of active agents during aqueous re-dispersion and their dissolution rate in vitro and in vivo.
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