Development of Atovaquone Nanosuspension: Quality by Design Approach.

Abstract:

OBJECTIVE:The present study reports the use of MicrofluidizerTM technology to form a stable nanosuspension of atovaquone (ATQ) using quality by design (QbD) approach. METHODS:The patient-centric quality target product profile and critical quality attributes (CQAs) were identified. A Box-Behnken design was employed for the optimization of dependent variables, while CQAs like particle size and PDI were evaluated as response variables. Effective optimization of ATQ nanosuspension preparation using Microfluidizer processor as a novel green technology was achieved using QbD approach. RESULT:The prepared nanosuspension had a mean particle size of 865 nm ± 5%, PDI of 0.261 ± 3%, and zeta potential of -1.79 ± 5 mV. The characterization of the prepared nanosuspension by SEM, DSC, and XRD revealed its nano-crystalline nature whereas FTIR spectroscopic analysis confirmed the absence of any physicochemical interaction because of process parameters between the drug and excipients. CONCLUSION:In vitro dissolution studies of the nanosuspension using USP-IV exhibited a 100% cumulative drug release over 90 minutes, which is significantly better than that of ATQ pure API. In vivo pharmacokinetic studies revealed bioequivalence of ATQ nanosuspensions by Microfluidizer homogenization process to the marketed formulation1.

journal_name

Curr Drug Deliv

journal_title

Current drug delivery

authors

Kakade P,Gite S,Patravale V

doi

10.2174/1567201817666191227095019

subject

Has Abstract

pub_date

2020-01-01 00:00:00

pages

112-125

issue

2

eissn

1567-2018

issn

1875-5704

pii

CDD-EPUB-103254

journal_volume

17

pub_type

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