Understanding effect of formulation and manufacturing variables on the critical quality attributes of warfarin sodium product

International Journal of Pharmaceutics
Ziyaur RahmanMansoor A Khan

Abstract

Warfarin sodium (WS) is a narrow therapeutic index drug and its product quality should be thoroughly understood and monitored in order to avoid clinical performance issues. This study was focused on understanding the effect of manufacturing and formulation variables on WS product critical quality attributes (CQAs). Eight formulations were developed with lactose monohydrate (LM) or lactose anhydrous (LA), and were either wet granulated or directly compressed. Formulations were granulated either with ethanol, isopropyl alcohol (IPA) and IPA-water mixture (50:50). Formulations were characterized for IPA, water content, hardness, disintegration time (DT), assay, dissolution and drug physical forms (scanning electron microscopy (SEM), near infrared chemical imaging (NIR-CI), X-ray powder diffraction (XRPD) and solid state nuclear magnetic resonance (ssNMR)), and performed accelerated stability studies at 40°C/75% RH for three days. The DT and dissolution of directly compressed formulations were faster than wet granulated formulations. This was due to phase transformation of crystalline drug into its amorphous form as indicated by SEM, NIR-CI, XRPD and ssNMR data which itself act as a binder. Similarly, LM showed faster disintegratio...Continue Reading

References

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Citations

Nov 5, 2016·International Journal of Pharmaceutics·Adam C FisherJanet Woodcock
Apr 6, 2017·CPT: Pharmacometrics & Systems Pharmacology·X ZhangR Lionberger
Sep 14, 2018·The AAPS Journal·Ziyaur RahmanMansoor A Khan
Feb 18, 2018·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Ziyaur RahmanMansoor A Khan

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