Quality by Design (QbD)

Abstract There is a significant deficiency of suitable pediatric medications, attributed to limited market, trial complexities, and strict regulatory requirements....

Abstract The current study presents a comprehensive pharmaceutical engineering approach to developing an advanced transdermal drug delivery system for addressing...

This paper covers a brief overview of the steps for pharmaceutical product development under the quality by design (QbD) framework;...

Abstract Ternary co-amorphous systems, comprising a drug, a low molecular weight co-former, and a polymer, are a promising approach to...

Introduction Neusilin Self-emulsifying drug delivery systems (SEDDS) have emerged as a promising approach for enhancing the oral bioavailability of challenging...

Purpose Understanding batch-to-batch variation of excipients and correlating this to process performance is a key concept of Quality-by-Design for pharmaceutical...

Itraconazole (ITZ), a BCS Class II drug exhibiting low solubility (1-4 ng/ mL in water) requires formulation enhancement to achieve...

Hydroxypropyl methylcellulose (HPMC) is a commonly used excipient to enable controlled release (CR) performance from a hydrophilic matrix tablet. Quality-by-Design...

Abstract This study hypothesizes that phospholipid-based naturosoomal nanocarriers can significantly enhance the oral solubility and bioavailability of naringin (NARNs) by...

Abstract In response to recent regulatory guidelines, including ICH (International Council for Harmonisation) Q2 (R2) and Q14, we developed a...