Implementation of Quality by Design in the Formulation and Development of Nanocarrier-Based Drug Delivery Systems

Sonal Mehrotra, A. Salwa, Lalit Kumar

Research output: Contribution to journalReview articlepeer-review


Quality by design (QbD) has recently fascinated researchers for utilizing it in various arenas of pharma trends. By overcoming the conventional process, QbD prevents the risk of errors caused by the 'guess and by god approach'. This framework fosters profound knowledge of product and process quality by implying sound science and risk assessment strategies. The virtue of QbD leads to the collaborative contribution to pharmaceutical industrialists and satisfies the regulatory bodies. Additionally, leading to rapid production, saves time and expenditure, tremendous versatility, provides immense knowledge, improves robustness, higher consistency, reduces user's dilemma, decreases certainty of failure, declining inter-batch variation in pharmaceutical development. In this ever-increasing continuous production world, regulatory organizations such as the U.S. Food & Drug Administration and the International Conference on Harmonization recommend Q8 to Q14 guidelines in order to obtain the desired quality product. This review extensively discusses on various approaches of QbD for the pharmaceutical development of nano-carrier drug delivery systems. Additionally, QbD's applications in process and analytical method development techniques are documented.

Original languageEnglish
Pages (from-to)1-46
Number of pages46
JournalCritical Reviews in Therapeutic Drug Carrier Systems
Issue number3
Publication statusPublished - 2023

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science


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