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Quality by Design Approach in Liposomal Formulations: Robust Product Development.

Walhan Mohammad AlshaerHamdi NsairatZainab LafiOmar M HouraniAbdulfattah Al-KadashEzaldeen EsawiAlaaldin M Alkilany
Published in: Molecules (Basel, Switzerland) (2022)
Nanomedicine is an emerging field with continuous growth and differentiation. Liposomal formulations are a major platform in nanomedicine, with more than fifteen FDA-approved liposomal products in the market. However, as is the case for other types of nanoparticle-based delivery systems, liposomal formulations and manufacturing is intrinsically complex and associated with a set of dependent and independent variables, rendering experiential optimization a tedious process in general. Quality by design (QbD) is a powerful approach that can be applied in such complex systems to facilitate product development and ensure reproducible manufacturing processes, which are an essential pre-requisite for efficient and safe therapeutics. Input variables (related to materials, processes and experiment design) and the quality attributes for the final liposomal product should follow a systematic and planned experimental design to identify critical variables and optimal formulations/processes, where these elements are subjected to risk assessment. This review discusses the current practices that employ QbD in developing liposomal-based nano-pharmaceuticals.
Keyphrases
  • risk assessment
  • healthcare
  • primary care
  • small molecule
  • cancer therapy
  • high throughput
  • drug delivery
  • human health
  • drug induced