Abstract
The development of biodegradable hemostatic and absorbable sponges containing chlorhexidine digluconate and their in vitro characterization—A QbD approach
Highlights
The pharmaceutical industry is constantly looking for ways to ensure and improve the safety, quality, and efficiency of products
Using the concept of Quality by Design, the desired quality target product profile, critical quality attributes, risk assessment by Failure Mode Effects Analysis was determined that the number of excipients affects the pharmaco-technological parameters
The aim of this work was to develop and optimize the composition of a structured medical sponge based on a material of biological origin, namely, xenoderm, which is enriched with macro- and micronutrients, amino acids, and chlorhexidine digluconate (1%) as the active pharmaceutical ingredient (API), using Quality by Design (QbD) at each stage of technological formation (Leonard et al, 2016; Lytvynyuk et al, 2016; Pavliuk et al, 2020; Vons et al, 2018)
Summary
The pharmaceutical industry is constantly looking for ways to ensure and improve the safety, quality, and efficiency of products. For this purpose, the principles of the scientific and technical approach to Quality by Design (QbD) are used, which by reducing its possible variations improves the understanding of the technological process and provides the ability to manage it, while requiring in-depth knowledge of production technologies of a particular dosage form (Ohage et al, 2016; Mogal, 2016). There are currently several documents (of a recommendatory manner) that help to ensure the proper quality of QbD: ICH Q8 “Pharmaceutical Development,” ICH Q9 “Quality Risk Management,” and ICH Q10 “Pharmaceutical Quality Recommendations related to mathematical models are used to ensure the establishment and use of knowledge of drug technology independently and in an integrated manner (Politis et al, 2017; Sylvester et al, 2018).
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