Eni Beçi Bushi

Over the last few decades, there have been advancements in our comprehension of the design and development of topical semisolid formulations; however, they still follow an empirical development. Our study focuses on building a framework for designing and developing topical semisolid products using the "Quality-by-Design" (QbD) approach. A review of the literature was conducted to identify and list the factors related to the design and development of topical semi solid dosage forms using Quality by Design approach. The information extracted from the relevant articles was used to build a QbD framework based on four main pillars: Define the quality target product profile (QTPP); identify critical quality attributes (CQAs); identify critical material attributes (CMAs) and critical process parameters (CPPs); understand how CMAs and CPPs affect CQAs and establish a control strategy. Some typical elements of the QTPP for topical products include dosage form, route of administration, shelf-life, critical quality attributes of the final formulation. Critical material attributes such as characteristics of API (molecular weight, lipophilicity, solubility, metamorphosis events, and polymorphism), characteristics of excipients, and critical process parameters (temperature, heating and cooling rates, mixing speed, pumping speed, order of addition) were identified and explained for their impact on CQAs. Proper characterization of the API and drug delivery system will increase the likelihood of developing a stable, pleasing, and tolerable topical formulation and minimize the risk of failure.

BACKGROUND: The core idea of the Lean philosophy in healthcare is a continuous improvement by minimizing waste and maximizing the value delivered to patients. Although there is growing interest in lean applications in healthcare organizations, the study of readiness factors for implementing Lean in this sector remains one of the reasons for Lean failure. OBJECTIVE: This study aims to identify and validate the readiness factors that influence the successful and sustainable implementation of Lean in healthcare organizations. METHODS: A systematic review of the literature was performed to synthesize readiness factors that help healthcare organizations implement lean practices. The Delphi method was used to validate the identified factors from the perspective of the healthcare experts. RESULTS: This systematic review revealed eleven readiness factors that are important contributors to the success of Lean implementation in healthcare. After three rounds of Delphi, a moderate consensus (Kendall's W=0.519; P<0.001) was achieved among the experts’ panel regarding the nine readiness factors. Seven factors were extracted from the literature review and two were derived from experts’ suggestions. CONCLUSIONS: The investigation of organizational readiness to implement lean may help healthcare organizations be better prepared for their initiation of the Lean journey and enable the sustainability of improvements.