Design of an injectable lyophilized powder product formulation containing lornoxicam in the scope of quality by design (QBD) with risk assesment

In this study, it was aimed to develop the lyophilized powder formulation containing lornoxicam which was produced by lyophilization (freze-drying) method with consistent quality attributes via "Quality by Design (QbD)" approach and with the help of artificial intelligence programs. While creating the design of experiment (DOE) within the QbD, determination of the Critical Quality Attributes (CQAs), formulation variables and Critical Process Parameters (CPPs) that affect the CQAs were studied risk-based approach according to the ICH Q8 and Q9. Experimental knowledge area has been created with physical, chemical and microbiological tests results obtained from the produced products according to the designated formulation and lyophilization process parameters. Data sets forming the knowledge area were evaluated firstly with FormRules (neuro-fuzzy logic) program; later with InForm (artificial neural networks) program to make optimization and create a design space. In consequence of formulation study; the bulk solution contains 0.4 g lornoxicam, 0.6 g tromethamol, 0.011 g disodium EDTA and 5.0 g mannitol in 100 mL water for injection. The optimum lyophilization process found as aresult of the modeling study is consistent with the lyophilization process design data and product quality attributes. Applying the Quality by Design (QbD) approach to develop a lyophilized powder formulation that indicates appropriate quality characteristics and to ensure the product quality has provided a better understanding of the product and process and increased the efficiency of development processes. Key Words: Lornoxicam, injectable lyophilized powder, lyophilization, Quality by Design (QbD), InForm.