Process development in Quality‐by‐Design paradigm for anti‐solvent aided crystallization: impact of crystallization parameters on particle morphology and dissolution behaviour of Dexlansoprazole active pharmaceutical ingredient
Abstract
Abstract BACKGROUND In this work, a process development study for the crystallization step of dexlansoprazole API has been demonstrated under the Quality‐by‐Design (QbD) paradigm. Dexlansoprazole (crystalline) samples prepared under different crystallization conditions of reactor temperature and addition time of anti‐solvent were subjected to solid‐state characterization with variety of analytical techniques, including X‐ray powder diffraction (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), dynamic vapour sorption (DVS), scanning electron microscopy (SEM), particle size distribution (PSD) by laser diffraction and intrinsic dissolution rate (IDR). RESULTS The crystalline samples were observed to have identical polymorphic phase integrity but differed in their physical characteristics. The particle size distribution and microscopy data collectively elucidated the particle growth kinetics and the extent of agglomeration could be correlated to crystallization conditions, namely reactor temperature and addition time of anti‐solvent. The intrinsic dissolution rate of samples was in good agreement with the morphological properties. CONCLUSION An empirical model has been proposed for intrinsic dissolution rate correlating with crystallization process parameters. In conclusion, it was possible to elucidate the impact of crystallization parameters on the solid‐state behaviour of dexlansoprazole for development of appropriate pharmaceutical dosage…
Read the paper
Related studies
- Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials
- Tocilizumab in patients with severe COVID-19: a retrospective cohort study
- A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study
- Fruit, vegetable, and legume intake, and cardiovascular disease and deaths in 18 countries (PURE): a prospective cohort study
- Are noise and air pollution related to the incidence of dementia? A cohort study in London, England
- Long COVID symptoms and duration in SARS-CoV-2 positive children — a nationwide cohort study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.