Assessing the Risk of pH-Dependent Absorption for New Molecular Entities: A Novel in Vitro Dissolution Test, Physicochemical Analysis, and Risk Assessment Strategy

2013 ◽  
Vol 10 (11) ◽  
pp. 4063-4073 ◽  
Author(s):  
Neil R. Mathias ◽  
Yan Xu ◽  
Dhaval Patel ◽  
Michael Grass ◽  
Brett Caldwell ◽  
...  
Keyword(s):  
Risk Assessment ◽  
Physicochemical Analysis ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Assessment Strategy ◽  
Dependent Absorption ◽  
Risk Assessment Strategy ◽  
Ph Dependent

scholarly journals Development and Validation of an Eco-friendly HPLC-UV-DAD Method for the Determination of Allopurinol in Pharmaceuticals with Application to In vitro Dissolution Studies

2021 ◽  
Vol 11 (5) ◽  
pp. 13089-13101
Keyword(s):  
Factorial Design ◽  
Matrix Effects ◽  
Dissolution Kinetics ◽  
In Vitro Dissolution ◽  
Dissolution Test ◽  
Dissolution Studies ◽  
Dissolution Tests ◽  
Development And Validation

In this study, a sustainable HPLC-UV-DAD method was developed and validated for the determination of allopurinol in tablets and optimization of the dissolution test using factorial design. The separation of the analyte from the sample matrix was achieved in 3.01 minutes in a C8 column (4.6 mm X 150 mm X 5 μm), using mobile phase 0.1 mol L-1 HCl (25%) + ethanol (50%) + ultrapure water (25%) by UV detection at 249 nm. The method presented satisfactory analytical parameters of validation (specificity, selectivity, linearity, stability, precision, accuracy, and robustness), showing no matrix effects. The dissolution test was optimized by complete factorial design 23 and, the optimal conditions were: HCl 0.001 mol L-1, apparatus II (paddle) and 75 rpm. The analytical procedures and dissolution tests were applied to allopurinol tablets marketed in Bahia, Brazil, to evaluate the dissolution studies. The pharmaceuticals had similar dissolution profiles and first-order dissolution kinetics. This new and sustainable HPLC-UV-DAD method is friendly to the environment and can be used for the routine pharmaceutical analysis of allopurinol in fixed dosage forms.

Prediction of pH dependent absorption using in vitro, in silico, and in vivo rat models: Early liability assessment during lead optimization

2015 ◽  
Vol 76 ◽  
pp. 173-180 ◽  
Author(s):  
Ajay Saxena ◽  
Devang Shah ◽  
Shweta Padmanabhan ◽  
Shashyendra Singh Gautam ◽  
Gajendra Singh Chowan ◽  
...  
Keyword(s):  
In Silico ◽  
Lead Optimization ◽  
Rat Models ◽  
Dependent Absorption ◽  
Ph Dependent

Clinical Immunogenicity Risk Assessment Strategy for a Low Risk Monoclonal Antibody

2020 ◽  
Vol 22 (3) ◽  
Author(s):  
Robert Kernstock ◽  
Gizette Sperinde ◽  
Deborah Finco ◽  
Roslyn Davis ◽  
Diana Montgomery
Keyword(s):  
Risk Assessment ◽  
Monoclonal Antibody ◽  
Low Risk ◽  
Assessment Strategy ◽  
Risk Assessment Strategy
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