Development and Validation of In Vitro Discriminatory Dissolution Testing Method for Fast Dispersible Tablets of BCS Class II Drug
Journal Title: Turkish Journal of Pharmaceutical Sciences - Year 2020, Vol 17, Issue 1
Abstract
Objectives: Fast dispersible tablets (FDTs) get dispersed very fast due to which the discrimination of in vitro drug release and their evaluation is difficult. Hence in the present study a new in vitro discriminatory dissolution method was developed and validated for FDTs of domperidone of BCS class II. Materials and Methods: FDTs of domperidone were prepared by direct compression method. The dissolution studies were performed in an eight-station Electrolab TDT-082 dissolution testing apparatus, analyzed by ultraviolet spectrophotometer and evaluated in different dissolution mediums i.e. sodium lauryl sulphate (0.5%, 1.0% and 1.5%) with fresh distilled water, simulated intestinal fluid pH 6.8, simulated gastric fluid pH 1.2 without enzymes, phosphate buffer solution (pH 6.8) and 0.1 N hydrochloric acid at different agitation speeds. Results: The developed method was validated in terms of specificity, accuracy, precision, linearity and robustness. Amongst the different mediums, 0.5% sodium lauryl sulfate (SLS) with distilled water was found to be optimum with higher rate of discriminatory power. The percentage recovery was found to be 96 to 100.12 % and the % relative standard deviation value for precision (intraday and interday) was found to be less than 1%. Also a dissolution profile of prepared FDTs were compared in distilled water containing 0.5% SLS using similarity (f2) and dissimilarity (f1) factor calculation which showed dissimilarity in release profile and confirms the discriminatory nature of developed method. Conclusion: The discriminatory dissolution method for FDTs was developed and validated. All the obtained results were satisfactory, accurate and in range. The current method could be beneficial for formulation development and for assessment of quality of FDTs.
Authors and Affiliations
Shailendra BHATT, Dabashis ROY, Manish KUMAR, Renu SAHARAN, Anuj MALIK, Vipin SAINI
Keywords
Related Articles
- EP ID EP684733
- DOI 10.4274/tjps.galenos.2018.90582
- Views 160
- Downloads 0
In Vivo Antioxidant Activity of Different Fractions of Indigofera Barberi Against Paracetamol-induced Toxicity in Rats
Objectives: To evaluate the in vivo antioxidant activity of chloroform extract fractions of Indigofera barberi (whole plant) against paracetamol-induced toxicity in rats. Materials and Methods: For 7 days, rats were tre...
Tualang Honey Improves Memory and Prevents Hippocampal Changes in Prenatally Stressed Rats
Objectives: This study investigated whether the alterations in memory and hippocampus morphology and levels of malondialdehyde (MDA) and N-methyl-D-aspartate (NMDA) receptor in the hippocampus of adult rats after prenata...
The Anticancer and Anti-inflammatory Effects of Centaurea solstitialis Extract on Human Cancer Cell Lines
Objectives: Natural products originating from plants have been used for many years in the treatment of various diseases, including cancer. Centaurea solstitialis subsp. solstitialis is used in Turkish folk medicine. This...
Synthesis and Structure Elucidation of New Benzimidazole Amidoxime Derivatives
Objectives: In our previous studies we synthesized some potent antiparasitic, anticancer and antimicrobial amidine derivatives. Despite all their potent activities, it is well known that due to their cationic charge, ami...
Considering the Effect of Rosa damascena Mill. Essential Oil on Oxidative Stress and COX-2 Gene Expression in the Liver of Septic Rats
Objectives: Sepsis is a clinical illness with a high rate of mortality all over the world. Oxidative stress is considered the main phenomenon that occurs in sepsis. Rosa damascena Mill. is an ancient herbal plant with hi...