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PHARMASPIRE - Volume 11, Issue 1, January-March, 2019

Pages: 18-23

Date of Publication: 14-Jun-2022

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Preparation and evaluation of rofecoxib polysaccharide-based matrix tablets using nanoparticular approach

Author: Sankha Bhattacharya

Category: Pharmaceutics


Rofecoxib has a tremendous role in the treatment of colon polyps and Crohn’s disease. However, gastric resistant has always been an issue for drug delivery to the colon. The main intention of this research was to prepare and evaluate an optimized formulation that could resist gastrointestinal fluid and releases drug content not more than 10% within simulated gastric fluid for 2 h from the time of administration. Rofecoxib nanoparticles were prepared using Dyno mill, considering Acconon MC8-2EP as a surfactant and Capmul MCM L-8 as co-surfactant. Freshly prepared rofecoxib nanoparticles were then admixed with Lactopress® anhydrous and using dry granulation technique ten batches of rofecoxib tablets were formulated by altering various ratios of resistant starch, dextran, and gellan gum. Tablets were prepared using a dry granulation technique, where ALTRIN® was considered as a principal binder. All the pre- and post-compression parameters were evaluated and it was found that D-3 batch has a legitimate cumulative percentage dissolution profile, i.e., 98.12% at 24th h. Furthermore, similarity and dissimilarity studies were performed against Orthobid tablets (marketed) and with optimized formulation (D-3). The similarity factor (F2) and difference or dissimilarity factors (F1) were found to be 60.90 and 10.16, respectively, which is within the specified limits. Finally, as per ICH (Q1A (R2) guideline, accelerated stability studies were performed in the D-3 formulation for 6 months. Stability results were reliable and trustworthy for considering as a stable formulation. Hence, it can be concluded that the optimized D-3 batch can be conceded for the pilot scalp.

Keywords: Rofecoxib, similarity factor, polysaccharides, Acconon MC8-2EP, accelerated stability studies


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