Author: Shyamkant Sahdeorao Nevle and Santosh Ramrao Butle
Journal Name:
Fluoroquinolone antibiotic moxifloxacin (MOX) is a second-line therapy for multidrug-resistant tuberculosis (MDR TB) and drug-susceptible TB. Low patient compliance with MOX is caused by taste and odour issues, particularly in the paediatric population. By utilising mannitol, aspartame as a sweetener, and lemon flavour as a flavouring agent, wet granulation was used to create MOX taste-masked granules. One of the major challenges was to get the free-flowing granules so the wet granulation technique was used and desired flow properties were achieved. The flow characteristics and in vitro drug release of the produced granules were assessed. FTIR, DSC, and XRD instrumental analyses were also carried out. Based on the results, it was determined that the flow qualities of the granules from batch F6 were outstanding. The optimised batch demonstrated full medication release in about 10 minutes. In the FTIR and DSC studies, no incompatibility between the drug excipients was observed. According to XRD, the MOX in the final formulation was present in crystalline form. MOX taste-masked granules would be a superior alternative for treating paediatric TB.
Tuberculosis, moxifloxacin, dispersible tablets, taste mask, disintegration
The present study concludes that the taste-masked granules of the MOX can be successfully developed by using the wet granulation technique by incorporating sugars and flavouring agents. The optimised granules showed excellent flow properties and can be easily filled in suitable packaging material. The optimised batch showed complete drug release within 10 min period. FTIR and DSC studies revealed no drug excipient incompatibility. XRD demonstrated that the MOX in the final formulation was present in crystalline form. The taste-masked granules of the MOX could be a potential alternative for the treatment of pediatric TB.
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Shyamkant Sahdeorao Nevle and Santosh Ramrao Butle (2023). Formulation Development and Evaluation of Taste-masked Moxifloxacin granules for the Treatment of Pediatric Tuberculosis. Biological Forum – An International Journal, 15(4): 450-455.