diario americano de Administración de Medicamentos y Terapéutica Acceso abierto

Abstracto

Fast Disintegrating Tablets of Methylene Blue as Diagnostic Aid in Upper GI Endoscopy

Sarada Anepu

Barrett’s esophagus is generally evaluated by upper gastro-intestinal endoscopy. In chromoendoscopy technique, methylene blue is used by spraying along the esophagus and upper stomach.  The objective of present study is to prepare fast disintegrating tablets of methylene blue, which can disintegrate and dissolve rapidly in the saliva. Fast disintegrating tablets when administered 30 minutes prior to endoscopy will reach the esophagus and provide uniform staining for easy diagnosis during endoscopy. Methods: Fast disintegrating tablets of methylene blue were prepared by varying concentration of superdisintegrant and sublimating agent.  Prepared tablets were evaluated after sublimation. Dye-Excipient compatibility studies were performed, and stability studies were carried according to ICH guidelines. Prepared formulations were evaluated in healthy animals. Results: All the precompression blends showed free flowing property and hence, were used in direct compression technique for tablet formulation. Tabletting parameters were within the compendial limits. Disintegration times of all the prepared tablets were less than 60 seconds indicating their suitability as fast disintegrating tablets. In vitro dissolution studies were performed in pH 6.8 phosphate buffer and tablets showing greater than 85% dye release in 10 minutes with minimum friability (10% camphor, 8% crospovidone). Dye-excipient compatibility studies did not show any interactions. Uniform staining along the esophagus indicated the suitability of developed methylene blue tablets. Conclusions: Prepared and evaluated tablets can be administered as diagnostic aid for diagnosis of Barrett’s esophagus, 30 minutes prior to endoscopy.