Abstract
Objective: The rationale for the study was to develop multiple unit pellet system (MUPS) of delayed release pantoprazole with desired physical properties and unaltered drug release profile from pellets even after compression into a fast disintegrating tablet.Methods: In the presented study, delayed release pellets of pantoprazole were developed by two methods, i.e. extrusion-spheronization and drug layering techniques, coated using enteric polymer and subsequently compressed in to tablet. In drug layering technique, pantoprazole was loaded on Celphere®102 (microcrystalline cellulose spheres) as well as on Suglet® (sugar spheres) in fluid bed processor. Acid resistant polymer Eudragit ND 30D was subsequently coated on each type of drug loaded pellets. Suitable tableting excipients were prepared such as soft pellets, Ceolus® (fibrous grade of microcrystalline cellulose) granules, Ludipress® (compressible lactose composition), Avicel® PH 200 and different combination of them. Various factors like property of pellets to be compressed, coating level, the composition of tableting excipient and ratio of drug-loaded pellets to tableting excipients were identified and optimized.Results: MUPS with delayed releasing pellets of pantoprazole proved to provide sufficient hardness, rapid disintegration property, and unaltered release profile after compression. Delayed release pantoprazole pellets prepared by drug layering on celphere® 102 followed by coating with Eudragit® NE 30D showed better compressibility to withstand the drug release properties. The combination of Ceolus® granules and Ludipress (in 1:1 ratio) was found to be suitable tableting excipient that helped compression of pellets without rupturing polymeric coat. Pellets to excipients ratio at 1:3 was found optimum.Conclusion: Compaction behaviour of pantoprazole delayed-release pellets without loss of original delayed release profile was achieved by formulating as MUPS based tablet of pantoprazole delayed release pellets using celephere® 102 was developed which was found suitable for desired release profile and physical properties.
Highlights
Gastro esophageal reflux disease (GERD) and related complications such as erosive esophagitis, esophageal stricture, and Barrett's esophagus are some of the digestive disorders that are caused by gastric acid flowing from the stomach into the esophagus [1,2]
Current research aims at developing delayed release pantoprazole pellets which can be compressed into a multiple unit pellet system (MUPS) fast disintegrating tablet formulation
Pellets prepared by drug layering on suglet failed in delaying the drug release
Summary
Gastro esophageal reflux disease (GERD) and related complications such as erosive esophagitis, esophageal stricture, and Barrett's esophagus are some of the digestive disorders that are caused by gastric acid flowing from the stomach into the esophagus [1,2]. Coated pellets can be compressed into fast disintegrating tablets [12,13] as a final dosage form. Delayed release multi-particulate formulations are reliable for intestinal drug delivery system to avoid dose dumping and lower variability in dosage in each patient. Current research aims at developing delayed release pantoprazole pellets which can be compressed into a MUPS fast disintegrating tablet formulation. Tableting excipients suitable for compression of pellets were identified to make MUPS formulation with desired properties and unaltered release profile
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