Abstract
In an effort to reduce production costs, a simple, direct compression delayed release formulation consisting of pantoprazole was investigated. Pantoprazole is a proton pump inhibitor belongs to group of benzimidazole. It is very efficient for the treatment of gastric and duodenum ulcers. Even in solid state pantoprazole is sensitive to heat, humidity, light and especially to substances containing an acidic group. For such types of drugs, enteric coating added to the formulation tends to avoid the stomach's acidic exposure, delivering them instead to a basic pH environment where they do not degrade, and give their desired action. Subcoating is desirable to protect the enteric coating. Opadry and Acryl-EZE systems have been utilized for subcoating and enteric coating respectively. Delayed-release tablets with good physical, mechanical and technological properties were obtained with use of different combinations of diluents, binders, superdisintegrants and lubricants. A comparative kinetic study of the present tablets and commercial tablets was established. The value for the similarity factor (f2 = 71.6) suggested that the dissolution profile of the present two delayed-release oral dosage forms are similar. Hixon–Crowell (erosion) kinetic profiles were achieved
Highlights
Pantoprazole is a selective and irreversible proton pump inhibitor (PPI) used in medicine as an antiulcerative agent
Since pantoprazole is very acid labile, it is necessary to process it in the form of alkaline salts or together with alkaline salts. 1/4th of sodium carbonate was added to water
The particle size distribution (PSD) of a powder is a list of values that defines the relative amounts of particles present, sorted according to size. 85-90% of particles were found to be greater than 85 mesh
Summary
Pantoprazole is a selective and irreversible proton pump inhibitor (PPI) used in medicine as an antiulcerative agent. The bioavailability of pantoprazole is high and unaffected by food intake It is more stable than other PPIs at slightly acidic and neutral pH. The active form, a tetracyclic cationic sulfenamide, reacts with thiol group of cysteines 813 and 822 of the transmembranal H+/K+ATPase 1,5. This conversion must occur inside the gastric parietal cells, so pantoprazole must be absorbed intact by gastrointestinal tract 2. Tablets can be manufactured by wet granulation, dry granulation, or direct compression. Most of the pharmaceutical manufacturers are opting for direct compression tableting, as it requires fewer processing steps, simplified validation, elimination of heat and moisture, economy, and improved drug stability compared with wet granulation technique. The current trend in the pharmaceutical industry is to adopt direct compression
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