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Armaghane-danesh. 2005; 10 (3): 25-34
in Persian | IMEMR | ID: emr-168671

ABSTRACT

Ibuprofen is one of the safest and most potent non-steroidal anti-inflammatory agents available in the market. Its oral dosage forms available in Iranian market are sugar-coated tablet, film coated tablet and suspension as well. However, the tablets suffer from potential bioinequivalance problem, the limited aqueous solubility, gastrointestinal side effects and hardening of the tablets on aging. Sugar coated and film coated tablets of ibuprofen were examined in terms of dissolution equivalency and compared with a standard brand tablet [Nurofen]. The physicochemical characteristics e.g. hardness, friability, assay, disintegration time and content uniformity of coated and uncoated tablets were determined. Dissolution testing was done by rotating basket method in various dissolution media including distilled water, phosphate buffer and HCl 0.1 N. The amount of drug released during dissolution test was determined using spectrophotometer at [lamda]=221 nm. Content uniformity, hardness, friability, assay and disintegration time of both sugar coated and film coated tablets were in the acceptable pharmacopeias limits. The amount of drug released from Neurofen, sugar coated and film coated tablet in acidic media during a period of 30 min were 5%, 8% and 12%, respectively. Furthermore, both sugar and film coated tablets released 80% of their content after 20 minutes in phosphate buffer. The amount of ibuprofen released from Neurofen was completed [100%] during similar period of time. Although the release profiles of both sugar coated and film coated tablets are similar in phosphate buffer medium, however, sugar coated tablets release less amounts of drug in acidic medium something which indicates superiority of sugar coated relative to film coated one for ibuprofen tablets

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