Granules and mini-tablets containing theophylline were film coated by fluidised bed technology with various amounts of ethylcellulose and Eudragit RL. Scanning electron micrographs of both whole and fractured film coated granules and mini-tablets were taken. In vitro dissolution studies were carried out on encapsulated samples of film coated material equivalent to about 150mg of theophylline. Dissolution studies were also carried out on individual granules and mini-tablets and the time for 10% release (t10% values) of drug were determined. A comparison of the dissolution profiles showed that granules required about 2.5 to 3 times more coating material than mini-tablets to achieve the same release rate. It is also shown from the t10% values that drug release from mini-tablets is more consistent than from granules. Since the mini-tablets contain uniform weights of theophylline, their use allows precise adjustment of the number of encapsulated mini-tablets for individual dosage titration.
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D.L. Munday (1994) studied this question.
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