Dissolution profile, tolerability, and acceptability of the orally disintegrating olanzapine tablet in patients with schizophrenia.

OBJECTIVE This pilot study investigates the dissolution profile, tolerability, and acceptability of an orally disintegrating olanzapine tablet in patients with schizophrenia. METHOD Eleven patients with schizophrenia stabilized on oral olanzapine (mean dosage 12.7 mg daily [SD5.2]) were given an orally disintegrating olanzapine tablet, rather than their usual tablet, daily for 7 days. At each visit, visual assessments were made for elapsed time to initial disintegration (every 15 seconds) and complete disintegration (every 1 minute). At the end of the study, patients completed a drug-acceptance questionnaire. RESULTS The mean time to initial disintegration was 15.78 seconds, and mean time to complete disintegration was 0.97 minutes. All patients found the orally disintegrating tablet acceptable and expressed positive comments. Nonserious clinically significant adverse events, asthenia, purpuric rash, headache, depression, and insomnia (preexisting, except for asthenia and insomnia) were reported in 3 patients. CONCLUSION The orally disintegrating olanzapine tablet disintegrates rapidly and is a well-tolerated and acceptable alternative to standard olanzapine tablets in patients with schizophrenia.