Abstract
Quetiapine is an atypical antipsychotic approved for treating schizophrenia, bipolar depression, and mania but is frequently used in an off-label manner to control the behavioral and psychological symptoms of dementia in elderly patients with dementia. Due to the need to personalize doses for elderly patients with dementia, quetiapine tablet manipulation is widespread in hospital settings, long-term care facilities, and patient homes. The aim of this study was to assess the impact of the different splitting techniques on quetiapine fumarate tablets by analysing the obtained sub-divided tablets and to discuss compliance with the European Pharmacopoeia limits on whole and split tablets. Quetiapine fumarate tablets of two dose strengths were taken at random (in a number able to assure a power of 0.8 during statistical comparison) and were split with a kitchen knife or tablet cutter. The weight and the drug content were determined for each half tablet. The obtained data were compared to the European Pharmacopoeia limits. The differences between the different splitting techniques were statistically tested. Data showed that split tablets, independently of the dose strength and the technique employed, were not compliant with the European Pharmacopoeia specifications for both entire and subdivided tablets in terms of weight and content uniformity. Thus, such a common practice could have potential effects on treatment efficacy and toxicity, especially when also considering the fragility of the elderly target population in which polypharmacotherapy is very common. These results indicate a compelling need for flexible quetiapine formulations that can assure more accurate dose personalization.
Highlights
Patients with Alzheimer’s disease, vascular dementia, Parkinson’s dementia, frontotemporal dementia, and Lewy body dementia can develop changes in behaviour and personality
Atypical antipsychotic medications are the only class of drugs showing consistent benefit in controlling the behavioral and psychological symptoms of dementia (BPSD) for short-term treatment [3,4]
Taking into account the widespread prescription of quetiapine fumarate tablets for BPSD treatment in elderly patients with dementia and the specific need for dose adjustment as a function of clinical response, quetiapine tablet manipulation is widespread in hospital settings, long-term care facilities, and patient homes
Summary
Patients with Alzheimer’s disease, vascular dementia, Parkinson’s dementia, frontotemporal dementia, and Lewy body dementia can develop changes in behaviour and personality. The frequency and nature of these symptoms might vary over the course of the disease [1]. In the majority of patients, lack of insight occurs even in the early stages of the disease and represents an important predictive factor for the occurrence of neuropsychiatric 4.0/). Pharmaceutics 2021, 13, 1523 symptoms, including apathy, agitation, irritability, psychosis, or behavioral symptoms in general [2]. Atypical antipsychotic medications are the only class of drugs showing consistent benefit in controlling the behavioral and psychological symptoms of dementia (BPSD) for short-term treatment [3,4]. BPSD include agitation, verbal aggression, sleep disturbances, hallucinations, persecutory delirium, psychosis, and mood disorders and are associated with high levels of distress in both patients and caregivers [5]. BSD are a significant clinical target for intervention [6], even if the use of antipsychotics must be balanced against their serious adverse effect profile [7]
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