Stability and compatibility of Basmisanil granules co-administered with soft food

Co-administration of solid oral dosage forms with soft food or beverages is commonly used to facilitate administration and to improve compliance in the paediatric and geriatric population and in patient groups with swallowing difficulties. The present case study was conducted to investigate the compatibility, stability and dissolution of Basmisanil administered as granules mixed with different soft food matrices. The data were generated to justify dosing instructions, according which Basmisanil should be sprinkled on or mixed with one tablespoon of soft food to aid swallowing. Different soft food types were selected to cover a broad range of various food components (e.g. fat, protein, carbohydrates, fiber and water) and pH. Active content and degradation products of the active substance were determined after mixing the granules with the semisolid food matrix and after two hours of storage under ambient conditions, respectively. In-vitro dissolution tests of granule/food mixtures were also conducted. Furthermore, the stability of the API polymorph was evaluated. Basmisanil shows good chemical stability when the granules are mixed with soft food and consumed within two hours. No polymorphic conversion (anhydrate to monohydrate) could be detected in the granule/food mixtures after preparation and after storage up to 24 h. The in-vitro dissolution of the API from the granules was not adversely affected by the presence of the food matrix. All results were comparable regardless of the tested food matrix. The results do not prohibit the administration of the granules with soft food to the patient.