Pediatric-friendly Smart Oro-solid Carbamazepine Dry Suspension (SOS-CDS): optimization, functionality and in-vivo taste determination

Background Pediatric formulations are challenging to design due to considerations of convenience. Many children are suffering from an epileptic condition at an early age. Continuing anti-epileptic treatment can influence bone metabolism in children. The research was undertaken to design a pediatric and industry approachable smart stable dosage form of carbamazepine (CBZ) supplemented with Vitamin D (Vit D). Methods Smart Oro-solid Carbamazepine Dry Suspension (SOS-CDS) was formulated using a liquorice-based suspending agent. DSC and FTIR were performed to observe interactions among CBZ, Vit D, and other excipients. Screening of various variables was performed using Failure Mode and Effects Analysis (FMEA), and the results were further optimized using a Central Composite Design (CCD) with two independent variables (suspending agent and mixing speed) and three dependent variables (sedimentation volume, blend uniformity, and %CDR). The designed SOS-CDS was evaluated for its stability and other physicochemical parameters. BATA model was utilized to assess the taste masking of carbamazepine. Results DSC and FTIR spectra showed no interaction between the drug and excipients. QbD approach successfully optimized the SOS-CDS, identifying suspending agent concentration and mixing speed as critical variables. A total of 13 experiments were designed and evaluated. Optimized SOS-CDS showed good micromeritics properties and a desired sedimentation volume, with 93.7% release at 420 min. BATA model revealed the taste masking of CBZ. Conclusion The major concern with the current formulation was its instability in the presence of light and moisture. The developed SOS-CDS was stable due to its intelligent mechanism. In addition, long-term use of CBZ causes bone degeneration, which may be overcome by supplementing Vitamin D. Liquorice was explored as a masking agent for the bitter taste of CBZ and was confirmed in the BATA model. The newer SOS-CDS was stable and had controlled release. The developed formulation will be useful at an industrial scale.