Depression patient-friendly formulation containing escitalopram and ascorbic acid: design, optimization,...

Deficiencies in micronutrients are often overlooked in the treatment of the disease. The current research was undertaken to use ascorbic acid (AA) with Escitalopram oxalate (EO) for the treatment of depression. Designing a patient-friendly formulation that accelerates treatment, developing analytical methods, taste masking, and exploring a simulated dissolution apparatus for medicated chewing gum (MCG) are other objectives. The analytical method was developed and validated for the estimation of AA and EO. The interaction between AA-EO and AA-EO excipients was assessed. MCG was designed using an industry-friendly method. A Plackett-Burman design (PBD) was used to screen for significant variables. Variables were then correlated using the central composite design (CCD). EO release, AA release using a fabricated simulated dissolution apparatus, and texture analysis were evaluated for the designed formulation. An in vivo taste assessment and an accelerated stability study were performed. A simultaneous equation, first and second-order derivative UV method was developed and validated. FTIR and DSC confirmed the absence of any interaction amongst AA-EO and AA-EO- excipients. The amounts of elastomer, plasticizer, and softener were selected as significant variables from the Pareto chart. The optimal MCG from CCD was identified as containing 283.18 mg PVA, 129.10 mg GMO, 119.19 mg soya lecithin, 50 mg Xylitol, and 5 mg Mint, and showed the desired texture, drug release, and stability. The taste was masked, which was confirmed by in vivo assessment. The industry-patient-friendly formulation can accelerate the cure of depression-related symptoms. The use of AA with EO will benefit the patient. The newer fabricated dissolution apparatus can be advantageous for the in vivo simulation. The approach can be delivered to industry after successful preclinical trials.