Psyllium husk, carbohydrate polymer based novel plug-in capsule device for pulsatile release from...

Chronomodulated diseases demonstrate circadian fluctuations. Conventional dosage forms are inadequate for mitigating these ailments; instead, time-scheduled drug release is necessary for pharmacological efficacy. The current investigation aims to develop natural, carbohydrate polymer-based novel plug-in capsule, pulsatile drug delivery system with engineered specificity of meloxicam with low aqueous solubility. β-CD is employed to boost solubility by forming solid ternary inclusion complexes where natural polymers, viz., pectin and agar, act as ternary agents. Plug-in capsule device is prepared using formaldehyde-treated capsule bodies and optimized by 3²full factorial design by considering concentrations of HPMC-E15 (X₁) and psyllium husk (X₂) as independent variables and lag time (Y₁), time required to release 80 % drug (Y₂), release of drug at 6 h, (Y₃) as responses. Dissolution order was ternary complex (pectin 60.21 %) > ternary complex (agar 53.64 %) > binary complex (41.56 %) > pure drug (18.87 %). Batch F6, demonstrated a significant lag time of 6.15 ± 0.07 h followed by maximum drug release (85.21 % at 60 min) from its ternary complex containing β-CD and pectin. X₁ and X₂ demonstrates significant positive effects on Y₁ and Y₂ but decrease in Y₃. Thus, developed formulation serves as remedy for early morning pain with stiffness that rheumatoid arthritis patients experience, as it follows circadian pattern. Simultaneously, it maximizes drug delivery and achieves desired therapeutic effect, thus eliminating risk of early morning pain.