FORMULATION AND EVALUATION OF MULTIPARTICULATE PULSATILE DRUG DELIVERY SYSTEM

AbstractPulsatile drug delivery systems are modified-release dosage forms designed to provide apredetermined lag time followed by rapid drug release. They are particularly useful in chronotherapy,where drug availability is synchronized with the circadian pattern of disease symptoms.Multiparticulate systems, such as pellets, offer several advantages, including good flow properties,relatively uniform coating, reduced risk of dose dumping, and flexibility in modifying drug-releasecharacteristics. The present research work focuses on the formulation and evaluation of amultiparticulate pulsatile drug delivery system using polymer-coated pellets. A published salbutamolsulphate model employed solution-layering technology for the preparation of drug-loaded pellets andused Eudragit RSPO and Eudragit L100 as pH-independent and pH-dependent coating polymers,respectively. Different polymer ratios and coating levels were investigated to optimize the pulsatilerelease profile. The reported optimized formulation consisted of EudragitRSPO:Eudragit L100 in a30:70 ratio at a 10% coating level and demonstrated the desired pulsatile drug-release behavior. Thestudy reported pellet friability below 1% and drug content ranging from 94.60 ± 0.01% to 98.27 ±0.012%, indicating satisfactory physical integrity and drug-content uniformity. The findingsdemonstrate that polymer type, polymer ratio, and coating level are important formulation variablesfor controlling lag time and subsequent drug release. Multiparticulate pulsatile drug delivery systemstherefore represent a promising approach for chronotherapeutic applications requiring drug release ata predetermined time.