Preparation and characterization studies of etodolac suppositories: investigation on oleaginous blends of Witepsol® H15.

Etodolac is a non-steroidal anti-inflammatory drug that is categorized as a BCS class-II drug due to its low aqueous solubility and high permeability. Frequent dosing, extensive liver metabolism, and low dissolution rates are major limitations of etodolac. The present study focuses on the designing of novel suppository base blends for providing an effective delivery of etodolac. The oils (Caprylic/capric triglyceride, isopropyl isostearate, and isopropyl palmitate) were added to Witepsol® H15 to form suppository base blends. White, odorless, and torpedo-shaped suppositories were developed by using two parts of Witepsol® H15 and one part of the oil. All of the suppositories prepared with different blends were found uniform in weight and content. The mechanical strength of all suppositories was in an acceptable range for suppositories (2.0 – 3.8 kg/cm²). The suppositories showed a disintegration time between 13 and 19 minutes. First-order release kinetics were observed after the in vitro release studies. The suppository base blends released 85%- 90% of etodolac in the first hour while 60% of etodolac was released from Witepsol® H15 base alone. Prolonged drug release was achieved after 2 hours all of the formulations reached the plateau levels. The oil blends exhibited higher release percentages (96% - 99%) than plain Witepsol® H15 base (89%). Therefore novel suppository base blends could be a promising formulation ingredient for the etodolac suppositories. [ABSTRACT FROM AUTHOR]