Objectives: This study aimed to develop a controlled drug delivery device for aceclofenac, a non-steroidal anti-inflammatory drug. Therefore, the agent was projected to develop an osmotic pump with enteric coating. The strength of the semipermeable membrane was improved by optimizing the formulation of the device, which can control the drug release over a prolonged period of time.
Materials and methods: The formulations were designed and optimized by using the statistical design of experiment followed by 32 factorial design to discover the best formulation. Several evaluation tests were performed to assess the physical parameters of the formulations. The percentage drug release of the formulations was observed for up to 9 h.
Results: The model 3D graph analysis indicated that as an osmogen, a higher percentage of potassium chloride was utilized more effectively than mannitol for the rapid dissolution of osmotic tablets. The optimized formulation can release 88.60±0.02% up to 9 h. The accelerated stability study confirmed that the optimized formulation was stable.
Conclusion: The formulated osmotic tablets of aceclofenac were therapeutically safe and effective and did not release any drug content in the simulated gastric medium for a predetermined time.
Keywords: 32 factorial design; 3D graph analysis; Statistical design of experiment; osmotic tablet.