Development and Evaluation of a Meloxicam Extended Release Injectable Suspension

The United States has been crippled by an unprecedented opioid crisis for nearly three decades. Opioids are the most frequently prescribed painkillers for moderate to severe pain in patients who have undergone invasive procedures. This has led to a sharp uptick in opioid dependency and illicit use. Despite the effort from various public and private sector organizations to tackle this public health crisis, opioid overdose related deaths have been on the rise for many years now. This shows that the consequences of this epidemic continue to be devastating. Hence, there is now an urgent need to determine equivalent alternatives to opioid-based pain management. Several researchers have been investigating the efficacy of NSAIDs for opioid-sparing pain management. Meloxicam is a COX-2 selective NSAID that is indicated for the treatment of conditions such as osteoarthritis and rheumatoid arthritis. It provides pain relief through selective COX-2 inhibition. Thus, in comparison to non-selective NSAIDs, meloxicam displays a superior gastrointestinal (GI) safety profile. Oral formulations of meloxicam such as MOBIC are mostly used for pain management. However, the use of oral formulations can be challenging during post-operative periods due to the after-effects of surgical procedures. Hence, medication non-compliance during this time is not uncommon and remains a cause for concern. This highlights the need for determining alternate routes of administration for meloxicam. We propose the development of a meloxicam depot formulation, intended for subcutaneous administration. Depot formulations are advantageous as they are designed to decrease drug dosing frequency and improve medication adherence. Through this route, we expect meloxicam to exert its action in a slow and controlled manner, over an extended period. This will aid in extending the duration of analgesic effects, thus reducing the need for repeated dosing of oral painkillers. Thus, this formulation is potentially an attractive option as a non-oral opioid-sparing pain management strategy