Pharmacokinetics And Preliminary Data On Safety of Meloxicam Subcutaneous Extended-Release Formulation in Sprague-Dawley Rats

Avantika Gupta¹Harshita Akkaraju¹Vignesh Vasudevan¹Sruthi Turaga¹Lisa Rohan¹Sravan Patel¹Barry Levinson²Steven Leary²Susan Witham²Imam Shaik^1*Raman Venkataramanan¹

• ¹University of Pittsburgh, Pittsburgh, United States
• ²Fidelis Pharmaceuticals LLC, North Brunswick Township, United States

Nonsteroidal anti-inflammatory drugs (NSAIDs) play a critical role in managing pain and inflammation in veterinary medicine. Meloxicam, a widely used NSAID, is commonly administered as oral or injectable solution but there is a demand for formulations that can be administered less frequently. Our objective was to develop a safe extended-release subcutaneous meloxicam formulation that can be administered less frequently yet maintaining the plasma levels sufficient for adequate response. This study evaluates pharmacokinetics of meloxicam of a subcutaneous suspension [extended release (SC-XR)] formulation in Sprague Dawley rats in comparison to intravenous (IV), subcutaneous (SC)] and sustained release (SC-SR), formulations. Dose-escalation and multiple-dosing studies were conducted to assess the drug exposure and safety of the SC-XR suspension formulation. The new meloxicam XR suspension (4mg/kg) was safe and well tolerated. Pharmacokinetic analysis revealed that the XR suspension formulation achieved prolonged drug release and sustained meloxicam concentrations above 1 µg/ml in plasma for up to 72 hours. Multiple dosing of SC-XR formulation (5mg/mL) at escalating doses of 4 mg/kg, 12 mg/kg, and 20 mg/kg demonstrated minimal drug accumulation. No dose-dependent adverse findings observed in the histological, hematological and organ function marker (AST, ALT, Scr, BUN) assessments. The meloxicam XR suspension represents a potential option for enhancing pain management and compliance in animal care, offering the prospect of less frequent administration for veterinary purposes.