摘要
Anorexia is a clinically significant condition in companion animals, particularly cats, that disrupts metabolic homeostasis and impedes recovery from underlying diseases. Mirtazapine (MRZ), a commonly prescribed appetite stimulant in veterinary medicine, has limited clinical utility due to its intense bitterness and suboptimal bioavailability in conventional dosage forms. To address these limitations, we developed a novel drug delivery system integrating microencapsulation technology with an orally disintegrating tablet (ODT) formulation. Using an optimized emulsification-solvent diffusion method, we produced ethyl cellulose-based microspheres exhibiting high encapsulation efficiency (93.19 ± 0.71%), uniform particle size distribution (106.12 ± 1.49 μm), and pH-responsive drug release characteristics. Comprehensive physicochemical characterization confirmed the structural integrity of the microspheres and the absence of detrimental drug-polymer interactions. Furthermore, the ODT formulation exhibited excellent pharmaceutical properties, including rapid disintegration and complete drug release under gastric conditions, and effective masking of MRZ's bitter taste in the oral cavity. In vivo evaluations revealed significantly improved palatability (p < 0.05) and preliminary evidence of appetite stimulation (p < 0.05) compared with conventional formulations, supporting further clinical development. Stability studies indicated robustness under standard storage conditions. This advanced delivery system successfully overcomes the major limitations of current MRZ therapies, offering a promising solution for enhancing treatment compliance and therapeutic outcomes in veterinary practice. Moreover, the developed technology platform provides valuable insights for formulating other challenging active pharmaceutical ingredients requiring taste masking and controlled release.
危险品化学品经营许可证（带存储）