Precision Formulation of Ocular Films for Eye Infections using Innovative Quality by Design Optimization.

Drug metabolism and bioanalysis letters Pub Date : 2024-01-01 DOI:10.2174/0118723128364823250130094219

Repollu Maddileti, Haranath Chinthaginjala

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Abstract

Aim: The current study focused on formulating ocular films embedded with levofloxacin for the treatment of conjunctivitis by employing the solvent-casting technique.

Methods: These films were formulated with gelatin, Aloe barbadensis leaves mucilage (ABLM), and HPMC K4M to enhance the therapeutic effectiveness of levofloxacin. Various evaluations were carried out to confirm the quality and stability of the films, including assessments of thickness, weight uniformity, uniformity in LFX, % loss of moisture, and permeation. In vitro drug release studies were conducted to simulate ocular environments and analyze the precise release of LFX.

Results: The films exhibited uniform thickness (0.15-0.19 mm) and weight (61.85-65.54 mg) with a consistent film area (0.502 cm²). LFX content ranged from 85.66% to 97.03%, with T-6 being the most uniform. Moisture loss was found to be 7.98-9.55%, and absorption (highest in T-6, i.e., 18.05%) increased with gelatin. LFX permeation peaked at 97.03% (T-6) in 24-h diffusion studies. T-8 demonstrated exceptional mucoadhesion (>10 h), and ANOVA confirmed the important influence of gelatin, ABLM, and HPMC K4M on LFX content (F-value: 129.91, p=0.0010).

Conclusion: The study concluded that combining ABLM with HPMC K4M enabled consistent, diffusion-controlled release of LFX, offering an effective and sustained formulation for treating conjunctivitis.

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通过设计优化创新质量的眼部感染眼膜的精确配方。

目的：采用溶剂型铸造技术制备左氧氟沙星包埋眼膜治疗结膜炎。方法：采用明胶、芦荟叶黏液（ABLM）和HPMC K4M配制这些膜，提高左氧氟沙星的治疗效果。为了确认薄膜的质量和稳定性，进行了各种评价，包括厚度、重量均匀性、LFX均匀性、水分损失率和渗透率。通过体外药物释放实验模拟眼环境，分析LFX的精确释放。结果：膜厚均匀（0.15 ~ 0.19 mm），重量均匀（61.85 ~ 65.54 mg），膜面积均匀（0.502 cm²）。LFX含量在85.66% ~ 97.03%之间，以T-6最为均匀。水分损失率为7.98-9.55%，吸收率（在T-6中最高，即18.05%）随着明胶的加入而增加。在24小时的扩散研究中，LFX的渗透率达到97.03% （T-6）。T-8表现出异常的黏附（bbb10 h），方差分析证实明胶、ABLM和HPMC K4M对LFX含量有重要影响（f值：129.91,p=0.0010）。结论：本研究认为ABLM联合HPMC K4M可使LFX具有一致的扩散控制释放，为治疗结膜炎提供了一种有效且持续的制剂。

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Drug metabolism and bioanalysis letters

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1.60

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