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用于中耳炎局部治疗的热敏原位耳用凝胶的制剂

Formulation of Thermosensitive in situ Otic Gel for Topical Management of Otitis Media.

作者信息

Shau P A, Dangre P V, Potnis V V

机构信息

Department of Pharmaceutics, Kamla Nehru College of Pharmacy, Butibori, Nagpur-441 108, India.

出版信息

Indian J Pharm Sci. 2015 Nov-Dec;77(6):764-70. doi: 10.4103/0250-474x.174970.

Abstract

Antibiotics and antiinflammatory agents are the primary and main therapeutic categories in the treatment of otitis media. One of the simpler and feasible approaches of minimizing the problem of repeated use and subsequent resistance is development of sustained release formulation. Therefore, the present investigation aimed to develop a sustained release in situ gel formulation containing combination of broad spectrum antibiotic and antiinflammatory agents for the management of otits media. The prolonged release is achieved by phase transition of Poloxamer 407 (in situ) from sol to gel at a physiological temperature in combination with viscosity imparting agent Natrasol 250 and Klucel HF. The formulation P3N3 (19% w/v Poloxamer 407, 1.5% w/v Natrasol 250) and P3K3 (19% w/v Poloxamer 407, 1.5% w/v Klucel HF) showed mucoadhesive strength 37.17±0.32×10(3) and 38.12±0.13×10(3) dyne/cm(2), respectively, and gel strength 2.1 and 2 cm, respectively. Both these formulations indicated good drug content and viscosity besides a good gelling ability. The in vitro diffusion has demonstrated prolongation of release of both the drugs over a period of 8 h.

摘要

抗生素和抗炎药是治疗中耳炎的主要治疗类别。减少重复使用及后续耐药性问题的一种较为简单可行的方法是开发缓释制剂。因此,本研究旨在开发一种含广谱抗生素和抗炎药组合的原位凝胶缓释制剂,用于治疗中耳炎。泊洛沙姆407(原位)在生理温度下从溶胶转变为凝胶,并与增稠剂羟丙基甲基纤维素和羟丙基纤维素相结合,从而实现药物的长效释放。制剂P3N3(19% w/v泊洛沙姆407,1.5% w/v羟丙基甲基纤维素)和P3K3(19% w/v泊洛沙姆407,1.5% w/v羟丙基纤维素)的粘膜粘附强度分别为37.17±0.32×10(3)和38.12±0.13×10(3)达因/平方厘米,凝胶强度分别为2.1厘米和2厘米。这两种制剂除了具有良好的胶凝能力外,还显示出良好的药物含量和粘度。体外扩散表明,两种药物的释放时间均延长至8小时。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db36/4778238/43186c1c36e7/IJPhS-77-764-g008.jpg

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