AAPS PharmSciTech ( IF 3.4 ) Pub Date : 2023-02-09 , DOI: 10.1208/s12249-023-02515-w Hina Javed 1 , Syed Nisar Hussain Shah 1 , Furqan Muhammad Iqbal 1 , Nida Javed 1 , Benish Saeed 2
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The study aims to determine histamine efficacy on hematologic values in experimental animal model, under physiological and pathological conditions after inducing diphenhydramine-formulated nasal nano-gel/nano-emulgel in comparison with conventional nasal spray regime. In this study, we conducted experiment on New Zealand white male rabbits to prove our hypothesis that nasal diphenhydramine nano-gel and nano-emulgel can penetrate the nasal mucosa faster to show drug response and subside histaminic symptoms than market nasal spray (as reference). Blood samples from 48 New Zealand white male rabbits, under both experimental conditions (physiological and pathological) divided into four groups for each (n = 6) were investigated after inducing each dosage form intranasally. Hematologic parameters (WBCs, RBCs, HGB, PLTs, lymphocytes, monocytes, eosinophils, granulocyte counts) were analyzed in whole blood samples, collected at different time intervals. ANOVA and completely randomized design (CRD) were applied for statistical analysis. Histopathologically, nasal tissues of all groups were analyzed to see intramucosal surface changes. Data of descriptive statistics of hematological parameters analyzed at confidence level 95% showed that under physiological condition, hematological parameters of all groups were lying in normal range, whereas under pathological condition, low values of all hematological parameters were observed in all groups due to allergenic condition. The groups B (allergenic rabbits treated with formulated diphenhydramine nasal nano-gel) and C (allergenic rabbits treated with formulated diphenhydramine nasal nano-emulgel) have shown good changes in the treatment of allergenic rabbits as compared to group D (allergenic rabbits treated with formulated diphenhydramine nasal spray). The completely randomized ANOVA and Tukey HSD all-pairwise comparison tests of hematological parameters were applied that showed all groups in both studies were significantly different from each other. It was observed after histopathological study of nasal membrane tissues that change in mucosa has occurred due to the passage of drug. In summary, hematological profile and histopathological study have demonstrated the comparable results with conventional diphenhydramine nasal spray and formulated diphenhydramine nasal nano-gel/nano-emulgel which can exhibit considerable drug delivery dosage forms in the management of allergic rhinitis in animal model.
Graphical Abstract
中文翻译：
苯海拉明鼻用纳米凝胶和纳米乳剂治疗过敏性鼻炎动物模型的血液学和组织病理学研究
该研究旨在确定组胺对实验动物模型血液学值的疗效，在生理和病理条件下诱导苯海拉明配制的鼻用纳米凝胶/纳米乳胶与常规鼻腔喷雾方案相比。在本研究中，我们对新西兰雄性白兔进行了实验，以证明我们的假设，即鼻用苯海拉明纳米凝胶和纳米乳胶比市场上的鼻腔喷雾剂（作为参考）能更快地穿透鼻粘膜以显示药物反应并消退组胺症状。来自 48 只新西兰白色雄性兔子的血样，在两种实验条件下（生理和病理）分为四组，每组（n = 6）在鼻内诱导每种剂型后进行研究。血液学参数（WBC、RBC、HGB、PLT、淋巴细胞、单核细胞、嗜酸性粒细胞、粒细胞计数）在不同时间间隔采集的全血样本中进行了分析。应用方差分析和完全随机化设计（CRD）进行统计分析。在组织病理学上，分析所有组的鼻组织以观察粘膜内表面变化。95%置信度下血液学参数的描述性统计数据显示，在生理状态下，各组血液学参数均在正常范围内，而在病理状态下，由于过敏原状态，各组血液学参数均偏低. B组（配制苯海拉明鼻用纳米凝胶治疗的过敏兔）和C组（配制苯海拉明鼻用纳米乳胶治疗的过敏兔）较D组（配制苯海拉明鼻用纳米乳胶治疗的过敏兔）表现出良好的治疗效果。苯海拉明鼻喷雾剂）。应用了血液学参数的完全随机方差分析和 Tukey HSD 全成对比较检验，显示两项研究中的所有组彼此之间存在显着差异。对鼻粘膜组织进行组织病理学研究后发现，由于药物的通过，粘膜发生了变化。总之，
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