Pharmacokinetic profile of novel multi-layer stable effervescent tablet: a cross-over study with an established European brand in healthy young male adults.

IF 2.8 3区 医学 Q2 PHARMACOLOGY & PHARMACY BMC Pharmacology & Toxicology Pub Date : 2024-11-05 DOI:10.1186/s40360-024-00808-9
Danish Hassan Dani, Syed Baqir Shyum Naqvi, Muhammad Akram, Matti Ullah, Sheikh Abdul Khaliq, Muhammad Masoom Akhtar, Orva Abdullah, Syed Faisal Badshah, Mohammed Bourhia, Gamal A Shazly, Yousef A Bin Jardan, Srosh Fazil
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Abstract

Effervescent formulation helps in faster and better absorption of drugs, especially those that are rapidly soluble in water. However, these tablets require special packaging in order to prevent them from absorbing moisture, hence increasing cost. We compared an effervescent tablet prepared using an in-house developed method (multi-layer tablet with acid and base part separated by an inert layer) to a European effervescent tablet (Efferalgan®) in a single-center, randomized cross-over study among twelve healthy volunteers. Blood samples were collected for 8 h and analyzed for paracetamol concentration using HPLC. Our results showed that both the products have similar pharmacokinetic profiles with no significant difference observed for Clast, Thalf, Kelim, and MRT (p-value > 0.05). Moreover, to assess bioequivalence we did not find any significant difference (p-value > 0.05) in AUC (27.12 ± 6.02 vs. 27.29 ± 2.64 µg.h/ml), Cmax (7.42 ± 1.06 vs. 7.83 ± 1.19 µg/ml) and tmax (0.85 ± 0.22 vs. 0.83 ± 0.25 h). The TR ratios for AUC, Cmax, and tmax were 0.99, 0.95, and 1.02 respectively, and were all within the specified FDA limits i.e., 0.8-1.25. We found our test tablet to be bioequivalent to that of Efferalgan®.

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新型多层稳定泡腾片的药代动力学特征:与欧洲知名品牌在健康年轻男性成年人中进行的交叉研究。
泡腾制剂有助于更快、更好地吸收药物,尤其是速溶于水的药物。然而,这些药片需要特殊包装以防止吸湿,从而增加了成本。在一项单中心随机交叉研究中,我们在 12 名健康志愿者中比较了使用内部开发方法制备的泡腾片(多层片剂,酸和碱部分由惰性层隔开)和欧洲泡腾片(Efferalgan®)。研究人员采集了 8 小时的血液样本,并使用高效液相色谱法分析了扑热息痛的浓度。结果显示,两种产品的药代动力学特征相似,Clast、Thalf、Kelim 和 MRT 均无明显差异(p 值 > 0.05)。此外,为评估生物等效性,我们在 AUC(27.12 ± 6.02 vs. 27.29 ± 2.64 µg.h/ml)、Cmax(7.42 ± 1.06 vs. 7.83 ± 1.19 µg/ml)和 tmax(0.85 ± 0.22 vs. 0.83 ± 0.25 h)方面也未发现任何显著差异(p 值 > 0.05)。AUC、Cmax 和 tmax 的 TR 比值分别为 0.99、0.95 和 1.02,均在 FDA 规定的范围内,即 0.8-1.25。我们发现我们的试验片剂与 Efferalgan® 具有生物等效性。
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来源期刊
BMC Pharmacology & Toxicology
BMC Pharmacology & Toxicology PHARMACOLOGY & PHARMACYTOXICOLOGY&nb-TOXICOLOGY
CiteScore
4.80
自引率
0.00%
发文量
87
审稿时长
12 weeks
期刊介绍: BMC Pharmacology and Toxicology is an open access, peer-reviewed journal that considers articles on all aspects of chemically defined therapeutic and toxic agents. The journal welcomes submissions from all fields of experimental and clinical pharmacology including clinical trials and toxicology.
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