Formulation development and evaluation of push-pull osmotic pump bi-layered tablets for phencynonate HCl in the treatment of motion sickness.

IF 2.6 4区 医学 Q2 PHARMACOLOGY & PHARMACY
Si-Rui Liu, Wen Lin, Xiang-Yang Xie, Yuan Zeng
{"title":"Formulation development and evaluation of push-pull osmotic pump bi-layered tablets for phencynonate HCl in the treatment of motion sickness.","authors":"Si-Rui Liu, Wen Lin, Xiang-Yang Xie, Yuan Zeng","doi":"10.1080/10837450.2025.2465548","DOIUrl":null,"url":null,"abstract":"<p><p>The aim of this study was to develop and evaluate an extended-release (ER) push-pull osmotic pump (PPOP) tablet for phencynonate HCl (PCN), which could release the drug at zero-order profile for a duration of 24 h. The core tablets were designed as bi-layered, primarily composed of sodium chloride and polyethylene oxide (PEO). The central composite design (CCD) within a response surface methodology (RSM) was used to optimize the formulation. An optimized PCN-PPOP tablet formulation was achieved with the following values for key factors: 10 mg NaCl, 70 mg PEO, and 13.56% coating membrane weight gain. It revealed that this formulation could release PCN <i>in vitro</i> at a zero-order manner for 18 h. The <i>in vivo</i> release property of the PCN-PPOP tablet was assessed and contrasted with that of immediate-release (IR) tablet following a single oral administration to beagle dogs. The pharmacokinetic data indicated that the PPOP tablet achieved a sustained <i>in vivo</i> release of PCN, as evidenced by a longer T<sub>max</sub> (7.17 ± 1.83 h) and mean residence time (11.57 ± 1.12 h). This work demonstrated that PCN-PPOP tablet could be designed for oral administration to provide a long-term pharmacological intervention for motion sickness.</p>","PeriodicalId":20004,"journal":{"name":"Pharmaceutical Development and Technology","volume":" ","pages":"220-232"},"PeriodicalIF":2.6000,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Development and Technology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10837450.2025.2465548","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/12 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0

Abstract

The aim of this study was to develop and evaluate an extended-release (ER) push-pull osmotic pump (PPOP) tablet for phencynonate HCl (PCN), which could release the drug at zero-order profile for a duration of 24 h. The core tablets were designed as bi-layered, primarily composed of sodium chloride and polyethylene oxide (PEO). The central composite design (CCD) within a response surface methodology (RSM) was used to optimize the formulation. An optimized PCN-PPOP tablet formulation was achieved with the following values for key factors: 10 mg NaCl, 70 mg PEO, and 13.56% coating membrane weight gain. It revealed that this formulation could release PCN in vitro at a zero-order manner for 18 h. The in vivo release property of the PCN-PPOP tablet was assessed and contrasted with that of immediate-release (IR) tablet following a single oral administration to beagle dogs. The pharmacokinetic data indicated that the PPOP tablet achieved a sustained in vivo release of PCN, as evidenced by a longer Tmax (7.17 ± 1.83 h) and mean residence time (11.57 ± 1.12 h). This work demonstrated that PCN-PPOP tablet could be designed for oral administration to provide a long-term pharmacological intervention for motion sickness.

推拉式渗透泵双层盐酸苯己酸酯片治疗晕动病的配方研制及评价。
本研究的目的是开发并评价一种苯环壬酸酯(PCN)的推拉渗透泵(PPOP)缓释片,该片剂可在24 h内以零级释放。芯片设计为双层结构,主要由氯化钠和聚氧聚乙烯(PEO)组成。采用响应面法(RSM)中的中心复合设计(CCD)优化配方。以NaCl 10 mg、PEO 70 mg、包膜增重13.56%为主要影响因素,优化了PCN-PPOP片剂配方。结果表明,该制剂可在体外零级释放PCN 18 h。研究了PCN-PPOP片的体内释放特性,并与单次口服比格犬的速释片进行了对比。药动学数据表明,PPOP片实现了PCN的体内持续释放,其最大释放时间(7.17±1.83 h)和平均滞留时间(11.57±1.12 h)较长。本研究表明,PCN-PPOP片剂可设计为口服给药,为晕动病提供长期的药物干预。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
CiteScore
5.90
自引率
2.90%
发文量
82
审稿时长
1 months
期刊介绍: Pharmaceutical Development & Technology publishes research on the design, development, manufacture, and evaluation of conventional and novel drug delivery systems, emphasizing practical solutions and applications to theoretical and research-based problems. The journal aims to publish significant, innovative and original research to advance the frontiers of pharmaceutical development and technology. Through original articles, reviews (where prior discussion with the EIC is encouraged), short reports, book reviews and technical notes, Pharmaceutical Development & Technology covers aspects such as: -Preformulation and pharmaceutical formulation studies -Pharmaceutical materials selection and characterization -Pharmaceutical process development, engineering, scale-up and industrialisation, and process validation -QbD in the form a risk assessment and DoE driven approaches -Design of dosage forms and drug delivery systems -Emerging pharmaceutical formulation and drug delivery technologies with a focus on personalised therapies -Drug delivery systems research and quality improvement -Pharmaceutical regulatory affairs This journal will not consider for publication manuscripts focusing purely on clinical evaluations, botanicals, or animal models.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信