多通道三维打印仿生颗粒负载片剂(M3DPBT):设计、开发和体外功能评估

IF 3.4 Q2 PHARMACOLOGY & PHARMACY Future Journal of Pharmaceutical Sciences Pub Date : 2024-09-16 DOI:10.1186/s43094-024-00702-5
Hardik Rana, Priyanka Pathak, Vimal Patel, Vaishali Thakkar, Mansi Dholakia, Saloni Dalwadi, Tejal Gandhi
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引用次数: 0

摘要

背景与基因构成有关的受试者间变异是导致同一剂型在不同人体中的药理学和药代动力学行为发生变化的主要原因。三维打印技术将有助于治疗的发展并消除传统技术的局限性。奈必洛尔(NBL)的口服生物利用度受限主要是由于其水溶性较差。该研究旨在结合先进的三维打印技术和纳米技术,设计定制化疗法,并利用统计方法增强 NBL 的功能。纳米颗粒给药技术是一种很有前景的溶解度增强技术,它能提高 NBL 的溶解度。采用 32 全因子设计,以聚(乳酸-共-乙醇酸 50:50)(PLGA 50:50)和 poloxamer-407 为表面活性剂,通过溶剂蒸发技术开发和优化仿生颗粒(BNPs)。对 BNPs 的表征包括封装效率(% EE)、傅立叶变换红外光谱(FTIR)和差示扫描量热仪(DSC)、透射电子显微镜(TEM)、ZETA 电位、多分散指数(PDI)、粒度、体外药物释放等。采用中心复合设计(CCD)优化的熔融沉积建模(FDM)技术,将负载 NBL 的 BNPs 添加到由 PVA 长丝制成的多通道三维控释片剂中。利用 CCD 对多通道三维打印仿生颗粒负载片剂(M3DPBT)进行了优化。对所有设计的 M3DPBT 进行了制造后参数评估。结论新制备的 M3DPBT 非常稳定。PLGA 50:50 和 Polaxomer 的用量对开发 BNPs 具有重要意义。据观察,填充率和层高对 M3DPBT 的设计至关重要。新型三维打印和纳米技术的结合将为患者的依从性和更好的治疗效果开辟一个新的方向。
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Multichannel 3D-printed bionanoparticles-loaded tablet (M3DPBT): designing, development, and in vitro functionality assessment

Background

The intersubject variability which was related to the genetic makeup was the major cause of change in pharmacological and pharmacokinetic behavior of same dosage form in varied human being. 3D printing technology will help therapy evolve and eliminate the limitations of conventional technologies. Nebivolol's (NBL)-limited oral bioavailability is mainly due to its poor aqueous solubility. The research aims to combine advanced 3D printing technology and nanotechnology to design customized therapy and enhance the functionality of NBL using a statistical approach.

Results and discussion

The results of the phase solubility indicated that NBL was a poorly aqueous soluble drug. Its solubility was increased by employing nanoparticle drug delivery, which is a promising solubility enhancement technique. The 32 full factorial design was employed to develop and optimize bionanoparticles (BNPs) by solvent evaporation technique using poly (lactic-co-glycolic acid 50:50) (PLGA 50:50) and poloxamer-407 as a surfactant. The BNPs were characterized by % encapsulation efficiency (% EE), Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimeter (DSC), transmission electron microscope (TEM), zeta potential, polydispersity index (PDI), particle size, in vitro drug release, etc. The BNPs loaded of NBL were further incorporated into the multichannel 3D-controlled release tablets made by PVA filaments employing fused deposition modeling (FDM) technology optimized by central composite design (CCD). Multichannel 3D-printed bionanoparticles-loaded tablet (M3DPBT) was optimized using CCD. All designed M3DPBTs were evaluated for post-fabrication parameters. The optimized M3DPBT could release more than 85% NBL within 10 h.

Conclusions

The newly fabricated M3DPBT was found stable. The amount of PLGA 50:50 and Polaxomer was significant for developing BNPs. % infill and layer height were observed as critical for the designing M3DPBT. The combined novel 3D printing and nanotechnology technology will open a new direction for patient compliance and better therapeutic effects.

Graphical abstract

Designing and developing of M3DPBT is substantially improve the patient compliance and therapeutic effectiveness of Nebivolol.

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来源期刊
自引率
0.00%
发文量
44
审稿时长
23 weeks
期刊介绍: Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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