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Investigation of formulation and processing technique on the characteristics of polymeric powders produced for suspension type pressurized metered dose inhaler systems

机译：悬浮式加压定量吸入器系统生产的聚合物粉末特性的配方和加工技术研究

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摘要

The objective of this study was to investigate and develop processing techniques for producing powder formulations applicable in pressurized metered dose inhalers (pMDIs). Co-grinding the model drug, triamcinolone acetonide (TAA), with a polymeric surfactant was the first technique investigated. The physicochemical properties of TAA after co-grinding with the surfactant, Pluronic F77RTM, were determined by laser light diffraction, helium pycnometry and equilibrium solubility measurements. TAA-surfactant interaction was investigated by differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR). The suspension characteristics of pMDI formulations prepared with co-ground TAA and surfactant were investigated by determining their in situ sedimentation, rheological profiles and vapor pressure. The performance characteristics of the pMDI formulations were determined by cascade impaction and dose delivery through-the-valve (DDV) measurements. It was found that the presence of Pluronic F77RTM decreased the solubility of TAA in the propellant medium. Co-grinding TAA particles with Pluronic F77 RTM influenced the particle size distribution, sedimentation and flocculation characteristics of the pMDI suspension formulation. The addition of Pluronic F77RTM decreased the viscosity of the pMDI formulation. Formulating the suspension pMDI system with co-ground TAA and Pluronic F77 RTM decreased the mass median aerodynamic diameter (MMAD) of the emitted aerosol and increased the fine particle fraction (%FPF). The co-ground TAA and Pluronic F77RTM pMDI suspension formulation exhibited greater physical stability which was due to the influence of the co-grinding technique on the physicochemical properties of the TAA particle surface and the propellant dispersion medium. The changes induced by co-grinding with Pluronic F77RTM improved the performance characteristics of a pMDI suspension formulation by stabilizing the suspension and influencing the flocculation characteristics. Co-grinding is a process that may be useful for developing new pMDI systems containing hydrofluoroalkane (HFA) propellants, P134a and P227. The second technique investigated was the production of microspheres made of chitosan, a biodegradable polymer, by a spray drying technique developed by Carmen Remunan-Lopez, Ph.D. Through the use of different cross-linking agents and additives, the physicochemical properties of chitosan microspheres were modified to improve compatibility in a pMDI delivery system.;Finally, a novel cryogenic spray process was developed for the production of porous polymeric matrix microsphere powder formulations for delivery to the respiratory tract via a pMDI aerosol system. It was determined that by varying the process parameters, the physicochemical characteristics of model polymeric microspheres of polyethylene glycol (PEG) could be modified in order to maximize their applicability and performance in a suspension type pMDI system. (Abstract shortened by UMI.).
机译：这项研究的目的是研究和开发用于生产适用于加压定量吸入器（pMDI）的粉末制剂的加工技术。与聚合物表面活性剂共研磨模型药物曲安奈德（TAA）是第一个研究的技术。通过激光衍射，氦比重瓶法和平衡溶解度测量来确定与表面活性剂Pluronic F77RTM共研磨后TAA的理化性质。通过差示扫描量热法（DSC）和傅里叶变换红外光谱（FTIR）研究了TAA-表面活性剂的相互作用。通过测定原位沉淀，流变曲线和蒸气压，研究了用共研磨的TAA和表面活性剂制备的pMDI制剂的悬浮特性。 pMDI制剂的性能特征通过级联冲击力和通过阀门的剂量输送（DDV）测量来确定。发现Pluronic F77RTM的存在降低了TAA在推进剂介质中的溶解度。将TAA颗粒与Pluronic F77 RTM共研磨会影响pMDI悬浮液配方的粒径分布，沉降和絮凝特性。添加Pluronic F77RTM会降低pMDI配方的粘度。用TAA和Pluronic F77 RTM共研磨的悬浮液pMDI系统的配制可降低排放气溶胶的质量中值空气动力学直径（MMAD），并增加细颗粒分数（％FPF）。共研磨的TAA和Pluronic F77RTM pMDI悬浮液配方显示出更高的物理稳定性，这是由于共研磨技术对TAA颗粒表面和推进剂分散介质的物理化学性质的影响所致。与Pluronic F77RTM共研磨引起的变化通过稳定悬浮液并影响絮凝特性而改善了pMDI悬浮液配方的性能特征。共研磨是一种对开发含有氢氟烷烃（HFA）推进剂P134a和P227的新型pMDI系统有用的过程。研究的第二项技术是通过Carmen Remunan-Lopez博士开发的喷雾干燥技术生产由壳聚糖（一种可生物降解的聚合物）制成的微球。通过使用不同的交联剂和添加剂，改变了壳聚糖微球的理化性质，以改善在pMDI输送系统中的相容性。最后，开发了一种新颖的低温喷雾工艺，用于生产多孔聚合物基体微球粉末配方，用于通过pMDI气雾剂系统输送到呼吸道。已确定可以通过改变工艺参数来改变聚乙二醇（PEG）模型聚合物微球的理化特性，以使其在悬浮型pMDI系统中的适用性和性能最大化。 （摘要由UMI缩短。）。

著录项

  • 作者

    Barron, Melisa Kay.;

  • 作者单位

    The University of Texas at Austin.;

  • 授予单位 The University of Texas at Austin.;
  • 学科 Pharmaceutical sciences.
  • 学位 Ph.D.
  • 年度 2000
  • 页码 282 p.
  • 总页数 282
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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