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A Chitosan-Polymer Hydrogel Bead System For A Metformin Hydrochloride Controlled Release Oral Dosage Form.

机译：盐酸二甲双胍控释口服剂型的壳聚糖-聚合物水凝胶微珠系统。

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摘要

The hydrogels or polyelectrolyte systems are based on ionic cross linking. They have been employed to prepare a controlled release dosage forms. These systems are based upon the fact that their structure can entrap the drug within them. They normally employ a hydrophilic matrix system.;Metformin hydrochloride (MH) a Class III drug was used as the model drug. Metformin hydrochloride (MH) is a highly water soluble and low permeability drug. Thus, a controllable dosage form system for the controlled release of metformin hydrochloride (MH) was attempted. Metformin hydrochloride (MH) loaded chitosan polyelectrolyte complex (PEC) hydrogel beads were prepared via ionotropic crosslinking with sodium tripolyphosphate (TPP). A combination of various polymers were studied with chitosan having metformin hydrochloride (MH) dispersed within them. Thus, metformin hydrochloride (MH) dispersed in 1.5% glacial acetic acid and having chitosan and polymers dispersed within it was cross linked with 1% sodium tripolyphosphate solution adjusted to a pH of 6.0--6.4. The beads prepared were examined for the optimal stirring conditions and curing time in order to obtain spherical beads. The prepared beads were filtered and kept at 35°C overnight to dry. The ratio of polymer: drug combination was kept around 1:1. The physical and chemical characterization of the resultant beads was done to determine their particle shape, particle diameter, weight, percent swelling, DSC studies, drug entrapment efficiency (DEE) as well as in vitro release. Fourier Transform Infrared (FTIR) and Powder X-ray Diffraction (PXRD) studies were performed to determine any possible drug polymer interaction. The effect of incorporating polymers such as sodium alginate, xanthan gum, hydroxy propyl methyl cellulose, and hydroxy ethyl cellulose on the physico-chemical properties of the beads were also studied. Spherical to oval beads with varying particle size, weight, DEE, and sustained release profile were obtained depending on the polymer combination used. These beads were able to sustain the release of the metformin HCl from the beads. The in vitro dissolution studies were done to assess the release pattern of the drug from the beads over a five to six hour period. A sample volume of 5 mL was taken from the dissolution apparatus and the same amount was replaced with an equal volume of phosphate buffer to maintain the sink conditions. The in vitro dissolution rate profile showed a sustained release of the drug from the beads. The dissolution profile was observed to be similar in nature for all the polymers studied. The chitosan beads were subjected to stability studies for one month. The stability results for the chitosan beads after one month were shown to be favorable with respect to providing a possible controlled release dosage form from the beads.
机译：水凝胶或聚电解质体系基于离子交联。它们已被用于制备控释剂型。这些系统基于这样的事实，即它们的结构可以将药物截留在其中。它们通常采用亲水性基质体系。盐酸二甲双胍（MH）是III类药物。盐酸二甲双胍（MH）是一种高度水溶性和低渗透性的药物。因此，尝试了用于盐酸二甲双胍（MH）的控释的可控剂型系统。通过与三聚磷酸钠（TPP）进行离子交联，制备了负载盐酸二甲双胍（MH）的壳聚糖聚电解质复合物（PEC）水凝胶珠。研究了各种聚合物的组合以及其中分散有盐酸二甲双胍（MH）的壳聚糖。因此，将分散在1.5％冰醋酸中并具有壳聚糖和聚合物的盐酸二甲双胍盐酸盐（MH）与1％的三聚磷酸钠溶液调节至6.0--6.4的pH值进行交联。检查制备的珠粒的最佳搅拌条件和固化时间，以获得球形珠粒。将制得的珠粒过滤并在35℃下保持过夜以干燥。聚合物：药物组合的比例保持在1：1左右。进行所得珠粒的物理和化学表征以确定它们的颗粒形状，粒径，重量，溶胀百分比，DSC研究，药物截留效率（DEE）以及体外释放。进行了傅里叶变换红外（FTIR）和粉末X射线衍射（PXRD）研究，以确定任何可能的药物聚合物相互作用。还研究了掺入诸如藻酸钠，黄原胶，羟丙基甲基纤维素和羟乙基纤维素之类的聚合物对珠子的理化性质的影响。根据所用的聚合物组合，获得了具有不同粒径，重量，DEE和持续释放曲线的球形至椭圆形珠。这些珠子能够维持从珠子中释放盐酸二甲双胍。进行了体外溶出研究，以评估药物在五到六小时内从珠粒释放的方式。从溶出度仪中取出5 mL样品，并用等体积的磷酸盐缓冲液代替相同量的样品以保持水槽条件。体外溶出速率曲线显示药物从珠粒中持续释放。对于所有研究的聚合物，观察到的溶出曲线本质上是相似的。对壳聚糖珠进行稳定性研究一个月。对于从珠粒提供可能的控释剂型而言，显示一个月后的壳聚糖珠粒的稳定性结果是有利的。

著录项

  • 作者

    Dogra, Sanjeev.;

  • 作者单位

    The University of Toledo.;

  • 授予单位 The University of Toledo.;
  • 学科 Health Sciences Pharmacy.
  • 学位 M.S.P.
  • 年度 2011
  • 页码 139 p.
  • 总页数 139
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类
  • 关键词

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