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Preparation and evaluation of pH-dependent gradient-release pellets for TCM
Xing Tang1, XiaoLin Tian, Lei Ci
1School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China. tangpharm@sina.com
Drug Development and Industrial Pharmacy
|December 15, 2004
Summary
This study developed Guanxin Suhe Sustained-release Capsules (GSSC) for Traditional Chinese Medicinal Compound Recipes (TCMCR). The novel sustained-release system demonstrated comparable pharmacokinetic profiles to the original Guanxin Suhe Wan (GSW).
Area of Science:
- Pharmaceutical Sciences
- Pharmacology
- Traditional Chinese Medicine
Background:
- Traditional Chinese Medicinal Compound Recipes (TCMCR) often present challenges in achieving consistent therapeutic effects due to their complex formulations.
- Guanxin Suhe Wan (GSW), a traditional honey bolus formulation, requires optimization for sustained drug delivery.
- Developing novel drug delivery systems can enhance the efficacy and patient compliance of TCMCRs.
Purpose of the Study:
- To investigate a novel pH-dependent gradient-release coated pellet system for sustained drug release of TCMCR.
- To reformulate Guanxin Suhe Wan (GSW) into Guanxin Suhe Sustained-release Capsules (GSSC) with enhanced pharmacokinetic properties.
- To evaluate the pharmacokinetic behavior and relative bioavailability of the new GSSC formulation compared to the traditional GSW.
Main Methods:
- Preparation of beta-CD inclusion complexes for key components of GSW.
- Development of pH-dependent gradient-release pellets using powder layering and distinct coating materials (HPMC, HPMCP HP-55, Eudragit L100/S100).
- Formulation of GSSC by mixing three types of coated pellets in a 1:1:1 ratio and conducting pharmacokinetic studies using plasma drug concentration and serum pharmacology methods.
Main Results:
- The GSSC formulation achieved sustained release with Tmax values of 1.08 h (plasma) and 0.52 h (serum), compared to GSW's Tmax of 0.42 h (plasma) and 0.56 h (serum).
- Relative bioavailability of GSSC to GSW was 95.62% (plasma) and 121.82% (serum), indicating good drug absorption.
- Both pharmacokinetic methods showed similar predictive behavior for GSSC, validating the formulation's performance.
Conclusions:
- The developed Guanxin Suhe Sustained-release Capsules (GSSC) represent a novel and effective pH-dependent sustained-release system for TCMCR.
- The GSSC formulation demonstrates favorable pharmacokinetic characteristics and comparable bioavailability to the traditional Guanxin Suhe Wan (GSW).
- This sustained-release system holds potential for improving the therapeutic outcomes of TCMCRs through optimized drug delivery.
