Abstract
Abstract Aim The in vivo pharmacokinetics of thermoplastic-coated tablets prepared by a new technology of thermoplastic coating in Beagle dogs were studied, and the correlation between in vitro release and in vivo absorption was analyzed. Methods The in vitro release profiles of metformin hydrochloride thermoplastic-coated tablets and nifedipine thermoplastic-coated tablets were investigated. The single-dose pharmacokinetic study of these tablets in Beagle dogs was performed, and the obtained results were separately compared with the data of conventional osmotic pump tablets reported in the literature. Results Metformin hydrochloride thermoplastic-coated tablets and nifedipine thermoplastic-coated tablets displayed controlled drug-release characteristics and had a good in vivo–in vitro correlation in Beagle dogs, respectively. The literature-compared results further demonstrated that both thermoplastic-coated tablets had release characteristics of osmotic pump tablets in vivo. Conclusion The thermoplastic-coated tablets could control drug release in vivo and it was further confirmed that the new thermoplastic coating technology could replace the spray coating of osmotic pump controlled-release tablets. This study provides a theoretical basis and practical support for the industrialization and clinical application of the new thermoplastic coating technology.
Highlights
The preparation process of a new thermoplastic coating technology (HHL method),[1] the properties of the thermoplastic coating membrane,[2] and the in vitro release profiles of thermoplastic-coated tablets[3] have been published separately previously
The release data of M15–80 and N5–90 were fitted with drug-release models, such as zero-order, first-order, and the Higuchi square-root of time release equations by calculating the correlation coefficient r2,4 respectively
Release Profiles and Drug-Release Models The release profiles of M15–80 and N5–90 are shown in ►Figs. 1 and 2.3 The results showed that both tablets released slowly in vitro
Summary
The preparation process of a new thermoplastic coating technology (HHL method),[1] the properties of the thermoplastic coating membrane,[2] and the in vitro release profiles of thermoplastic-coated tablets[3] have been published separately previously. E2 New Technology of Thermoplastic Coating for OPTs Yuan et al. Metformin hydrochloride, a water-soluble drug, has been prepared as single-chamber OPTs while nifedipine, a waterinsoluble drug, is available as double-chamber OPTs on the market. A water-soluble drug, has been prepared as single-chamber OPTs while nifedipine, a waterinsoluble drug, is available as double-chamber OPTs on the market We selected these two representative drugs to evaluate the applicability of this new thermoplastic coating technology. To verify the in vivo drug-release properties of thermoplastic-coated tablets, metformin hydrochloride thermoplastic-coated tablets (HHL-METF) and nifedipine thermoplastic-coated tablets (HHL-NIF) were prepared and their pharmacokinetics in Beagle dogs were investigated and compared with OPTs prepared by the conventional spray coating. The in vitro–in vivo correlation was investigated to further confirm the substitutability of the HHL method, which laid a solid foundation for the industrialization and clinical application of the HHL method
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