The subject and the research objective presented in this article is
establishing of the relationship between quality assurance and
implementation of cleaner production in the generic pharmaceutical industry
through the comprehensive concept of continuous improvement. This is mostly
related to application of Lean and Six Sigma tools and techniques for
process improvement and their link to other known concepts used in the
industrial environment, especially manufacturing of generic pharmaceutical
products from which two representative case studies were selected for
comparative analysis, also considering relevant regulatory requirements in
the field of quality management, as well as appropriate quality standards.
Although the methodology discussed in this conceptual and practice oriented
article is strongly related to chemical engineering, the focus is mainly on
process industry, i.e. production systems, rather than any specific
technological process itself. The scope of this research is an engineering
approach to evaluation of the production systems in terms of continuous
improvement concepts application, considering both quality aspects and
efficiency of such systems. [Projekat Ministarstva nauke Republike Srbije,
br. TR 34009]
Results of this study have shown significantly prolonged release of selected antibiotic from liposome dispersion as compared to free antibiotic solution of the same initial concentration. Two models of non-steady one-dimensional diffusion were successfully applied to the experimental data and the antibiotic diffusion coefficients were estimated. In addition, the mass transfer resistance of the membrane was shown to be insignificant confirming the suitability of the applied experimental system. Since liposomes are known as systems with slower drug release, then, when it comes to their incorporation in the final form of a preparation for further experiments in vivo, the system of choice would be liposomes with an encapsulated antibiotic drug. The established experimental system could be extended to other liposome formulations with respect to the release rate of the active components
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