Preparation and in Vitro Evaluation of Generics of Guanfacine Hydrochloride Extended-release Tablets
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Graphical Abstract
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Abstract
OBJECTIVE To prepare generics of guanfacine hydrochloride extended-release tablets and study the development way of generics extended-release prescription. METHODS Following the guiding principles of the CFDA on generics research and analysis of the reference listed drug, the formulation was proposed and evaluated with regards to the in vitro release, stability and technology. RESULTS The optimal formulation had the acceptable attributes for mass production. Ggeneric drugs and reference preparation can be released in a variety of media similar curves, while meeting the bioequivalency exemption requirements of small qenerics. CONCLUSION The formulation and technology of guanfacine extended-release tablets is properly developed.
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