• Journal of Pharmaceutical Investigation
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• 제35권6호
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• pp.471-481
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• 2005

In Korea, generic drug and bioequivalence test are the hot issues since a new medical system of separation of dispensary from medical practice was started in 2000. The KFDA(Korea FDA) had revised several times ${\ulcorner}Guidance\;for\;bioequivalence\;test{\lrcorner}$. In vitro dissolution test has been extensively used as a quality control tool for solid oral dosage forms. In an effort to minimize unnecessary human testing, in vitro/in vivo correlations (IVIVC) between in vitro dissolution and in vivo bioavailability are increasingly becoming an integral part on extended release drug product development. The recently published US guidance, ${\ulcorner}Extended\;release\;oral\;dosage\;forms\;:\;development,\;evaluation,\;and\;application\;of\;in\;vitro/in\;vivo\;correlations{\lrcorner}$ will be helpful for us to make our own guideline.

• Journal of Pharmaceutical Investigation
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• 제41권5호
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• pp.263-272
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• 2011

Tablet dosage forms have been preferred over other formulations for the oral drug administration due to their low manufacturing costs and ease of administrations, especially controlled-release applications. Controlled-release tablets are oral dosage forms from which the active pharmaceutical ingredient (API) is released over an intended or extended period of time upon ingestion. This may allow a decrease in the dosing frequency and a reduction in peak plasma concentrations and hence improves patient compliance while reducing the risk of undesirable side effects. Conventional singlelayered matrix tablets have been extensively utilized to deliver APIs into the body. However, these conventional single-layered matrix tablets present suboptimal delivery properties, such as non-linear drug delivery profiles which may cause higher side effects. Recently, a multi-layered technology has been developed to overcome or eliminate the limitations of the singlelayered tablet with more flexibility. This technology can give a good opportunity in formulating new products and help pharmaceutical companies enhancing their life cycle management. In this review, a brief overview on the multi-layered tablets is given focusing on the various tablet designs, manufacturing issues and drug release profiles.