2014
DOI: 10.1007/s40204-014-0029-4
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In vitro–in vivo correlation from lactide-co-glycolide polymeric dosage forms

Abstract: The objective of this study was to compare the in vitro behavior of four long-acting subcutaneous risperidone formulations with in vivo performance, with the intent of establishing an IVIVC. Two copolymers of PLGA (50:50 and 75:25) were used to prepare four microsphere formulations of risperidone, an atypical antipsychotic. In vitro behavior was assessed at the physiological temperature (37 °C) using the ‘modified dialysis’ technique. The in vitro release profile demonstrated rank order behavior with Formulati… Show more

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Cited by 37 publications
(28 citation statements)
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“…Among the in vitro release methods developed so far, the sample‐and‐separate approach is the most widely used, mainly because this methodology is simple and does not require complex apparatus . However, there are certain concerns about this approach, in particular, inability to mimic various in vivo release conditions, loss of the particles during sampling procedure, and poor hydrodynamic conditions .…”
Section: Discussionmentioning
confidence: 99%
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“…Among the in vitro release methods developed so far, the sample‐and‐separate approach is the most widely used, mainly because this methodology is simple and does not require complex apparatus . However, there are certain concerns about this approach, in particular, inability to mimic various in vivo release conditions, loss of the particles during sampling procedure, and poor hydrodynamic conditions .…”
Section: Discussionmentioning
confidence: 99%
“…Many studies have shown that membrane dialysis approach provides a good correlation with in vivo experiments . However, due to its inability to achieve sink conditions, use of the dialysis approach to analyze the release of hydrophobic drugs can lead to ambiguous interpretations.…”
Section: Discussionmentioning
confidence: 99%
See 1 more Smart Citation
“…Over the past decades, the development of IVIVCs for parenteral microspheres has increasingly gained more significance. The same principles as detailed in the FDA IVIVC Guidance on extended release oral dosage forms have been applied in literature to develop IVIVCs for parenteral drug products [15][16][17][18][19][20]. However, due to their complex release characteristics (e.g.…”
Section: Introductionmentioning
confidence: 99%
“…bi-or tri-phasic release profiles), deconvolution of in vivo data and correlation with in vitro release data have been challenging. Until now, there are only a few literature reports on the establishment of IVIVCs for parenteral polymeric microspheres, albeit with different in vitro release testing approaches, such as the USP 4 method [19,20], dialysis based methods [17,18], as well as sample-and-separate methods [21][22][23]. None of these has addressed the importance of developing an IVIVC for compositionally equivalent PLGA microspheres with manufacturing differences.…”
Section: Introductionmentioning
confidence: 99%