Search results for "In vitro in vivo"
showing 5 items of 5 documents
Pharmacokinetics of a sustained release formulation of PDGFβ-receptor directed carrier proteins to target the fibrotic liver
2018
Liver fibrogenesis is associated with excessive production of extracellular matrix by myofibroblasts that often leads to cirrhosis and consequently liver dysfunction and death. Novel protein-based antifibrotic drugs show high specificity and efficacy, but their use in the treatment of fibrosis causes a high burden for patients, since repetitive and long-term parenteral administration is required as most proteins and peptides are rapidly cleared from the circulation. Therefore, we developed biodegradable polymeric microspheres for the sustained release of proteinaceous drugs. We encapsulated the drug carrier pPB-HSA, which specifically binds to the PDGF beta R that is highly upregulated on a…
Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool
2020
[EN] The main objective of this investigation was to develop an in vitro-in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by designing an in vitro dissolution test to be used as development tool. The IVIVC could be used to reduce failures in future bioequivalence studies. Data from two bioequivalence studies were scaled and combined to obtain the dataset for the IVIVC. Two-step and one-step approaches were used to develop the IVIVC. Experimental solubility and permeability data confirmed candesartan cilexetil. Biopharmaceutic Classification System (BCS) class II candesartan average plasma profiles were deconvoluted by the Loo-Riegelman method to obtain th…
In vitro–in vivocorrelations: general concepts, methodologies and regulatory applications
2015
The major objective of in vitro-in vivo correlations is to be able to use in vitro data to predict in vivo performance serving as a surrogate for an in vivo bioavailability test and to support biowaivers. Therefore, the aims of this review are: (i) to clarify the factors involved during bio-predictive dissolution method development; and (ii) the elements that may affect the mathematical analysis in order to exploit all information available. This article covers the basic aspects of dissolution media and apparatus used in the development of in vivo predictive dissolution methods, including the latest proposals in this field as well as the summary of the mathematical methods for establishing …
In vivopredictive release methods for medicated chewing gums
2012
Understanding the performance of a drug product in vivo plays a key role in the development of meaningful in vitro drug release methodology. In case of functional chewing gums, the mode and the mechanism of release and the site of application differ significantly from other conventional solid oral dosage forms and require a special consideration to extract meaningful information from clinical studies. In the current study, suitable drug release methodology was developed to predict the in vivo performance of an investigated chewing gum product. Different parameters of the drug release testing apparatus described in the Ph. Eur. and Pharmeuropa were evaluated. Drug release data indicate that …
Influence of Different Rehydration Protocols on Biomechanical Properties of Allogeneic Cortical Bone Plates: A Combined in-vitro/in-vivo Study
2020
Introduction: Allogeneic cortical bone plates (CP) are used for alveolar ridge augmentation. Since CP are freeze-dried and dehydrated during processing, the breaking strength (BS) and the flexibility (FX) are reduced, resulting in a relevant risk for plate fractures during insertion. The aim of this study was to evaluate the influence of rehydration time on the biomechanical properties (BS & FX) of CP in-vitro and in vivo.Material and Methods: 40 CP were randomly divided into four experimental groups. (A) untreated control (n = 10), rehydration for 10 (B), 30 (C) and 60 (D) minutes in 0.9% saline solution (n = 10 each). BS [Newton, N] and FX [mm] (force till fracture and distance of deflect…