12
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: not found

      Lidocaine Transdermal Patch: Pharmacokinetic Modeling and In Vitro-In Vivo Correlation (IVIVC).

      Read this article at

      ScienceOpenPublisherPubMed
      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          The present study aims to develop the correlation between in vitro and in vivo skin permeation of lidocaine in its transdermal patch. In order to minimize the run-to-run variability during in vitro skin permeation studies, release normalized cumulative percent (%Ct n) was calculated. A suitable polynomial mathematical model was used to establish a correlation between time and %Ct n. Percent in vivo absorbed was calculated by using numerical deconvolution (NDC) and non-compartmental analysis (NCA) methods. Pharmacokinetic (PK) parameters such as AUC last and C max were predicted with the established in vitro-in vivo correlation (IVIVC) models. The minimum prediction errors in NDC method for C max were found to be -30.9 and -25.4% for studies I (in vivo study in human volunteers with one batch of Lidoderm patch; internal validation) and II (in vivo study in human volunteers with another batch of Lidoderm patch; external validation), respectively, whereas minimum prediction errors in NCA method were relatively low (3.9 and 0.03% for studies I and II, respectively) compared to those in NDC method. The prediction errors for AUC last were found to be less than 2% for both methods and studies. The established method in this study could be a potential approach for predicting the bioavailability and/or bioequivalence for transdermal drug delivery systems.

          Related collections

          Author and article information

          Journal
          AAPS PharmSciTech
          AAPS PharmSciTech
          Springer Nature America, Inc
          1530-9932
          1530-9932
          Jun 2016
          : 17
          : 3
          Affiliations
          [1 ] Centre of Excellence- Bio Studies, Hyderabad, Telangana, India.
          [2 ] Integrated Product Development Organisation, IPDO- Innovation Plaza, Dr. Reddy's Laboratories, Bachupally, R R District, Hyderabad, 500090, India.
          [3 ] Formulations R & D, Softgel, Topical, Transdermal and Respiratory (STaR) Vertical, Hyderabad, India.
          [4 ] Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal, 576104, Karnataka, India.
          [5 ] Softgel-Transdermal/Topical-Respiratory (STaR) Product Development, Dr.Reddy's Laboratories, Hyderabad, 500090, Andhra Pradesh, India. ravip@drreddys.com.
          [6 ] Integrated Product Development Organisation, IPDO- Innovation Plaza, Dr. Reddy's Laboratories, Bachupally, R R District, Hyderabad, 500090, India. ravip@drreddys.com.
          Article
          10.1208/s12249-015-0390-1
          10.1208/s12249-015-0390-1
          26283198
          5a236c26-3d28-49a3-98be-c801a71b49b9
          History

          IVIVC,transdermal,numerical deconvolution,lidocaine,bioequivalence

          Comments

          Comment on this article