In vivo performance evaluation and establishment of IVIVC for osmotic pump based extended release formulation of milnacipran HCl. (11th April 2013)

• Record Type: Journal Article
• Authors: Parejiya, Punit B.; Barot, Bhavesh S.; Patel, Hetal K.; Chorawala, Mehul R.; Shelat, Pragna K.; Shukla, Arunkumar
• Is Part Of: Biopharmaceutics & drug disposition. Volume 34:Number 4(2013:May)
• Page Start: 227
• Page End: 235
• Publication Date: 2013-04-11
• Subjects: Biopharmaceutics -- Periodicals; Drugs -- Metabolism -- Periodicals; Pharmacology -- Periodicals; Biopharmaceutics -- Periodicals; Pharmaceutical Preparations -- metabolism -- Periodicals; 615.19
• DOI: 10.1002/bdd.1840
• Languages: English
• ISSNs: 0142-2782

Abstract

<abstract abstract-type="main"> <title>ABSTRACT</title> <p>The objective of the present study was to carry out a pharmacokinetics evaluation of an oral modified release formulation [Aquarius EKX 19102 SRX–2 based osmotic pump (OP)] containing highly soluble milnacipran HCl (MH) as a model drug. It was also aimed at developing an <italic>in vitro–in vivo</italic> correlation (IVIVC) model for a developed OP. <italic>In vivo</italic> plasma concentration data were obtained from six healthy male New Zealand albino rabbits after administration of immediate‐release milnacipran HCl solution (IRMHSOL) and milnacipran HCl osmotic pump (MHOP). <italic>In vitro</italic> samples were analysed using an in house developed spectrophotometry method and <italic>in vivo</italic> samples were analysed using a RP‐HPLC method developed by the author. A deconvolution based Level A model was attempted through a correlation of the percent <italic>in vivo</italic> input obtained through deconvolution and the percent <italic>in vitro</italic> dissolution obtained experimentally. A good correlation between the percentages dissolved vs absorbed (<italic>R</italic><sup>2</sup> = 0.978) was obtained using level A correlation. Evaluation of the internal predictability of level A correlation was calculated in terms of the percent prediction error, which was found to be below 15%. In a nutshell, the success of the present study warrants further studies in patient volunteers to assess the ability of the MHOP to provide an effective therapy for depression. Copyright © 2013 John Wiley & Sons, Ltd.</p> </abstract>