title: In vivo performance evaluation and establishment of IVIVC for osmotic pump based extended release formulation of milnacipran HCl.
abstract: 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 in vitro-in vivo correlation (IVIVC) model for a developed OP. In vivo 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). In vitro samples were analysed using an in house developed spectrophotometry method and in vivo 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 in vivo input obtained through deconvolution and the percent in vitro dissolution obtained experimentally. A good correlation between the percentages dissolved vs absorbed (R(2) = 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.
authors: K. B. Institute of Pharmaceutical Education and Research, Gandhinagar, India- 382023. punit_pharma@yahoo.co.in
authors: Punit B
authors: PB
authors: Parejiya
authors: Bhavesh S
authors: BS
authors: Barot
authors: Hetal K
authors: HK
authors: Patel
authors: Mehul R
authors: MR
authors: Chorawala
authors: Pragna K
authors: PK
authors: Shelat
authors: Arunkumar
authors: A
authors: Shukla
mesh_terms: D000284:Administration, Oral; D018759:Adrenergic Uptake Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D000818:Animals; D002851:Chromatography, High Pressure Liquid; D056148:Chromatography, Reverse-Phase; D003521:Cyclopropanes / Q000008:administration & dosage / Q000493:pharmacokinetics*; D003692:Delayed-Action Preparations; D008297:Male; D000078764:Milnacipran; D008954:Models, Biological; D009995:Osmosis; D011817:Rabbits; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D012995:Solubility; D013053:Spectrophotometry
chemical_list: D018759:Adrenergic Uptake Inhibitors; D003521:Cyclopropanes; D003692:Delayed-Action Preparations; D000078764:Milnacipran; D017367:Selective Serotonin Reuptake Inhibitors