Dissolution Method for Milnacipran Hydrochloride Capsules: Development, Validation, and Study of Changes in Dissolution Rate after Storage

Dias, Carolina Lupi; Rossi, Rochele Cassanta; Bajerski, Lisiane; Fröehlich, Pedro Eduardo

doi:10.14227/dt180311p47

Cited by 1 publication

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“…Milnacipran hydrochloride (MH), is a cyclopropane derivative with the chemical name (±)‐[1 R ( S ), 2 S ( R )]‐2‐(aminomethyl)‐ N , N ‐diethyl‐1‐phenylcyclopropanecarboxamide hydrochloride . It is a drug of choice for both depression and pain.…”

Section: Introductionmentioning

confidence: 99%

In vivo performance evaluation and establishment of IVIVC for osmotic pump based extended release formulation of milnacipran HCl

Parejiya¹,

Barot²,

Patel³

et al. 2013

Biopharm & Drug Disp

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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.

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Section: Introductionmentioning

confidence: 99%