Analytical Performance of a Fiber Optic Probe Dissolution System

Abstract

Introduction issolution testing is a time-consuming and l a bo r i nte n s i ve test proce d u re.The te c hnique re q u i res a sample of dissolution medium be re m oved from each of the te s t vessels at a specified time po i nt ( s ) . This sampling p roce d u re can be handled either manually or by means of an auto m ated sipper mechanism.Ea c h m e t h od has its own inhere nt errors assoc i ated with i t .The manual technique is subject to analyst va ria b i l i ty.Two of the most common errors assoc i ate d with the manual sampling technique are impro pe r sampling within the vessel and timing errors in s a m p l i n g.Ad d i t i o n a l l y,this is the most labo r i nte ns i ve technique and is especially taxing fo r co nt ro l l e d release fo rm u l at i o n s,which ofte n re q u i re 24-hour testing pe ri od s.Au to m at i c sampling techniques can save analyst labo r,but still re q u i re a good deal of mainte n a n ce and set-up t i m e.Al s o,a u to m ated sipping mechanisms are co m p l ex and co ntain many moving parts that ca n m a l f u n ct i o n , resulting in sampling erro r s.Si p pe r mechanisms are prone to sample co nt a m i n at i o n , ca rryove r,b u b b l e s,d i l u t i o n ,f i l ter clog g i n g,a n d tubing leaks. An In-Situ dissolution technique will eliminate all of these sampling pro b l e m s.A number of re s e a rchers have inve s t i g ated this technique to s t u dy the fe a s i b i l i ty of this te c h n o l ogy ( 1 , 2 , 3 ) .Mo re re ce ntly wo rk has been done with pro bes in tra d itional sampling locat i o n ( 4 , 5 , 6 , 7 ) ,as well as with a p ro be i n s h a ft sampling te c h n i q u e ( 9 ) . This publication will discuss a fiber optic pro be dissolution sys tem that we have deve l o ped at Pu rdue Ph a rma LP.Wh at sets our dev i ce apart is t h at it is a fully inte g rated sys tem consisting of va l id ated hardwa re and softwa re.We have suce s s f u l y used the sys tem in our RDa wide range of pat hlengths may be used with the sys tem ( Fi g u re 2). We a re curre ntly using pro bes with 2cm to 0.2 cm Abstract A UV Fi ber Optic Pro be Dissolution Sy s tem has been deve l o ped for the analysis of solid dosage fo r m s. The syste m uses 12 dip-ty pe fibe r-optic pro bes coupled to 12 separa te Ph o to Di ode Ar ray (PDA) spe ct ro p h o to m e ters to acquire continuous dissolution curves in real time. The system is applicable to the analysis of both immediate and co n t ro l l e d release fo r m u l a t i o n s. The system is accura te, q u i c ke r,and easier to set up when co m p a red with co nve ntional HPLC or UVs i p per syste m s. The data is acquire d,ca l c u l a te d, and secured using an in-house deve l o ped and va l i d a ted softwa re packa g e. The softwa re package uses a novel sca t te rco r re ction algorithm to genera te accura te dissolution curves in a turbid medium. The data that the system genera tes is as accura te as the HPLC methods that it is re p l a c i n g.