Journal of Bioequivalence & Bioavailability

Application of pharmacokinetics and dissolution tests to the prediction of In-Vivo performance of an oral sustained-release pellet dosage form

4^th World Congress on Bioavailability and Bioequivalence: Pharmaceutical R&D Summit

May 20-22, 2013 DoubleTree by Hilton, Beijing, China

Ravisekhar Kasibhatta

AcceptedAbstracts: J Bioequiv Availab

Abstract:

Successful generic drug development needs a holistic approach of adequate pharmacokinetic knowledge of the molecule. Prediction of pharmacokinetic behavior at the early stage of drug development could be more beneficial for mitigating unsuccessful outcome. The major obstacle in making such predictions is the inability to correlate the In vitro data to the In vivo data. Key formulation variables like polymer selection and its coating and other scale up parameters are most critical factors influencing the success of the generic formulations. The presentation is designed to provide establishing relationships between different level of Eudragit RS 30D polymer coating (5%, 6% and 7%) and the effect of batch size (120 gm vs 1.200 kg), on pharmacokinetics of BCS Class 2 Sustained Release Capsules. The data from bioavailability study was used to construct In vitro and in vivo correlation. Appropriate dissolution methods and study designs for in-vivo outcome were used to predict better IVIVC. Results demonstrated that, increase in polymer coating concentration showed delay in the release rate and decrease in obtained Cmax and AUC values. The results evidencing that the reasonable influence of scale-up effects on bioavailability during 10 X scale-up employing similar equipment. Thus, characterizing some of the critical formulation variables in advance will definitely reduce the number of pharmacokinetic studies using healthy human subjects and also development time and cost in R&D establishment of generic players.

Biography :

Ravisekhar Kasibhatta has completed his Ph.D. from Nizam's Institute of Medical Sciences, Hyderabad, India. He is currently working as Vice President of Lupin Bioresearch Center, Pune, India a division of Lupin Ltd, India. He has published about 25 papers in reputed journals and recognized guide of Ph.D. programme in couple of universities in India in Pharmaceutical Sciences.