Development of An Antidiabetic Phytocomposite Loaded Phytoceutical Formulation, Its Quality Control and Pharmacokinetic Studies and Establishing In Vitro- In Vivo Correlation

De Baishakhi, Bhandari Koushik, Katakam Prakash, Adiki Shanta, Mitra Analava


This study reports the development of solid oral phytoceutical formulations with Phytocomposite (PHC), an antidiabetic
poly herbal preparation as the active core material. Spherical, monolithic PHC microspheres of size range (10 -100 µm)
were obtained with Hausner ratio, Carr’s index and angle of repose of 1.141± 0.010, 12.418±0.769 and 25.17±0.96
respectively. Encapsulation efficiency amongst different batches (F1-F5) ranged from 96.8- 100.7, with 99% release
profile up to 12h. Conventional and sustained release tablets were prepared by direct compression and compatibility
amongst polymers and the PHC checked by FTIR studies. Natural polymers viz. gum kondagogu, gum karaya, Aegle
marmelos gum were used as release retardant. Optimized batch of conventional tablets (F6) showed 99.8 % release in 35
min and optimized batch of PHC-SR tablets (F12) showed 99.9% release at 12th hr, both followed zero order kinetics and
non-Fickian diffusion. These optimized formulations were subjected to stability studies and the similarity factors (f2) of
the conventional and SR tablets were 88.75 and 66.76 respectively. Pharmacokinetic parameters of three formulations in
rat plasma were analyzed by PK Solver 2.0. In vitro-in vivo correlation (IVIVC) of three different formulations showed
Level A correlation in all cases.


phytocomposite, microspheres, conventional, sustained release, phytoceutical, Level A correlation.

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