FORMULATION AND EVALUATION OF EXTENDED RELEASE PELLETS OF PIOGLITAZONE HYDROCHLORIDE USING NATURAL AND SYNTHETIC POLYMERS BY FLUIDIZED BED COATING TECHNIQUE
Objective: The objective of the current work was to develop Pioglitazone hydrochloride (HCl) pellets coated with natural polymer extracted from peas gum and also to compare the drug release profile with coatings containing semi-synthetic and synthetic polymers.
Methods: Fluidized bed coating technique was used to develop pellets. A 22 factorial design was employed to study the effect of independent variables (inlet air temperature and spray rate), on dependent variables (percentage entrapment efficiency, percentage friability, and average particle size). Optimization was done by fitting experimental data to the software program. Obtained pellets were subjected to different evaluation parameters which are critical in the development of the dosage form. An in vitro lag phase study was carried out for all batches in simulated gastric fluid (0.1N HCl) for 5 h and in vitro drug release study was carried out for optimized batch (E-2 and P-3) in simulated intestinal fluid (pH 7.4 phosphate buffer).
Results: The optimized batches E-2 and P-3 showed satisfactory percentage entrapment efficiency of 92.66±1.52, percentage friability of 0.57±0.03, and average particle size of 1424±16 μm. All batches maintained lag phase for 5 h in 0.1N HCl. An optimized batch of two different sizes exhibited a burst release within 30 min in a simulated intestinal fluid with no significant difference in release rate constant (*p>0.05) and followed first-order kinetics.
Conclusion: Thus, Pioglitazone HCl pulsatile pellets were successfully developed for treating diabetes mellitus by fluidized bed coating technique employing factorial design.
2. Ramesh C, Rani AP. In vivo and in vitro evaluation of Tephrosia calophylla for anti-diabetic properties. Int J Pharm Pharm Sci 2018;10:77-84.
3. Aalto AM, Uutela A, Aro AR. Health related quality of life among insulin-dependent diabetics: Disease-related and psychosocial correlates. Patient Educ Couns 1997;30(3):215-25.
4. Patel SA, Patel NG, Joshi AB. Multiple unit pellet system (MUPS) based fast disintegrating delayed-release tablets for pantoprazole delivery. Int J Pharm Pharm Sci 2018;10:138-44.
5. Jain K. Gastro Retentive Drug Delivery: Progress in Controlled and Novel Drug Delivery System. 1st ed. New Delhi: CBS Publisher and Distributer; 2004. p. 82-90.
6. Asian Edition. The United State Pharmacopeia. New York: Asian Edition; 2000. p. 2059.
7. Grass GM., Robinson JR, Dekker M. In: Banker GS, Rhodes CT, editors. Modern Pharmaceutics. New York: Informa Healthcare USA Inc.; 1996. p. 635.
8. Ali M. Textbook of Pharmacognosy. 2nd ed. New Delhi: CBS Publishers and Distributors; 2012. p. 71-90.
9. Kokate C, Purohit A, Gokhle S. Pharmacognosy. 42nd ed. Pune: Nirali Prakashan; 2008.
10. Begum R, Aleemudin M, Gautam T. Effect of natural gums on oral sustained release matrix tablets of chloroxone. Int Res J Pharm 2012;3:426-7.
11. Rao NR, Yadav A. Formultion and evaluation of zero order release glipizide bilayer matrix tablet using natural and synthetic polymers. Int J Curr Pharm Res 2010;2:34-42.
12. Kumar AA. Formulation and evaluation of sustained release valsatran matrix tablets by using natural polymers. Int J Pharm Chem Biol Sci 2012;2:146-50.
This work is licensed under a Creative Commons Attribution 4.0 International License.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.