EVALUATION OF DIFFERENT SYNTHETIC AND NATURAL POLYMERS AS PROTECTIVE LAYER POLYMERS ON TOLTERODINE TARTRATE CONTROL RELEASE MUPS TABLETSAbstract
Evaluation of different natural and synthetic polymers as protective layer polymers in the manufacturing of control release multi-unit pellet tablets, Tolterodine Tartrate was selected as a model drug with aqueous ethylcellulose suspension is used as control release polymer. Tolterodine Tartrate is highly soluble BCS Class- I molecule, hence selected aqueous solution layering method for drug loading in Fluid bed processor, Optimized formulation was manufactured by using seal coating on microcrystalline cellulose pellets followed by drug loading and control release coating applied by using solution and suspension layering method respectively in Fluid bed processor. Given coating on these functional coated pellets with different natural and synthetic polymers like Klucel, Polyethylene glycol 6000, Hypromellose 5 cps, Guar gum, and Xanthan gum. Evaluated these pellets for physical characterization, DSC, SEM and comparative in-vitro dissolution profiles. Drug release profiles of Control release MUPS tablets containing protective layer coating was compared to those control release pellets and f2 values observed was more than 50 with Klucel, Polyethylene glycol 6000, Hypromellose 5 cps, Guar gum, and Xanthan gum coated multi-unit pellet tablets respectively. whereas faster release profiles were observed with Polyethylene glycol 6000 protective layer MUPS tablets. Based on these dissolution profiles it was concluded that by applying low viscous natural or synthetic binders on functional coating pellets gives good protection to functional coating pellets from damage during compression and also provided similar dissolution profiles compared to control release pellets. It is a very effective and potential strategy for manufacturing of MUPS tablets.
S. P. Borra *, M. C. Eswaraiah and G. K. Reddy
Formulation Development, Hetero Labs Ltd., Hyderabad, Telangana, India.
27 August, 2018
05 November, 2018
22 November, 2018
01 December, 2018