increasing need for patient friendly dosage forms such as orally disintegrating tablets (ODT). The present study employs. Multi Unit Particulate System (MUPS) to ...
Development of Taste Masked Orally Disintegrating Extended Release Tablets of Memantine Hydrochloride Employing Multi Unit Particulate System P. RAMKUMAR, V. SRINIVASAN, R. SANKAR, J. SURYAKUMAR Orchid Chemicals & Pharmaceuticals Ltd. Purpose. Memantine is used for treatment of Alzheimer's disease which is the most common form of dementia among the elderly. Memantine Extended-Release (ER) Capsules are reported to be safe and well tolerated with associated benefits of once-daily administration and reduced side effects. These patients have difficulty in swallowing solid dosage forms, and there is an increasing need for patient friendly dosage forms such as orally disintegrating tablets (ODT). The present study employs Multi Unit Particulate System (MUPS) to provide an extended release of Memantine, which is further incorporated into a taste masking orally disintegrating tablet. Methods. Memantine ER pellets are prepared by drug layering on spherical seed cores in fluidized bed processor. Drug loaded pellets were further coated with suitable controlled-release polymer. Memantine ER ODT was formulated by combining pellets coated with different percentage of controlled-release polymer, and evaluated for in vitro release profile. ODT composition includes directly compressible mannitol providing compressibility and good mouth feel, superdisintegrant, glidant, flavor, sweetener etc. The developed formulation was evaluated for physical and chemical properties including in vitro dissolution rate, disintegration time and mouth feel. Results. Developed ODT formulation had a disintegration time of 12 seconds, and hardness of 5 kp. Post-compression, the extended release profile of pellets was unaltered, indicating their robustness. Dissolution studies were performed in 0.1N HCl for one hour followed by pH 6.8 phosphate buffer up to 16 hours using USP I apparatus, at 50 rpm, providing a zero order release profile with more than 95% drug release in 16 hours. Conclusion. Memantine ER ODT provided a promising option of once daily administration of Memantine, overcoming the swallowing difficulties of Alzheimer patients, with pleasant mouth feel and taste masking. A zero order in vitro release profile for 16 hours may thus provide a patient-convenient alternate to the current extended release capsules.
