Revista estadounidense de administración avanzada de fármacos Acceso abierto

Abstracto

Formulation and Evaluation of Immidiate Release and Sustained Release Bilayer Tablets of Tramadol Hydrochloride

Arti Mohan, T. Vaishali

Tramadol is a centrally acting analgesic having amino cyclo hexanol group, which has a strong analgesic action .It is administered when non steroidal anti inflammatory drugs fail to mitigate pain. Conventional sustained release formulation of Tramadol hydrochloride is not adequate because of lack of initial bolus dose. This drawback can be overcome by combining immediate release and sustained release in a single bilayer tablet. Hence, the aim of the current work is to develop a bilayer dosage form which would release 30% of the drug within 30 minutes and the balance 70% would then release over a period of 12 to 24 hours. In order to optimize the various parameters six different formulations of IR layer and twelve different formulations of SR layer were prepared and compressed separately . The best formulation for both IR nd SR layer selected on the basis of their dissolution profiles. A tablet press had been specifically designed and developed for the production of bilayer tablets. From the study it was concluded that bilayer tablets of Tramadol Hydrochloride can be successfully formulated with 4% crosspovidone as superdisintegrant for immediate release layer and 25% HPMC K 100M and 25% PEO N80 as polymers for sustained release layer. The percentage drug release of the optimized batch was found to be 97.51% at 24th hour. Thus bilayer tablets could be a potential dosage form for delivering Tramadol as immediate release and controlled release manner.