Evaluation of galen IQ polymer in Tramadol Hydrochloride orally disintegrating tablet.
Keywords:
Tramadol Hydrochloride, galen IQ, Orally Disintegrating TabletAbstract
The present work aims at the formulation development and evaluation of Tramadol Hydrochloride orally disintegrating tablets using galen IQ as a diluent. galen IQ, official as Isomalt doesn’t have much generation of data with respect to its functionality. Attempts were made to prepare binder-free, 250 mg Tramadol Hydrochloride orally disintegrating tablets using different concentrations of Crospovidone, Croscarmellose Sodium, Sodium Starch Glycolate and Starch 1500 as disintegrants in different combinations by direct compression method. Tramadol Hydrochloride is a water soluble drug and the dose taken was 50 mg. Preformulation studies on Tramadol Hydrochloride were carried out, followed by excipient compatibility studies between the drug , galen IQ and other excipients being used in the formulation. Spectroscopic studies were also conducted in order to deduce out the λmax (lambda-max).A total of ten formulations (F1 to F10) were developed .F10 batch was found to give best results on the basis of disintegration time of 21 seconds. The powdered blend of F10 was evaluated for flow properties. The tablets of F10 batch were also evaluated for post compression tests like hardness, friability, weight variation, wetting time, water absorption ratio, content uniformity, assay, disintegration time and dissolution which were found to be within the prescribed limits. The tablets of F10 batch were also compared with the marketed formulation and were found to show pharmaceutical equivalence with a similarity factor (f2) of 85.72.All this work suggested that galen IQ could be successfully used as a diluent in the formulation of Tramadol Hydrochloride orally disintegrating tablet.
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