Formulation and evaluation mouth dissolving tablets of Tramadol HCL

According to United States Pharmacopoeia, the orodispersible tablets may be defined as solid dosage form containing medicinal substance or active ingredient which disintegrates rapidly within a matter of seconds when placed upon the tongue. This means that the tablets dissolve or disintegrate in the oral cavity without use of water. In this regard, the tablets need to improve disintegration time, dispersion time, drug release studies, bioavailability and patient compliance and also need to mask the bitter taste of the drug and to maintain the drug stable at accelerated condition i.e. 40C/75% RH up to 6 months period as per ICH guidelines. Tramadol HCl is centrally acting synthetic opioid analgesic for the treatment of moderate to severe pain and is readily soluble in water. The half life of the drug is around 5.5 hours. The MDTs place a major role for rapid onset of action for geriatrics, pediatrics and the patients who have less access of water. The drug itself having bitter taste, so the present authors developed mouth dissolving tablets of tramadol HCl with the aim to mask the bitter taste of the drug, to minimize the disintegration time and improve the drug release rate.