Design and Evaluation of Oro-Dispersible Tablets of Tramadol Hydrochloride

Background: Oral Drug Delivery is the Most Preferred and Convenient route of Drug administration due to High Patient Compliance, Cost-effectiveness, Flexibility in the Design of Dosage form and Ease of Production. Many Patient Groups Such as Elderly children, Mentally Retarded have difficulty in swallowing. Conventional dosage forms like Tablets will be further hindered by Conditions such as the Unavailability of water, Allergic reactions and Episodes of Coughing. Hence, these problems can be Solved by Developing Rapidly Disintegrating and Dissolving Tablet dosage forms for Oral administration because they Dissolve in saliva and do not Require water for swallowing.

Aim: Tramadol Hydrochloride is a Centrally Acting Synthetic Opioid Analgesic. The aim of the present study was to Formulate Mouth Dissolving Tablets of Tramadol Hydrochloride.

Methods: The Tramadol Hydrochloride Mouth Dissolving Tablets were prepared by Direct Compression and Wet Granulation Methods. The Composition of the Present Study includes Tramadol Hydrochloride, Mannitol, Crospovidone, Copovidone, Ethyl Cellulose, Silicon dioxide and Magnesium stearate. The initial Four batches (TM1-TM4) were Formulated by the Direct Compression Method and (TM5- TM13) were Formulated by the Wet Granulation Method. With the Same Composition. Physico-chemical Parameters include Hardness, Friability [1] Weight Variation Disintegration Time and Dissolution Studies were Determined for all the Invitro Drug Release Studies and Stability Studies were Performed with the Same Composition as that of the Reference Product (Rybix, ODT).

Results: The Results indicate that the Hardness of the Tablet Prepared by Direct Compression and Wet Granulation Methods has increased with an increase in the concentration of Super Disintegrating Agents like Crospovidone, Copovidone and also Pharmaburst. In the case of Disintegration Time TM13 was considered to be the Best Formulation for 15 sec and TM01 is considered to be the Poor formulation for 104 sec because of its Hardness and More Porous structure. The Trial TM11 is considered as Optimized Formulation as part of Dissolution and Flow Properties.TM11-TM13 was Formulated and given to 5 human volunteers to study the Organoleptic Characters. The Stability Studies Indicate that the Drug is stable for a period of 3 months.

Conclusion: By Considering all the Results and Stability Data, it was concluded that Trial TM13 is the most Stable and met the Predetermined Specifications Of Dissolution, Assay, Friability, Disintegration Time Dispersion Time and stability for a period of 3 months.