Formulation and Evaluation of Orodispersible Tablets of Milnacipran Hydrochloride

The present study Oro dispersible tablets of Milnacipran Hydrochloride is an anti depressant drug which is highly appropriate as it has ease of administration for the patients having major depressive disorder. Orodispersible tablets (ODT) have better patient acceptance and compliance ,may offer improved patient compliance compared with conventional oral dosage forms as the drug dissolves in saliva within a matter of seconds. Literature regarding drug, excipients selection, manufacturing method, etc, has been collected and reviewed. Analytical method was developed for Milnacipran Hydrochloride using UV-spectrophotometer at 223nm.It obeys beer-lamberts law between 4-40 g/ml. FTIR study of the pure drug and Final Lubricated blend was performed and result confirms that the drug is compatabile with other excipents. Pre-compression parameters such as bulk density tapped density, compressibility index, hausner’s ratio and angle of repose were performed and results indicate that all the final lubricated blends are having good flow property. Initial trials with Sodium Starch Glycolate ,Crospovidone, Crosscarmelose sodium and Kyron T-314 were taken with 5%of superdisintegrant. Among these batches taken,kyron T-314 and crospovidone shows better dispersion time within 30 seconds compared to the other two superdisintegrants. To optimize the concentration of superdisintegrant batches with 5% of crospovidone, 5% kyron T-314 and batch with 2.5% of crospovidone and 2.5 % of kyron T-314 were taken .Dispersion Time of batches mentioned are sec,26 sec and 20 seconds respectively. Post compression parameters such as weight variation, hardness, thickness, friability and drug content,uniformity of dosage forms were performed and tablets of these formulation were found to be within the limits. To select a final formula,dissolution profiling of all the three batches were performed and found that batch with kyron T-134 and crospovidone (2.5% each) given better rate of dissolution than other two batches.Hence the batches with both disintegrant was selected as a final formula. Here, the vital rationale of developing the oral disintegrating tablet was achieved. Formulation F7 showed the disintegration within 20 sec and the dispersion time at 21 sec by using the combination of crospovidone and Kyron T-314 as a superdisintegrants. as the concentration increases.dispersion time also get decreases. The formulation of oro dispersible tablets of Milnacipran hydrochloride complines all the requirements of mouth dissolving tablet . From the results of the study we conclude that formula F7 (mannitol crospovidone,Kyron T-314,povidone ,magnesium stearate ,sucralose,Vanilla) processes good disintegration and dissolution profile with the addition of superdisintegrants.On comparing all the batches, passess all the quality control tests Milnacipran Hydrochloride is not avaliabe as a patient compliance orally disintegrating tablet dosage form in market.Hence by preparing Orally disintegrating tablet of Milnacipran hydrochloride ,the fulfilment and speedy recovery of patients is possible in future