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Formulation Development of Cevimeline Hydrochloride Mouth Dissolving Tablets Using 23 Factorial Design Approach

Kothawade Sagar1*, Thallpally Vijay2, Bagul Uddhav1, Rutuja Wakure1, Biyani Shubham3, Bukya Bhagwan2

In the present work, the mouth dissolving tablets of cevimeline hydrochloride were prepared to target those patients suffering from Sjogren syndrome, due to this syndrome patient faces problems such as difficulty in swallowing tablets or capsules because of dryness in mouth, resulting in noncompliance and ineffective therapy. Mouth dissolving tablets were prepared by direct compression method. The preliminary trial batches were formulated with three super-disintegrant viz. crospovidone, sodium starch glycolate, croscarmellose sodium in different concentration along with pearlitol SD 200 alone and in combination with microcrystalline cellulose (Avicel102). The prepared batches were evaluated for weight variation, hardness, thickness, mechanical strength, wetting ability, disintegration time and in vitro drug release. Amongst all four-formulation batches, batch no A4 containing crospovidone 8 mg, mannitol & MCC in the ratio of 10:1 has shown disintegration time of 8 seconds along with 96% drug release within 30 min. The compatibility study of drug and excipients was carried out by using FTIR and DSC. Based on the results, trial A4 was selected for further optimisation by using 23 factorial design. Among all trials generated by 23 factorial design, D4 shows most satisfactory result like disintegration time about 8 sec and drug release 98 % in 30 min, hence formulation D4 considered as optimised formulation.