Clonazepam, Crospovidone, Cros carmellose sodium and Sodium starch glycolate were gifted sample from Chandra labs, Hyderabad. Other chemicals like MCC, Mg stearate and Talc were analytical grade.

Calibraton curve of Clonazepam: Weighed 100 mg of Clonazepam and shifted into 100 ml of volumetric flask & dissolved in less amount of water and diluted with phosphate buffer of pH 6.8 up to the mark to give stock solution 1 mg/ml. 1 ml was pick out from stock solution in another volumetric flask and diluted up to 10 ml to give a standard solution 100 µg/ml. Further dilutions were made from 10-50 µg/ml using phosphate buffer pH 6.8 and absorbance were measured at 254 nm (figure no.1 spectrum of clonazepam drug) Figure 1.

Drug and Excipients compatibility studies: The selection of excipients was based on the prior experience or literature survey; excipients listed by the innovator in the package insert (Micardis) tablets. Compatibility was observed of these excipients with Clonazepam. In the present study, the potassium bromide disc (pellet) method was employed.

Preparation of Clonazepam ODT’s³: The main aim of the present study was to formulate different batches using three various superdisintegrants and other ingredients in varying concentrations. So, different batches of formulations were planned accordingly. According to that C1, C2 formulations (with Crospovidone + croscarmellose sodium - 5%, 10%), C3, C4 formulations (with Sodium starch glycolate+ Crospovidone - 5%, 10%),C5,C6 formulations (with Sodium starch glycolate + croscarmellose sodium - 5%,10%) prepared by direct compression method (Table 1).

Table 2 and Figure 2

Figures 3 and 4

Table 3

Paddle method Dissolution data of Matrix tablets formulations of Clonazepam by Paddle method (USP II) are reported in table 4 and cumulative % drug release were shown in figures 5 to 7.

Table 5 and Figures 8 to 11.

Table 6

In the current work, immediate release tablets of Clonazepam were prepared by direct compression technique. The designed formulations were subjected into weight of variation, drug uniformity content, hardness & friability, and post formulation studies like as ratio of water absorption, wetting time, dissolution, drug excipients interaction and short-term stability studies.

• IR-spectroscopic studies indicated that there are no drug–excipients interactions.

• By the direct compression the designed tablets were punched without any chipping, capping and sticking.

• The prepared tablets of the hardness were found to be in b/w of 1.1 to 1.8kg/ cm².

• The values of friability were found to be in b/w of 0.65 to 0.72%.

• Disintegration time was found to be in b/w of 1-3min.

• The average weight & content of drug prepared tablets indicate weight and uniformity of drug content within the batches prepared.

• Maximum drug release was found to be with formulation C6 (98%).

There was no significant change in physical and chemical properties of the tablets of formulation C6 after 3 Months, parameters like % drug release and assay values at various conditions (at 40°C/ 75% RH) as per ICH guidelines quantified at various time intervals.