DEVELOPMENT OF TABLET CONTAINING NSAIDS DRUGS WITH EXCIPIENTS TREATED WITH CO – PROCESSED TREATMENT OF SPRAY TECHNOLOGY WITH DETAIL STUDY OF OPTIMIZATION AND EVALUATION

Dr. Santosh Kirtane and Dr. Darshit Ram*

ABSTRACT

Objective: To optimize suitable processing parameters for the preparation of directly compressible co-excipient, develop suitable method for preparation of directly compressible co-excipient. To develop fast disintegrating directly compressible co-excipient. To develop time and cost saving methods for the development of Fast disintegrating tablet dosage form. To compare the release profile of developed formulation with marketed formulations. Material and Methods: UV and IR were carried out with Standard Calibration Curve. The drug-excipients interaction study was carried out by physical observation and also by using FTIR spectroscopy and DSC. From this spray dried diluents; diluent used for further preparation of co-excipients was selected on the basis of their evaluation like spray dried yield, moisture content in spray dried product, flow properties and post-compression characteristics. Result and Discussion: For the selection of suitable spray drying parameters, a general suspension containing selected diluent i.e. mannitol, along with disintegrant and binder was sprayed into spray dryer and optimization was done by Box-Behnken design. It was found that for fast disintegrating co-excipient, small quantities of disintegrating agent and binder were required. Therefore, the general suspension (20% w/v) containing diluent, along with disintegrant and binder was prepared by dispersing them in water and then continuous stirring and heating on magnetic stirrer which was then spray dried in Labultima-LU222 lab spray dryer and evaluated for response factors. so as to make the selection of suitable spray drying parameters. The general suspension was contained selected diluent (i.e. mannitol- 94%w/w), disintegrant (Kollidon- 4%w/w) and binder (HPMC-E15LV-2%w/w). quadratic effects of the process parameters of spray dryer on the % yield, moisture content and compressibility index of co-excipient. A 3-factor, 2-level design was used to explore the quadratic and linear response surfaces using Design Expert (Version 8.0.1, Stat- Ease Inc., Minneapolis, MN). Conclusion: Spray drying method is suitable for the preparation of directly compressible fast disintegrating co-processed excipient. This co-processed excipient showed improved flow properties, compressibility and less disintegration time with less friability when compressed in tablet form with model drugs. Many Fast disintegrating tablets are prone to friable as their aim is to achieve the less disintegration time; but this problem is successfully solved by using fast disintegrating co-excipient. This new technique saves the time and cost for the development of table dosage forms because of direct compression behavior and multifunctional of co-excipients. The co-processed excipient containing mannitol, HPMC-E15LV and Kollidon has provided less disintegration time with less friability and sufficient strength to the tablets. So it can be used for formulation of Fast Disintegration.

Keywords: Ibuprofen, SEM, HPMC, co-excipient, Box-Behnken design.