Development and Optimization of Prednisone Delayed Release System for Treatment of Rheumatoid Arthritis

Abstract

Nowadays Oral solids are used more and more apart of these tablets we engaged into making different release system or dosage forms to get the more safety, efficacy and bioavailability from the dosage forms. Same here in this project work it has been discussed about the drug named Prednisone where it is generally BCS class I which is widely used for the treatment of Rheumatoid Arthritis. Here the work of this project was to overcome the already approved Prednisone delayed release 5 mg tablet named as Rayos by Horizon Pharma. So Rayos tablet were found to be Tablet in Tablet type of system and here we overcome the tablet is tablet process where we simply used coating process to overcome the hurdle, so by this one can save time, cost of the tablet and deviation of drug release as well. As we all know about the effect of prednisone for the arthritis but the main reason to deliver the drug as right time is called Chronotherapeutic so here we develop the tablet as chronotherapy where we have to take the tablet before bed time and it release the drug after 4 hrs when there is more amount to cytokine present at night time so it decreases the level of cytokines and cure the symptoms related to Rheumatoid Arthritis. Here we used different concentration, different ratio and different Diluent agents like Lactose and MCC, Binder like PVP K30, Disintegrating agents like CMC, SSG, Crospovidone, Starch, Glidant like Colloidal silicon Dioxide, Lubricant like Talc to formulate the tablet where the drug concentration was found to be 5mg same for all the batches. Hence optimized batch was carried out which meets the specification of reference product. Further we used different coating agents like Eudragit E100 and Ethyl Cellulose, different ratio of coating agents and different level of coating agents to get desired profile of drug release according to the reference product’s specification. Hence, we performed all the necessary Preformulation and post formulation studies and all the necessary characterization parameters of the respective batch. Thus, DOE was used to get the optimized formulation with less efforts, energy and time. Last but not the least we concluded that the Optimized formulation shows better result compared to the reference product