Process Optimization and Characterization of Medicated Chewing Gum of Β-Blocker By Employing Sedem Tool

Abstract

Oral administration has been the most favorable route of drug delivery as 90% of all drugs used to produce systemic effects are administered by this route. PHL_110 is a BCS class-I drug used in the treatment of Angina pectoris and Myocardial Infarction. It is absorbed throughout the GI tract hence an ideal drug for preparation of MCG (Medicated Chewing Gum). MCGs were prepared by direct compression as this technique is economic, fewer manufacturing steps, required reduced processing time, less process validation, less equipment, and reduced labour costs compared to extrusion. The formulation was developed and optimized based on the current concept of “Quality by Design ICH Q8”. The SeDeM expert system is based on the implementation of ICH Q8. In the study, the SeDeM expert system has been applied to the prediction of the behaviour of the material to be used in the formulation of MCGs. Suitability of the material for direct compression was successfully predicted using the SeDeM expert system. Required % of Gum Base and 30:70 ratio of Avicel PH-102 to Pearlitol 200 SD were calculated by means of mathematical equation given by the SeDeM expert system. All excipients show predicted result as per the SeDeM expert system. Design of Experiment concept was applied at compression as it affects the release profile and chewability of MCG. Compression was carried out by KORSCH XL 100 by using 3² factorial design. 5 KN compression force was found sufficient to compress chewing gum with good chewability. Batch-to-batch reproducibility is proposed by the SeDeM system. Batch-to-batch reproducibility results were verified and it was reasoned that this system is desirable for testing batch-to-batch reproducibility of characteristics in powdered APIs substances. Formulation had the excellent mouth feel, no grittiness was observed and desirable taste was obtained. The drug release study was performed on human volunteers. More than 95% drug released was observed from MCG. Therefore, it can be concluded that SeDeM expert system and DOE helped in the systemic optimization of Medicated Chewing Gum.