P. Shanmugapriya, K. Manivel, R. Selvamuthukumar
Oct 12, 2020
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Quality indicators
Journal
Research Journal of Pharmacy and Technology
Abstract
Potassium chloride is an electrolyte replenisher used in the treatment of hypokalemia. It has a short biological half-life of 1 to 1.5hours. It is a freely soluble drug in the gastric contents while taking it orally. Due to its rapid release, it causes local tissue irritation in the stomach. So, it is considered as an ideal drug for designing an extended release formulation. In the study of commercially prepared batches of Potassium chloride 600mg ER tablets, a few critical factors were identified. They are low hardness, high friability, lower side of assay, coating issues and rapid drug release rate. So the trials were made to overcome the issues by developed the formulation using hydrophobic polymers i.e., Eudragit RSPO and Ethyl cellulose in different ratios and optimized the process using various interrelated variables such as process and granulator parameters to achieve the desired quality of product. Among the various formulation development trials, the results indicated that trial C9 with Eudragit RSPO (11.68%) was the best formulation. Eventually, a reproducibility batch was done to check the similar results. Applying mathematical models, the dissolution profile of C9 formulation follow Korsmeyer-Peppas model and showed similarity factor f2 of 92.76 when compared with the marketed product, Span-K. The stability study was carried out as per ICH guidelines. The stability study indicated there was no significant change in the parameters.