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THE IMPACT OF PULVERIZATION DURATIONON THE HOMOGENEITY AND CHEMICAL STABILITY OF PULVERIZED PREPARATIONS CONTAINING A COMBINATION OF KETOTIFEN FUMARATE AND CYPROHEPTADINE HCl


Author: S. M. S. Prasetyo, S. H. Yuliani and F. D. O. Riswanto
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Abstract

Drug compounding is carried out by trained healthcare professionals following established standards to ensure boththe safety and effectiveness of drugs. This study examines the practice of preparing compounded drugs. The qualitycan be determined by their homogeneity and stability during storage, ensuring that they remain effective and safetouse. This study aims to evaluate how the duration of pulverisation affects the homogeneity and stabilityof acombined pulverised preparation containing Cyproheptadine HCl and Ketotifen Fumarate, which are two drugs usedto treat allergy symptoms. This research employs UV spectrophotometry in conjunction with the partial least squareschemometric model. The pulverisation durations used for homogeneity and chemical stability tests were 30, 60, 120, and 150 seconds. The evaluation of chemical stability was conducted over a storage period extending to 90 days. This study revealed that the homogeneity and stability of a compounded preparation containing ketotifen fumarateand cyproheptadine HCl can be attained with pulverisation times of 120 and 150 seconds, respectively. This studyhighlights the significance of controlling pulverisation duration to preserve the quality and stability of drugpreparations and to guarantee accurate dosage for optimal therapeutic effects. Further, this study contributes toimproving the quality of drugs and relates to SDG-3 of good health and well-being.

Keywords: Pulverizers, Cyproheptadine HCl, Ketotifen Fumarate, Stability, Homogeneity






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