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Swati Adhikari*, Dr. Mittal Maheshwari and Dr. Pragnesh Patani


Stability studies plays major role in the pharmaceutical industry. Guidelines to conduct Stability studies for pharmaceutical drug products are available in ICH, USFDA, EMEA, WHO guidelines. It is important to perform the hold time study of drug product, in order to predict the time period for which the product is on hold shall be justified with adequate data to demonstrate the product will be stable throughout the approved shelf life. Hold samples need to store at GMP conditions i.e. where the lot or stage holds in the manufacturing area. All the regulatory agencies also may expect the hold time study at critical stages to understand the trend of degradation during holding at in-process stages. During the hold time study of hard gelatin capsules, Binder, Lubricated blend and filled capsules were collected and analyzed. Sample for hold time should be stored at the controlled condition in well-closed IPC/SS holder containing two-fold polythene bags. The hold time of the hard gelatin capsules was evaluated or calculated by comparing results of chemical and physical parameters with the pharmacopoeia limits. A specification chart is designed for indication of limits of the determined results. The chemical and physical parameters in different interval were analyzed and results at the pharmacopoeia limits were plotted. The probabilities of the erroneous decisions of initial and other interval were calculated from these studies. Therefore, extremely accurate hold-time data were obtained. In light of this data the correct trends in hold-time study as a function of storage period for hard gelatin capsules can be established.

Keywords: Hold time study, Hard gelatin capsule, Hold time study intervals.

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