HOLD TIME STUDY FOR HARD GELATINE CAPSULES DURING MANUFACTURING PROCESS: A REVIEW
Journal Title: WORLD JOURNAL PHARMACY AND PHARMACEUTICAL SCIENCE - Year 2019, Vol 8, Issue 5
Abstract
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.
Authors and Affiliations
Swati Adhikari
Keywords
Related Articles
- EP ID EP667794
- DOI -
- Views 127
- Downloads 0
A REVIEW ON TECHNIQUES TO IMPROVE SOLUBILITY OF POORLY SOLUBLE DRUGS
Solubility is the phenomenon in which the conversion of solute into solution, and it is very important for the absorption, bioavailability and pharmacological response. About 40% new drug has water solubility, which is d...
LITERATURE REVIEW ON ABNORMAL UTERINE BLEEDING AND ITS AYURVEDIC MANAGEMENT
In presents state large number of women from reproductive age suffers from Abnormal uterine bleeding(AUB). The normal period of menstruation is start at the age of 12 to 14 years, and persist through out reproductive lif...
DEVELOPMENTAL TOXICITY OF ACETAMIPRID IN RATS
Neonicotinoids are the most widely used group of insecticides. In the current investigation, developmental toxicity of acetamiprid as a representative of neonicotinoids was studied in rats. Acetamiprid was orally given t...
THE STUDY OF TRIPLE AND QUADRUPLE ANTITUBERCULOUS DRUG THERAPY INDUCED HEPATOTOXICITY
It istheoreticalanalysis of the hepatotoxicity induced by antituberculosis drug therapies. The most commonly used therapies for tuberculosis are triple and quadruple antituberculosis drug therapy. We analyse by theoretic...
SUCCESSFUL COGNITIVE AGING-PREREQUISITE OF AN IMPROVED QUALITY OF LIFE IN ELDERLY PATIENTS
Addressing the demographic challenges is among the basic political and social priorities of the European Union. The multidimensional problems of advanced and late age (biological, psychological, socio-economic, cultural,...