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The conventional method of hygroscopicity determination proposed by Callahan and co-workers utilizes more sample and time, may not be precise in all the cases, and is a relatively broader classification system. The method of indicating degree of hygroscopicity as per European Pharmacopoeia considers equilibration of sample for 24 hours under single humidity condition and may not necessarily ensure equilibration in all the cases. Additionally, both these methods do not provide information on solid state changes occurring within the sample during the course of experiment. This research work envisages an efficient throughput method for hygroscopicity determination, and validates it with active and inactive pharmaceutical ingredients using sorption analysis. Further, this method has been performed under optimal equilibration conditions, in a throughput manner (consuming less sample and time), with additional information on solid state changes occurring within the experimental conditions. This throughput method would be a valuable tool for hygroscopicity assessment of new chemical entities, during drug development in particular, and across all pharmaceutical materials in general.
Pharmaceutical Development, Aurigene Discovery Technologies Limited , Bollaram Road, Miyapur, Hyderabad, Andhra Pradesh , India.
This article was published in the following journal.
Name: Pharmaceutical development and technology
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Method of tissue preparation in which the tissue specimen is frozen and then dehydrated at low temperature in a high vacuum. This method is also used for dehydrating pharmaceutical and food products.
Physiologically inactive substances that can be converted to active enzymes.
A genus of brown-rot fungi in the family Coriolaceae. The biologically active ingredients of its species have potential pharmaceutical value.
A carrier or inert medium used as a solvent (or diluent) in which the medicinally active agent is formulated and or administered. (Dictionary of Pharmacy, 1986)
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