Chronotherapeutic drug delivery systems:
There are several reports indicating that the peformance of a pharmacuetical dosage form is influenced by the changes in suppliers of the same excipient due to the variations in physicochemical properties and quality of excipient. There is increased demand for excipients with pre-determined specifications to control the physical properties of excipients like size, shape, tecture, density and moisture content. Spray dried excipients improves the flow property and freeze dried excipients enhances the dissolution rate.
There were many reasons for dose dumping of an extended release dosage form like improper design of dosage form, drug excipient interactions, crushing or chewing by patient1, intake of food or alcohol2 of which dose dumping due to alcohol is of more concern. Dose dumping due to alcohol was initially identified in palladone capsules that contain hydromorphone used to treat pain2. It is a potent narcotic with the dose of 12mg.
Dose dumping is defined as "Unintended, rapid drug release in a short period of time of the entire amount or a significant fraction of the drug contained in a modified release dosage form1." A sustained/extended/controlled release dosage form is intended to release the drug in desired concentrations for a prolonged period of time. A dosage form is said to be dose dumped when there is an excess release of drug at a particular time interval other than the stated or required amount. This results in higher systemic drug concentrations that may result in toxicity.