Tablets and capsules are widely manufactured and prescribed and may provide a number of advantages over other dosage forms, including ease of storage, portability, ease of administration, and accuracy in dosing. Difficulty swallowing tablets and capsules can be a problem for many individuals and can lead to a variety of adverse events and patient noncompliance with treatment regimens. For these individuals, swallowing a tablet or a capsule can be particularly challenging.
Size and shape of tablets and capsules affect the transit of the product through the pharynx and esophagus and may directly affect a patient’s ability to swallow a particular drug product.
In June 2015, the US Food and Drug Administration (FDA) published guidance on the size, shape and other physical attributes of generic tablets and capsules
This guidance is available on the Internet at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm under Bioequivalence Recommendations for Specific Products
0 Comments