Ensuring that tablets and capsules are designed with appropriate size, shape, and other physical attributes is crucial for patient compliance and safety. Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) provide guidance on these aspects.
United States (FDA Guidance)
The FDA's guidance titled "Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules" offers recommendations for generic drug manufacturers:
Tablet Size: The largest dimension of a tablet should not exceed 22 mm. If the reference listed drug (RLD) is larger than this, the generic product should match the RLD's size.
Capsule Size: Capsules should not exceed a standard 00 size. Similar to tablets, if the RLD capsule is larger, the generic should match its size.
Shape Considerations: Certain shapes may be easier to swallow. For instance, oval tablets tend to have faster esophageal transit times compared to round tablets of the same weight.
Other Physical Attributes: Factors like tablet coating, weight, surface area, disintegration time, palatability, and propensity for swelling should be considered to enhance patient compliance and minimize medication errors.
European Union (EMA Guidance)
The EMA's "Guideline on Manufacture of the Finished Dosage Form" provides directives on the physical attributes of tablets and capsules:
Pharmaceutical Form Description: A visual description of the product's appearance, including color, markings, and size, should be provided. For tablets with a score line, information should indicate whether the tablet can be divided into equal halves.
Patient Considerations: The guideline emphasizes the importance of considering patient factors, such as the ability to swallow tablets or capsules, especially in populations like the elderly or children. The design should facilitate ease of administration to ensure compliance.
In summary, both the FDA and EMA stress the importance of designing tablets and capsules with patient-friendly physical attributes to promote compliance and ensure safety. Manufacturers are encouraged to align their products' size, shape, and other characteristics with these guidelines.
Read also:
Resource Person: Moinuddin syed. Ph.D, PMP
