New FDA Guidelines for Generic Manufacturers

Increase Patient Compliance by Improving Physical attributes of Tablets and Capsules: New FDA Guidelines for Generic Manufacturers

Dysphagia associated with tablets or capsules is a major problem for many individuals. This rather unheeded problem is one of the major reasons for non-compliance with therapeutic regimens. Patient-related factors such as age (children/adolescents or elderly), body position, fluid intake, presence of certain medical conditions (multiple sclerosis, muscular dystrophy, Parkinson’s disease) can impact patient’s ability to swallow thereby affecting patient compliance. In addition, size and shape of the tablets or capsules may have an impact on patient compliance by affecting the Esophageal Transit Time (ETT). Large, light and oval shaped tablets have been shown to have a prolonged ETT. Small and round tablets have a significantly faster transit time. Similarly, the lack of film coating can decrease or prevent tablet mobility compared to a coated tablet. Coating can also affect other factors that contribute to patient acceptance, such as palatability and smell. Pharmaceutical manufacturers should be cognizant of these factors while designing new tablets or capsules.

In order to meet regulatory requirements, generic formulations of tablets and capsules are required to be therapeutically equivalent to their respective Reference Listed Drug (RLD). However, it is also important to address differences in physical characteristics (shape and size) that may affect patient compliance and lead to medication error. In order to address these differences, the FDA has laid down recommendations on physical attributes for generic drugs that generic drug manufacturers may consider while applying for an abbreviated new drug application (ANDA). The article summarizes these recommendations given by the FDA guidelines, 2015 that are applicable while filing for an ANDA.


Recommendations on physical attributes of Tablets and Capsules

In order to improve compliance in all age groups, generic manufacturers should consider physical attributes while developing quality target product profiles (QTTPs) when applying for ANDAs to the Office of Generic Drugs. However, these recommendations are not binding for the approved ANDAs unless it poses a risk to public health, in which case a modification will be recommended.

As per the FDA, generic oral tablets and capsules intended to be swallowed should be of a similar size to the corresponding RLD. For RLD that is less than 17mm in its largest dimension, the generic product should not be more than 20% larger than the RLD in any single dimension and should be not be more than 40% larger than the volume of the RLD. For RLD that is equal or greater than 17mm in its largest dimension, the generic product should not be larger than the RLD in any single dimension and should not be larger than the volume of the RLD. In addition to the size, tablets should have a shape that has been found to be easier to swallow in comparison with the shape of the RLD. Tablets and capsules with the same volume but smaller cross sectional area are easier to swallow.


Other recommendations

Apart from size and shape, attributes like tablet coating, weight, surface area, disintegration time and propensity for swelling should be considered when developing a QTTP for generic tablets. The FDA generally grants a biowaiver (i.e., the waiver of in vivo bioequivalence data) for additional strengths of a solid oral dosage form, if it meets one of the criteria set forth in the regulations, including proportional similarity between strengths in active and inactive ingredients


Dysphagia related to oral dosage form is an overlooked problem that leads to patient non-compliance. Apart from patient-related factors, physical attributes of tablets and capsule has a major impact on patient non-compliance. The FDA has laid down certain recommendations on the physical attributes for generic drugs in order to address this problem. Generic manufacturers can follow these recommendations not only for achieve compliance with the regulations while submitting an ANDA, but also ensure that the generic product has highest possible patient compliance.



U .S. Food and Drug Administration, Center for Drug Evaluation and Research [Internet]. Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules. Guidance for [updated 2015 June; cited 2016 Oct 11]. Available from:

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