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US FDA issues draft norms on quality attributes for chewable tablets, industry to respond before August end
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Nandita Vijay, Bengaluru
June 29 , 2016
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US FDA has issued a draft guidance on critical quality attributes that
should be assessed during the development of chewable tablets. The
regulatory authority has asked the industry to comment on the same and
revert before August end.
The recommendations in this guidance
apply mainly to new drug applications (NDAs), abbreviated new drug
applications (ANDAs), and certain chemistry, manufacturing, and controls
(CMC) supplements to these applications.
Chewable tablets are
an immediate release (IR) oral dosage form intended to be chewed and
then swallowed by the patient rather than swallowed whole. They should
be designed to have a pleasant taste and be easily chewed and swallowed.
These tablets should be safe and easy to use in a diverse patient
population, paediatric, adult, or elderly patients, who are unable or
unwilling to swallow intact tablets due to the size of the tablet or
difficulty with swallowing. The availability of safe, easy-to-use dosage
forms is important in clinical practice. Chewable tablets are available
for many over-the-counter (OTC) and prescription drug products.
The
United States Pharmacopoeia (USP) recognizes and differentiates between
two types of chewable tablets:. One is chewed for ease of
administration, and the other crushed before swallowing to avoid choking
to ensure the release of the active ingredient. The concepts in this
guidance are applicable to both types of chewable tablets, said the
regulatory authority.
Adverse events for chewable tablets can
include gastrointestinal (GI) obstruction resulting from patients
swallowing whole or incompletely chewed tablets, as well as tooth damage
and denture breakage resulting from excessive tablet hardness. A
related potential adverse event that sponsors should also consider is
esophageal irritation from chewable tablets.
A review of
numerous approved drug product applications for chewable tablets
revealed that in certain cases critical quality attributes such as
hardness, disintegration, and dissolution were not given as much
consideration as may have been warranted. This was evidenced by
instances of incomplete monitoring and a wide variation in analytical
procedures.
The regulator note has stated that its latest draft
guidance describes the critical quality attributes that should be
considered when developing chewable tablets and recommends that the
selected acceptance criteria be appropriate and meaningful indicators of
product performance throughout the shelf life of the product.
A
variety of physical characteristics should be considered in the
manufacturing process for chewable tablets. An ideal chewable tablet
should be: Easy to chew, palatable, of appropriate size and shape and
able to disintegrate readily to minimise aspiration and facilitate
dissolution.
Critical quality attributes for chewable tablets
should include hardness, disintegration, and dissolution, as well as all
factors that may influence drug bioavailability and bioequivalence. In
addition, careful attention should be given to tablet size, thickness,
and friability, as well as taste, which may impact the ability or
willingness of a patient to chew the chewable tablet. No single quality
characteristic should be considered sufficient to control the
performance of a chewable tablet. Instead, the goal should be to develop
the proper combination of these attributes to ensure the performance of
the chewable tablet for its intended use.
Even during conduct
of pivotal clinical studies, information should be collected on whether
the chewable tablets swallowed were intact. If the shape and size of
chewable tablet posed a choking or bowel obstruction risk and whether
water was used to aid swallowing and its volume. The subject’s sensory
experience like taste, mouth feel, and aftertaste needs to be reported,
stated the regulatory authority.
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