eBook: Formulation Technologies and Strategies for Successful New Product Development - 34

Qualifying ODT Excipient
Systems Beyond
Disintegration Performance
by Hans-Leonhard Ohrem and Adela Kasselkus, Ph.D.
Orally disintegrating tablets
(ODTs) can offer many
advantages for patients, but
only if formulated with the
optimum excipient system. In
addition to rapid disintegration
and dissolution, ODT excipient
systems should provide longterm
stability and performance
over a wide range of active
pharmaceutical ingredient (API)
loading levels.
34
Why Formulate as an Orally
Disintegrating Tablet?
Rapid disintegration in the mouth without the need
for liquid offers many advantages. For patients that
have difficulty swallowing, most often children
and seniors, orally disintegrating tablets
(ODTs)
eliminate the burden of chewing or swallowing
whole tablets. This mode of administration is
also beneficial to patient groups who prefer the
convenience of a dosage form that doesn't require
water for administration or do not have access to
potable water.
ODTs are typically used to formulate medication
for indications that must offer fast relief, such as
antihistamines, hypnotics, sedatives, antipsychotics,
and pain, and anti-migraine medications.
ODT formulations may also offer the potential for
enhanced bioavailability in certain APIs by enabling

eBook: Formulation Technologies and Strategies for Successful New Product Development

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