ABSTRACT
Regulatory aspects regarding the dissolution of poorly soluble oral
solid drug compounds involve developing and documenting the
appropriate dissolution procedures and specifications that ensure
product quality over its life cycle as well as, when needed, the
conducting of bioequivalence (BE) studies. For poorly soluble
compounds, dissolution tests are often empirically derived and the
specifications may not be reflective of product quality. Without
the appropriate dissolution methods, formulation development
is hampered and can result in product delays and regulatory
failures. Regardless of the solubility of your dosage form, it is
fundamental to understand the dissolution characteristics of the
active pharmaceutical ingredient (API) and drug product. U.S.
registrations require relevant dissolution specifications for release
and testing of most oral solid dosage forms, and the pharmaceutical
scientist must comply with the regulations as well as the intent of
the associated guidelines. Dissolution is cited in 21 CFR §211, §314, §320, §343 in the Codes of the Federal Registrar (CFR):
