INTRINSIC DISSOLUTION STUDY

The intrinsic dissolution rate is defined as the decomposition of the pure drug when certain physical-chemical conditions of the medium are kept constant.

It is an essential analysis to correctly characterize and assess the bioavailability of an under-development drug, in addition to determining fundamental thermodynamic parameters of the active ingredient.

Some factors influence the study, for example: the phenomenon of mass transfer during the dissolution process; the influence of pH and temperature of the dissolution medium; the interaction between possible components of the formulation; particle-size effects; and understanding the relationship between dissolution rate and crystalline form of the substance.

Taking as an example the dissolution rate vs crystalline form, it is visible that different polymorphs of a drug can have varying dissolution and/or solubility rates. When significant, these differences compromise the active ingredient bioavailability, directly impacting the expected pharmacological activity and making the drug less efficient, inactive or possibly toxic to the body.

NanoBusiness offers the complete Intrinsic Dissolution Study per active substance, including risk assessment.

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