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Poorly Soluble Drugs - Dissolution and Drug Release (Hardcover)
Loot Price: R6,207
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Poorly Soluble Drugs - Dissolution and Drug Release (Hardcover)
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This book is the first text to provide a comprehensive assessment
of the application of fundamental principles of dissolution and
drug release testing to poorly soluble compounds and formulations.
Such drug products are, vis-a-vis their physical and chemical
properties, inherently incompatible with aqueous dissolution.
However, dissolution methods are required for product development
and selection, as well as for the fulfillment of regulatory
obligations with respect to biopharmaceutical assessment and
product quality understanding. The percentage of poorly soluble
drugs, defined in classes 2 and 4 of the Biopharmaceutics
Classification System (BCS), has significantly increased in the
modern pharmaceutical development pipeline. This book provides a
thorough exposition of general method development strategies for
such drugs, including instrumentation and media selection, the use
of compendial and non-compendial techniques in product development,
and phase-appropriate approaches to dissolution development.
Emerging topics in the field of dissolution are also discussed,
including biorelevant and biphasic dissolution, the use on enzymes
in dissolution testing, dissolution of suspensions, and drug
release of non-oral products. Of particular interest to the
industrial pharmaceutical professional, a brief overview of the
formulation and solubilization techniques employed in the
development of BCS class 2 and 4 drugs to overcome solubility
challenges is provided and is complemented by a collection of
chapters that survey the approaches and considerations in
developing dissolution methodologies for enabling drug delivery
technologies, including nanosuspensions, lipid-based formulations,
and stabilized amorphous drug formulations.
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