Poorly Soluble Drugs

Poorly Soluble Drugs

Dissolution and Drug Release

Bell, Robert G.; Jackson, J. Derek; Webster, Gregory K.

Pan Stanford Publishing Pte Ltd

12/2016

728

Dura

Inglês

9789814745451

15 a 20 dias

1510

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Introduction. Solubility determination for pharmaceutical API. Use of surfactants in dissolution testing. Intrinsic dissolution evaluation of poorly soluble drugs. Oral delivery of poorly soluble drugs. A staged approach to pharmaceutical dissolution testing. Development and application of in vitro two-phase dissolution method for poorly water soluble drugs. The use of Apparatus 3 in dissolution testing of poorly soluble drug formulations. Use of Apparatus 4 in dissolution testing, including sparingly and poorly soluble drugs. Dissolution of nanoparticle drug formulations. Dissolution of lipid based drug formulations. Dissolution of stabilized amorphous drug formulations. Dissolution of pharmaceutical suspensions. Dissolution testing of poorly soluble drugs: 'Biorelevant dissolution'. Clinically relevant dissolution for low solubility immediate release products. The QbD approach to method development and validation for dissolution testing. Regulatory considerations in dissolution and drug release of BCS class II and IV compounds. Dissolution of liquid-filled capsules based formulations. Current and emerging non-compendial methods for dissolution testing.
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Dissolution Testing;dissolution;USP Apparatus;testing;Dosage Forms;dosage;PSP Book;form;Dissolution Medium;release;Dissolution Method;media;BCS Class;method;Biorelevant Media;substance;Dissolution Rate;biorelevant;Drug Substance;sink;Non-sink Conditions;Drug Release;Amorphous Solid Dispersion;UV Imaging;Capsule Shell;Solid Dispersion;Dissolution Test Method;Biorelevant Dissolution;Nanoparticle Drug Formulations;SEDDS Formulation;BCS Ii;Vivo Performance;Compacted Drug;Hot Melt Extrusion;Reciprocating Cylinder