| Description |
1 online resource (573 pages) |
| Series |
Pan Stanford series on pharmaceutical analysis ; volume 1 |
| Contents |
Cover; Half Title; Title Page; Copyright Page; Contents; Foreword; 1 The Modern Pharmaceutical Development Challenge: BCS Class II and IV Drugs; 1.1 Introduction; 1.2 Changing Drug Emphasis; 1.2.1 BCS Classification System; 1.2.2 Poorly Soluble Drugs; 1.3 The Dissolution Market; 1.4 Dissolution and Drug Release in the Pharmaceutical Industry; 1.4.1 Solubility Determinations for Pharmaceutical API; 1.4.2 Use of Surfactants in Dissolution Testing; 1.4.3 Intrinsic Dissolution Evaluation of Poorly Soluble Drugs; 1.4.4 Strategies for Oral Delivery of Poorly Soluble Drugs |
|
1.4.5 A Staged Approach to Pharmaceutical Dissolution Testing1.4.6 Development and Application of in vitro Two-Phase Dissolution Method for Poorly Water-Soluble Drugs; 1.4.7 Use of Apparatus 3 in Dissolution Testing of Poorly Soluble Drug Formulations; 1.4.8 Use of Apparatus 4 in Dissolution Testing of Poorly Soluble Drug Formulations; 1.4.9 Dissolution of Nanoparticle Drug Formulations; 1.4.10 Dissolution of Lipid-Based Drug Formulations; 1.4.11 Dissolution of Stabilized Amorphous Drug Formulations; 1.4.12 Dissolution of Pharmaceutical Suspensions; 1.4.13 Biorelevant Dissolution |
|
1.4.14 Clinically Relevant Dissolution for Low-Solubility Immediate-Release Products1.4.15 Method Validation and QbD for Dissolution Testing of BCS Class II/IV Products; 1.4.16 Regulatory Considerations in Drug Release Testing of BCS Class II/IV Products; 1.4.17 Dissolution of Capsule-Based Formulations; 1.4.18 Emerging and Non-compendial Drug Release Techniques; 2 Solubility Determinations for Pharmaceutical API; 2.1 Introduction; 2.2 Drug Solubility Assay Development; 2.2.1 Media for Solubility Studies; 2.2.1.1 Biorelevant media; 2.2.1.2 Organic solvents (DMSO); 2.2.1.3 Detection methods |
|
2.3 Drug Solubility Determination2.3.1 Shake-Flask Method; 2.3.2 Miniaturized Shake-Flask Method; 2.3.2.1 Sample preparation and analysis; 2.3.3 Potentiometric Titration Methods; 2.3.4 High-throughput Solubility Determinations; 2.4 In silico Predictions; 2.5 Other Physicochemical Determinations; 2.5.1 pKa; 2.5.2 Lipophilicity; 2.6 Summary; 3 Use of Surfactants in Dissolution Testing; 3.1 Introduction; 3.2 Surfactants; 3.2.1 Use of Surfactants in Dissolution Media Development; 3.2.2 Types of Surfactants in Dissolution Development; 3.2.3 Surfactant Concentration in Dissolution Media |
|
3.2.4 Other Non-surfactant Media Adjuvants3.3 Impact of Surfactants on Dissolved Gases; 3.4 Case Studies; 3.4.1 Roflumilast; 3.4.2 Fingolimod; 3.4.3 Lamotrigine; 3.4.4 Tacrolimus; 3.4.5 Amiodarone; 3.4.6 Enzyme Addition; 3.5 Regulatory Concerns; 4 Intrinsic Dissolution Evaluation of Poorly Soluble Drugs; 4.1 Introduction; 4.2 Apparatuses Used in Evaluating the Intrinsic Dissolution Rate; 4.2.1 Rotating Disk System; 4.2.2 Fixed Disk System; 4.2.3 Flow Cell: Dissolution by UV Imaging; 4.3 Calculating the Intrinsic Dissolution Rate (IDR) |
| Notes |
4.4 Evaluation of Intrinsic Dissolution of Poorly Soluble Drugs |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Pharmacology.
|
|
Drugs -- Dosage forms.
|
|
Dosage Forms
|
|
Pharmacology
|
|
pharmacology.
|
|
MEDICAL -- Pharmacy.
|
|
MEDICAL -- Pharmacology.
|
|
SCIENCE -- Chemistry -- Analytic.
|
|
Drugs -- Dosage forms
|
|
Pharmacology
|
| Form |
Electronic book
|
| Author |
Bell, Robert G
|
|
Jackson, J. Derek
|
| ISBN |
9781315340869 |
|
1315340860 |
|
9789814745468 |
|
9814745464 |
|
