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Solvent Systems and Their Selection in Pharmaceutics and Biopharmaceutics (eBook)

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2007 | 2007
X, 462 Seiten
Springer New York (Verlag)
978-0-387-69154-1 (ISBN)

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Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.


Solvent systems are integral to drug development and pharmaceutical technology. This single topic encompasses numerous allied subjects running the gamut from recrystallization solvents to biorelevant media. The goal of this contribution to the AAPS Biotechnology: Pharmaceutical Aspects series is to generate both a practical handbook as well as a reference allowing the reader to make effective decisions concerning the use of solvents and solvent systems. To this end, the monograph was created by inviting recognized experts from a number of fields to author relevant sections. Specifically, 15 chapters have been designed covering the theoretical background of solubility, the effect of ionic equilibria and pH on solubilization, the use of solvents to effect drug substance crystallization and polymorph selection, the use of solvent systems in high throughput screening and early discovery, solvent use in preformulation, the use of solvents in bio-relevant dissolution and permeation experiments, solvents and their use as toxicology vehicles, solubilizing media and excipients in oral and parenteral formulation development, specialized vehicles for protein formulation and solvent systems for topical and pulmonary drug administration. The chapters are organized such that useful decision trees are included together with the scientific underpinning for their application. In addition, trends in the use of solvent systems and a balance of current views make this monograph useful to both the novice and experienced researcher and to scientists at all developmental stages from early discovery to late pharmaceutical operations.

Contents 7
Preface 9
Principles of Solubility 10
Ionic Equilibria and the pH Dependence of Solubility 37
Solvent Systems for Crystallization and Polymorph Selection 60
Solubility Issues in Early Discovery and HTS 117
Practical Aspects of Solubility Determination in Pharmaceutical Preformulation 143
Biorelevant Dissolution Media 156
Selection of Solvent Systems for Membrane-, Cell- and Tissue- Based Permeability Assessment 183
The Use of Solubilizing Excipients and Approaches to Generate Toxicology Vehicles for Contemporary Drug Pipelines 225
Solubilizing Vehicles for Oral Formulation Development 261
Solubilizing Systems for Parenteral Formulation DevelopmentÛ Small Molecules 313
Aqueous Solubilizing Systems for Parenteral Formulation DevelopmentÛ Proteins 344
Non-Aqueous Systems for Formulation DevelopmentÛProteins 361
Pharmaceutical Solvents as Vehicles for Topical Dosage Forms 405
Pharmaceutical Solvents for Pulmonary Drug Delivery 429
Index 444

Erscheint lt. Verlag 6.8.2007
Reihe/Serie Biotechnology: Pharmaceutical Aspects
Biotechnology: Pharmaceutical Aspects
Zusatzinfo X, 462 p. 119 illus., 9 illus. in color.
Verlagsort New York
Sprache englisch
Themenwelt Medizin / Pharmazie Gesundheitsfachberufe
Medizin / Pharmazie Medizinische Fachgebiete Pharmakologie / Pharmakotherapie
Medizin / Pharmazie Pharmazie
Studium 1. Studienabschnitt (Vorklinik) Biochemie / Molekularbiologie
Technik
Schlagworte Augustijns • Biopharmaceutics • Brewster • Pharmaceutics • selection • Solvent • Systems
ISBN-10 0-387-69154-5 / 0387691545
ISBN-13 978-0-387-69154-1 / 9780387691541
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