Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
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Table of Contents
1. Preformulation in drug research and pharmaceutical product development2. Physicochemical aspects to be considered in Pharmaceutical Product Development
3. Role of physicochemical parameters on drug absorption and their Implications in Pharmaceutical Product Development
4. Physiologic Factors Related to Drug Absorption
5. Physico-chemical, pharmaceutical and biological considerations in GIT Absorption of drugs
6. Influence of Drug Properties and Routes of Drug Administration on the design of controlled release systems
7. Drug stability and degradation studies
8. First pass metabolism considerations in Pharmaceutical Product Development
9. Dissolution profile considerations during Pharmaceutical Product Development
10. Drug disposition considerations in Pharmaceutical Product Development
11. Protein and tissue binding: Implication on pharmacokinetic parameters
12. Preformulation studies of drug substances, proteins and peptides: Role in drug discovery and Pharmaceutical Product Development
13. Role of salt selection in drug discovery and development
14. Drug Complexation: Implications in drug solubilization and oral bioavailability enhancement
15. Solubility and solubilization approaches in Pharmaceutical Product Development
16. Rheology and its implications on performance of liquid dosage forms
17. Micromeritics in Pharmaceutical Product Development
18. Four stages in Pharmaceutical Product Development Preformulation Prototype development Biological aspects Scale up studies Commercialization
19. Scale up studies in Pharmaceutical Product Development
20. Manipulation of physiological processes for Pharmaceutical Product Development
21. Impact of pharmaceutical product Quality on Clinical Efficacy
22. Formulation additives used in Pharmaceutical Products: Emphasis on regulatory perspectives and GRAS
