Teaches future and current drug developers the latest innovations in drug formulation design and optimization
This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation.
Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more.
-Provides information that is essential for the drug development effort
-Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals
-Describes current approaches in early pre-formulation to achieve the best in vivo results
-Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies
-Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design
Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
Table of contents
Impact of the polymorphic form of drugs on the preformulation and formulation development
Strategies for the formulation development of poorly soluble drugs
- Solid dispersions
- Mesoporous silica particles
- Lipid based formulation
Role of reactive impurities from the excipients on the formulation shelf life
Preclinical formulation assessment of new chemical entitiess
Regulatory aspects for formulation design
Innovative formulations for special indications: oncology injectables, delayed release and depot formulations
Assessing Pharmacokinetics of various dosage forms
Medical devices: Formulation aspects
Physical characterization techniques to assess amorphous nature
Preclinical safety aspects for excipients
Novel formulations for protein oral dosage