BACHHAV, Y.; MANNHOLD, R.; BUSCHMANN, H.; HOLENZ, J.
1 Impact of the Polymorphic Form of Drugs/NCEs on Preformulation and Formulation Development 1
2 Strategies for the Formulation Development of Poorly Soluble Drugs via Oral Route 49
3 Effect of Residual Reactive Impurities in Excipients on the Stability of Pharmaceutical Products 91
4 Preclinical Formulation Assessment of NCEs 119
5 Regulatory Aspects for Formulation Design – with Focus on the Solid State 155
6 Insight into Innovative Applications of Parenteral Formulations 209
®®7 Assessing Pharmacokinetics of Various Dosage Forms at Early Stage 227
8 Transdermal Medical Devices: Formulation Aspects 245
9 Physical Characterization Techniques to Access Amorphous Nature 281
10 Design and Development of Ocular Formulations for Preclinical and Clinical Trials 331
11 Preclinical Safety Aspects for Excipients: Oral, IV, and Topical Routes 367
12 Formulation of Therapeutic Proteins: Strategies for Developing Oral Protein Formulations 391
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.
Yogeshwar Bachhav, PhD, is currently working as consultant to the pharmaceutical industry in Europe and Asia supporting the pharmaceutical development of new and approved drugs. He is a pharmacist by training and completed a PhD at the Institute of Chemical Technology, Matunga, Mumbai (India) in 2007. He has worked in Europe for more than 10 years with different start-up and mid-sized biotech/pharmaceutical companies. During this tenure, he has successfully managed pharmaceutical development of several projects from POC to phase 1, 2 and 3 clinical trials.