Essential Chemistry for Formulators of Semisolid and Liquid Dosages

1st Edition - October 15, 2015
Authors: Vitthal S. Kulkarni, Charles Shaw
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 0 1 0 2 4 - 2
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 0 1 0 7 2 - 3

A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemis… Read more

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A needed resource for pharmaceutical scientists and cosmetic chemists, Essential Chemistry for Formulators of Semisolid and Liquid Dosages provides insight into the basic chemistry of mixing different phases and test methods for the stability study of nonsolid formulations. The book covers foundational surface/colloid chemistry, which forms the necessary background for making emulsions, suspensions, solutions, and nano drug delivery systems, and the chemistry of mixing, which is critical for further formulation of drug delivery systems into semisolid (gels, creams, lotions, and ointments) or liquid final dosages. Expanding on these foundational principles, this useful guide explores stability testing methods, such as particle size, rheological/viscosity, microscopy, and chemical, and closes with a valuable discussion of regulatory issues. Essential Chemistry for Formulators of Semisolid and Liquid Dosages offers scientists and students the foundation and practical guidance to make and analyze semisolid and liquid formulations.

Preface
Chapter 1. Introduction
Chapter 2. Surfactants, Lipids, and Surface Chemistry
- 2.1. Introduction
- 2.2. Types of Surfactants
- 2.3. Natural Surfactants
- 2.4. The Role of Surfactants in Pharmaceutical Formulations
- 2.5. Surface Chemistry for Pharmaceutical Formulations
- 2.6. Conclusion
Chapter 3. Drug Delivery Vehicles
- 3.1. Introduction
- 3.2. Emulsion Drug Delivery Systems
- 3.3. Liposome Drug Delivery Systems
- 3.4. Other Nanodrug Delivery Systems
- 3.5. Conclusion
Chapter 4. Formulating Creams, Gels, Lotions, and Suspensions
- 4.1. Introduction
- 4.2. Creams and Lotions
- 4.3. Gels, Ointments, and Suspensions
- 4.4. Formulating with Liposomes
- 4.5. Excipients
- 4.6. Conclusion
Chapter 5. Use of Polymers and Thickeners in Semisolid and Liquid Formulations
- Background
- 5.1. Polymers as Styling Agents
- 5.2. Polymers as Conditioning Agents
- 5.3. Polymers as Preservatives
- 5.4. Polymers as Penetration Enhancers
- 5.5. Polymers as Thickening and Suspending Agents
- 5.6. Characteristics of Commonly Used Thickening, Gelling, and Suspending Agents
Chapter 6. Aerosols and Nasal Sprays
- 6.1. Aerosols
- 6.2. Nasal Sprays
Chapter 7. Preparation and Stability Testing
- 7.1. How Formulations Are Put Together
- 7.2. Mixing Systems
- 7.3. Quality by Design (QbD) for Formulation and Process Development
- 7.4. Stability Testing
Chapter 8. Particle Size Analysis: An Overview of Commonly Applied Methods for Drug Materials and Products
- 8.1. Introduction
- 8.2. Laser Diffraction
- 8.3. Particle Size Evaluation by Microscopy
- 8.4. Conclusion
Chapter 9. Rheological Studies
- 9.1. General Terms and Definitions
- 9.2. Instruments and Measuring Geometries
- 9.3. Material Behavior
- 9.4. Rheological Studies
- 9.5. Practical Application of Rheological Data
Chapter 10. Microscopy Techniques
- 10.1. Introduction
- 10.2. Optical Microscopy
- 10.3. Scanning Electron Microscopy
- 10.4. Transmission Electron Microscopy
- 10.5. Atomic Force Microscopy
- 10.6. Conclusion
Chapter 11. Miscellaneous Physical, Chemical, and Microbiological Test Methods
- 11.1. General Physical Tests
- 11.2. General Chemical Tests
- 11.3. General Microbiological Tests
- 11.4. Product-Specific Tests
Chapter 12. An Overview of Regulatory Aspects for Pharmaceutical Semisolid Dosages
- 12.1. Quality Data
- 12.2. Types of Regulatory Submissions
- 12.3. Resources—ICH
- 12.4. Resources—FDA
- 12.5. Resources—WHO
Index

Vitthal S. Kulkarni

Vitthal Kulkarni, Ph.D. is Scientific Advisor at DPT Laboratories San Antonio, Texas. After earning Ph.D. in Chemistry at National Chemical Laboratory, Pune, India in the area of surface/colloid chemistry, Dr. Kulkarni studied lipid monolayers, bilayers, self-assembled nano-structures, and protein electron crystallography at various institutions including Université de Provence, Marseille, France, JEOL Ltd., Tokyo, Japan, Vanderbilt University, Nashville, Tennessee, University of Minnesota, Austin, Minnesota and Yale University, New Haven, Connecticut before moving into industry. Dr. Kulkarni has been with DPT Laboratories since 2003.

Dr. Kulkarni is experienced in developing and characterizing various non-invasive drug delivery systems including topical drug delivery systems comprised of liposomes, and nano-particles, emulsions and nasal spray products. He has published scientific research articles in peer reviewed journals, patents, book chapters, and edited a book titled Handbook of Non-Invasive Drug Delivery Systems: Science and Technology. He is a current member of American Association of Pharmaceutical Scientists.

Affiliations and expertise

Scientific Advisor, DPT Laboratories, San Antonio, Texas

Charles Shaw

Charles Shaw, Ph.D. is Scientific Advisor at DPT Lakewood LLC, Lakewood, NJ. Dr. Shaw has more than 30 years of experience in pharmaceutical and medical device development and manufacturing, and holds board certifications that include Chartered Scientist; Chartered Chemist; Fellow of the Royal Society of Chemistry, London; and European Chemist. Before joining DPT Laboratories in 2004, he was Product Development and Technical Services Manager with Smith & Nephew Medical Ltd. He earned a Ph.D. in Chemistry at the University of Hull, England in the area of reaction kinetics.

Dr. Shaw is experienced in the development and characterization of wound dressings, semi-solid and liquid formulations, and nasal spray products. He has published scientific research articles in peer reviewed journals, book chapters, trade journals and conferences. He has also presented webinars and conference workshops for nasal spray products. He is a current member of American Association of Pharmaceutical Scientists.

Affiliations and expertise

Scientific Advisor, Research and Development, DPT Lakewood, LLC, Lakewood, NJ

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