Advances in Pharmaceutical Product Development

See the new book, edited by Keerti Jain and Awesh K. Yadav. This book discusses the stages involved in pharmaceutical product development including the importance, requirement, and effect of each stage and process.

Description: It also covers prototype development for pharmaceutical formulations, scale-up studies, optimization, testing, packaging, and commercialization of different dosage forms for pharmaceutical products like tablets, suspensions, emulsions, coating, inhalational products, sterile products, and herbal formulations. The book also presents advancements in tablet production and tablet coating, including materials, material handling, granulation and granulation technologies, process automation, processing problems in tablet production and troubleshooting, advances in equipment for coating and coating materials. Further, the chapter explores the advances in the formulation and development of aerosols, nebulizers, inhalers, metered Dose Inhalers (MDI), and dry powder Inhalers (DPIs). Towards the end, the book examines the challenges, formulation development, testing, stability, and regulatory guidelines in the development of herbal formulations. This book provides a valuable source of information for the researcher, scientists, students, and people working in the area mainly focused on the challenges in pharmaceutical product development.

Chapter 4

Pharmaceutical Product Development: Formulation Additives

This chapter offers a complete assessment of the key role played by formulation additives in the development of pharmaceutical dosage forms. Beginning with an insightful introduction to formulation additives, the chapter emphasises on their significance in achieving desired product characteristics. A systematic breakdown follows, categorising formulation additives based on the types of dosage forms and providing detailed insights into the additives used in each category, shedding light on their functions and applications. The importance of understanding drug-additive interactions during formulation development has also been discussed, covering physical, chemical and therapeutic incompatibilities, along with analytical techniques to characterise such interactions. Recent advances in additive science, such as functional and co-processed additives and novel materials, are also explored along with international patented excipients. Additionally, the chapter provides insights into related regulatory perspectives, including generally recognised as safe (GRAS), international impurity guidelines (IIG) and International Pharmaceutical Excipients Council (IPEC), to ensure compliance and safety in pharmaceutical formulations. This chapter serves as a necessary source for those engaged in pharmaceutical product development, providing a comprehensive and up-to-date perspective on formulation additives.

See the chapter

Patel, M., Patel, D., Patel, H.M., Jha, L.L. (2025). Pharmaceutical Product Development: Formulation Additives. In: Jain, K., Yadav, A.K. (eds) Advances in Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-97-9230-6_4

Chapter 5

Advances in Pharmaceutical Oral Solid Dosage Forms

The pharmaceutical and healthcare industries are constantly moving through a period of unmatched changes. Oral administration of solid dosage forms is one of the most preferred route and is highly patient compliant as well as stable when compared to other dosage forms. However, the challenge of transition from a traditional manufacturing approach to continuous automated processing approach remains unmet. Continuous modifications in materials and manufacturing technologies are gradually being implemented in the industry to avail the benefits related to process automation, improved quality and reduced costs. Therefore, it is well accepted that there is a growing demand to discover alternative processes and design formulation strategies that can significantly improve powder processing techniques, granulation methods and equipment to ensure safe, reproducible and quality products are manufactured. The intended chapter presents an overview of the state-of-the-art research equipment, material handling techniques, process analytical technique implementation and 3D printing application strategies. It covers recent advances in techniques and processes at every stage of pharmaceutical product development and methods employed to troubleshoot the processing hurdles.

See the chapter

Saikiran, P. et al. (2025). Advances in Pharmaceutical Oral Solid Dosage Forms. In: Jain, K., Yadav, A.K. (eds) Advances in Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-97-9230-6_5

Chapter 6

Advances in Tablet Production and Tablet Coating

Tablets have long been a preferred pharmaceutical dosage form due to their convenience, stability, and ease of administration. Significant advancements in tablet production and coating technologies have revolutionized the pharmaceutical and nutraceutical industries in recent years. This book chapter provides an overview of key innovations in tablet manufacturing and coating processes, highlighting their impact on drug delivery, product quality, and patient compliance. Advancements in granulation methods such as spray drying, fluid bed granulation, and hot-melt extrusion have improved drug content uniformity, dissolution rates, and overall product stability. The adoption of these technologies promises continued progress in the field of tablet manufacturing, offering new opportunities for personalized medicine and enhanced therapeutic outcomes. Notably, coating technologies have also evolved significantly to enhance tablet appearance, taste-masking, and drug release profiles. Film coating using aqueous and organic solutions has become more efficient, environmentally friendly, and cost-effective. Furthermore, automation involves the utilization of machinery and tools to execute both physical and cognitive tasks within a production process. The growing focus on automated technology in the pharmaceutical industry is driven by the promising trend of fully automating tablet production. This book chapter also emphasized issues concerning the process of tablet manufacturing and recent advancements in the tablet coating process.

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Jitendra, N.N., Garg, R., Alam, M.I., Yadav, A.K. (2025). Advances in Tablet Production and Tablet Coating. In: Jain, K., Yadav, A.K. (eds) Advances in Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-97-9230-6_6

Chapter 7

Formulation Evaluation and Development of Specialized Tablets

Oral solid formulations are the most popular and convenient among all kinds of dosage forms available in the market. Tablets are the solid dosage forms that ensure fixed dose, tamper resistance, and easy handling and administration. The merits of tablets make them survive in the pharmaceutical market with huge profit. Tablets have been modified from time to time into several types to be accepted by all groups and kinds of patients. Based on release profile, tablets are basically divided into immediate, sustained, delayed release, and many more. Chewable, effervescent, and orodispersible tablets hold a specific position in the market. In this chapter we have discussed formulation, evaluation, and development of these specialized tablets to cater needs of particular groups of patients in brief. The future of the tablets starts with the exploration of the world of 3D printing which makes the customized tablets easily available for the patients as per their needs, hence improving the patient compliance and acceptability.

See the chapter

Tarannum, S., Jain, K. (2025). Formulation Evaluation and Development of Specialized Tablets. In: Jain, K., Yadav, A.K. (eds) Advances in Pharmaceutical Product Development. Springer, Singapore. https://doi.org/10.1007/978-981-97-9230-6_7

See the full book here

Keerti Jain, Awesh K. Yadav, Advances in Pharmaceutical Product Development, Springer Singapore, Hardcover ISBN: 978-981-97-9229-0, Published: 19 March 2025, Softcover ISBN: 978-981-97-9232-0, Due: 02 April 2026, eBook ISBN: 978-981-97-9230-6, Published: 18. March 2025, https://doi.org/10.1007/978-981-97-9230-6