NARENDRA AMBHAIKAR, DHILEEP KRISHNAMURTHY
Piramal Enterprises Limited, Ennore Express Highway, Ennore, Chennai, Tamilnadu 600057, India

Abstract

The pharmaceutical manufacturing industry faces the challenging task of operating sustainably with minimal safety, cost and environmental impact. While the ‘D’ part or process development in R&D is a very critical activity toward the scale-up of Active Pharmaceutical Ingredients (APIs) and intermediates, the ‘R’ part (process research) can also profoundly influence the API manufacturing industry; and it can be a deciding factor in the greenness of the process. The concept of Green Chemistry by Design (GCbD) enables one to understand the relationship between process research, sustainability and economics with respect to API. Proactively designing synthetic routes by recognizing criteria such as safety, environmental, legal, economics, control as well as throughput is an important step in the selection of a practical synthetic route. More often than not, a cost effective process is a green process. Existing and emerging scientific tools and technologies when identified and applied appropriately contribute to greener and more economical routes on large scale. Additionally, with the wealth of new reactions that continue to be discovered in the academic world, the field of process research toward organic compounds continues to remain dynamic, thus providing opportunities to develop green synthetic routes.

INTRODUCTION

The pharmaceutical industry has continued to go through major changes since its inception. More drugs than before continue to be discovered, developed and launched, benefiting the patient and thus reducing the burden of disease. While the advantages of this established and yet growing industry are undeniably obvious, the challenges that it continues to face are unique. Sustainable and efficient production of chemicals with the least impact on the environment remains a difficult task, given the various hurdles faced by the industry such as cost-effectiveness, regulatory, legal, robustness, “greenness” and safety. These changing times have stirred the industrial and academic scientific community to work toward developing better reactions and processes. Until recently, the development of green and environmentally friendly processes remained confined mostly to the innovator and generic pharmaceutical companies; while today the growing API business demands the same in pursuit of sustainability, cost-effectiveness and value addition for its customers.

A sustainable process for an intermediate or an API stems from an innovative, well-th ...