Lily Lin, PhD, is a senior applications scientist at Roquette in the Health and Pharma Solutions Business Unit, specializing in formulation design and excipient innovation. She holds a PhD in polymer chemistry from Texas A&M University and completed postdoctoral training at MIT.

Lily Lin 

Medicinal capsules green pills in lab. Top view. 3d rendering | Image Credit: ©svitlini - stock.adobe.com

Sustainability has become a core consideration in pharmaceutical manufacturing. It is driven by evolving global regulations, consumer expectations, and increasingly complex supply chains, which all demand a shift toward greener practices. Industrial sustainability efforts often focus on reducing emissions, optimizing resource efficiency, and minimizing waste across the product life cycle, without compromising human rights. From a manufacturing perspective, these efforts include responsible and sustainable sourcing, innovative product design, efficient manufacturing and shipping, and waste reduction.

Excipients can play a meaningful role in achieving sustainability goals in the pharmaceutical industry. Sourcing excipients that have a low carbon footprint and are derived from renewable sources is just part of the equation. Excipients designed to enable simpler, lower-energy processes are often overlooked for improving sustainability. This article explores the diverse ways excipient companies can support sustainable pharmaceutical production across the life cycle of a drug product.

How Is Environmental Impact Reduced at the Source?

The environmental impact of pharmaceuticals can be reduced by responsible sourcing, efficient manufacturing, waste reduction, lifecycle assessment, and collaboration.

 At the heart of sustainability is responsible and sustainable sourcing. With a global perspective, these programs ensure ethical and environmental practices in procurement and implementation of traceability of raw materials, such as wood pulp and seaweed, which are widely used in the pharmaceutical industry. Many excipient manufacturers are prioritizing renewable feedstock and local and traceable supply chains through collaborations with raw material suppliers and external programs focused on ethical practices. For example, wood pulp, a starting material for cellulose-based excipients, including microcrystalline cellulose and hypromellose, can be responsibly sourced from suppliers that are certified by organizations such as the Forest Stewardship Council, Sustainable Forestry Initiative, or Programme for the Endorsement of Forest Certification. Key practices required for these certificates include sourcing from responsibly managed forests, protecting rights and dignity of indigenous communities, and managing high conservation value areas, while avoiding controversial sources like mature-growth forests to achieve deforestation-free value chains.

Each raw material going into plant-based excipients has its own set of needs to ensure an environmentally-friendly supply. Seaweed, a raw material used in the manufacturing of alginates, alginate-based materials, and carrageenan, does not require use of fertilizers or arable land like many land-based crops. However, minimal disruption to aquatic life is key to the responsible harvesting of seaweed, especially in a time of climate change. To maintain aquatic biodiversity, it’s important to develop and follow a sustainable harvest management plan. Many countries where seaweed is harvested, such as Norway and Iceland, have strict regulations on harvesting, requiring a five-year growth cycle and rotating zones in harvest fields.

Excipients coming from crop raw materials (corn, wheat, pea, and potato) can be certified from the field to customers through chain-of-custody processes. Excipient manufacturers can guarantee these excipients are coming from fields without deforestation and farms using good agricultural and ethical practices. By participating in regenerative agricultural programs (eg, Covalo in France and Truterra in the US), excipient companies are dedicated to strengthening the resilience of farms facing climate change and securing more sustainable sources for raw materials.

Excipient companies (eg, Roquette, BASF, Ashland, and JRS) have implemented transparent sourcing protocols for raw materials and ensure compliance with responsible sourcing certificates.

Green chemistry and energy-efficient manufacturing

. Excipient companies are increasingly adopting greener production technologies to achieve energy efficiency. Process optimization, predictive modeling, and adoption of continuous manufacturing can increase yields and decrease the energy required per kilogram of material produced.

Solvent selection is another critical factor. The choice of solvent within a chemical process can affect both potential toxicity and environmental impact if not properly controlled. Some Class 2 solvents are also volatile organic compounds that can react with nitrogen oxides in the presence of sunlight to form ground-level ozone (smog). Replacing a Class 2 solvent with a safer Class 3 alternative may reduce toxicity and environmental hazards associated with some chemical syntheses.

Biocatalysis is gaining traction as scalable solutions for lowering carbon footprints in the production of APIs.

 These processes use enzymes or whole cells to perform chemical reactions that produce molecules with highly precise chemical and stereo selectivity under mild conditions. A few excipients (eg, xanthan gum and citric acid) currently use bioprocesses such as fermentation in their synthesis. Expansion of biocatalytic processes in excipient production will depend on the industry’s ability to scale these bioprocesses for production in the thousands of kilograms (excipients) compared to kilograms for API.

 Excipient suppliers are increasingly embedding circular economic principles into their operations, with a focus on reducing waste and maximizing resource efficiency. Recycling and/or recovery systems can reduce incineration and disposal of waste streams. Water reuse strategies including advanced filtration and reverse osmosis are effective at separating water from a range of materials from large particles down to ions, substantially reducing freshwater withdrawal and wastewater discharge.

 These efforts not only reduce environmental impact and lower operational costs but also align with good manufacturing practice (GMP) frameworks requiring validation of solvent recovery processes—covering critical parameters, impurity monitoring, and annual requalification.

Excipient packaging is another area where suppliers can make changes to reduce waste. Companies are shifting from traditional fiber drums to recyclable, lightweight packaging formats, (eg, bag-in-box), thereby cutting packaging waste by over 85% and improving pallet loading efficiency.

 Boosting pallet density lowers the emissions per unit with regards to shipping of the material around the world. These improvements come as regulatory initiatives such as Packaging and Packaging Waste Regulation (PPWR) (EU) 2025/40 set out sustainability requirements for packaging through its life cycle, including production, use, and waste management.

Excipient packaging selection can have more impact on waste management than just the physical packaging material waste. Properly selected packaging can extend the shelf life of the excipient material, allowing for more flexible supply chain maintenance and resulting in less unusable material making its way to landfills or incinerators.

Regulatory frameworks—spanning EU directives, US standards, and international GMP guidelines—are driving excipient suppliers and pharmaceutical manufacturers to invest heavily in circular infrastructure; the outcome is reduced waste, reduced greenhouse emissions, and compliance readiness. The EU PPWR (EU) 2025/40, effective from August 2026, mandates that all packaging across industries—including pharmaceuticals—must be designed for recyclability by 2030 and be recyclable at scale by 2035. It also imposes minimum recycled-content requirements for plastic packaging, with potential exemptions for primary pharmaceutical packaging until 2035. New obligations such as harmonized recycling symbols and QR codes (due by 2028) further support clear end-of-life handling.

 Extended Producer Responsibility under PPWR compels excipient and pharmaceutical producers to finance reverse logistics, such as packaging end-of-life collection, sorting, and recycling, with fees modulated by environmental performance. In the United States, FDA’s ICH (International Council for Harmonisation) Q3C guideline and companion residual solvents guidance emphasize minimizing residual solvents in drugs—including excipients—encouraging manufacturers to recover and reuse solvents instead of disposing of them, because reducing solvent use also lowers residual risk.

 The US Environmental Protection Agency (EPA) Subpart P (40 

Part 266) enforces strict controls on hazardous pharmaceuticals—including excipient residues—banning sewer disposal and requiring safe management, which motivates facilities to implement closed-loop solvent and water systems to avoid discharges and protect the environment.

 To enhance transparency with customers and suppliers, pharma industry companies work relentlessly on conducting lifecycle assessments (LCAs) for their products. LCAs play a central role in quantifying and communicating the environmental impact of excipients across their entire value chain— including raw material sourcing, production, distribution, and end-of-life. Pharma companies often conduct product carbon footprint calculations in alignment with the International Organization for Standardization (ISO) standards and the Greenhouse Gas protocol. In support of these efforts, excipient companies are providing their own LCAs on their products. Many companies publish sustainability reports detailing carbon footprints, energy usage, and progress toward emission reduction targets—providing transparency to regulators and customers alike. 

Roquette has aligned its operations with various climate regulatory and circular economy frameworks,

 including the principles of the Product Sustainability Assessment (PSA) published by the World Business Council for Sustainable Development. SPARQ provides a sustainability score based on the environmental footprint through quantitative LCA and the extent to which the product provides environmental and societal benefits when used. One of Roquette’s targets by 2030 is to cover 100% of their products with an LCA.

BASF has developed a rigorous methodological framework for product carbon foot printing, adhering to ISO 14067:2018. Individual LCAs assess carbon emissions and resource use and waste generation across the product lifecycle, enabling optimized formulations and production processes.

 IMCD, a global distributor of specialty chemical ingredients (including excipients), reports annually under Global Reporting Initiative standards and frameworks like the UN Global Compact. Its dashboards detail supplier emissions, logistics energy efficiency, and waste performance—offering insights into environmental impacts across sourcing and distribution activities.

 By openly sharing LCA data, both BASF and IMCD demonstrate environmental accountability and empower formulators and planners with data that support sustainable decision-making, regulatory compliance, and end-product transparency. Conducting LCAs also helps companies understand their own resource use and environmental impacts focusing on product sustainability.

Collaborative sustainability frameworks. 

The pharmaceutical excipient industry is increasingly leveraging collective action—through partnerships, consortia, and cross-sector initiatives—to drive sustainable outcomes. Suppliers are collaborating with farming cooperatives and agronomists to promote regenerative agriculture practices for crops and cellulose feedstocks. These programs focus on soil health, biodiversity, and carbon sequestration, enabling a more circular and resilient agricultural ecosystem. Cross-industry audit frameworks, such as Together for Sustainability and UN Global Compact, help suppliers ensure that ethical labor standards and biodiversity-preservation practices are embedded in raw material sourcing and feedstock cultivation.

These collaborative models signify a profound transition in the pharmaceutical supply chain: sustainability is no longer a marketing add-on but a fundamental design principle. Formulators can now source excipients that are both functionally robust and aligned with environmental, social, and governance (ESG) objectives bolstered by verified traceability, environmental integrity, and social responsibility. Industry consortia and partnerships are fostering shared standards for sustainable excipient development. Initiatives include joint programs for regenerative agriculture supporting crops and cellulose feedstocks and cross-industry audits to ensure ethical labor practices and biodiversity preservation.

To go further, Roquette decided to target a 25% reduction in emissions by 2030. This target aligns with the Science Based Targets initiative and the Paris Agreement, ensuring that Roquette’s efforts contribute meaningfully to global climate goals.

How Are Technical Advancements in Excipients Reducing Energy, Water, and Waste in Pharma Manufacturing?

Formulation design represents one of the most impactful opportunities to reduce energy, water, and waste in pharmaceutical manufacturing. By leveraging innovative excipients, manufacturers can simplify processes, minimize waste, and enhance operational efficiency without compromising product performance or regulatory compliance. Excipients can reduce environmental impact beyond manufacturing too. By enabling smaller, more stable dosage forms, supporting recyclable packaging, and reducing environmental persistence, excipients help minimize waste and emissions from production to patient use and disposal. The following are some examples of how excipient and formulation innovation can impact sustainability initiatives.

Reducing water and energy consumption using moisture-activated dry granulation (MADG). 

Traditional wet granulation is resource-intensive, requiring significant water (20–50% of the weight of the dry powder) and energy for drying. MADG offers a sustainable alternative by using minimal liquid (1–4 wt% water) to agglomerate powders without a heat-drying phase (

). Eliminating the heating phase reduces energy consumption by about 50% (or more) compared to conventional wet granulation processes.

 The MADG process comprises two main phases: agglomeration and moisture distribution. During the agglomeration phase, a small amount of water is added to a subset of ingredients, including the API, to create agglomerates with a predetermined particle size that will ensure satisfactory flow. The second step involves blending in an excipient (or two) that will absorb and redistribute the moisture within the mixture. Subsequent addition of excipients, like lubricants, proceed as typically done. The key to this process is selecting excipients that absorb and distribute water throughout the formulation. Avicel PH200 LM, a low-moisture-grade microcrystalline cellulose, enables MADG by providing excellent binding, water redistribution, and flow properties under low moisture conditions.

Figure 1. Typical processing steps needed for (a) wet granulation, (b) MADG, and (c) direct compression from measuring to tableting. Figure courtesy of the authors.

Reducing energy consumption by direct compression with made-for-purpose excipients

. Direct compression (DC) eliminates multiple steps inherent in wet granulation, such as wet massing, drying, and milling (

). DC saves time, water, energy and money. One study estimates that the drying stage needed in wet granulation accounts for 45–84% of the total energy consumption of the entire production process.

 Not all formulations are well designed for DC. The blended formulation must flow well and not segregate. Careful selection of excipients can provide good flow, consistent particle size, and good compressibility properties to aid in successful DC production with suitable API. Excipient manufacturers recognize the benefits of DC and are designing excipients for direct compression, like Avicel silicified microcrystalline cellulose (SMCC; Roquette), mannitol and hydroxypropyl methylcellulose (PEARLITOL CR-H; Roquette), and direct compression hydroxypropyl methylcellulose (METHOCEL DC2 HPMC; Roquette).

Co-processing excipients can improve the flow and reduce segregation of critical excipients within a formulation, often rendering them superior to their individual components in direct compression processes. SMCC, a co-processed excipient, flows better than both microcrystalline cellulose (MCC) and the blended mixture of silica and MCC, while also providing better tablet strength and uniformity compared to the blended combination.

 The co-processing step does not chemically change either the silica or the MCC,

 but provides intimate integration that outperforms the simple blended mixture in direct compression. Similarly, co-processing mannitol with HPMC produces an excipient that flows well and has good compressibility in direct compression processes for controlled-release formulations.

Not all excipients made for direct compression need to be co-processed. Direct compression hydroxypropyl methylcellulose is morphologically designed for better flow than standard HPMC products without any change to chemistry or composition. The direct compression grades of HPMC show reduced tablet variability (hardness and weight) compared to the standard HPMC grades using several model API formulations in DC processes [28, 29].

One study showed that moving from a production process that includes wet granulation with HPMC to a direct compression process with direct compression grades of HPMC could save 42% in production time and 61% in production costs,

 further emphasizing that excipients and excipient manufacturers can support pharma’s goals in efficiency gains.

. Film coating is another energy-intensive process, often requiring high temperatures and long cycle times. Coating processes and formulations that can reduce the drying temperature and drying time (and thus the overall energy input to the system) are more eco-friendly. A hydroxypropyl pea starch-based coating system addresses these challenges by enabling up to 50% reduction in coating time, 25% lower processing temperatures, and half the CO

 emissions compared to traditional coating systems.

Beyond energy savings, this system simplifies cleaning cycles, reducing water usage by 45% and eliminating the need for harsh solvents, further supporting sustainability goals.

These technical advancements demonstrate how excipient innovation can serve as a catalyst for sustainable pharmaceutical manufacturing, reducing resource consumption, improving efficiency, and aligning with global climate and ESG objectives.

Excipient innovation is part of a broader eco-design strategy that integrates sustainability into every stage of product development. By reducing energy consumption, minimizing waste, and sourcing responsibly, excipients are helping the pharmaceutical industry meet their sustainability targets without compromising quality or safety.

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Prathiba Devadas is a sustainability engineer at Roquette Health & Pharma Solutions focusing on responsible sourcing, scope 3 emissions, zero waste to landfill, sustainability in R&D, and strategy development.

Articles

Excipients contribute to more sustainable practices throughout the life cycle of a drug. 