The global pharmaceutical industry is shifting toward green manufacturing and sustainable development. As one of the most traditional oral dosage forms, capsules are undergoing a profound transformation in their base materials. From gelatin to HPMC (hydroxypropyl methylcellulose) and further to pullulan, eco-friendly capsules are no longer just alternatives—they are gradually becoming a core component embedded in the next-generation formulation system.
I. Regulatory and ESG Pressure: Environmental Protection Becomes a Mandatory Requirement
Regulatory frameworks such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), together with the ESG strategies of major pharmaceutical companies, have continuously tightened requirements for raw material sourcing, carbon footprint and biological safety in recent years. The inherent bovine spongiform encephalopathy (BSE) risks and supply chain volatility of animal-derived gelatin have become increasingly prominent. Plant-derived materials naturally better meet halal, vegetarian and cross-regional registration requirements.
Meanwhile, a growing number of pharmaceutical companies have incorporated supply chain carbon emissions into procurement evaluations. Eco-friendly capsules are shifting from an "optional choice" to a necessary prerequisite for global products to enter the market.
II. Breakthroughs in Materials Science: Environmental Protection No Longer Comes at the Cost of Performance
The industry has long held the common belief that eco-friendly materials inevitably sacrifice performance. Recent research is overturning this perception.
Pullulan is a natural polysaccharide produced by microbial fermentation, with excellent film-forming properties, high biocompatibility and outstanding oxygen barrier performance. Experiments by Muratbayev et al. [1] show that 1% alginate-pullulan capsules remain intact in simulated gastric fluid (pH 2.0) and completely disintegrate within 120 minutes in simulated intestinal fluid (pH 7.2), protecting botanical extracts from gastric degradation and enabling targeted intestinal release.
For colon-specific delivery, Muselík et al. [2] developed 3D-printed HPMC-pectin composite capsules. Through dual time-triggered and microbiota-triggered mechanisms, they limit drug release in the upper gastrointestinal tract to approximately 5%, achieving effective colon targeting. Aghajannataj Ahangarkola et al. [3] reported an enteric hard capsule composed of pullulan and Eudragit L100, which stays stable in gastric acid for 2 hours without external coating and ruptures rapidly to release drugs when entering intestinal fluid. At the 2025 AAPS PharmSci 360 Annual Meeting, Millet [4] presented a dual-layer enteric capsule—inner layer of HPMC/pullulan and outer layer of ethyl cellulose/sodium alginate. By adjusting sodium alginate concentration and curing conditions, it realizes site-specific release in the terminal ileum.
3D printing technology has also been successfully applied to produce customized HPMC-based capsules. New composite material systems keep emerging.
III. Supply Chain and Commercial Value: From a Cost Item to a Competitive Barrier
The value of eco-friendly capsules is being re-evaluated.
At the supply chain level, fermentation-derived raw materials reduce reliance on animal resources, helping to lower uncertainty from raw material fluctuations. At the market level, plant-based and clean-label attributes boost end-product acceptance—especially in the dietary supplement and high-end formulation markets, where this differentiation has gradually turned into premium pricing power. At the manufacturing level, eco-friendly capsules involve technological accumulation in material modification, film-forming processes and production control. Taking the core patent of Capsugel Belgium NV [5] as an example, it covers pullulan capsule compositions (pullulan, gelling systems, surfactants such as sugar glycerides) and the dip-molding production process. Such technological accumulation builds long-term competitive advantages for enterprises.
IV. Industry Trends: From Alternative Materials to an Integral Part of the Formulation System
The development of eco-friendly capsules is moving along several clear trajectories: plant-based capsules are rapidly replacing gelatin capsules; functional capsules (enteric, sustained-release) are deeply integrated with eco-friendly materials; pharmaceutical companies are starting to incorporate capsules into drug delivery system design, rather than treating them merely as packaging carriers.
This means capsule materials are evolving from an excipient role to a critical variable that affects drug performance.
Conclusion
The critical role of eco-friendly capsules in the modern pharmaceutical industry is driven by a combination of regulatory requirements, advances in materials science and market demand.
For capsule manufacturers, this is far more than a material upgrade—it is a systemic restructuring centered on technological capabilities, supply chain systems and market positioning. In future formulation competition, those who balance environmental protection and performance will be more likely to secure key positions in the industrial chain.
References
[1] Muratbayev A, et al. Development of alginate–pullulan capsules for targeted delivery of herbal dietary supplements in functional fermented milk products. Foods. 2025;14(16):2878. DOI: 10.3390/foods14162878
[2] Muselík J, et al. Tailored biopolymer capsules for colon-specific drug delivery: A 3D printing perspective. J Pharm Sci. 2025;114(7):103815. DOI: 10.1016/j.xphs.2025.103815
[3] Aghajannataj Ahangarkola F, Najafpour-Darzi G, Kalmer RR. Towards a novel pullulan and pullulan-enteric hard capsules: Study of drug release and crucial capsule features. J Drug Deliv Sci Technol. 2024;92:105297. DOI: 10.1016/j.jddst.2023.105297
[4] Millet E. Design of site-specific enteric capsule for terminal ileal drug delivery. Poster presented at: AAPS PharmSci 360; November 10, 2025; San Antonio, TX.
[5] Capsugel Belgium NV. Pullulan capsules. World Intellectual Property Organization patent WO-2018189584-A1. 2018.
Post time:2026-04-16