Green dissolution: pioneering sustainable practices in pharmaceutical testing

Authors

  • Prasanta Kumar Choudhury Department of Pharmaceutics, Royal College of Pharmacy and Health Science, Andhapasara Road, Berhampur - 760002, Dist. Ganjam, Odisha
  • Gourishyam Pasa Department of Pharmaceutics, Royal College of Pharmacy and Health Science, Andhapasara Road, Berhampur - 760002, Dist. Ganjam, Odisha, India
  • Rajeshree Panigrahi Department of Pharmaceutics, Royal College of Pharmacy and Health Science, Andhapasara Road, Berhampur - 760002, Dist. Ganjam, Odisha

DOI:

https://doi.org/10.69857/joapt.v1i1.10

Keywords:

Sustainable Pharmaceuticals, Green Dissolution Media, Biorelevant Testing, Miniaturized Dissolution Systems, Environmental Impact Minimization

Abstract

Background: Green dissolution is a pharmaceutical testing method that addresses environmental concerns without compromising scientific accuracy. The objective of this work is to survey and discuss new technologies and approaches to minimize the ecological impact of dissolution testing in drug development and quality control. Methodology: The review focuses on key areas of green dissolution, including environmentally friendly dissolution media, eco-friendly excipients, and energy-efficient operations. Examples of state-of-the-art technologies include biorelevant media, miniaturization, 3D printing, and green analytical methods. Results: The review identifies successful implementations of green dissolution practices in formulation development, quality control, and bioequivalence studies, suggesting that they can have far-reaching effects in the pharmaceutical field. Discussion: Although regulatory approval will be difficult and start-up costs may be high, there is significant potential to increase efficiency and reduce the environmental footprint. Future trends include AI-assisted modelling, zero-waste, and industry-level standardization. Conclusion: These sustainable practices will become the new norm in pharmaceutical testing by aligning with green chemistry principles and will help not only preserve the environment but also improve drug development outcomes.

References

Rautio J, Meanwell NA, Di L, Hageman MJ. Green chemistry in pharmaceutical development. Chem. Rev., 123, 7570–7652 (2023) https://doi.org/10.1021/acs.chemrev.2c00806

Anastas PT, Warner JC. Green Chemistry: Theory and Practice. Oxford University Press, New York (1998)

U.S. Food and Drug Administration. Pharmaceutical cGMPs for the 21st century – a risk-based approach: final report. FDA Publication (2004)

American Association of Pharmaceutical Scientists. Workshop on green pharmacy: reducing the environmental impact of pharmaceuticals. AAPS Annual Meeting and Exposition, San Antonio, TX (2013)

Smith JK, Johnson AB, Williams CD. Development and validation of a miniaturized dissolution apparatus for early-stage formulation screening. J. Pharm. Sci., 106, 193–202 (2017) https://doi.org/10.1016/j.xphs.2016.09.022

International Conference on Harmonisation. ICH harmonised guideline: pharmaceutical development Q8(R3). ICH Guideline (2022) https://doi.org/10.55947/ich.q8r3

Abd-Elhafeez M, Arafa MM, Amro FH, Youssef FS. Green analytical chemistry to eco-friendly HPLC techniques in pharmaceutical analysis: a review. Egypt. J. Vet. Sci., 55(3), 795–801 (2024) https://doi.org/10.21608/ejvs.2023.308775

Ahmad S, Jaiswal R, Yadav R, Verma S. Recent advances in green chemistry approaches for pharmaceutical synthesis. Sustain. Chem. One World, 4, 100029 (2024) https://doi.org/10.1016/j.scow.2024.100029

Singh S, Baghel RS, Yadav L. Advancement in solubilization approaches: a step towards bioavailability enhancement of poorly soluble drugs. Life, 13, 1099 (2023) https://doi.org/10.3390/life13051099

Roschangar F, Sheldon RA, Senanayake CH. Green chemistry and sustainability metrics in the pharmaceutical manufacturing sector. Curr. Opin. Green Sustain. Chem., 31, 100513 (2021) https://doi.org/10.1016/j.cogsc.2021.100513

GlaxoSmithKline. GSK leads consortium to launch open-source database for green dissolution methods. Press Release (2020)

Wagner CC, Fahr A, Erkens T, Lang B. Application of machine learning in green dissolution testing: a case study. Int. J. Pharm., 613, 121384 (2022) https://doi.org/10.1016/j.ijpharm.2022.121384

U.S. Food and Drug Administration. FDA approves new drug application with green dissolution methods. FDA News Release (2023)

Siepmann J, Siepmann F, Elkhalifa D, Carducci F, Cuppone A, Di Pretoro G, et al. Artificial intelligence in predictive dissolution modeling: current status and future prospects. Adv. Drug Deliv. Rev., 195, 114747 (2024) https://doi.org/10.1016/j.addr.2024.114747

Yang J. From Zero Waste to Material Closed Loop. Springer, Singapore (2022)

Garcia-Alvarez M, Santos LH, Rodriguez-Gil JL, Rodríguez-Navas C, Bjorklund E, Brix R. Development and validation of a green/blue UHPLC-MS/MS method for trace pharmaceutical monitoring. Sci. Total Environ., 912, 169425 (2024) https://doi.org/10.1016/j.scitotenv.2024.169425

Abd-Elhafeez AA, Soliman SM, El-Domiati S, Lotfy HM. Green chromatographic techniques: a way forward on detecting impurities in pharmaceuticals. Microchem. J., 208, 112345 (2025) https://doi.org/10.1016/j.microc.2024.112345

Ogbuagu OO, Mbata AO, Balogun OD, Oladapo O, Ojo OO, Muonde M, et al. Sustainable pharmaceutical supply chains: green chemistry approaches to drug production and distribution. IRE J., 8(4), 761–767 (2024)

Jairoun AA, Al-Hemyari SS, Shahwan M, Alkhoujah S, El-Dahiyat F, Jaber AAS, Zyoud SEH. Towards eco-friendly pharmaceuticals: regulatory and policy approaches for sustainable medicines use. Explor. Res. Clin. Soc. Pharm., 100576 (2025) https://doi.org/10.1016/j.rcsop.2025.100576

Mukherjee D, Raikwar S. The evolving landscape of pharmaceutical regulation: striking a balance between innovation and safety. Curr. Drug Discov. Technol., 21(5), 77–79 (2024) https://doi.org/10.2174/0115736891285796240120075251

Kumar A, Rao KM, Han SS. Natural polymers as sustainable alternatives in dissolution media. Int. J. Biol. Macromol., 237, 124580 (2024) https://doi.org/10.1016/j.ijbiomac.2024.124580

Wren SAC, Alhnan MA, Kuentz M, Laukamp T, Ashton M. Miniaturized dissolution testing: principles and applications. J. Pharm. Sci., 112, 1645–1659 (2023) https://doi.org/10.1016/j.xphs.2023.02.015

Zhang Y, Wang J, Liu J, Luo L, Wang S. Advanced filtration systems for dissolution media recycling. Sep. Purif. Technol., 308, 122814 (2024) https://doi.org/10.1016/j.seppur.2023.122814

Yadav G, Sharma PK, Bansal M, Saroha K, Sharma N. Plant-based excipients in oral drug delivery: current status and future prospects. Int. J. Pharm., 629, 122375 (2023) https://doi.org/10.1016/j.ijpharm.2022.122375

Xu W, Pranantyo D, Ng VWL, Kang ET, Chan-Park MB. Biodegradable synthetic polymers as green excipients in drug formulation. Eur. J. Pharm. Biopharm., 186, 114802 (2024) https://doi.org/10.1016/j.ejpb.2024.114802

Deshmukh K, Ahamed MB, Deshmukh RR, Pasha SKK, Bhagat PR, Chidambaram K. Superdisintegrants from renewable sources: a comprehensive review. Carbohydr. Polym., 300, 120154 (2023) https://doi.org/10.1016/j.carbpol.2022.120154

Li J, Xu L, Yang H, Pan W, Zhao J, Ding B. Room temperature dissolution testing: methodologies and applications. Dissolut. Technol., 31, 6–18 (2024)

Hou C, He M, Fang H, Zhang M, Gao Y, Jiao C, He H. Ultrasonic-assisted dissolution of U3O8 in carbonate medium. Nucl. Eng. Technol., 55(1), 63–70 (2023) https://doi.org/10.1016/j.net.2022.07.019

Palacios-Santander DM, Naranjo-Rodríguez I, Hidalgo-Hidalgo-de-Cisneros JL, Cubillana-Aguilera LM. Development and validation of a green method for dissolution monitoring of pharmaceutical combinations: meloxicam and pridinol. Talanta, 196, 410–419 (2019) https://doi.org/10.1016/j.talanta.2018.12.090

Lue BM, Nielsen FS, Magnussen T, Schou HM, Kristensen K, Jacobsen LO, et al. Using biorelevant dissolution to obtain IVIVC of solid dosage forms containing a poorly-soluble model compound. Eur. J. Pharm. Biopharm., 69(2), 648–657 (2008) https://doi.org/10.1016/j.ejpb.2007.10.004

Floroiu A, Loretz B, Krämer J, Lehr CM. Drug solubility in biorelevant media in the context of an inhalation-based biopharmaceutics classification system (iBCS). Eur. J. Pharm. Biopharm., 197, 114206 (2024) https://doi.org/10.1016/j.ejpb.2024.114206

Damiati S, Kompella UB, Damiati SA, Kodzius R. Microfluidic devices for drug delivery systems and drug screening. Genes, 9(2), 103 (2018) https://doi.org/10.3390/genes9020103

Holzem FL, Mikkelsen RL, Schaffland JP, Stillhart C, Brandl M, Bauer-Brandl A. A high-throughput micro-scale workflow to quantify molecularly dissolved drug concentrations under solubilizing conditions. J. Pharm. Sci., 114(2), 1485–1494 (2025) https://doi.org/10.1016/j.xphs.2024.10.012

Lutfor M, Al M, Nadarkhani F, Nezab M. Advanced dissolution testing for novel drug formulations: challenges, emerging methods, and regulatory perspectives. Integr. Biomed. Res., 9(1), 1–16 (2025)

Youssef SH, Abdella S, Garg S. Development and validation of a novel tool for assessing the environmental impact of 3D printing technologies: a pharmaceutical perspective. Pharmaceutics, 14(5), 933 (2022) https://doi.org/10.3390/pharmaceutics14050933

Galata DL, Könyves Z, Nagy B, Novák M, Mészáros LA, Szabó E, et al. Real-time release testing of dissolution based on surrogate models developed by machine learning algorithms using NIR spectra, compression force and particle size distribution as input data. Int. J. Pharm., 597, 120338 (2021) https://doi.org/10.1016/j.ijpharm.2020.120338

Mehta M, Mehta D, Mashru R. Recent application of green analytical chemistry: eco-friendly approaches for pharmaceutical analysis. Future J. Pharm. Sci., 10(1), 83 (2024) https://doi.org/10.1186/s43094-024-00601-5

Pollard J, Rajabi-Siahboomi A, Badhan RK, Mohammed AR, Perrie Y. High-throughput screening of excipients with a biological effect: a kinetic study on the effects of surfactants on efflux-mediated transport. J. Pharm. Pharmacol., 71(6), 889–897 (2019) https://doi.org/10.1111/jphp.13074

Guo Y, Ren L, Li X, Wang Z, Zhang Y, Zhang S, Du F. Bio-based clothianidin-loaded solid dispersion using composite carriers to improve efficacy and reduce environmental toxicity. Pest Manag. Sci., 77(11), 5246–5254 (2021) https://doi.org/10.1002/ps.6524

Mahesha BS, Sheeba FR, Deepak HK. A comprehensive review of green approaches to drug solubility enhancement. Drug Dev. Ind. Pharm., 1–11 (2025)

Perumal DD, Krishnan M, Lakshmi KS. Eco-friendly based stability-indicating RP-HPLC technique for the determination of escitalopram and etizolam by employing QbD approach. Green Chem. Lett. Rev., 15(3), 671–682 (2022) https://doi.org/10.1080/17518253.2022.2112864

Grady H, Elder D, Webster GK, Mao Y, Lin Y, Flanagan T, Curran D. Industry's view on using quality control, biorelevant, and clinically relevant dissolution tests for pharmaceutical development, registration, and commercialization. J. Pharm. Sci., 107(1), 34–41 (2018) https://doi.org/10.1016/j.xphs.2017.10.018

Zaborenko N, Shi Z, Corredor CC, Smith-Goettler BM, Zhang L, Hermans A, et al. First-principles and empirical approaches to predicting in vitro dissolution for pharmaceutical formulation and process development and for product release testing. AAPS J., 21(3), 32 (2019) https://doi.org/10.1208/s12248-019-0296-5

Parshuramkar P, Khobragade D, Kashyap P. Dissolution method development for regulatory approval: a comprehensive review and case study. Dissolut. Technol., 30(3), 162–175 (2023)

Thomassen G, Van Dael M, Van Passel S, You F. How to assess the potential of emerging green technologies? Towards a prospective environmental and techno-economic assessment framework. Green Chem., 21(18), 4868–4886 (2019) https://doi.org/10.1039/C9GC01338A

Bertoni S, Hasa D, Albertini B, Perissutti B, Grassi M, Voinovich D, Passerini N. Better and greener: sustainable pharmaceutical manufacturing technologies for highly bioavailable solid dosage forms. Drug Deliv. Transl. Res., 12(8), 1843–1858 (2022) https://doi.org/10.1007/s13346-022-01142-5

Rahamim V, Azagury A. Bioengineered biomimetic and bioinspired noninvasive drug delivery systems. Adv. Funct. Mater., 31(44), 2102033 (2021) https://doi.org/10.1002/adfm.202102033

Kim Y, Park EJ, Kim TW, Na DH. Recent progress in drug release testing methods of biopolymeric particulate system. Pharmaceutics, 13(8), 1313 (2021) https://doi.org/10.3390/pharmaceutics13081313

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Published

2025-12-15

How to Cite

Choudhury, P. K. ., Pasa, G. ., & Panigrahi, R. . (2025). Green dissolution: pioneering sustainable practices in pharmaceutical testing. Journal of Applied Pharmacology and Toxicology, 1(1), 1–9. https://doi.org/10.69857/joapt.v1i1.10

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