Author(s):
Patel Mehul, Anuradha Prajapati, Sachin Narkhede, Shailesh Luhar, Ekta Patel
Email(s):
patelmehul7295@gmail.com
DOI:
10.52711/2231-3915.2025.00014 
Address:
Patel Mehul*, Anuradha Prajapati, Sachin Narkhede, Shailesh Luhar, Ekta Patel
Smt. B.N.B Swaminarayan Pharmacy College, Salvav-Vapi, Gujarat-396191, India.
*Corresponding Author
Published In:
Volume - 15,
Issue - 2,
Year - 2025
ABSTRACT:
The integration of artificial intelligence (AI) into QbD frameworks has further revolutionized this process, enabling enhanced efficiency, precision, and innovation in formulation development. This review explores the role of AI in advancing QbD for pharmaceutical formulations, highlighting its applications, benefits, challenges, and future potential. By analyzing recent advancements, Our goal is to present a thorough grasp of how AI-driven QbD is influencing medication development going forward. Quality by Design (QbD) frameworks that incorporate artificial intelligence (AI) offer a revolutionary method for developing pharmaceutical formulations..This review explores how AI-driven tools enhance the QbD process by optimizing formulation design, predicting critical quality attributes (CQAs), and streamlining risk assessment. By utilizing machine learning models, AI enables accurate determination of essential material characteristics (EMCs) and vital process parameters (VPPs), reducing experimental trial-and-error. The abstract highlights case studies where AI has improved formulation stability, bioavailability, and manufacturing efficiency. Furthermore, it discusses the potential of AI to integrate real-time data analytics for continuous process verification, ensuring robust quality control. The authors emphasize that AI-augmented QbD accelerates development timelines.
Cite this article:
Patel Mehul, Anuradha Prajapati, Sachin Narkhede, Shailesh Luhar, Ekta Patel. AI-Enable Quality by Design in Pharmaceutical Formulation. International Journal of Technology. 2025; 15(2):75-1. doi: 10.52711/2231-3915.2025.00014
Cite(Electronic):
Patel Mehul, Anuradha Prajapati, Sachin Narkhede, Shailesh Luhar, Ekta Patel. AI-Enable Quality by Design in Pharmaceutical Formulation. International Journal of Technology. 2025; 15(2):75-1. doi: 10.52711/2231-3915.2025.00014 Available on: https://ijtonline.com/AbstractView.aspx?PID=2025-15-2-5
8. REFERENCES:
1. Mahajan S, Dave H, Bothe S, Mahpatra D, Sonawane S, Kshirsagar S, et al. Objective monitoring of cardiovascular biomarkers using artificial intelligence (AI). Asian J Pharm Res. 2022; 12(3): 229-34.
2. Bairagi A, Singhai AK, Jain A. Artificial intelligence: future aspects in the pharmaceutical industry – an overview. Asian J Pharm Technol. 2024; 14(3): 237-46.
3. Patel YA, Narkhede K, Prajapati A, Narkhede S, Luhar S. [Title missing]. Asian J Pharm Technol. 2025; 15(1): 51-6.
4. Kartheek RN, Raju VR, Shafi RM. Blue brain – a new subway to artificial intelligence and human machine: a proposal. Int J Tech. 2014; 4(2): 287-90.
5. Ingale S, Shrisunder N, Gophane G, Birajdar A. Ascent of artificial intelligence (AI) in pharmacy. Int J Tech. 2024; 14(1): 54-8.
6. Malkawi R. Evaluating artificial intelligence tools in the pharmaceutical industry: a case study on paracetamol dissolution and calibration curves. Res J Pharm Technol. 2025; 18(5): 2269-74.
7. Sumi KK, Narayan VS, Manu KS. Applications of artificial intelligence in e-commerce – from clicks to convictions. Asian J Manag. 2024; 15(2): 205-10.
8. Santos SB, Ferreira EI, Gremião MPD. Nanotechnology and artificial intelligence: the future of pharmaceutical formulation design under QbD principles. Pharmaceutics. 2022; 14(9): 1897.
9. Gupta R, Kumar A. Leveraging artificial intelligence for quality by design in pharmaceutical product development. Drug Dev Ind Pharm. 2024; 50(3): 215-30.
10. Sachan AK, Sachan NK, Kumar S. Role of artificial intelligence in quality by design for pharmaceuticals. Curr Pharm Biotechnol. 2023; 24(12): 1509-22.
11. Rantanen J, Khinast J. The Future of Pharmaceutical Manufacturing Sciences. J Pharm Sci. 2015;104(11):3612-38.
12. Paul D, Sanap G, Shenoy S, Kalyane D, Kalia K, Tekade RK. Artificial Intelligence in Drug Discovery and Development. Drug Discov Today. 2021; 26(1): 80-93.
13. Yu LX, Amidon G, Khan MA, Hoag SW, Polli J, Raju GK, Woodcock J. Understanding pharmaceutical quality by design. AAPS J. 2014; 16(4): 771-83.
14 Raman K, Kumar R, Musante CJ, Madhavan S. Integrating model-informed drug development with AI: a synergistic approach to accelerating pharmaceutical innovation. Clin Transl Sci. 2025; 18(1): e70124.
15 Noorain S, Srivastava V, Parveen B, Parveen R. Artificial intelligence in drug formulation and development: applications and future prospects. Curr Drug Metab. 2023; 24(9): 622-34.