Abstract
The pharmaceutical product development process is a challenging process involving two significant steps, namely formulation development and product manufacturing. A formulation comprises of an API/drug (pharmacological active compound) and a group of inactive substances known as excipients. The process of selecting excipients and their proportion in an intended physical form of the drug for its administration (dosage form or pharmaceutical product) is known as the formulation. The selection of excipient(s) is a complex process that depends upon various factors associated with the drug, drug-excipient interaction, and the impact of the excipient on the product efficacy, i.e., its intended attributes like product stability, drug release, bioavailability, and many more. Thus, it involves extensive experimentation and hence is challenging in terms of carrying out these requisite trial runs. The application of artificial intelligence may help in reducing the time required to carry out trials and wastage of resources via providing limited and promising formulation designs based upon the evaluation and correlation of existing experimental data through various networking models. In this manuscript, we have represented the outcome of an AI-based pharmaceutical formulation design model which supports the active involvement of AI into fully automated computer-assisted pharmaceutical product development solution, leading to optimization of resource and overcoming the financial constraints via avoiding excessive wastages expected during product design trials.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Institute of Medicine. (2014). Improving and accelerating therapeutic development for nervous system disorders: Workshop summary. National Academies Press (US). https://www.ncbi.nlm.nih.gov/books/NBK195047/
USF. (2018). The drug development process. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process
Zhang, X., Xing, H., Zhao, Y., & Ma, Z. (2018). Pharmaceutical dispersion techniques for dissolution and bioavailability enhancement of poorly water-soluble drugs. Pharmaceutics, 10(3). https://doi.org/10.3390/pharmaceutics10030074
Papich, M. G., & Martinez, M. N. (2015). Applying Biopharmaceutical Classification System (BCS) criteria to predict oral absorption of drugs in dogs: Challenges and pitfalls. The AAPS Journal, 17(4), 948–964. https://doi.org/10.1208/s12248-015-9743-7
Rajeswari, S., Prasanthi, T., & Malli, R. (2021). Natural polymers: A recent review. World Journal of Pharmacy and Pharmaceutical Sciences, 6, 472–494.
Mittal, S., & Pawar, S. (2019). International Journal of Pharmacognosy and Pharmaceutical Sciences, 1(1), 5–6.
Nyamweya, N., & Kimani, S. (2020). Chewable tablets: A review of formulation considerations. Pharmaceutical Technology North America, 44, 38–44.
Parkash, V., Maan, S., Dasari, D., Yadav, S. K., Hemlata, & Jogpal, V. (2011). Fast disintegrating tablets: Opportunity in drug delivery system. Journal of Advanced Pharmaceutical Technology & Research, 2, 223–235. https://doi.org/10.4103/2231-4040.90877
Häse, F., Roch, L. M., Friederich, P., & Aspuru-Guzik, A. (2020). Designing and understanding light-harvesting devices with machine learning. Nature Communications, 11(1), 4587. https://doi.org/10.1038/s41467-020-17995-8
Sellwood, M. A., Ahmed, M., Segler, M. H., & Brown, N. (2018). Artificial intelligence in drug discovery. Future Medicinal Chemistry, 10(17), 2025–2028. https://doi.org/10.4155/fmc-2018-0212
Quiñones, L., Sasso, J., Tamayo, E., Catalán, J., González, J. P., Escala, M., Varela, N., León, J., Cáceres, D. D., & Saavedra, I. (2010). A comparative bioavailability study of two formulations of pregabalin in healthy Chilean volunteers. Therapeutic Advances in Chronic Disease, 1(4), 141–148. https://doi.org/10.1177/2040622310379932
Guengerich, F. P. (2011). Mechanisms of drug toxicity and relevance to pharmaceutical development. Drug Metabolism and Pharmacokinetics, 26(1), 3–14. https://doi.org/10.2133/dmpk.dmpk-10-rv-062
Amani, A., York, P., Chrystyn, H., Clark, B. J., & Do, D. Q. (2008). Determination of factors controlling the particle size in nanoemulsions using artificial neural networks. European Journal of Pharmaceutical Sciences, 35(1), 42–51. https://doi.org/10.1016/j.ejps.2008.06.002
Sarantopoulos, P. D., Altiok, T., & Elsayed, E. A. (1995). Manufacturing in the pharmaceutical industry. Journal of Manufacturing Systems, 14(6), 452–467. https://doi.org/10.1016/0278-6125(95)99917-3
Bini, S. A. (2018). Artificial intelligence, machine learning, deep learning, and cognitive computing: What do these terms mean and how will they impact health care? The Journal of Arthroplasty, 33(8), 2358–2361. https://doi.org/10.1016/j.arth.2018.02.067
Mohs, R. C., & Greig, N. H. (2017). Drug discovery and development: Role of basic biological research. Alzheimer’s & Dementia (New York, N.Y.), 3(4), 651–657. https://doi.org/10.1016/j.trci.2017.10.005
Agarwal, R., & Yadav, N. (2011). Pharmaceutical processing—A review on wet granulation technology. International Journal of Pharmaceutical Frontier Research, 1, 65–83.
Mistry, A. K., Nagda, C. D., Nagda, D. C., Dixit, B. C., & Dixit, R. B. (2014). Formulation and in vitro evaluation of ofloxacin tablets using natural gums as binders. Scientia Pharmaceutica, 82(2), 441–448. https://doi.org/10.3797/scipharm.1401-14
Pakhale, N., Gondkar, S. B., & Saudagar, R. (2019). Formulation development and evaluation of fluoxetine effervescent floating tablet. Journal of Drug Delivery and Therapeutics, 9, 358–366. https://doi.org/10.22270/jddt.v9i4-A.3490
Acknowledgements
I would like to acknowledge the inputs given by the team members of University Institute of Computer Sciences and Engineering for their support in compiling and framing the algorithms and networking-related components of the project.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2023 The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd.
About this paper
Cite this paper
Goud, J.S., Elisetti, S.K., Kaur, N., Singh, R., Saini, K.S., Arora, V. (2023). Artificial Intelligence in Formulation and Product Design of BCS Class I and II Drugs. In: Sharma, D.K., Peng, SL., Sharma, R., Jeon, G. (eds) Micro-Electronics and Telecommunication Engineering . Lecture Notes in Networks and Systems, vol 617. Springer, Singapore. https://doi.org/10.1007/978-981-19-9512-5_44
Download citation
DOI: https://doi.org/10.1007/978-981-19-9512-5_44
Published:
Publisher Name: Springer, Singapore
Print ISBN: 978-981-19-9511-8
Online ISBN: 978-981-19-9512-5
eBook Packages: EngineeringEngineering (R0)