The Historical Review of Paclitaxel Formulation Development

Authors

  • Pichamon Pongprom Rangsit University
  • Wasita Suntreekasem Rangsit University
  • Patchaya Kochsiripong Rangsit University

Keywords:

Hypersensitivity reaction, Paclitaxel, NAB-paclitaxel, micellar paclitaxel, Formulation development

Abstract

Paclitaxel is a chemotherapy drug that is widely used as a first-line drug and in cases of recurrence cancer. It extracted from the bark of the Pacific Yew. In the production process, the problem is the hydrophobic properties, therefore; it could not be prepared as an injection. Cremophor EL must be added as a solvent to improve solubility that caused hypersensitivity reactions (HSRs). NAB-paclitaxel is a drug loaded nanoparticles which can improve the solubility of paclitaxel and then bound with human albumin to prevent aggregation. According to several studies, they concluded that nab-paclitaxel had better efficacy compared to standard paclitaxel and could reduce the incidence of HSRs but some adverse drug reactions might increase such as thrombocytopenia and anemia. Recently, new drug formula has been developed in 2015 as a nanoparticle drug delivery like NAB-paclitaxel but it combined with the new technology called XR-17®, a mixture of two iso-forms of N-retinoyl-l-cysteic acid methyl ester sodium salt. The result manifested that micellar paclitaxel was not inferior to standard paclitaxel and NAB-paclitaxel in term of efficacy and cause of HSRs. Nevertheless, it should be focusing on other adverse drug reactions in post-marketing.

Author Biographies

Pichamon Pongprom, Rangsit University

Pharm D. student (Pharmaceutical Care), College of Pharmacy

Wasita Suntreekasem, Rangsit University

Pharm D. student (Pharmaceutical Care), College of Pharmacy

Patchaya Kochsiripong, Rangsit University

Division of General Pharmacy Practice, College of Pharmacy

References

Joerger M. Treatment regimens of classical and newer taxanes. Cancer chemotherapy and pharmacology. 2016;77:221-33.

Rowinsky EK, Donehower RC. Paclitaxel (taxol). New England Journal of Medicine. 1995;332:1004-14.

Bedard PL, Di Leo A, Piccart-Gebhart MJ. Taxanes: optimizing adjuvant chemotherapy for early-stage breast cancer. Nature Reviews Clinical Oncology. 2010 Jan;7(1):22.

Vogel WH. Infusion reactions: diagnosis, assessment, and management. Clinical journal of oncology nursing. 2010;14:E10.

Tangsaghasaksri R, Jainan P. Incidence of hypersensitivity reactions from paclitaxel. Journal of the Medical Association of Thailand. 2018;101:150.

Picard M, Castells MC. Re-visiting hypersensitivity reactions to taxanes: a comprehensive review. Clinical reviews in allergy & immunology. 2015;49:177-91.

Gelderblom H, Verweij J, Nooter K, Sparreboom A. Cremophor EL: the drawbacks and advantages of vehicle selection for drug formulation. European journal of cancer. 2001;37:1590-8.

Jameson J, Fauci AS, Kasper DL, Hauser SL, Longo DL, Loscalzo J. Harrison's principles of internal medicine. 20th ed. New York: McGraw-Hill; 2019.

European Medicines Agency Evaluation of Medicines for Human Use. Assessment report for Abraxane [Internet]. 2008 [Cited 2019 Feb 13]. Available from: https://www.ema.europa.eu/en/documents/assessment-report/abraxane-epar-public-assessment-report_en.pdf

Gradishar W, Tjulandin S, Davidson N, Shaw H, Desai N, Bhar P, et al. Phase III trial of nanoparticle albumin-bound paclitaxel compared with polyethylated castor oil–based paclitaxel in women with breast cancer. J Clin Oncol. 2005;23:7794-803.

Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, et al. Weekly NAB-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non–small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012;30:2055-62.

Mahtani RL, Parisi M, Glück S, Ni Q, Park S, Pelletier C, et al. Comparative effectiveness of early-line NAB-paclitaxel vs. paclitaxel in patients with metastatic breast cancer: a US community-based real-world analysis. Cancer management and research. 2018;10:249.

Maurer K, Michener C, Mahdi H, Rose PG. Universal tolerance of NAB-paclitaxel for gynecologic malignancies in patients with prior taxane hypersensitivity reactions. Journal of gynecologic oncology. 2017;28.

Lazzaro C, Bordonaro R, Cognetti F, Fabi A, De Placido S, Arpino G, et al. An Italian cost-effectiveness analysis of paclitaxel albumin (NAB-paclitaxel) versus conventional paclitaxel for metastatic breast cancer patients: the COSTANza study. Clinico Economics and outcomes research: CEOR. 2013;5:125.

Oasmia Pharmaceutical AB. Oasmia Pharmaceutical AB (NASDAQ: OASM) Corporate Presentation – Spring 2016 [internet]. 2016 [Cited 2019 Feb 28]. Available from: http://www.thelifesciencesreport.com/cs/user/download/co_file/4765/OasmiaCorporatePPTSpring2016.pdf

Ignace Vergote, Arija Brize, Alla Sergeevua Lisyanskaya, Mikhail Lichinitser. Randomized phase III study comparing paclical-carboplatin with paclitaxel-carboplatin in patients with recurrent platinum-sensitive epithelial ovarian cancer. J Clin Oncol. 2015; 33(suppl May 20 2015):5517.

Downloads

Published

2020-05-07 — Updated on 2026-02-17

Versions