Flubendazole Ph. Eur.

Flubendazole is a synthetic anthelmintic compound that has been utilized in the medical and veterinary fields to combat parasitic infections. With its potent properties and therapeutic potential, flubendazole has proven to be a valuable tool in the fight against parasitic diseases.

Properties

Flubendazole is an organic compound characterized by several important properties that contribute to its effectiveness against parasitic infections:

1. Broad-Spectrum Anthelmintic: Flubendazole is known for its broad-spectrum activity against various parasitic worms, including nematodes and cestodes. It interferes with the metabolism and energy production of these parasites.

2. Low Solubility: Flubendazole's limited solubility in water contributes to its controlled release within the gastrointestinal tract, enhancing its efficacy against intestinal parasites.

3. Well-Tolerated: Flubendazole is generally well-tolerated by both humans and animals when administered at appropriate doses, with minimal side effects.

4. Potential Anticancer Activity: Recent studies have explored the potential of flubendazole as an anticancer agent, showing promising results in inhibiting the growth of cancer cells.

Uses

1. Treatment of Intestinal Worm Infections: Flubendazole is primarily employed in the medical field for the treatment of intestinal worm infections caused by various parasitic species, including pinworms, roundworms, and tapeworms.

2. Veterinary Medicine: Flubendazole is widely used in veterinary medicine to treat parasitic infections in livestock and pets, helping to improve animal health and prevent economic losses in the livestock industry.

3. Investigational Anticancer Agent: Recent research has explored the potential of flubendazole as an anticancer agent. Preclinical studies have shown promising results in inhibiting the growth of cancer cells, although further research is needed.

4. Investigational Treatment for Other Diseases: Flubendazole is currently being investigated for its potential use in treating various diseases beyond parasitic infections, including neurodegenerative disorders.

Health Benefits

1. Effective Treatment for Parasitic Infections: Flubendazole is highly effective in treating parasitic worm infections in humans and animals, helping to alleviate symptoms and reduce the burden of these diseases.

2. Potential Anticancer Activity: Preliminary research suggests that flubendazole may have anticancer properties, inhibiting the growth of cancer cells. This potential benefit could open new avenues for cancer treatment.

3. Investigational Treatment for Neurodegenerative Disorders: Ongoing studies are exploring the use of flubendazole in the treatment of neurodegenerative disorders, offering hope for potential therapies in the future.

Flubendazole, with its broad-spectrum anthelmintic properties, has proven to be a valuable tool in the treatment of parasitic infections in both humans and animals. Additionally, ongoing research has unveiled the compound's potential as an anticancer agent and its investigational role in treating neurodegenerative disorders. While further studies are needed to fully harness these benefits, flubendazole's role in addressing parasitic diseases remains critical in improving global health and animal well-being. As science advances, it is likely that new therapeutic applications for flubendazole will continue to emerge, expanding its reach in the field of medicine.

References

1. Zhang M., et al. (2016). High-Throughput Screening Identifies Two Classes of Antibiotics as Radioprotectors: tetracyclines and fluoroquinolones. Clinical Cancer Research, 22(19), 4691-4701.

2. Spagnuolo P.A., et al. (2010). Anthelmintic Effects of Benzimidazoles against Cyathostomins from Cattle, with an Analysis of Factors Influencing In Vivo Efficacy. Journal of Veterinary Pharmacology and Therapeutics, 33(1), 13-20.

3. Prichard R., et al. (2012). A Review of the In Vivo and In Vitro Effects of Praziquantel and Levamisole Alone or in Combination. Trends in Parasitology, 28(7), 305-314.

4. Yin D.D., et al. (2010). Synthesis and Biological Evaluation of the Flubendazole Analogues as Hedgehog Pathway Inhibitors. Bioorganic & Medicinal Chemistry Letters, 20(24), 7252-7254.

5. Li Y., et al. (2019). Flubendazole, FDA-approved anthelmintic, targets breast cancer stem-like cells. Oncotarget, 10(18), 1678-1689.

6. Kaplan R.M. (2004). Drug Resistance in Nematodes of Veterinary Importance: A Status Report. Trends in Parasitology, 20(10), 477-481.

7. Craig T.M., et al. (2007). Resistance of Gulf Coast Native Sheep to Haemonchus contortus: Fecal Egg Excretion and Peripheral Blood Eosinophil Counts. Veterinary Parasitology, 147(3-4), 217-222.

8. Spagnuolo P.A., et al. (2010). A Short-term Antiproliferative Assay Using Multidrug Resistant Cells to Evaluate the Mode of Action of Anthelmintic Compounds. International Journal of Parasitology, 40(6), 691-702.

9. Benbrook C.M. (2005). Elevating Antioxidant Levels in Food through Organic Farming and Food Processing. In HortScience, 40(2), 312-319.

10. Vercruysse J., et al. (2002). Anthelmintic Resistance in Haemonchus contortus: History, Mechanisms and Diagnosis. In Veterinary Parasitology, 103(3), 165-190.

11. Martínez-Valladares M., et al. (2015). The Use of Flubendazole as Oral Anthelmintic in Captive Red Deer (Cervus elaphus): Efficacy against a Multiple Resistant Gastrointestinal Strongyle Population. Research in Veterinary Science, 100, 234-239.

PRODUCT SPECIFICATION

CHARACTERISTICS         

Assay (content)

Identification

Loss on drying

Sulphated ash

Impurity A (methyl [5-[4-(formylamino)benzoyl]-1H-benzimidazol-2-yl]carbamate)

Impurity B (2-amino-1H-benzimidazol-5-yl)(4-fluorophenyl)methanone)

Impurity C ((4-fluorophenyl)(2-hydroxy-1H-benzimidazol-5-yl)methanone)

Impurity D ((1H-benzimidazol-5-yl)(4-fluorophenyl)methanone)

Impurity E (methyl [5-(2-fluorobenzoyl)-1H-benzimidazol-2-yl]carbamate)

Impurity F (methyl [5-(4-fluorobenzoyl)-1-methyl-1H-benzimidazol-2-yl]carbamate)

Impurity G (methyl [5-[4-(1-methylethoxy)benzoyl]-1H-benzimidazol-2-yl]carbamate)

Any other impurity with a relative retention between 1.2 and 1.3

Total impurities      

HAZARDOUS IDENTIFICATION

STORAGE