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Sorafenib
Ahmed A Abdelgalil1, Hamad M Alkahtani2, Fahad I Al-Jenoobi2
1Central Laboratory, College of Pharmacy, King Saud University, Riyadh, Kingdom of Saudi Arabia.
Abstract:
Sorafenib (BAY-43-9006), marketed by Bayer as Nexavar® (USA), is anticancer drug approved by US-FDA for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. Sorafenib inhibited tumor growth and angiogenesis through targeting both the RAF/MEK/ERK pathway and receptor tyrosine kinases. This study presents a comprehensive profile of sorafenib, including detailed nomenclature, formula, elemental analysis, methods of preparation, physico-chemical characteristics, and methods of analysis (including spectroscopic, electrochemical, and chromatographic methods of analysis). Spectroscopic and spectrometric analyses include UV/vis spectroscopy, vibrational spectroscopy, nuclear magnetic resonance spectrometry ((1)H and (13)C NMR), and mass spectrometry. Chromatographic methods of analyses include thin layer chromatography and high-performance liquid chromatography. Only few stability indicating methods were found for quantification of sorafenib after exposing tablet dosage form to various stress conditions such as hydrolysis, oxidation, thermal stress, photo and UV light. However, none of these described methods were made to separate and quantify the degradation products. Pharmacology studies including pharmacodynamics, mechanism of action, pharmacokinetics and drug-drug interactions were also presented. An appropriate table and figures were attached to each of the above mentioned sections along with total of 55 references.
Insights
This study profiles sorafenib, an anticancer drug, detailing its chemical properties, analytical methods, and pharmacology. It highlights the need for improved methods to quantify sorafenib degradation products in pharmaceutical formulations.
Area of Science:
- Pharmaceutical Chemistry
- Oncology
- Analytical Chemistry
Background:
- Sorafenib (Nexavar®) is an FDA-approved anticancer drug for hepatocellular carcinoma and renal cell carcinoma.
- It functions by inhibiting tumor growth and angiogenesis via the RAF/MEK/ERK pathway and receptor tyrosine kinases.
Purpose of the Study:
- To provide a comprehensive profile of sorafenib.
- To review analytical methods for its characterization and quantification.
- To assess existing stability-indicating methods and identify gaps in degradation product analysis.
Main Methods:
- Detailed review of sorafenib's nomenclature, formula, elemental analysis, preparation, and physicochemical properties.
- Analysis of spectroscopic (UV/vis, vibrational, NMR, MS) and chromatographic (TLC, HPLC) methods.
- Examination of pharmacodynamics, pharmacokinetics, and drug-drug interactions.
Main Results:
- A thorough compilation of sorafenib's chemical and analytical data.
- Identification of limited stability-indicating methods for sorafenib quantification.
- Lack of methods specifically designed to separate and quantify sorafenib degradation products.
Conclusions:
- Sorafenib is a crucial targeted therapy with a well-defined mechanism of action.
- Current analytical methods require enhancement, particularly for stability studies and degradation product analysis.
- Further research is needed to develop robust methods for comprehensive sorafenib stability assessment.