References
- A. S. Taha, N. Hudson, C. J. Hawkey, A. J. Swannell, P. N. Trye, J. Cottrell, S. G. Mann, T. J. Simon, R. D. Sturrock and R. I. Russell, Famotidine for the prevention of gastric and duodenal ulcers caused by nonsteroidal antiinflammatory drugs, N. Engl. J. Med. 334(22) (1996) 1435–1439; https://doi.org/10.1056/NEJM199605303342204
- A. S. Taha, C. McCloskey, R. Prasad and V. Bezlyak, Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial, Lancet 374(9684) (2009) 119–125; https://doi.org/10.1016/S0140-6736(09)61246-0
- S. Bajaj, D. Singla and N. Sakhuja, Stability testing of pharmaceutical products, J. Appl. Pharm. Sci. 2(3) (2012) 129–138; https://doi.org/10.7324/JAPS.2012.2322
- M. Bakshi and S. Singh, Development of validated stability-indicating assay methods—critical review, J. Pharm. Biomed. Anal. 28(6) (2002) 1011–1040; https://doi.org/10.1016/S0731-7085(02)00047-X
- M. Blessy, R. D. Patel, P. N. Prajapati and Y. K. Agrawal, Development of forced degradation and stability indicating studies of drugs – A review, J. Pharm. Anal. 4(3) (2014) 159–165; https://doi.org/10.1016/j.jpha.2013.09.003
- M. Dong, K. Huynh-Ba and J. Ayers, Development of stability-indicating analytical procedures by HPLC: An overview and best practices, Pharm. Technol. 38(8) (2020) 440–456.
- A. Roy, J. Henry, A. Wilken and L. Collazo-Malave, Current practices and considerations for a stability-indicating method in pharmaceutical analysis, Pharm. Technol. 32 (2014) 568–575.
- J. M. Campbell, C. Foti, C. Wang, N. Adams, L. R. Allain, G. Araujo, R. Azevedo, J. R. Franca, S. R. Hicks, S. Hostyn, P. J. Jansen, D. Kotoni, A. Kuemmell, S. Marden, G. Rullo, A. C. O. Santos, G. W. Sluggett, T. Zelesky and S. W. Baertschi, Assessing the relevance of solution phase stress testing of solid dosage form drug products: A cross-industry benchmarking study, J. Pharm. Sci. 111 (2022) 298–305; https://doi.org/10.1016/j.xphs.2021.06.012
- S. Singh, M. Junwal, G. Modhe, H. Tiwari, M. Kurmi, N. Parashar and P. Sidduri, Forced degradation studies to assess the stability of drugs and products, Trends Anal. Chem. 49 (2013) 71–88; https://doi.org/10.1016/j.trac.2013.05.006
- V. Dave, R. Haware, N. Sangave, M. Sayles and M. Popielarczyk, Drug-excipient compatibility studies in formulation development: Current trends and techniques, AAPS Formul. Des. Dev. Sect. Newsl. (2015) 9–15.
- G. Bruni, L. Amici, V. Berbenni, A. Marini and A. Orlandi, Drug-excipient compatibility studies: Search of interaction indicators, J. Therm. Anal. Calorim. 68 (2002) 561–573; https://doi.org/10.1023/a:1016052121973
- R. Chadha and S. Bhandari, Drug-excipient compatibility screening – Role of thermoanalytical and spectroscopic techniques, J. Pharm. Biomed. Anal. 87 (2014) 82–97; https://doi.org/10.1016/j.jpba.2013.06.016
- A. Gabrič, Ž. Hodnik and S. Pajk, Oxidation of drugs during drug product development: Problems and solutions, Pharmaceutics 14(2) (2022) Article ID 325 (19 pages); https://doi.org/10.3390/pharmaceutics14020325
- A. S. Narang, V. M. Rao and D. S. Desai, Effect of antioxidants and silicates on peroxides in povi-done, J. Pharm. Sci. 101(1) (2012) 127–139; https://doi.org/10.1002/jps.22729
- W. R. Wasylaschuk, P. A. Harmon, G. Wagner, A. B. Harman, A. C. Templeton, H. Xu and R. A. Reed, Evaluation of hydroperoxides in common pharmaceutical excipients, J. Pharm. Sci. 96(1) (2007) 106–116; https://doi.org/10.1002/jps.20726
- Y. Wu, J. Levons, A. S. Narang, K. Raghavan and V. M. Rao, Reactive impurities in excipients: profiling, identification and mitigation of drug-excipient incompatibility, AAPS PharmSciTech 12 (2011) 1248–1263; https://doi.org/10.1208/s12249-011-9677-z