Experimental investigation of ternary mixture of diclofenac sodium with pharmaceutical excipients
-
Djellouli Fayrouz
,
Dahmani Abdallah
Abstract
The goal of this work was the study of drug-excipient interactions of ternary mixtures between diclofenac sodium when introduced with excipients commonly explored in solid dosage formulas such as microcrystalline cellulose and stearic acid obtained by three methods. Differential scanning calorimetry (DSC) (DSC), Fourier transform infrared spectroscopy (FTIR), scanning electron microscopy (SEM), and the structural characterization technique of diffraction (XRPD) were used to investigate the characterization and potential physical and chemical interactions of solid products of diclofenac sodium with excipients prepared by different methods. This work revealed a possible interaction between diclofenac sodium, microcrystalline cellulose, and stearic acid in mixture prepared by microwave irradiation also; it was found compatibility for ternary mixtures prepared by physical mixture and co evaporation methods. Results of this study can be useful in the development of the method of preparation and select adequate excipients with suitable compatibility.
Funding source: MESRS
Award Identifier / Grant number: N° E00220130108
-
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
-
Research funding: This scientific work was financial sustained by CNEPRU Project (MESRS) N° E00220130108.
-
Conflict of interest statement: The authors declare no conflicts of interest regarding this article.
References
1. Jackson, K. Drug excipient interactions and their effect on absorption. Pharm Sci Technol 2000;3:336–45.10.1016/S1461-5347(00)00301-1Search in Google Scholar PubMed
2. Rowe, RC, Sheskey, PJ, Quinn, ME. Handbook of pharmaceutical excipients, 6th ed. London: Pharmaceutical Press; 2009.Search in Google Scholar
3. Giron, D. Applications of thermal analysis in the pharmaceutical industry. J Pharmaceut Biomed Anal 1986;4:755–70.10.1016/0731-7085(86)80086-3Search in Google Scholar PubMed
4. Barboza, F, Vecchia, DD, Tagliari, MP, Silva, MAS, Stulzer, HK. Differential scanning calorimetry as a screening technique in compatibility studies of acyclovir extended release formulations. Pharm Chem J 2009;43:363–8.10.1007/s11094-009-0304-1Search in Google Scholar
5. Vueba, ML, Veiga, F, Sousa, JJ, Pina, ME. Compatibility studies between ibuprofen or ketoprofen with cellulose ether polymer mixtures using thermal analysis. Drug Dev Ind Pharm 2005;31:943–9.10.1080/03639040500306153Search in Google Scholar PubMed
6. Bharate, SS, Bharate, SB, Bajaj, AN. Interactions and incompatibilities of pharmaceutical excipients with active pharmaceutical ingredients: a comprehensive review. J Excipients Food Chem 2010;1:3–26.10.1002/chin.201147271Search in Google Scholar
7. Tita, B, Fulias, A, Bandur, G, Ledeti, I, Tita, D. Application of thermal analysis to study the compatibility of sodium diclofenac with different pharmaceutical excipients. Rev Chim 2009;62:443–54.Search in Google Scholar
8. Crowley, P, Martini, L. Drug-excipient interactions. Pharm Technol Eur 2001;13:26–34.Search in Google Scholar
9. Ozawa, T. Thermal analysis-review and prospect. Thermochim Acta 2000;355:35–42.10.1016/S0040-6031(00)00435-4Search in Google Scholar
10. Verma, RK, Garg, S. Compatibility studies between isosorbide mononitrate and selected excipients used in the development of extended release formulations. J Pharmaceut Biomed Anal 2004;35:449–58.10.1016/j.jpba.2004.01.012Search in Google Scholar PubMed
11. Tomassetti, M, Catalani, A, Rossi, V, Vecchio, S. Thermal analysis study of the interactions between acetaminophen and excipients in solid dosage forms and in some binary mixtures. J Pharmaceut Biomed Anal 2005;37:949–55.10.1016/j.jpba.2004.10.008Search in Google Scholar PubMed
12. Marini, A, Berbenni, V, Moioli, S, Bruni, G, Vecchio, S, Cofrancesco, P, et al.. Drug-excipient compatibility studies by physico-chemical techniques. The case of indomethacin. J Therm Anal Calorim 2003;73:529–45.10.1023/A:1025426012578Search in Google Scholar
13. Mura, P, Faucci, MT, Manderioli, A, Bramanti, G, Ceccarelli, L. Compatibility study between ibuproxam and pharmaceutical excipients using differential scanning calorimetry, hot-stage microscopy and scanning electron microscopy. J Pharmaceut Biomed Anal 1998;18:151–63.10.1016/S0731-7085(98)00171-XSearch in Google Scholar PubMed
14. Chuasuwan, B, Binjesoh, V, Polli, JE, Zhang, H, Amidon, G, Junginger, HE, et al.. Biowaiver monographs for immediate release solid oral dosage form: diclofenac sodium and diclofenac potassium. J Pharmacol Sci 2009;98:1206–19.10.1002/jps.21525Search in Google Scholar PubMed
15. Bartolomei, M, Rodomonte, A, Antoniella, E, Minelli, G, Bertocchi, P. Hydrate modifications of the non-steroidal anti-inflammatory drug diclofenac sodium: solid-state characterization of a trihydrate form. J Pharmaceut Biomed Anal 2007;45:443–9.10.1016/j.jpba.2007.07.002Search in Google Scholar PubMed
16. Bucci, R, Magri, AD, Magri, AL. Determination of diclofenac salts in pharmaceutical formulations. Fresenius’ J Anal Chem 1998;362:577–82.10.1007/s002160051127Search in Google Scholar
17. Tudja, P, Khan, MZ, Mestrović, E, Horvat, M, Golja, P. Thermal behaviour of diclofenac sodium: decomposition and melting characteristics. Chem Pharm Bull 2001;49:1245–50.10.1248/cpb.49.1245Search in Google Scholar PubMed
18. Palomo, ME, Ballesteros, MP, Frutos, P. Analysis of diclofenac sodium and derivatives. J Pharmaceut Biomed Anal 1999;21:83–94.10.1016/S0731-7085(99)00089-8Search in Google Scholar PubMed
19. Bettini, R, Giordano, F, Donini, C, Massimo, G, Catellani, PL, Colombo, P. Swelling force development as a result of hydrate formation in diclofenac sodium or nitrofurantoin tablets. Pharmaceut Sci 2000;10:335–9.Search in Google Scholar
20. Fini, A, Garuti, M, Fazio, G, Alvarez-Fuentes, J, Holgado, MA. Diclofenac salts. I. fractal and thermal analysis of sodium and potassium diclofenac salts. J Pharmacol Sci 2001;90:2049–57.10.1002/jps.1156Search in Google Scholar PubMed
21. Fini, A, Fazio, G, Rosetti, F, et al.. Diclofenac salts. III. Alkaline and earth alkaline salts. J Pharmacol Sci 2005;94:2416–31.10.1002/jps.20436Search in Google Scholar PubMed
22. Reck, G, Faust, G, Dietz, G. X-ray crystallographic studies of diclofenac-sodium-structural analysis of diclofenac-sodium tetrahydrate. Pharmazie 1988;43:771–4.Search in Google Scholar
23. Muangsin, N, Prajaubsook, M, Chaichit, N, Siritaedmukul, K, Hannongbua, S. Crystal structure of a unique sodium distorted linkage in diclofenac sodium pentahydrate. Anal Sci 2002;18:967–8.10.2116/analsci.18.967Search in Google Scholar PubMed
24. Bartolomei, M, Bertocchi, P, Antoniella, E, Rodomonte, A. Physico-chemical characterisation and intrinsic dissolution studies of a new hydrate form of diclofenac sodium: comparison with anhydrous form. J Pharmaceut Biomed Anal 2006;40:1105–13.10.1016/j.jpba.2005.09.009Search in Google Scholar PubMed
25. Pygall, SR, Griffiths, PC, Wolf, B, Timmins, P, Melia, CD, et al.. Solution interactions of diclofenac sodium and meclofenamic acid sodium with hydroxypropyl methylcellulose (HPMC). Int J Pharm 2011;312:55–62.10.1016/j.ijpharm.2010.11.043Search in Google Scholar PubMed
26. Al Gohary, OMN. Preformulation stability screening of diclofenac sodium and mebeverine hydrochloride with tablet excipients and polymers using differential scanning calorimetry. Pharm Ind 1998;60:168–73.Search in Google Scholar
27. Velasco, MV, Ford, JL, Rowe, P, Rajabi-Siahboomi, AR. Influence of drug:hydroxypropylmethylcellulose ratio, drug and polymer particle size and compression force on the release of diclofenac sodium from HPMC tablets. J Contr Release 1999;57:75–85.10.1016/S0168-3659(98)00110-2Search in Google Scholar
28. Llinàs, A, Burley, JC, Box, KJ, Glen, RC, Goodman, JM. Diclofenac solubility: independent determination of the intrinsic solubility of three crystal forms. J Med Chem 2007;50:979–83.10.1021/jm0612970Search in Google Scholar PubMed
29. Christian, MA, LP, K. Analytical profiles of drug substances, Florey, K, editor. New York: Academic Press; 1990:123–41 pp.Search in Google Scholar
30. Nugrahani, I, Kumalasari, RA, Auli, WN, Horikawa, A, Uekusa, H. Salt cocrystal of diclofenac sodium-l-proline: structural, pseudopolymorphism, and pharmaceutics performance study. Pharmaceutics 2020;12:690.10.3390/pharmaceutics12070690Search in Google Scholar PubMed PubMed Central
© 2021 Walter de Gruyter GmbH, Berlin/Boston
Articles in the same Issue
- Frontmatter
- Reviews
- Electronic structure theory study of the reactivity and structural molecular properties of halo-substituted (F, Cl, Br) and heteroatom (N, O, S) doped cyclobutane
- Design of hydrogen supply chains under demand uncertainty – a case study of passenger transport in Germany
- Experimental investigation of ternary mixture of diclofenac sodium with pharmaceutical excipients
- Detection of cysteine-rich peptides in Tragia benthamii Baker (Euphorbiaceae) and in vivo antiinflammatory effect in a chick model
- Role of heteroatoms and substituents on the structure, reactivity, aromaticity, and absorption spectra of pyrene: a density functional theory study
- Contribution of the volatile components from fresh egg, adult female and male of Pestarella tyrrhena to odour production
Articles in the same Issue
- Frontmatter
- Reviews
- Electronic structure theory study of the reactivity and structural molecular properties of halo-substituted (F, Cl, Br) and heteroatom (N, O, S) doped cyclobutane
- Design of hydrogen supply chains under demand uncertainty – a case study of passenger transport in Germany
- Experimental investigation of ternary mixture of diclofenac sodium with pharmaceutical excipients
- Detection of cysteine-rich peptides in Tragia benthamii Baker (Euphorbiaceae) and in vivo antiinflammatory effect in a chick model
- Role of heteroatoms and substituents on the structure, reactivity, aromaticity, and absorption spectra of pyrene: a density functional theory study
- Contribution of the volatile components from fresh egg, adult female and male of Pestarella tyrrhena to odour production
