Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up

Badawi, Aliaa A.; Hegazy, Mahmoud M.; Louis, Dina; Eldegwy, Mohammed A.

doi:10.1515/acph-2017-0033

References

1. M. Nishimura, T. Tokoro, T. Takatani, N. Sato, M. Nishida, T. Hashimoto, S. Yamazaki, H. Kobayashi and T. Ono, Effects of intravenous l-carnitine on myocardial fatty acid imaging in hemodialysis patients: responders or non-responders to l-carnitine, Springerplus 4 (2015) 353-362; https://doi.org/10.1186/s40064-015-1119-z10.1186/s40064-015-1119-z
Search in Google Scholar Back to article
2. P. Mason, Dietary Supplements, 3rd ed., Pharmaceutical Press, London 2007.
Search in Google Scholar Back to article
3. J. L. Flanagan, P. A. Simmons, J. Vehige, M. D. P. Wilcox and Q. Garett, Role of carnitine in disease, Nutr. Metab. (Lond) 7 (2010) 30; https://doi.org/10.1186/1743-7075-7-3010.1186/1743-7075-7-30
Search in Google Scholar Back to article
4. A. Hassan, Y. Tsuda, A. Asai, K. Yokohma, K. Nakamura, T. Sujishi, H. Ohama, Y. Tsuchimoto, S. Fukunishi, U. M. Abdelaal, U. A. Arafa, A. T. Hassan, A. M. Kassem and K. Higuchi, Effects of oral L-Carnitine on liver functions after transarterial chemoembolization in intermediate-stage HCC patients, Mediators of Inflammation (2015), Article ID 608216, http://dx.doi.org/10.1155/2015/60821610.1155/2015/608216
Search in Google Scholar Back to article
5. T. Răşanu, M. Mehedinţi-Hâncu, M. Alexianu, T. Mehedinţi, E. Gheorghe and L. Damian, Carnitine deficiency - case report, Roman. J. Morphol Embryol. 53 (2012) 203-206.
Search in Google Scholar Back to article
6. C. Ulbricht (Ed.), Natural Standard Medical Conditions Reference - An Integrative Approach, Elsevier- Mosby, St. Louis, MO, 2009.
Search in Google Scholar Back to article
7. J. Yee, L-Carnitine for anemia in hemodialysis patients: A last resort, Clin. J. Am. Soc. Nephrol. 7 (2012) 1746-1748; https://doi.org/10.2215/CJN.0992091210.2215/CJN.09920912
Search in Google Scholar Back to article
8. European Pharmacopoeia, E. Council of Europe, Strasbourg 2014.
Search in Google Scholar Back to article
9. The United States Pharmacopeia, NF30, US Pharmacopeial Convention, Maryland 2012.
Search in Google Scholar Back to article
10. J. Swarbrick (Ed.), Encyclopedia of Pharmaceutical Technology, 3rd Ed., Informa Healthcare, New York 2007.
Search in Google Scholar Back to article
11. M. Ciper and R. Bodmeier, Modified conventional hard gelatin capsules as fast disintegrating dosage form in the oral cavity, Eur. J. Pharm. Biopharm. 62 (2006) 178-184.10.1016/j.ejpb.2005.08.014
Search in Google Scholar Back to article
12. I. El-Bagory, N. Barakat, M. A. Ibrahim and F. El-Enazi, Formulation and in vitro evaluation of theophylline matrix tablets prepared by direct compression: Effect of polymer blends, Saudi Pharm. J. 20 (2012) 229-238.10.1016/j.jsps.2011.11.007
Search in Google Scholar Back to article
13. J. Wanga, H. Wenb and D. Desai, Lubrication in tablet formulations, Eur. J. Pharm. Biopharm. 75 (2010) 1-15.10.1016/j.ejpb.2010.01.007
Search in Google Scholar Back to article
14. S. Mohan, Compression physics of pharmaceutical powders: a review, Int. J. Pharm. Sci. Res.; http://dx.doi.org/10.13040/IJPSR.0975-8232.3(6).1580-9210.13040/IJPSR.0975-8232.3(6).1580-92
Search in Google Scholar Back to article
15. R. C. Rowe, P. J. Sheskey, W. G. Cook and M. E. Fenton, Handbook of Pharmaceutical Excipients, 7th ed., Pharmaceutical Press, London 2012.
Search in Google Scholar Back to article
16. Physicians’ Desk Reference (PDR), 67th Ed. PDR Network 2012-01-01, https://06833842-a-62cb3a1as-sites.googlegroups.com/site/wegvergg/ganbate/Physicians-Desk-Reference-.pdf?attachauth=ANoY7cr9vlzLOqqmfplls_9fycwkg7n4tNBeh_DDkuOFHlNLBOL8VMINpJk4TR_WXev_7EinwRSMMJZ-COja82jGaxZL6lOmx0FfjJQg93w08w7_Dh66_nSllfHShXcoqZVqYXS2lvIZCKE-90T3ohWJgU5Epl0PSiWjkE2sqedXyxB442yjE6L3hyfZYUCFIrCknK6M3O1CPPuME3MMc8JTsmvIJZ2alZTcNZcD5EU4e6EXdKSGk%3D&attredirects=0, access date July 25, 2017.
Search in Google Scholar Back to article
17. British Pharmacopoeia, Flowability, The Pharmaceutical Press, London 2013.
Search in Google Scholar Back to article
18. N. R. Jadhav, A. R. Paradkar, N. H. Salunkhe, R. S. Karade and G. G. Mane, Talc: A versatile pharmaceutical excipient, World J. Pharm. Pharmaceut. Sci. 2 (2013) 4639-3660.
Search in Google Scholar Back to article
19. AEROSIL® and AEROPERL® Colloidal silicon dioxide for pharmaceuticals technical information TI 1281 : https://www.aerosil.com/sites/lists/RE/DocumentsSI/TI-1281-AEROSIL-and-AEROPERLColloidal-Silicon-Dioxide-for-Pharmaceuticals-EN.pdf; access date July 25, 2017.
Search in Google Scholar Back to article
20. G. Ragnarsson, A. W. Hdlzer and J. Sjogren, The influence of mixing time and colloidal silica on the lubricating properties of magnesium stearate, Int. J. Pharm. 3 (1979) 127-131.10.1016/0378-5173(79)90074-7
Search in Google Scholar Back to article
21. G. Thoorens, F. Krier, B. Leclercq, B. Carlin and B. Evrard, Microcrystalline cellulose, a direct compression binder in a quality by design environment - A review, Int. J. Pharm. 473 (2014) 64-72.10.1016/j.ijpharm.2014.06.05524993785
Search in Google Scholar Back to article
22. M. Jivraj, L. G. Martini and C. M. Thomson, An overview of the different excipients useful for the direct compression of tablets, Pharmaceut. Sci. Technol. Today 3 (2000) 58-63.10.1016/S1461-5347(99)00237-0
Search in Google Scholar Back to article
23. L. Jinjiang and W. Yongmei, Review: Lubricants in pharmaceutical solid dosage forms, Lubricants 2 (2014) 21-43.
Search in Google Scholar Back to article

Solving manufacturing problems for L-carnitine-L-tartrate to improve the likelihood of successful product scale-up

References

Paradigm

My account