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Pharmaceutical Development and Technology Volume 9, 2005 - Issue 3
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Research Article

Effect of Processing and Formulation Variables on the Stability of a Salt of a Weakly Basic Drug Candidate

Sherif Badawy Pharmaceutical Research Institute, Bristol‐Myers Squibb Company, One Squibb Dr, New Brunswick, New Jersey, 08903, USA
, Ph.D.,
Rodney Vickery Pharmaceutical Research Institute, Bristol‐Myers Squibb Company, One Squibb Dr, New Brunswick, New Jersey, 08903, USA
,
Keyur Shah Pharmaceutical Research Institute, Bristol‐Myers Squibb Company, One Squibb Dr, New Brunswick, New Jersey, 08903, USA
&
Munir Hussain Pharmaceutical Research Institute, Bristol‐Myers Squibb Company, One Squibb Dr, New Brunswick, New Jersey, 08903, USA
Pages 239-245 | Received 26 Aug 2003, Accepted 12 Nov 2003, Published online: 08 Sep 2004

Citations (17)

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Divyakant Desai, Venkatramana Rao, Hang Guo, Danping Li, Daniel Stein, Frank Y. Hu & Chris Kiesnowski. (2012) An active film-coating approach to enhance chemical stability of a potent drug molecule. Pharmaceutical Development and Technology 17:2, pages 227-235.
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Phuong Ha-Lien Tran, Thao Truong-Dinh Tran, Kyoung-Ho Lee, Dong-Jin Kim & Beom-Jin Lee. (2010) Dissolution-modulating mechanism of pH modifiers in solid dispersion containing weakly acidic or basic drugs with poor water solubility. Expert Opinion on Drug Delivery 7:5, pages 647-661.
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Articles from other publishers (15)

Sherif I.F. Badawy. 2019. Handbook of Pharmaceutical Wet Granulation. Handbook of Pharmaceutical Wet Granulation 149 172 .
Haichen Nie, Wei Xu, Lynne S. Taylor, Patrick J. Marsac & Stephen R. Byrn. (2017) Crystalline solid dispersion-a strategy to slowdown salt disproportionation in solid state formulations during storage and wet granulation. International Journal of Pharmaceutics 517:1-2, pages 203-215.
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S. Badawy & P. Pandey. 2017. Developing Solid Oral Dosage Forms. Developing Solid Oral Dosage Forms 749 776 .
Monica L. Adams, Vijayata Sharma, Madhushree Gokhale, Yande Huang, Kevin Stefanski, Ching Su & Munir A. Hussain. (2016) Dehydration and Stabilization of a Reactive Tertiary Hydroxyl Group in Solid Oral Dosage Forms of BMS-779788. Journal of Pharmaceutical Sciences 105:4, pages 1478-1488.
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Ajit S. Narang, Divyakant Desai & Sherif Badawy. 2015. Excipient Applications in Formulation Design and Drug Delivery. Excipient Applications in Formulation Design and Drug Delivery 93 137 .
Ju-Young Kim, Jung-Myung Ha, Yun-Seok Rhee, Chun-Woong Park, Sang-Cheol Chi & Eun-Seok Park. (2013) Influence of pharmaceutical excipients on stability of pramipexole dihydrochloride monohydrate in tablets. Journal of Pharmaceutical Investigation 44:3, pages 177-185.
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Ajit S. Narang, Divyakant Desai & Sherif Badawy. (2012) Impact of Excipient Interactions on Solid Dosage Form Stability. Pharmaceutical Research 29:10, pages 2660-2683.
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Min Li. 2012. Organic Chemistry of Drug Degradation. Organic Chemistry of Drug Degradation 262 277 .
Peter Guerrieri, Kjell Jarring & Lynne S. Taylor. (2010) Impact of Counterion on the Chemical Stability of Crystalline Salts of Procaine. Journal of Pharmaceutical Sciences 99:9, pages 3719-3730.
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Shumet A. Hailu & Robin H. Bogner. (2010) Solid-State Surface Acidity and pH-Stability Profiles of Amorphous Quinapril Hydrochloride and Silicate Formulations. Journal of Pharmaceutical Sciences 99:6, pages 2786-2799.
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S. Badawy, M. Hussain, F. Zhao, Q. Ye, Y. Huang & V. Palaniswamy. (2009) Degradation Pathways of a Corticotropin-Releasing Factor Antagonist in Solution and Solid States. Journal of Pharmaceutical Sciences 98:8, pages 2636-2647.
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Ahmad Almaya. 2009. Formulation and Analytical Development for Low‐Dose Oral Drug Products. Formulation and Analytical Development for Low‐Dose Oral Drug Products 89 115 .
Madhu Pudipeddi, Erika A. Zannou, Madhav Vasanthavada, Aruna Dontabhaktuni, Alan E. Royce, Yatindra M. Joshi & Abu T.M. Serajuddin. (2008) Measurement of Surface pH of Pharmaceutical Solids: A Critical Evaluation of Indicator Dye-Sorption Method and its Comparison With Slurry pH Method. Journal of Pharmaceutical Sciences 97:5, pages 1831-1842.
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Sherif I. Farag Badawy & Munir A. Hussain. (2007) Microenvironmental pH Modulation in Solid Dosage Forms. Journal of Pharmaceutical Sciences 96:5, pages 948-959.
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Ramprakash Govindarajan, Andrey Zinchuk, Bruno Hancock, Evgenyi Shalaev & Raj Suryanarayanan. (2006) Ionization States in the Microenvironment of Solid Dosage Forms: Effect of Formulation Variables and Processing. Pharmaceutical Research 23:10, pages 2454-2468.
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