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Pharmaceutical Development and Technology Volume 3, 1998 - Issue 4
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Research Article

Identification of Formulation and Manufacturing Variables That Influence In Vitro Dissolution and In Vivo Bioavailability of Propranolol Hydrochloride Tablets

Natalie D. Eddington Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 100 Penn Street, AHB, Baltimore, Maryland, 21201-6808Correspondence[email protected]
,
Muhammad Ashraf Wyeth-Ayerst Research, Pearl River, New York, 10965
,
Larry L. Augsburger Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 100 Penn Street, AHB, Baltimore, Maryland, 21201-6808
,
James L. Leslie Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 100 Penn Street, AHB, Baltimore, Maryland, 21201-6808
,
Michael J. Fossler US. Food and Drug Administration, CDER, Rockville, Maryland, 20855
,
Lawrence J. Lesko US. Food and Drug Administration, CDER, Rockville, Maryland, 20855
,
Vinod P. Shah US. Food and Drug Administration, CDER, Rockville, Maryland, 20855
&
Gurvinder Singh Rekhi Elan Pharma, Inc., Gainesville, Georgia, 30504
 show all
Pages 535-547 | Received 27 Mar 1996, Accepted 27 Mar 1998, Published online: 27 Sep 2008

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Beatrice Nkem Chukwumezie, Mark Wojcik, Paul Malak, Frank D'Amico & Moji Christianah Adeyeye. (2004) Factorial Design in the Spheronization of Ibuprofen Microparticulates Using the Rotor Disk Fluid‐Bed Technology. Pharmaceutical Development and Technology 9:1, pages 49-62.
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Syed Naiem Raza & Nisar Ahmad Khan. (2018) HPMC-Eudragit-Based Gastro-retentive Hydrodynamically Balanced System—Suitable for Sparingly Soluble and Freely Soluble Drugs: an In Vitro Study. Journal of Pharmaceutical Innovation 13:4, pages 353-366.
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Susumu Takeuchi, Yasuhiro Tsume, Gregory E. Amidon & Gordon L. Amidon. (2014) Evaluation of a Three Compartment In Vitro Gastrointestinal Simulator Dissolution Apparatus to Predict In Vivo Dissolution. Journal of Pharmaceutical Sciences 103:11, pages 3416-3422.
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Chinhwa Cheng, Pao-Chu Wu, Hsin-Ya Lee & Kuang-Yang Hsu. (2014) Development and validation of an in vitro–in vivo correlation (IVIVC) model for propranolol hydrochloride extended-release matrix formulations. Journal of Food and Drug Analysis 22:2, pages 257-263.
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Ali Mujtaba, Mushir Ali & Kanchan Kohli. (2014) Statistical optimization and characterization of pH-independent extended-release drug delivery of cefpodoxime proxetil using Box–Behnken design. Chemical Engineering Research and Design 92:1, pages 156-165.
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Anirbandeep Bose & Wong Tin Wui. (2012) Convolution and validation of in vitro–in vivo correlation of water-insoluble sustained-release drug (domperidone) by first-order pharmacokinetic one-compartmental model fitting equation. European Journal of Drug Metabolism and Pharmacokinetics 38:3, pages 191-200.
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Jim E. RiviereMarilyn Martinez. 2011. Comparative Pharmacokinetics. Comparative Pharmacokinetics 315 346 .
Ajit S. Narang, Venkatramana M. Rao, Hang Guo, Jian Lu & Divyakant S. Desai. (2010) Effect of force feeder on tablet strength during compression. International Journal of Pharmaceutics 401:1-2, pages 7-15.
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Marcos Llusa, Michael Levin, Ronald D. Snee & Fernando J. Muzzio. (2010) Measuring the hydrophobicity of lubricated blends of pharmaceutical excipients. Powder Technology 198:1, pages 101-107.
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Pallavi Nithyanandan, Walter W. Hauck, Jimmy Munoz, Gang Deng, William Brown, Ronald G. Manning & Samir Wahab. (2008) Dissolution Variability: Comparison of Commercial Dosage Forms with US Pharmacopeia Lot P Prednisone Reference Standard Tablets—A Technical Note. AAPS PharmSciTech 9:1, pages 238-242.
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Raimar Löbenberg, Jae Seung Kim & Gordon L. Amidon. (2005) Pharmacokinetics of an immediate release, a controlled release and a two pulse dosage form in dogs. European Journal of Pharmaceutics and Biopharmaceutics 60:1, pages 17-23.
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Yaw-Bin Huang, Yi-Hung Tsai, Shu-Hui Lee, Jui-Sheng Chang & Pao-Chu Wu. (2005) Optimization of pH-independent release of nicardipine hydrochloride extended-release matrix tablets using response surface methodology. International Journal of Pharmaceutics 289:1-2, pages 87-95.
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Yaw-Bin Huang, Yi-Hung Tsai, Wan-Chiech Yang, Jui-Sheng Chang, Pao-Chu Wu & Kozo Takayama. (2004) Once-daily propranolol extended-release tablet dosage form: formulation design and in vitro/in vivo investigation. European Journal of Pharmaceutics and Biopharmaceutics 58:3, pages 607-614.
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Yaw‐Bin Huang, Yi‐Hung Tsai, Wan‐Chiech Yang, Jui‐Sheng Chang & Pao‐Chu Wu. (2004) Influence of formulation variables and manufacturing process on propranolol extended release profile from HPMC matrices tablets. Journal of Applied Polymer Science 93:4, pages 1886-1890.
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Saeed A Qureshi & Javad Shabnam. (2003) Applications of a new device (spindle) for improved characterization of drug release (dissolution) of pharmaceutical products. European Journal of Pharmaceutical Sciences 19:4, pages 291-297.
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Marilyn N. Martinez & Gordon L. Amidon. (2013) A Mechanistic Approach to Understanding the Factors Affecting Drug Absorption: A Review of Fundamentals. The Journal of Clinical Pharmacology 42:6, pages 620-643.
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Kimberley Jackson, David Young & Sonia Pant. (2000) Drug–excipient interactions and their affect on absorption. Pharmaceutical Science & Technology Today 3:10, pages 336-345.
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Natalie D. Eddington, Guvinder Singh Rekhi, Larry J. Lesko & Larry L. Augsburger. (2015) Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations. AAPS PharmSciTech 1:2, pages 63-71.
Crossref
Natalie D. Eddington, Guvinder Singh Rekhi, Larry J. Lesko & Larry L. Augsburger. (2000) Scale-up effects on dissolution and bioavailability of propranolol hydrochloride and metoprolol tartrate tablet formulations. AAPS PharmSciTech 1:2, pages 63-71.
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