A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Zhu, Hao; Chen, Xiaomei; Ahmed, Mariam; Wang, Yaning; Liu, Qi; Uppoor, Ramana S.; Kuemmel, Colleen; Mehta, Mehul

doi:10.1111/cts.12658

Title: A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Authors:

Zhu, Hao ^[1]; Chen, Xiaomei ^[1]; Ahmed, Mariam ^[1]; Wang, Yaning ^[1]; Liu, Qi ^[1]; Uppoor, Ramana S. ^[1]; Kuemmel, Colleen ^[1]; Mehta, Mehul ^[1]

Office of Clinical Pharmacology Office of Translational Science, Center for Drug Evaluation and Research US Food and Drug Administration Silver Spring Maryland USA

Publication Date:: 2019-08-16

Sponsoring Org.:: USDOE

OSTI Identifier:: 1574076

Alternate Identifier(s):: OSTI ID: 1574077

Resource Type:: Published Article

Journal Name:: Clinical and Translational Science

Additional Journal Information:: Journal Name: Clinical and Translational Science Journal Volume: 12 Journal Issue: 6; Journal ID: ISSN 1752-8054

Publisher:: Wiley-Blackwell

Country of Publication:: United Kingdom

Language:: English

Citation Formats


                    Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, and Mehta, Mehul. A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.  United Kingdom: N. p., 2019. 
Web.  doi:10.1111/cts.12658.

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                    Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, & Mehta, Mehul. A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH.  United Kingdom.  https://doi.org/10.1111/cts.12658

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                    Zhu, Hao, Chen, Xiaomei, Ahmed, Mariam, Wang, Yaning, Liu, Qi, Uppoor, Ramana S., Kuemmel, Colleen, and Mehta, Mehul. Fri .  
"A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH".  United Kingdom.  https://doi.org/10.1111/cts.12658.

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@article{osti_1574076,

  title        = {A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH},

  author       = {Zhu, Hao and Chen, Xiaomei and Ahmed, Mariam and Wang, Yaning and Liu, Qi and Uppoor, Ramana S. and Kuemmel, Colleen and Mehta, Mehul},

  abstractNote = {},

  doi          = {10.1111/cts.12658},

  journal      = {Clinical and Translational Science},

  number       = 6,

  volume       = 12,

  place        = {United Kingdom},

  year         = {2019},

  month        = {8}

}

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Title: A Proposal of Conducting Bioequivalence Trials with Gastric pH Modulators for Two Oral Formulations Demonstrating Different Dissolution Profiles at Elevated pH

Citation Formats

Improving the Oral Bioavailability of Albendazole in Rabbits by the Solid Dispersion Technique journal, February 1999

Posaconazole Tablet Pharmacokinetics: Lack of Effect of Concomitant Medications Altering Gastric pH and Gastric Motility in Healthy Subjects journal, May 2014

pH-Dependent Drug–Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development journal, April 2014

Oral Absorption of Poorly Water-Soluble Drugs: Computer Simulation of Fraction Absorbed in Humans from a Miniscale Dissolution Test journal, May 2006

Salt formation to improve drug solubility journal, July 2007

Dissolution Kinetics of Carboxylic Acids II: Effect of Buffers journal, January 1981

Effect of Diffusion Layer pH and Solubility on the Dissolution Rate of Pharmaceutical Bases and their Hydrochloride Salts I: Phenazopyridine journal, February 1985

Dissolution Kinetics of Carboxylic Acids I: Effect of pH Under Unbuffered Conditions journal, January 1981

Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor journal, April 2011

Impact of Food and the Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of GDC-0941 in Healthy Volunteers: Bench to Bedside Investigation of pH-Dependent Solubility journal, October 2013

Doxycycline carrageenate ? an improved formulation providing more reliable absorption and plasma concentrations at high gastric pH than doxycycline monohydrate journal, March 1994

Frequency analyses of gastric pH in control and gastro-oesophageal reflux disease subjects treated with a proton-pump inhibitor journal, December 2004

Fumaric Acid Microenvironment Tablet Formulation and Process Development for Crystalline Cenicriviroc Mesylate, a BCS IV Compound journal, September 2013

Using Absorption Simulation and Gastric pH Modulated Dog Model for Formulation Development To Overcome Achlorhydria Effect journal, October 2011

Investigation of Solubility and Dissolution of a Free Base and Two Different Salt Forms as a Function of pH journal, April 2005

Mathematical modeling of drug dissolution journal, August 2013

An in vitro–in silico–in vivo approach to predicting the oral pharmacokinetic profile of salts of weak acids: Case example dantrolene journal, May 2013

Effect of food on the bioavailability of palbociclib journal, February 2017

Gastric acidity-dependent bioavailability of commercial sustained release preparations of indomethacin, evaluated by gastric acidity-controlled beagle dogs. journal, January 1990

Pharmacokinetics and Absorption of Posaconazole Oral Suspension under Various Gastric Conditions in Healthy Volunteers journal, December 2008

Impact of Acid-Reducing Agents on the Pharmacokinetics of Palbociclib, a Weak Base With pH-Dependent Solubility, With Different Food Intake Conditions journal, April 2017

Formulation of Solid Dosage Forms to Overcome Gastric pH Interaction of the Factor Xa Inhibitor, BMS-561389 journal, May 2006

Improving the Oral Bioavailability of Albendazole in Rabbits by the Solid Dispersion Technique
journal, February 1999

Posaconazole Tablet Pharmacokinetics: Lack of Effect of Concomitant Medications Altering Gastric pH and Gastric Motility in Healthy Subjects
journal, May 2014

pH-Dependent Drug–Drug Interactions for Weak Base Drugs: Potential Implications for New Drug Development
journal, April 2014

Oral Absorption of Poorly Water-Soluble Drugs: Computer Simulation of Fraction Absorbed in Humans from a Miniscale Dissolution Test
journal, May 2006

Salt formation to improve drug solubility
journal, July 2007

Dissolution Kinetics of Carboxylic Acids II: Effect of Buffers
journal, January 1981

Effect of Diffusion Layer pH and Solubility on the Dissolution Rate of Pharmaceutical Bases and their Hydrochloride Salts I: Phenazopyridine
journal, February 1985

Dissolution Kinetics of Carboxylic Acids I: Effect of pH Under Unbuffered Conditions
journal, January 1981

Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor
journal, April 2011

Impact of Food and the Proton Pump Inhibitor Rabeprazole on the Pharmacokinetics of GDC-0941 in Healthy Volunteers: Bench to Bedside Investigation of pH-Dependent Solubility
journal, October 2013

Doxycycline carrageenate ? an improved formulation providing more reliable absorption and plasma concentrations at high gastric pH than doxycycline monohydrate
journal, March 1994

Frequency analyses of gastric pH in control and gastro-oesophageal reflux disease subjects treated with a proton-pump inhibitor
journal, December 2004

Fumaric Acid Microenvironment Tablet Formulation and Process Development for Crystalline Cenicriviroc Mesylate, a BCS IV Compound
journal, September 2013

Using Absorption Simulation and Gastric pH Modulated Dog Model for Formulation Development To Overcome Achlorhydria Effect
journal, October 2011

Investigation of Solubility and Dissolution of a Free Base and Two Different Salt Forms as a Function of pH
journal, April 2005

Mathematical modeling of drug dissolution
journal, August 2013

An in vitro–in silico–in vivo approach to predicting the oral pharmacokinetic profile of salts of weak acids: Case example dantrolene
journal, May 2013

Effect of food on the bioavailability of palbociclib
journal, February 2017

Gastric acidity-dependent bioavailability of commercial sustained release preparations of indomethacin, evaluated by gastric acidity-controlled beagle dogs.
journal, January 1990

Pharmacokinetics and Absorption of Posaconazole Oral Suspension under Various Gastric Conditions in Healthy Volunteers
journal, December 2008

Impact of Acid-Reducing Agents on the Pharmacokinetics of Palbociclib, a Weak Base With pH-Dependent Solubility, With Different Food Intake Conditions
journal, April 2017

Formulation of Solid Dosage Forms to Overcome Gastric pH Interaction of the Factor Xa Inhibitor, BMS-561389
journal, May 2006