Prescription & OTC Drugs – Mark vB Cleveland, John S. Fordtran, Edmund V. Dennett, Sebela Bt Holdings Inc, Sebela International Development Ltd
Abstract for “Sulfate salt solution laxative compositions and methods of use thereof”
The present invention is directed to an oral pharmaceutical composition containing a sulfate salt (e.g. sodium sulfate or potassium sulfate), where the composition is substantially devoid of magnesium sulfate. This invention also addresses the use of such oral pharmaceutical formulations to induce or treat constipation (e.g. opioid-induced constipation).
Background for “Sulfate salt solution laxative compositions and methods of use thereof”
“Laxative Formulations”
“Drug-Induced Constipation”
“BRIEF DESCRIPTION DES DRAWINGS”
“I. “I.
“Sulfate Salts”
“Formulations”
“Excipients”
“II. “II. Methods of Treatment”
“EXAMPLES”
“Example 1 – The Development of a Low Dose Sulfate Laxative to Treat Constipation in Normal Volunteers.”
“Summary”
“Study Objective”
“Study Plan”
“Study Subjects”
“Efficacy Evaluations”
“Safety Evaluation”
“Conclusion”
“Example 2 – A Pilot Efficacy Assessment of BLI 801 in Constipated Adults.”
“Summary”
“Study Objective”
“Study Plan”
“Study Procedures”
“Assessments”
“Analysis Methods”
“Efficacy Results”
“Safety Evaluation”
“Conclusion”
“Example 3 – A Safety and Efficacy Assessment of BLI801 in Constipated Adults.”
“Introduction”
“Methods”
“Results”
“Conclusion”
“Example 4 – Cross-Study Quality Of Life Comparison of MiraLax and BLI801”
“Example 5 – Cross-Study Comparation of BLI801 and Relistor”
“Example 6. Liquid Formulation”
“Example 7. Liquid Sulfate Reformulation”
“Example 8. “Example 8.” Study of the Solid Oral Dosage Formula
“EQUIVALENTS”
Summary for “Sulfate salt solution laxative compositions and methods of use thereof”
“Laxative Formulations”
“Drug-Induced Constipation”
“BRIEF DESCRIPTION DES DRAWINGS”
“I. “I.
“Sulfate Salts”
“Formulations”
“Excipients”
“II. “II. Methods of Treatment”
“EXAMPLES”
“Example 1 – The Development of a Low Dose Sulfate Laxative to Treat Constipation in Normal Volunteers.”
“Summary”
“Study Objective”
“Study Plan”
“Study Subjects”
“Efficacy Evaluations”
“Safety Evaluation”
“Conclusion”
“Example 2 – A Pilot Efficacy Assessment of BLI 801 in Constipated Adults.”
“Summary”
“Study Objective”
“Study Plan”
“Study Procedures”
“Assessments”
“Analysis Methods”
“Efficacy Results”
“Safety Evaluation”
“Conclusion”
“Example 3 – A Safety and Efficacy Assessment of BLI801 in Constipated Adults.”
“Introduction”
“Methods”
“Results”
“Conclusion”
“Example 4 – Cross-Study Quality Of Life Comparison of MiraLax and BLI801”
“Example 5 – Cross-Study Comparation of BLI801 and Relistor”
“Example 6. Liquid Formulation”
“Example 7. Liquid Sulfate Reformulation”
“Example 8. “Example 8.” Study of the Solid Oral Dosage Formula
“EQUIVALENTS”
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