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Efficacy and tolerability of a new formulation of sodium phosphate tablets (INKP‐101), and a reduced sodium phosphate dose, in colon cleansing: a single‐center open‐label pilot trial
Author(s) -
Khashab M.,
Rex D. K.
Publication year - 2005
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2005.02332.x
Subject(s) - tolerability , microcrystalline cellulose , medicine , colonoscopy , sodium , microcrystalline , phosphate , adverse effect , cellulose , pharmacology , colorectal cancer , chemistry , biochemistry , organic chemistry , cancer , crystallography
Summary Background : The tablet form of sodium phosphate for bowel preparation for colonoscopy contains microcrystalline cellulose. This inactive ingredient produces a residue that obscures mucosal visualization and is time‐consuming to remove during colonoscopy. Aim : To perform an open‐label study of efficacy and tolerability of a modified formulation with microcrystalline cellulose reduced by 50% (code named INKP‐101) and a lower total dose of sodium phosphate. Methods : Patients scheduled for colonoscopy self‐administered 28 INKP‐101 tablets (42 g sodium phosphate). Colon cleansing efficacy was evaluated using a standard 4‐point scoring system and the amount of microcrystalline cellulose present and time spent removing it using an 8‐point scale. Results : A total of 31 patients were screened and enrolled. Thirty patients had a colonoscopy and were evaluated for colon cleansing efficacy. Overall colon cleansing was rated as excellent and good in 90% and 10% of patients respectively. About 77% of patients had microcrystalline cellulose scores of 2 or 3 (corresponding to <1 or 1–2 min spent removing microcrystalline cellulose, respectively). The drug was well‐tolerated and adverse events were generally benign. Conclusion : A new formulation of sodium phosphate with reduced microcrystalline cellulose and a lower total dose of sodium phosphate was effective for colonoscopy and well‐tolerated.