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.
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.


OBJECTIVE
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.


CONCLUSIONS
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.
Khashab
M
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Indiana University Hospital, Indianapolis, IN 46202, USA. drex@iupui.edu
Rex
D K
DK
D000328:Adult; D000368:Aged; D002400:Cathartics / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D003113:Colonoscopy; D003460:Crystallization; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D010865:Pilot Projects; D012646:Self Administration; D013607:Tablets
D002400:Cathartics; D010710:Phosphates; D013607:Tablets; D002482:Cellulose; C018279:sodium phosphate