Cleansing efficacy and safety of bowel preparation protocol using sodium picosulfate/magnesium citrate considering subjective experiences:An observational study

BACKGROUND Research data from patient reports indicate that the least bearable part of colonoscopy is the administration of laxatives for bowel preparation.AIM To observe the intestinal cleansing efficacy and safety of sodium picosulfate/magnesium citrate and to discuss the patients’experiences due to the procedure.METHODS Subjects hospitalized in the International Medical Center Ward of Peking University International Hospital,Beijing,China,from April 29 to October 29,2020,for whom the colonoscopy was planned,were enrolled.Bowel preparation was performed using sodium picosulfate/magnesium citrate.The effect of bowel cleansing was evaluated according to the Ottawa Bowel Preparation Scale,defecation conditions and adverse reactions were recorded,and the comfort level and subjective satisfaction concerning medication were evaluated by the visual analogue scale/score(VAS).RESULTS The bowel preparation procedure was planned for all patients enrolled,which included 42 males and 22 females.The results showed an average liquid rehydration volume of 3000 mL,an average onset of action for the first dose at 89.04 min,an average number of bowel movements of 4.3 following the first dose,an average onset of action for the second dose at 38.90 min and an average number of bowel movements of 5.0 after the second dose.The total average Ottawa Bowel Preparation Scale score was 3.6,with 93.55%of bowel preparations in the“qualified”and 67.74%in the“excellent”grade.The average VAS score of effect on sleep was 0,and the average VAS score of perianal pain was also 0.The average VAS score for ease of taking and taste perception of the bowel cleanser was 10.Side effects included mild to moderate nausea(15.63%),mild vomiting(4.69%),mild to moderate abdominal pain(7.81%),mild to moderate abdominal distension(20.31%),mild palpitation(7.81%)and mild dizziness(4.69%).CONCLUSION Sodium picosulfate/magnesium citrate is effective and safe for bowel preparation before colonoscopy with high subjective patient acceptance,thus improving overall patient compliance.

Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs polyethylene glycol, a randomized trial

BACKGROUND Bowel preparation in children can be challenging.AIM To describe the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, and citric acid(SPMC) bowel preparation in children.METHODS Phase 3, randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 years were randomized 1:1:1 to SPMC ? dose × 2, SPMC 1 dose × 2, or polyethylene glycol(PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose × 2 or PEG. PEG-based bowel preparations were administered per local protocol. Primary efficacy endpoint for quality of bowel preparation was responders(rating of ‘excellent' or ‘good') by modified Aronchick Scale. Secondary efficacy endpoint was participant's tolerability and satisfaction from a 7-item questionnaire. Safety assessments included adverse events(AEs) and laboratory evaluations.RESULTS 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% were responders for SPMC ? dose × 2, SPMC 1 dose × 2, and PEG groups, respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose × 2 and 85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose × 2 reported it was ‘very easy' or ‘easy' to drink, compared with 20.0% receiving PEG. Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 dose × 2 and 63.0% receiving PEG.CONCLUSION SPMC was an efficacious and safe for bowel preparation in children 9-16 years, with comparable efficacy to PEG. Tolerability for SPMC was higher compared to PEG.

Forced Degradation Studies on Sodium Picosulfate and Separation of 15 Process Related Impurities/Degradants by HPLC

A selective, precise and stability-indicating, high performance liquid chromatographic method was developed for the analysis of active ingredient sodium Picosulfate and forced degradation behavior was studied. The current article describes forced degradation behavior of the Sodium Picosulfate drug substance in detail by analyzing 15 process related/degradants in a single HPLC method under ICH recommended stressed conditions. Mobile phase comprised of 0.01 M of Disodium hydrogen phosphate and 0.01 M of potassium phosphate monobasic buffer and 1 mL of triethyl amine in 1000 mL water adjusted to pH 7.5 with 10% phosphoric acid. Acetonitrile was used as Mobile Phase B. The separation was achieved on a gradient method. The reversed phase chromatography was performed in Hypersil BDS C18 5.0 μm, 4.6 × 250 mm column maintained at temperature 35°C. Injection volume was 60 μL. Milli-Q water used as diluent. The mobile phase was pumped at 0.9 mL/min-1. The eluted compounds were monitored at 220 nm. Secondary wavelength of the 263 nm was studied to check any further degradants during the forced degradation studies. New additional degradants Sodium Picosulfate Benzyl alcohol Impurity and N oxide degradations were discussed and studied during the forced degradation to understand the chemical stability of the drug substance.

Diphenyl methane laxatives do not induce electrolyte imbalance

Aim: To analyse whether there are changes in sodium and potassium serum levels during chronic treatment with the diphenyl methanes bisacodyl and sodium picosulfate. Methods: A literature search was done using PubMed, and the reference lists of pertinent papers were screened for additional studies. Only studies of at least 4 weeks duration were considered for further analysis. Results: Four relevant studies were identified. In three randomised controlled trials with 5 to 10 mg daily of bisacodyl or sodium picosulfate, respectively, over four weeks no electrolyte losses were found. Hypokalemia was also not a problem in a group of patients with paraplegia using bisacodyl suppositories for 2 to 34 years. Conclusions: Electrolyte losses, particularly hypokalemia, are not a problem when bisacodyl or sodium picosulfate are used long-term.