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Bsg poster - march 2000Colonic mucosal concentrations of prednisolone following oral administration
of a novel formulation of prednisolone metasulphobenzoate (Predocol)
1Bell GD, 2English J, 3Spiers C, 4Nylander D, 4Hancock J, 5Rowland RS 1Sunderland University Medical Sciences Faculty, 2School of Biological Sciences, University of Surrey, 3Flexpharm Ltd, Watford, Herts, 4Department of Gastroenterology, Sunderland Royal Hospital, 5RMR Systems Ltd, Kirton, Suffolk Background
mens were taken with standard endoscopy biopsy Tiss ue Prednisolone levels after 40mg dose C o n c l u s i o n s
forceps from each of seven different sites around the Prednisolone metasulphobenzoate (PMSB) is colon i.e. 1) Caecum 2) Hepatic flexure 3) Mid Trans- The magnetic endoscope imaging system [3,4] The authors would like to thank the patients and sparingly absorbed, but effective when adminis- verse colon 4) splenic flexure 5) descending colon played a vital role in ensuring that all samples were endoscopy nursing staff at the Sunderland Royal tered topically, in distal UC . A new oral formu- 6) sigmoid colon and 7) Rectum. The saline-washed taken from the correct anatomical segment of the Hospital for their help and co-operation during lation of PMSB (Predocol) has been developed in specimens were stored at minus 40 degrees centi- colon. The present results confirm that Predocol which the drug, contained in capsules coated with grade for later measurement of tissue prednisolone capsules delivers high concentrations of PMBS to Eudragit L, is disseminated throughout the large levels using a radio-immunassay .
the left half of the colon in a consistent manner.
bowel in controlled delivery pellets. Pilot stud-ies suggest there is little systemic absorption of prednisolone from Predocol, and earlier patient studies using a similar formulation were promis- Total colonoscopies were possible in all 20 pa- tients. No side effects were reported by any of the 17 patients given Predocol. The individual and Figure 1 - Mean (SEM) mucosal concentrations of prednisolone
(ng/mg tissue) taken at colonoscopy approximately 4 hours
mean (SEM) mucosal concentration of pred- after the last dose of a 7 day course of Predocol in a dose
nisolone (ng/mg tissue) of the 10 patients in the equivalent to 40mg of prednisolone base. On the horizontal
To measure a) the mucosal concentrations of pred- Predocol 40 group are shown in Table 1 and Fig- axis are shown the 7 sites along the length of the colon that
nisolone in seven different anatomical locations biopsies were taken. Sites 1-7 represent the caecum, hepatic
flexure, mid transverse colon, splenic flexure, descending co-
along the colon following oral administration of lon, sigmoid colon and rectum respectively. Peak concentra-
Predocol, and b) to see if the pattern of release of tions occurred in the descending colon
the PMSB from the pH dependant Eudragit/con- trolled delivery pellet formulation along the co- At all sites along the colon except the rectum, the lon was affected by altering gastric acidity with a mucosal concentrations of prednisolone were sig- nificantly lower in the Predocol 20 group whencompared with the Predocol 40 patients – see Fig- Ethical approval has been obtained to study a to- tal of 38 patients with relatively asymptomatic The colonic mucosal concentrations found in the 3 Ulcerative Colitis of greater than 10 years dura- patients (NG, RS, and TR) given 20mg of normal tion who are due to come up for routine surveil- prednisolone are shown in Figure 3 along with lance colonoscopy. To date (14th February 2000) the mean(SEM) results for the 7 patients studied to we have studied 20 patients. In 10 patients, Figure 3 - Mean (SEM) mucosal concentrations of prednisolone (ng/mg tissue) taken at colonoscopy approxi-
Predocol was administered in a dose equivalent to mately 4 hours after the last dose of a 7 day course of Predocol in a dose equivalent 20mg of prednisolone
20 mg of prednisolone base BD for 7 days (Predocol (orange data points ). For comparison the individual data points for three UC patients (NG, RS, and TR)
colonoscoped approximately 4 hours after their last dose of 20 mg of prednisolone are shown
40 group). In a further 7 UC patients, the dose ad- ministered was equivalent to 10mg of prednisolone BD for 7 days (Predocol 20 group). In addition, for purposes of comparison, we have studied 3 symp- The colonic tissue mucosal concentrations of ex- Table 1 - Tissue mucosal concentrations of prednisolone found
tomatic UC patients receiving conventional once in the 10 individual UC patients colonoscoped approximately
ogenous steroid in the Predocol 20 group are simi- daily oral prednisolone in a dose of 20mg mane for 4 hours after the last dose of Predocol. All received a seven day
lar to those achieved with 20mg of normal oral pred- 1. McIntyre PB, Mairn FA, Berghouse L, English J, Lennard-Jones JE. Therapeutic ben- course of BD predocol equivalent to 40mg of prednisolone per
efits from a poorly absorbed prednisolone enema in distal colitis. Gut 1985; 26: 822-4. at least 7 days prior to colonoscopy. The patients nisolone but without the systemic side effects.
2. Ford GA, Oliver PS, Shepherd NA, Wilkinson SP. An Eudragit-coated prednisolone received standard bowel preparation including 2 Predictably significantly higher concentrations preparation for ulcerative colitis: pharmacokinetics and preliminary therapeutic use. Ali- doses of Picolax on the day prior to colonoscopy.
were achieved in the Predocol 40 group. Studies ment Pharmacol Therap 1992; 6: 31-40. The patients were requested to take the last dose of As can be seen, the results are remarkably consist- currently in progress will look at both Predocol 3. Bladen JS,Anderson AP, Bell GD, Rameh B,Evans B,Heatley DJT. Non-radiologicalimaging of endoscopes. Lancet 1993;341:719-722. either Predocol or ordinary prednisolone at 7am ent. The relatively low mucosal concentrations of 60 as well as Predocol 40 plus Lansoprazole to 4. Rowland RS & Bell GD. Non-radiological technique for three dimensional imaging of on the morning of the surveillance colonoscopy.
prednisolone found in the caecum gave way to see if even higher colonic mucosal prednisolone intestinal endoscopes. - A new improved method of computerised graphical 3-D repre- The examination was scheduled so that the colonic progressively higher levels as one moved across levels can be achieved in the right side of the co- sentation of the endoscope and patient’s skeleton. Med.Biol.Eng.Comput., 1998;36:285-290. mucosal biopsies could be taken approximately 4- the large intestine from right to left with peak con- Figure 2 - Mean (SEM) mucosal concentrations of prednisolone
lons of UC patients. A clinical trial evaluating the 5. Chakraborty J, English J, Marks V, Dumasia MC, Chapman DJ. A radioimmunassay 4.5 hours after the last dose of the drug.
centrations being found in the descending colon.
(ng/mg tissue) taken at colonoscopy approximately 4 hours
method for prednisolone: comparison with competitive protein binding method.Br J Clin after the last dose of a 7 day course of Predocol in a dose
The levels of prednisolone in the mucosal samples equivalent to either 40mg of prednisolone base (red data) or
exacerbations of UC as well as maintaining remis- All colonoscopies were conducted with the aid of from the sigmoid colon were significantly lower 20mg of prednisolone (blue data). The differences between the
sion of the disease is due to start in the near future mean prednisolone mucosal levels were statistically signifi-
magnetic endoscope imaging to confirm the exact than the descending colon while concentrations (Dr S Wilkinson – personal communication).
cant at all sites except the rectum
anatomical site of the biopsies [3,4]. Two speci- in the rectum were similar from those in the caecum.
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