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Abstract

In this review, we examined studies published on oral and topical phrasings of budesonide (Entocort® and Budenofalk®, in Spain Entocord® and Intestifalk®) for the treatment of ulcerative colitis. This glycocorticosteroid has a potent original action and an important first- pass liver metabolism. It has proven successful over the last times as a controlled- release expression. It attained results analogous to prednisolone, without the ultimate’s significant repression of tube cortisol. numerous publications live on the goods of oral budesonide for the treatment of Crohn’s complaint(CD). These have led to the enrolment of this medicine for the treatment of CD. Studies on oral phrasings of budesonide for the treatment of ulcerative colitis(UC) are scarce. After reviewing published substantiation, we suggest the conduction of controlled trials for the treatment of UC to gain substantiation- grounded efficacity and safety results in order to profit cases with this form of seditious bowel complaint(IBD). Ulcerative colitis(UC) is an vulnerable- mediated complaint of the colon that's characterized by verbose and nonstop inflammation conterminous from the rectum. Half of UC cases have inflammation limited to the distal colon( proctitis or proctosigmoiditis) that primarily causes symptoms of bloody diarrhea and urgency. Mild- to-moderate distal UC can be effectively treated with topical phrasings( rectal suppositories, enemas, or froth) of mesalamine or steroids to reduce mucosal inflammation and palliate symptoms. Enemas or froth phrasings adequately reach up to the splenic flexure, have a minimum side- effect profile, and induce absolution alone or in combination with systemic immunosuppressive remedy.

Keywords

Ulcerative colitis, Crohn’s disease, treatment cost effectiveness, topical immunosuppressive therapy, budesonide , proctitis suppositories , colon mucosa

Reference

  1. Abraham  C,  Cho  JH.  Inflammatory  bowel  disease.  N  Engl  J  Med.2009;361:2066–2078.
  2. Malik TA. Inflammatory bowel disease: historical perspective, epide-miology, and risk factors. Surg Clin North Am.2015;95:1105–1122.
  3. Christophi GP, Rong R, Holtzapple PG, Massa PT, Landas SK. Immune markers  and  differential  signaling  networks  in  ulcerative  colitis  and  Crohn’s disease. Inflamm Bowel Dis.2012;18:2342–2356. 
  4. Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflamma-tory bowel disease. Nature.2011;474:307–317. 
  5. Rogler  G.  Medical  management  of  ulcerative  colitis.  Dig  Dis.2009;27:542–549.
  6. Frei P, Biedermann L, Manser CN, et al. Topical therapies in inflam-matory bowel disease. Digestion.2012;86(Suppl 1):36–44
  7. Seibold F, Fournier N, Beglinger C, Mottet C, Pittet V, Rogler G. Topi-cal therapy is underused in patients with ulcerative colitis. J Crohns Colitis.2014;8:56–63.
  8. GrossVTopical therapyDig Dis201230Suppl 39299  [Google Scholar]
  9. HamMMossACMesalamine in the treatment and maintenance of remission of ulcerative colitisExpert Rev Clin Pharmacol2012511312322390554  [Taylor & Francis Online] [PubMed] [Web of Science ®], [Google Scholar ]
  10. SninskyCACortDHShanahanFOral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. A multicenter studyAnn Intern Med19911153503551863024  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  11. WatanabeMNishinoHSameshimaYOtaANakamuraSHibiTRandomised clinical trial: evaluation of the efficacy of mesalazine (mesalamine) suppositories in patients with ulcerative colitis and active rectal inflammation – a placebo-controlled studyAliment Pharmacol Ther20133826427323734840  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  12. MarshallJKIrvineEJRectal aminosalicylate therapy for distal ulcerative colitis: a meta-analysisAliment Pharmacol Ther199592933007654892  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  13. KornbluthASacharDBUlcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters CommitteeAm J Gastroenterol2010105501523 quiz 52420068560  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  14. HanauerSGoodLIGoodmanMWLong-term use of mesalamine (Rowasa) suppositories in remission maintenance of ulcerative proctitisAm Gastroenterol2000951749175410925979  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  15. KruisWSchreiberSTheuerDLow dose balsalazide (1.5 g twice daily) and mesalazine (0.5 g three times daily) maintained remission of ulcerative colitis but high dose balsalazide (3.0 g twice daily) was superior in preventing relapsesGut20014978378911709512  [Crossref] [PubMed] [Web of Science ®], [Google Scholar].
  16. FaubionWAJrLoftusEVJrHarmsenWSZinsmeisterARSandbornWJThe natural history of corticosteroid therapy for inflammatory bowel disease: a population-based studyGastroenterology200112125526011487534  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  17. KusunokiMMoesleinGShojiYSteroid complications in patients with ulcerative colitisDis Colon Rectum199235100310091395976  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  18. HanauerSGoodLIGoodmanMWLong-term use of mesalamine (Rowasa) suppositories in remission maintenance of ulcerative proctitisAm J Gastroenterol2000951749175410925979  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  19. SandbornWJBosworthBZakkoSBudesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditisGastroenterology2015148740750.e225644096  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]                                                                            
  20. Bar-MeirSFidderHHFaszczykMBudesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditisDis Colon Rectum20034692993612847368  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  21. SandbornWJBosworthBZakkoSBudesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditisGastroenterology2015148740750.e225644096  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  22. Brunner  M,  Vogelsang  H,  Greinwald  R,  et  al.  Colonic  spread  and  serum pharmacokinetics of budesonide foam in patients with mildly to  moderately  active  ulcerative  colitis.  Aliment Pharmacol Ther.2005;22:463–470
  23. Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission  in  patients  with  mild  to  moderate  ulcerative  proctitis  and  ulcerative proctosigmoiditis. Gastroenterology.2015;148:740–750. e2.
  24. Bar-Meir  S,  Fidder  HH,  Faszczyk  M,  et  al.  Budesonide  foam  vs.  hydrocortisone acetate foam in the treatment of active ulcerative proc-tosigmoiditis. Dis Colon Rectum.2003;46:929–936
  25. Kusunoki M, Moeslein G, Shoji Y, et al. Steroid complications in patients with ulcerative colitis. Dis Colon Rectum.1992;35:1003–1009
  26. Gross V, Bar-Meir S, Lavy A, et al. Budesonide foam versus budesonide enema  in  active  ulcerative  proctitis  and  proctosigmoiditis.  Aliment Pharmacol Ther.2006;23:303–312.
  27. Klotz U, Schwab M. Topical delivery of therapeutic agents in the treatment of inflammatory bowel disease. Adv Drug Deliv Rev 2005; 57: 267-79.
  28. Ryrfeldt A, Edsbacker S, Pauwels R. Kinetics of the epimeric gluco- corticoid budesonide. Clin Pharmacol Ther 1984; 35: 525-30
  29. Jonsson G, Astrom A, Andersson P. Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver. Drug Metab Dispos 1995; 23: 137-42
  30. Edsbacker S, Andersson P, Lindberg C, Paulson J, Ryrfeldt A, ThalenLiver metabolism of budesonide in rat, mouse, and man. Compara- tive aspects. Drug Metab Dispos 1987; 15: 403-11.
  31. Nyman-Pantelidis M, Nilsson A, Wagner ZG, Borga O. Pharmacoki- netics and retrograde colonic spread of budesonide enemas in patients with distal ulcerative colitis. Aliment Pharmacol Ther 1994; 8: 617- 22.
  32. Miller-Larsson A, Gustafsson B, Persson CG, Brattsand R. Gut mu- cosal uptake and retention characteristics contribute to the high in- testinal selectivity of budesonide compared with prednisolone in the rat. Aliment Pharmacol Ther 2001; 15: 2019-25.
  33. Nolen H, 3rd, Fedorak RN, Friend DR. Budesonide-beta-D-glu- curonide: a potential prodrug for treatment of ulcerative colitis. J Pharm Sci 1995; 84: 677-81.
  34. Danielsson A, Edsbacker S, Lofberg R, Nilsson A, Nyman-Pantelidis M, Olsson O, et al. Pharmacokinetics of budesonide enema in patients with distal ulcerative colitis or proctitis. Aliment Pharmacol Ther 1993; 7: 401-7.
  35. Lindgren S, Lofberg R, Bergholm L, Hellblom M, Carling L, Ung KA, et al. Effect of budesonide enema on remission and relapse rate in distal ulcerative colitis and proctitis. Scand J Gastroenterol 2002; 37: 705-
  36. Danielsson A, Lofberg R, Persson T, Salde L, Schioler R, Suhr O, et al. A steroid enema, budesonide, lacking systemic effects for the treat- ment of distal ulcerative colitis or proctitis. Scand J Gastroenterol 1992; 27: 9-12.
  37. Hanauer SB, Robinson M, Pruitt R, Lazenby AJ, Persson T, Nilsson LG, et al. Budesonide enema for the treatment of active, distal ulcera- tive colitis and proctitis: a dose-ranging study. U.S. Budesonide ene- ma study group. Gastroenterology 1998; 115: 525-32.
  38. Bar-Meir S, Fidder HH, Faszczyk M, Bianchi Porro G, Sturniolo GC, Mickisch O, et al. Budesonide foam vs. hydrocortisone acetate foam in the treatment of active ulcerative proctosigmoiditis. Dis Colon Rec- tum 2003; 46: 929-36.
  39. Hammond A, Andus T, Gierend M, Ecker KW, Scholmerich J, Her- farth H. Controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of budes- onide foam and betamethasone enemas in patients with active distal ulcerative colitis. Hepatogastroenterology 2004; 51: 1345-9.
  40. Marshall JK, Irvine EJ. Rectal corticosteroids versus alternative treat- ments in ulcerative colitis: a meta-analysis. Gut 1997; 40: 775-81.
  41. Nos P, Hinojosa J, Gomollon F, Ponce J. Budesonide in inflammatory bowel disease: a meta-analysis. Med Clin (Barc) 2001; 116: 47-53.
  42. Lemann M, Galian A, Rutgeerts P, Van Heuverzwijn R, Cortot A, Viteau JM, et al. Comparison of budesonide and 5-aminosalicylic acid enemas in active distal ulcerative colitis. Aliment Pharmacol Ther 1995; 9: 557-62.
  43. Lamers C, Meijer J, Engels L, Bos L, van Hogezand R, Driessen W, et al. Comparative study of the topically acting glucocorticosteroid budesonide and 5-aminosalicylic acid enema therapy of proctitis and proctosigmoiditis. Gastroenterology 1991; 100: A223
  44. Sambuelli A, Boerr L, Negreira S, Gil A, Camartino G, Huernos S, et al. Budesonide enema in pouchitis—a double-blind, double-dummy, controlled trial. Aliment Pharmacol Ther 2002; 16: 27-34.
  45. Kolkman JJ, Mollmann HW, Mollmann AC, Pena AS, Greinwald R, Tauschel HD, et al. Evaluation of oral budesonide in the treatment of active distal ulcerative colitis. Drugs Today (Barc) 2004; 40: 589-601.
  46. Edsbacker S, Bengtsson B, Larsson P, Lundin P, Nilsson A, Ulmius J, et al. A pharmacoscintigraphic evaluation of oral budesonide given as controlled-release (Entocort) capsules. Aliment Pharmacol Ther 2003; 17: 525-36.
  47. Buttgereit F, Burmester GR, Lipworth BJ. Optimised glucocorticoid therapy: the sharpening of an old spear. Lancet 2005; 365: 801-3.
  48. Fedorak RN, Bistritz L. Targeted delivery, safety, and efficacy of oral enteric-coated formulations of budesonide. Adv Drug Deliv Rev 2005; 57: 303-16.
  49. SafdiMDeMiccoMSninskyCA double-blind comparison of oral versus rectal mesalamine versus combination therapy in the treatment of distal ulcerative colitisAm J Gastroenterol199792186718719382054  [PubMed] [Web of Science ®], [Google Scholar]
  50. CohenRDWosethDMThistedRAHanauerSBA meta-analysis and overview of the literature on treatment options for left-sided ulcerative colitis and ulcerative proctitisAm J Gastroenterol2000951263127610811338  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  51. RegueiroMLoftusEVJrSteinhartAHCohenRDMedical management of left-sided ulcerative colitis and ulcerative proctitis: critical evaluation of therapeutic trialsInflamm Bowel Dis20061297999417012969  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]
  52. SandbornWJBosworthBZakkoSBudesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditisGastroenterology2015148740750.e225644096  [Crossref] [PubMed] [Web of Science ®], [Google Scholar]

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Kalyani Kunte
Corresponding author

Late Bhagirathi Yashwant Rao college of pharmacy, Pathri Aurangabad

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Manisha B. Parhad
Co-author

Late Bhagirathi Yashwant Rao college of pharmacy, Pathri Aurangabad

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Gajanan Sanap
Co-author

Late Bhagirathi Yashwant Rao college of pharmacy, Pathri Aurangabad

Kalyani R. Kunte, Manisha B. Parhad, Gajanan S. Sanap, Rectal Budesonide Formulations In Active Ulcerative Proctosigmoidities, Efficacy, Tolerance And Treatment Approach, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 12, 719-734. https://doi.org/10.5281/zenodo.10426646

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