Role of rectal formulations: suppositories.

Area of Science:

• Gastroenterology
• Pharmacology

Background:

• Distal proctitis and idiopathic ulcerative proctitis require effective topical treatments.
• Mesalazine (5-aminosalicylic acid) is a key therapeutic agent for inflammatory bowel diseases.

Purpose of the Study:

• To evaluate the safety, efficacy, and retention of mesalazine suppositories in patients with active distal proctitis.
• To compare mesalazine suppositories with other treatments for distal ulcerative proctitis and related conditions.

Main Methods:

• Technetium-99m labeling to assess rectal coverage of mesalazine suppositories.
• Clinical assessment of healing, symptom resolution, and patient tolerance.
• Comparison of maintenance therapy efficacy with oral sulphasalazine.

Main Results:

• Mesalazine suppositories are safe, well-tolerated, and well-retained, achieving high healing rates (85% in 4 weeks, 100% in 10 weeks) in idiopathic ulcerative proctitis.
• Suppositories cover the distal 20 cm of the rectum.
• Maintenance therapy with mesalazine suppositories is as effective as oral sulphasalazine and shows utility in rectal Crohn's disease and solitary rectal ulcer syndrome.

Conclusions:

• Mesalazine suppositories are a highly effective and well-tolerated first-line treatment for active distal proctitis, especially idiopathic ulcerative proctitis.
• They provide excellent rectal coverage and are a viable maintenance therapy option.
• Mesalazine suppositories are also a useful adjunct in managing rectal Crohn's disease and solitary rectal ulcer syndrome.