Foam Preparations for the Treatment of Ulcerative Colitis

Abstract

Patients with ulcerative colitis uniformly have disease involving the distal colon. When patients have disease limited to the left colon or symptoms suggestive of active rectal inflammation, guidelines recommend topical rectal therapies as first-line agents either as monotherapy or in conjunction with oral products. Rectal delivery modalities offer the advantage of delivering high local concentrations of active medication to the site of maximal inflammation with minimization of systemic side effects. Methods of rectal administration include suppositories, liquid enemas and foams. Suppositories are limited to the treatment of rectal disease, and patients often have difficulty retaining the liquid enema secondary to its high volume and consistency. Rectal foams reliability extend to the descending and sigmoid colon with application. Foams are further characterized by increased viscosity, lower volumes, finer dispersion on the colonic mucosa, and increased adhesiveness to the colonic mucosa compared with liquid enemas. Additionally, rectal foam agents demonstrate equal efficacy to their liquid enema counterparts yet consistently yield better patient tolerance, lower incidence of side effects, and increased patient acceptability. Currently available agents include 5-aminosalicylic acid and corticosteroids, both first and newer generation. This review focuses on clinical trials assessing efficacy, tolerability, and patient preferences for these agents as well as describing the currently available rectal foam products.

Rectal hyposensitivity for non-noxious stimuli, postprandial hypersensitivity and its correlation with symptoms in complete spinal cord injury with neurogenic bowel dysfunction

“…It is reported that rectal delivery modalities offer the advantage of delivering high local concentrations of active medication with minimization of systemic side effects. 28 So, in light of our findings rectal delivery modalities should be consider more when prescribing drug therapy in patients with SCI.…”

“…Topical rectal therapies as first-line agents are at present recommended in patients with disease limited to the left colon or with active rectal inflammation. 28 Methods of rectal administration include suppositories, liquid enemas, and foams. It is reported that rectal delivery modalities offer the advantage of delivering high local concentrations of active medication with minimization of systemic side effects.…”

Physiological and Pharmaceutical Considerations for Rectal Drug Formulations

“…Drugs given by this route are typically formulated in solid dosage forms (e.g., suppositories) or in liquid/semi-liquid dosage forms (e.g., enemas and foams). In general, foams and suppositories are retained mainly in the rectum and sigmoid colon, while enema solutions have a greater spreading capacity (van Hoogdalem et al, 1991; Brown et al, 1997; Loew and Siegel, 2012). Enemas are able to spread over an area situated between the rectum and the splenic flexure, which is the sharp bend between the transverse colon and the descending colon (van Hoogdalem et al, 1991; Brown et al, 1997).…”

“…The molecules contain hydrophilic components that are soluble in the aqueous phase and hydrophobic components that form micelles to minimize contact with the aqueous phase (Arzhavitina and Steckel, 2010). Rectal foams are mostly aerosol foams that are formulated to treat anorectal inflammation (e.g., hemorrhoids and anal fissures) and distal proctocolitis (e.g., distal ulcerative colitis) (Campieri et al, 1992; Lee et al, 1996; Arzhavitina and Steckel, 2010; Loew and Siegel, 2012; Sandborn et al, 2015). The advantages of foams for rectal drug delivery include convenient administration with minimal discomfort and leakage.…”

Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis

“…Rectal therapies include suppositories, enemas, or foam preparations. Suppositories are not only difficult for some patients to administer [ 11 ], but the use of suppositories is restricted by their limited proximal distribution within the rectum [ 12 ], in contrast to foam preparations, which can spread to the descending colon [ 13 ]. Foam preparations provide greater retention and more uniform distribution within the distal colon and rectum compared with enema preparations [ 14 – 16 ].…”