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Publication Number
US-11458112-B2
Publication Date
2022-10-04
Expiration Date
Abstract
Methods, pharmaceutical formulations, and kits are provided for using capsaicin to effectuate voluntary defecation in mammals who cannot defecate without external invasion of the bowel or those who defecate involuntarily (i.e., those having fecal incontinence). The pharmaceutical formulations and kits can also be useful for inducing defecation in mammals that do not have defecation dysfunction such as, for example, in a person who is unconscious and may defecate unconsciously or in a pet at a convenient location at a specific time. The methods and compositions provide patients with defecation dysfunction control over when and where they defecate.
Core Innovation
The invention relates to capsaicin-based induction of defecation and treatment of defecation dysfunction in a mammal. The method administers capsaicin or a pharmaceutically acceptable salt thereof as an active agent, wherein inducing defecation or treating defecation dysfunction is performed by rectal administration, and capsaicin is the only active agent administered for inducing defecation. The patent frames the approach as intended to address conditions including fecal incontinence, constipation, and situations where a subject cannot voluntarily defecate.
The core concept is that rectal administration of capsaicin provides a rapid-onset, short duration of action with localized effects. The patent links the defecation response to rectal pressure and defecation outcomes, and describes timing relationships between rectal capsaicin administration and subsequent defecation. Embodiments include administration within about 0 to about 30 minutes before desired defecation and, in other embodiments, about 0 to about 10 minutes before desired defecation.
The disclosed treatment is further characterized as capable of inducing voluntary defecation, including an as-needed or on-demand basis dosing concept. The patent provides embodiments for pharmaceutical formulations including capsaicin and carriers, and also describes packaged kits for rectal administration. Documented examples include effects of intrarectal capsaicin on rectal pressure, expulsion of rectal contents, and inducing defecation in conscious chronic spinal cord injury animals within a defined early time window.
Claims Coverage
The patent includes three independent claims. Across the independent claims, the coverage is centered on rectal administration of capsaicin as the only active agent for inducing defecation or treating defecation dysfunction/fecal incontinence, with optional refinement via as-needed/on-demand use and pre-defecation timing windows, and in certain embodiments use of a rectal suppository and specific mammal species.
Rectal administration of capsaicin as the only active agent to induce defecation
Administering to a mammal a therapeutically effective amount of capsaicin or a pharmaceutically acceptable salt thereof as an active agent for inducing defecation, wherein the administering is rectal and capsaicin is the only active agent administered for inducing defecation.
Rectal administration of capsaicin as the only active agent to treat defecation dysfunction
Administering to the mammal a therapeutically effective amount of capsaicin or a pharmaceutically acceptable salt thereof as an active agent for treating defecation dysfunction, wherein the administering is rectal and capsaicin is the only active agent administered for treating defecation dysfunction.
Rectal administration of capsaicin as the only active agent for as-needed voluntary defecation in fecal incontinence
Administering to the mammal a therapeutically effective amount of capsaicin or a pharmaceutically acceptable salt thereof as an active agent for treating fecal incontinence by inducing voluntary defecation, wherein the administering is rectal and capsaicin is the only active agent administered for treating fecal incontinence, to induce the as-needed voluntary defecation.
The independent claims collectively define a rectal-capsaicin-only treatment paradigm where capsaicin, or a pharmaceutically acceptable salt, is the only active agent and is used to induce defecation directly or to treat defecation dysfunction and fecal incontinence by inducing voluntary, as-needed defecation. Additional claim coverage focuses on as-needed basis administration, rectal dosage form selection, timing windows relative to desired defecation, and limiting subjects to specific mammal species.
Stated Advantages
Rapid-onset, short duration of local action with reduced systemic exposure.
Potential suitability for patients such as those with spinal cord injury.
Documented Applications
Inducing defecation in mammals, including mammals with defecation dysfunction such as fecal incontinence and constipation, and situations where voluntary defecation cannot occur.
Treating defecation dysfunction in mammals in need of treatment by rectal administration of capsaicin as the only active agent.
Treating fecal incontinence in a mammal by inducing voluntary defecation on an as-needed basis using rectal capsaicin.
Use of rectal formulations and packaged kits for rectal administration, including embodiments with pharmaceutical formulations containing capsaicin and carriers and kits including containers and administration instructions.
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