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Publication Number
US-11717477-B2
Publication Date
2023-08-08
Expiration Date
Abstract
The present invention relates to a therapeutically active compound for the treatment of a medical condition, wherein the therapeutically active compound is administered in liquid formulation via the vagina by using an intravaginal ring. The present invention further relates to a therapeutically active compound selected from the group consisting of oxybutynin and other anti-muscarinic compounds, gonadotropin-releasing hormone (GnRH) and derivatives, both agonists and antagonists, nitroglycerin and other directly or indirectly acting cGMP enhancers, buprenorphine and other agonistic, antagonistic or partial (ant)agonistic opioids, nicotine and derivatives, lorazepam and other benzodiazepines, insulin and other blood glucose regulating compounds, FSH and other hormones for ovulation stimulation, pramipexol and other dopamine agonists, oxytocin and other hypothalamic peptides for the treatment of a medical condition, wherein the therapeutically active compound is administered in liquid formulation via the vagina by using an intravaginal ring.
Core Innovation
The invention relates to systemic vaginal administration of a therapeutically active compound using an intravaginal ring that provides a detectable level in blood or plasma in 1 hour or less. The intravaginal ring administers the therapeutically active compound in liquid formulation via the vagina to treat a medical condition, with the aim of rapid systemic absorption. The ring is configured to include reservoir functionality and delivery structure such that blood or plasma levels become detectable quickly after administration.
Structurally, the intravaginal ring includes rigid members and flexible members with at least partial elasticity that allow insertion and functional positioning. The ring can be squeezed from an extended shape to a collapsed shape for allowing insertion into a vagina of a user, and the device is pre-biased to assume an extended substantially oval or annular ring shape when little to no external force is being applied. The device assumes a shape substantially corresponding to the extended shape when placed and released at or near the fornix posterior vaginae of a user, enabling the liquid-formulation delivery system to be positioned for systemic delivery.
The delivery system includes a reservoir holding the therapeutically active compound to be delivered, an opening, and a pump for pumping the therapeutically active compound out of the opening. The ring further includes a diagnostic mechanism for performing an intravaginal diagnosis or measurement therefor. The document also describes example compounds and blood or plasma pharmacokinetics, including fast absorption outcomes in Beagle dogs, supporting the claimed rapid detectable blood or plasma level within the specified time window.
Claims Coverage
The independent claim coverage centers on a method of administering a therapeutically active compound via an intravaginal ring that provides a detectable blood or plasma level in 1 hour or less, with ring structure for squeeze insertion and return to an extended shape near the posterior fornix, reservoir and pump delivery, and an intravaginal diagnostic mechanism. One independent claim is provided in the partial content.
Detectable systemic delivery via vaginal intravaginal ring within 1 hour
Administering the therapeutically active compound in liquid formulation via the vagina by using an intravaginal ring configured to provide a detectable level in blood or plasma in 1 hour or less to treat a medical condition.
Rigid-flexible at least partially elastic ring for squeeze insertion and posterior fornix positioning
An intravaginal ring comprising rigid members and flexible members, wherein at least one flexible member is at least partially elastic so the ring can be squeezed from an extended shape to a collapsed shape for insertion, pre-biased to assume an extended substantially oval or annular shape, and assume a shape corresponding to the extended shape when placed and released at or near the fornix posterior vaginae of a user.
Reservoir and pump liquid formulation delivery with diagnostic intravaginal mechanism
A reservoir holding the therapeutically active compound to be delivered, an opening, and a pump for pumping the therapeutically active compound out of said opening, together with a diagnostic mechanism for performing an intravaginal diagnosis or measurement therefor.
The claim set focuses on rapid systemic delivery through a vaginal intravaginal ring with an at least partially elastic rigid-flexible structure, combined with reservoir-and-pump liquid delivery and an intravaginal diagnostic mechanism.
Stated Advantages
Provides a detectable level in blood or plasma in 1 hour or less.
Allows delivery of a therapeutically active compound in liquid formulation via the vagina using a configurable intravaginal ring.
Documented Applications
Treatment of a medical condition using the claimed method of administering a therapeutically active compound in liquid formulation via the vagina with an intravaginal ring.
Overactive bladder (OAB) using oxybutynin.
Infertility using a GnRH compound.
Parkinson's disease and restless legs, and hyperprolactinemie, using pramipexole.
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