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 Vaginal sponge delivery system

Details
Inventors: Myhling, John;
Assignee: Gynetech Laboratories, Ltd. (New York, NY)
Primary Examiner: Azpuru; Carlos
Assistant Examiner:
Attorney, Agent or Firm: Levisohn, Lerner, Berger and Langsam

A product for the administration of an active pharmaceutical agent via the vaginal canal comprising: (a) a sealed, air-tight package, enclosing therein; (b) a sponge impregnated with a liquid containing an effective amount of an active pharmaceutical agent, said liquid being present in an amount greater than that which is blocked within said sponge but less than the saturation value of said sponge such that when said sponge is inserted in the vaginal canal it will release liquid therefrom.

DETAILED DESCRIPTION These and other objects of the invention are achieved in a product which broadly comprises (a) a sealed, air-tight package, enclosing therein (b) a sponge impregnated with the liquid containing an effective amount of an active pharmaceutical agent, the liquid being present in an amount greater than that which is blocked within said sponge, but less than the saturation value of the sponge so that when the sponge is implanted in the vaginal canal it will release liquid therefrom.
Thus, the present invention now provides a removable, premoistened vaginal sponge impregnated with a solution containing a carrier and an active pharmaceutical agent.
The sponge contains both an amount of solution that is tightly held by the sponge, i.
e.
blocked therein, and a freely releasable amount of solution that is released upon mechanical deflection, i.
e.
squeezing of the sponge.
As used in the specification and claims of this application, the terms "releasable" or "freely releasable" or "mechanically releasable" are used interchangeably and mean an amount of liquid that can be expelled from the sponge by simple compression or squeezing of the sponge.
The term "tightly bound" or "blocked" means an amount of liquid retained by the sponge even when compressed and which is only removable from the sponge by some type of non-mechanical means, such as evaporation.
The term "saturation value" means the maximum amount of liquid that can be held by the sponge.
A saturated sponge will release liquid immediately upon being squeezed.
According to one embodiment of the invention there is provided a vaginal device comprising a hermetically sealed air tight package enclosing therein a sponge impregnated with a liquid containing an active pharmaceutical agent, the amount of liquid being sufficient to provide a reservoir of the liquid while the sponge is in place in the vagina.
The sponge contains a mechanically releasable amount of liquid containing an active pharmaceutical agent and that releasable amount of liquid may contain or itself may comprise a prescribed unit dosage for a specific window of therapy or half-life drug metabolism



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