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Intravaginal rings with insertable drug-containing core

A vaginal ring and drug core technology, applied in the field of intravaginal drug delivery device and vaginal drug delivery

Inactive Publication Date: 2004-06-23
THE POPULATION COUNCIL INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It also limits elastomer options when dealing with active drugs such as ethinyl estradiol

Method used

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  • Intravaginal rings with insertable drug-containing core
  • Intravaginal rings with insertable drug-containing core
  • Intravaginal rings with insertable drug-containing core

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Examples of burst effects and storage condition effects

[0054] Prepared with room temperature vulcanizable polydimethylsiloxane image 3 A vaginal ring that is medium but contains only one core. Stannous octoate (2-ethylhexanoate) was used as a catalyst to cause sulfidation. The annulus has dimensions of 56 mm overall diameter and 9 mm cross-sectional diameter. The core was made from the same polymer mixed with ethinyl estradiol, the steroid concentration in the core was 7%. The core size is 2.2 x 20mm.

[0055] The vaginal rings were prepared in a two-step process, with the core in the center of the first half-ring, and the rings were then coated with polydimethylsiloxane to complete the rings. As shown in Table 1, the release rate was determined in vitro after storage to make Image 6 . At each time with temperature, 4 rings were measured.

[0056] Table 1

[0057] In vitro release rate of ethinyl estradiol during stora...

Embodiment 2

[0072] Example of using the intravaginal drug delivery device of the present invention to avoid sudden release of steroids

[0073] A vaginal ring of the present invention was prepared with 2 grooves. The ring has an overall diameter of 56mm and a cross-sectional diameter of 8.4mm. The elastomer used in the molded ring was a platinum catalyzed dimethylsiloxane / methylvinylsiloxane copolymer manufactured by Applied Silicone Corp. of Ventura, CA. This elastomer, called LSR 25-10:1, was packaged in two parts and mixed together in a 10:1 ratio to cause the vulcanization reaction.

[0074] The mixture is poured into a mold with movable steel rods to create slots for inserting the core. Vulcanization was carried out at 105°C for 30 minutes. The core was made by mixing the steroid with room temperature curable polydimethylsiloxane (MED6382 from Nusil Silicone Technology of Carpinteria, CA.). Two cores are prepared and inserted into each ring. Each is 3×15mm. A 50% NESTORONE TM ...

Embodiment 3

[0076] Example of Avoiding Sudden Release of Steroids Using the Invention

[0077] The vaginal rings of the present invention are prepared using a platinum catalyzed dimethylsiloxane / methylvinylsiloxane copolymer called LSR 25-10:1 manufactured by Applied Silicone Corp. of Ventura, CA. The ring has an overall diameter of 56mm and a cross-sectional diameter of 8.4mm. The two parts of the elastomeric composition were mixed together in a ratio of 10:1 and poured into a mold with movable steel rods to create grooves for inserting the cores. Heating at 105°C for 30 minutes for vulcanization. Combining ethinyl estradiol and NESTORONE TM The core was made by mixing with stannous octoate catalyzed polydimethylsiloxane (R-2602 manufactured by Nusil Silicone Technology of Carpinteria, CA). The core contains 12% ethinyl estradiol and 40% NESTORONE TM . The core has a diameter of 3mm and a length of 15mm or 20mm. The groove in the ring was partially filled with polydimethylsiloxane ...

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Abstract

Disclosed is a vaginal ring containing a ring body made of a first polymeric material having at least one hollow internal channel defining an opening to the exterior of said body and which channel is adapted to receive a drug-containing core through said opening, and a core containing at least one intravaginally administerable drug dispersed in a second polymeric material disposed in the channel. The core is positioned in the vaginal ring body suitably prior to use in order to substantially avoid initial bursts of drug into the tissues of the subject and resultant side effects such as nausea and vomiting. Representative drugs include contraceptive agents and other steroidal substances for use in hormone replacement therapy. Also disclosed are methods for preparing the vaginal rings, kits for assembling the vaginal rings, and methods of using the vaginal rings to achieve intravaginal delivery of drugs to a female.

Description

technical field [0001] The present invention relates to intravaginal drug delivery devices and methods of vaginal drug delivery, and more particularly to vaginal delivery of contraceptive drugs and hormone replacement therapy agents. Background technique [0002] Vaginal rings are convex-shaped devices designed to deliver a relatively constant dose of medication into the vagina, typically over weeks to months. They are typically made of silicone elastomers and contain the drug released by diffusion through the elastomer. The most common commercial application is the delivery of low-dose steroids in the vaginal setting of menopause. They have, in turn, been used in contraception and hormone replacement therapy. Vaginal rings are also used to deliver spermicides and various locally or systemically active drugs. Vaginal rings offer several advantages: their use is controlled by the woman; they allow for better adjustment of drug doses without the user's awareness; and they a...

Claims

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Application Information

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IPC IPC(8): A61F6/14A61F6/08A61K9/00
CPCA61K9/0036A61F6/08
Inventor S·I·萨利赫H·纳什C·W·巴丁T·哈蒙
Owner THE POPULATION COUNCIL INC
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