Intravaginal drug delivery devices for the delivery of macromolecules and water-soluble drugs

A delivery device and water-soluble technology, applied in drug delivery, drug devices, microorganisms, etc., can solve problems such as inappropriate drug therapy

Inactive Publication Date: 2010-09-08
WARNER CHILCOTT CO LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is inappropriate for many drug therapies

Method used

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  • Intravaginal drug delivery devices for the delivery of macromolecules and water-soluble drugs
  • Intravaginal drug delivery devices for the delivery of macromolecules and water-soluble drugs
  • Intravaginal drug delivery devices for the delivery of macromolecules and water-soluble drugs

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-3

[0080] The silicone elastomer base MED-6382 is mixed with the cross-linking agent tetrapropyl orthosilicate at a ratio of 40:1. Add tin octoate catalyst (0.5%, w / w), and the mixture is injected into a specially designed vaginal ring mould. The mixture was cured at 80°C for 2 minutes to produce a silicone elastic vaginal ring containing 1 or 3 channels, which had the following dimensions: 7.6 mm cross-sectional diameter, 43.0 mm inner diameter, 58.0 mm outer diameter and 3.0 mm channel insert diameter.

[0081] The DAC 150 FVZ-K Speedmixer mixes the desired content of the drug with the appropriate silicone elastomer at 3000 rpm for 30 seconds to manufacture the drug-loaded silicone rod. The mixture was then injected into a 3mm diameter PVC pipe and cured at room temperature for 24 hours. Cut the PVC pipe to the desired length, and then use a scalpel to carefully remove the PVC shell from the cured silicone elastomer stick. Protocol for in vitro release studies-Examples 1-3

[008...

Embodiment 1

[0084] Those skilled in the art will easily understand that the release rate and release amount demonstrated in the following examples are not restrictive, and can be manipulated to change the water solubility of the insert by, for example, changing the loading amount of the drug substance in the insert The loading and / or type of release enhancer, and / or changing the size of the insert, or a combination of some or all of these parameters, to change the release rate and / or the release amount as required. Example 1 Sustained release of bovine serum albumin from intravaginal drug delivery device

[0085] The silicone elastomer vaginal ring containing a single channel is manufactured according to the general method as described above. According to the general method as described above, it also produced 1.0% w / w BSA, 20.0% w / w water-soluble release enhancer (glycine, glucose, PVP or PEG 3400) and 79.0% w / w LSR-9-9508- 30 Silicone Elastomer (Dow Corning) silicone elastomer insert, whi...

Embodiment 2

25 182.78

28 188.48

[0089] The drug delivery device was placed in a sample vial with 10ml sterile water; the vial was capped and placed in a 37°C orbital (60rpm) shaking incubator (Unitron HTInfors). Sampling was performed daily for 14 days with completely replaced release medium (sterile water), followed by sampling / replacement twice a week for another 2 weeks. A rod-shaped drug delivery device with a single drug-containing insert therein was used in the dissolution studies conducted in Examples 4-6. If loaded with wool poppy, the rod-shaped insert of BSA or 2F5 is in situ in the body of the ring device, this drug delivery device is an accurate representative of the expected release profile, that is, the drug will only be removed from the drug delivery device. The two open ends are released. Example 4 The effect of the type and concentration of the water-soluble release enhancer on the release of lanolin.

[0090] The silicone elastomer LSR9-9508-30 was provided by NuSil ...

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PUM

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Abstract

An intravaginal drug delivery device comprises a device body comprising a hydrophobic carrier material having at least one channel defining at least one opening to the exterior of said device body, said at least one channel being adapted to receive at least one drug-containing insert; at least one drug-containing insert positioned in said at least one channel, said drug-containing insert capable of releasing a pharmaceutically effective amount of at least one drug suitable for intravaginal administration and containing about 1% to about 70% of at least one water-soluble release enhancer, both the drug and the water-soluble release enhancer dispersed in an insert carrier material; wherein said hydrophobic carrier material and said insert carrier material may be the same or different; and wherein said at least one drug-containing insert is exposed on said exterior of said device body when said intravaginal drug delivery device is in use.

Description

Background of the invention [0001] The present invention relates to an intravaginal drug delivery device for administering pharmaceutically active water-soluble drugs or macromolecular agents to female humans or animals. [0002] Related background technology [0003] Annular devices for the controlled administration of drug substances to the vagina are known in the art. Several such products are already commercially available, such as with Each of them provides controlled and sustained release of steroid molecules (essentially water-insoluble drugs) within a few days. [0004] One type of vaginal ring is the reservoir ring, which includes a core of polymeric material loaded with a drug substance that is completely surrounded by a non-drug shell. Therefore, the release of the drug substance from this ring relies on the outer shell of the nucleus loaded with the drug substance to penetrate (ie, molecular dissolution and subsequent dispersion). So far, the polymeric materials used ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K38/00A61K39/00A61K48/00
CPCA61K2039/541C07K16/1063A61K31/00A61K9/0036A61K39/21C12N2740/16122C12N2740/16034C07K14/005A61K31/185A61K39/395A61K45/06A61K47/24A61K47/34A61M31/002A61K39/12A61P31/18
Inventor A·D·伍尔弗森K·马尔科姆
Owner WARNER CHILCOTT CO LLC
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