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Intravaginal drug delivery devices

A delivery device and vaginal technology, applied in drug delivery, pharmaceutical formulation, medical science, etc., can solve the problems of not having enough solubility, not allowing drug delivery and release, and large volume/weight ratio for rapid diffusion

Active Publication Date: 2012-04-11
APTALIS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The problem arises from relatively hydrophilic drugs that may not have sufficient solubility in the sheath of the intravaginal drug delivery device, and / or whose molecular size / volume / weight is too large for rapid diffusion to allow adequate Drug delivery to device surface and subsequent release

Method used

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  • Intravaginal drug delivery devices
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  • Intravaginal drug delivery devices

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0142] The present invention is not limited by the embodiments described and illustrated in this application, and improvements and modifications may be made without necessarily departing from the scope of the present invention. Thus, for example, it will be obvious to a person skilled in the art that the injection molding technique described in the present application can be replaced in whole or in part by other manufacturing techniques, in particular extrusion techniques, which lead to the same end product.

[0143] General Method of Manufacturing Intravaginal Devices - Examples 1-4

[0144] A hydrophobic elastomeric polymer containing about 25% (w / w) diatomaceous earth filler is provided. 97 parts by weight of this polymer were blended with 2.5 parts by weight of the crosslinker n-propyl orthosilicate (NPOS) to form an elastomeric compound. One suitable hydrophobic elastomeric polymer is a stannous octoate cured polydimethylsiloxane polymer, a suitable example of which is t...

Embodiment 5-8

[0150] A hydrophobic elastomeric polymer (PDMS) containing about 10% (w / w) diatomaceous earth as a filler is provided. 94.24 parts by weight of this polymer were blended with 5.76 parts by weight of the crosslinker n-propyl orthosilicate (NPOS) to form an elastomeric compound. One suitable hydrophobic elastomeric polymer is a stannous octoate cured polydimethylsiloxane polymer, a suitable example of which is the material known as NusilMed 7.6382.

[0151] This elastomeric compound is further blended with the required parts by weight of the desired pharmacologically active agent to form an active depot compound.

[0152] The reservoir of the intravaginal drug delivery device of the present invention is prepared by mixing 200 parts by weight of this active reservoir compound with 1 part by weight of an activated catalyst such as stannous octoate. This mixture can be placed under vacuum to remove air if desired. The obtained reservoir mix was injected into the reservoir mold an...

Embodiment 1

[0177] Embodiment 1 (the influence of number of holes)

[0178] 10% (w / w) metronidazole with 0, 4 or 8 holes on the outer surface of the device, in the form of a "core" structural ring and with a full length (140 mm) was prepared according to the general manufacturing method of Examples 1-4 Intravaginal drug delivery device with reservoir (total drug content ~400 mg metronidazole).

[0179] The effect of pore number on the cumulative release of metronidazole from the loop in vitro is illustrated graphically in figure 2 . An increase in the number of pores resulted in an increase in the daily release rate, eg after 14 days the cumulative amounts released from the 0, 4 and 8 hole rings were 2.5, 6.0 and 10.9 mg, respectively.

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Abstract

The present invention is one intravaginal medicine transferring unit, which includes at least one storing room containing at least one kind of pharmaceutically active agent dispersed in carrier system and sheath covering the storing room non-continuously for exposing at least one part of the storing room in use in the vaginal environment. Preferably, the sheath defines one or several holes or openings extending to the storing room for exposing at least one part of the storing room in use in the vaginal environment.

Description

technical field [0001] The present invention relates to intravaginal drug delivery devices for administering pharmacologically active agents to females of human or animal species. Background technique [0002] Although the following description refers primarily to intravaginal rings (IVRs), applicants intend that the term "intravaginal drug delivery device" shall include all device configurations such as, but not limited to, other fully or partially ring-shaped devices, and oval rings. Circular or cylindrical, rectilinear or substantially rectilinear devices. [0003] International Patent Publication WO 01 / 70154 discloses an improved "core" ring structure in which there is an open pore extending from the surface into the ring, and then an active agent-loaded core is inserted into the open pore, and subsequently, the developed pore ends, or each end is sealed with a cap. Thus, in this improved "core" construction, the core is completely sealed in use by the outer sheath. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00
CPCA61K9/0036
Inventor 卡尔·马尔科姆戴维·伍尔夫森
Owner APTALIS PHARMA
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