Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Intrauterine delivery system

A delivery system, uterine technology, applied in the field of improved intrauterine delivery system

Inactive Publication Date: 2016-06-01
BAYER AG
View PDF11 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Although Mizuki The contraceptive effect of levonorgestrel is mainly the result of local action, but the rather high systemic stability of levonorgestrel leads to Mirena It was also shown that the average plasma concentration of the active ingredient was approximately 206 pg / ml 1
Although this value is lower than that of orally administered levonorgestrel-containing contraceptives, it is still high enough to suppress ovulation in about 20% of users within the first year of use and to be able to cause known systemic adverse effects Reactions, such as acne, depressed mood, chest pain, or loss of libido 2
[0005] However, irregularity in the pattern of vaginal bleeding is the most common clinical side effect during the first few months of using an IUS or IUD (intrauterine delivery device) 3 , 4

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Intrauterine delivery system
  • Intrauterine delivery system
  • Intrauterine delivery system

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] Core preparation:

[0054] In an internal mixer, 65 parts by weight of 18-methyl-15β, 16β-methylene-19-nor-20-spiro-4-en-3-one and 35 parts by weight of poly(dimethyl Silicone) elastomer blend. The poly(dimethylsiloxane) elastomer used for the drug reservoir portion is a silicone-based filler-free PDMS (dimethylvinyl-terminated poly[dimethyl-co-methylvinyl]silicone Oxane) material crosslinked by a hydrosilylation reaction using platinum as a catalyst and poly(dimethyl-co-methylhydrogensiloxane) as a crosslinking agent. The drug-containing mixture was extruded into a tubular form with a wall thickness of 0.8 mm and an outer diameter of 2.8 mm, and heat cured while crosslinking occurred. The cross-linked cores were cut into lengths of 5 and 8 mm.

[0055] Preparation of the membrane of the "slower release" part (reservoir 2):

[0056] The elastomers used in the film were two silicone elastomers containing silica fillers - PDMS (Dimethylvinyl-terminated poly[dimethyl-c...

Embodiment 2

[0061] Embodiment 2: drug release test

[0062] method:

[0063] The release rate of drug from the IUS was measured in vitro as follows:

[0064] The intrauterine delivery system was secured in a longitudinal orientation in a stainless steel holder, and the holder and device were placed together in a glass vial containing 75 ml of dissolution medium. The glass vials were shaken in a shaking water bath at 37°C, 70 strokes / minute. The dissolution medium was withdrawn and replaced with fresh dissolution medium at predetermined time intervals and analyzed for the amount of released drug using standard HPLC methods. The concentration of the dissolution medium and the timing of changing (withdrawing and replacing) the medium are chosen to maintain sink conditions during the test.

[0065] Results: The release rates obtained from the individual fractions and the combined system were in Figure 1 / 7 shown in . It can be seen that the rate of release from the reservoir containing...

Embodiment 3

[0069] Comparative study in monkeys: Vehicle vs 2, 5 μg / day LNG vs 2, 5 μg / day NP Method:

[0070] Animal Handling: Adult non-pregnant cynomolgus monkeys were monitored for regular menstrual cycles. Uterine bleeding was assessed daily by vaginal swab (for occasional vaginal spotting) and menstrual blood loss by vaginal plug. After 2 menstrual cycles (~60 days), animals were divided into treatment groups, laparotomy was performed on days 6-8 (ideally day 7) of the follicular phase, an IUS was inserted into the uterine cavity via hysterotomy and original A bit of stitching. IUS treatment was as follows (n=5-6 / group):

[0071] Group 1: Vehicle IUS

[0072] Group 2: 2 μg / day LNG

[0073] Group 3: 5 μg / day LNG

[0074] Group 4: 2 μg / day NP

[0075] Group 5: 5 μg / day NP

[0076] Grading of Bleeding: Bleeding is classified into three grades: a) positive swab or frankenses, which is the most severe form of bleeding (BB, red), b) mildly positive swab, which is a moderate type of...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
Thicknessaaaaaaaaaa
Outer diameteraaaaaaaaaa
Lengthaaaaaaaaaa
Login to View More

Abstract

The present invention relates to an improved method of contraception which addresses the problems of initial bleeding and spotting associated with the use of intrauterine delivery systems, and to an improved intrauterine delivery system.

Description

technical field [0001] The present invention relates to an improved method of contraception which addresses the problems of incipient bleeding and spotting associated with the use of intrauterine delivery systems and to an improved intrauterine delivery system. Background technique [0002] Bleeding disorders are among the most frequently occurring gynecological problems. The causes of bleeding disorders, and especially their frequency, vary with the age of the affected woman. It has been shown that the levonogestrel intrauterine release system (LNG-IUS, such as Mirena ) itself is effective in the treatment of severe menstrual blood loss. In particular, this product is described in EP0652738B1 and EP0652737B1. [0003] Manyue is a systemic hormonal contraceptive that provides effective long-term contraception and a fully reversible method with an excellent tolerability record. Levonogestrel (Mirena The local release of the active ingredient in the endometrium) in th...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): A61K9/00A61F6/14A61P15/18A61K31/57A61K31/58
CPCA61K9/0039A61K31/57A61K31/58A61K31/567A61F6/14A61F6/144A61P15/18A61K47/34A61M31/002
Inventor M·阿霍拉C·塔林B·林登塔尔U·福尔曼L·M·费尔斯K·普雷莱N·施梅斯
Owner BAYER AG
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com