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العنوان
In Vitro Release of Levonorgestrel from a new form of Levonorgestrel Releasing Intrauterine Devices ”Metraplant-E”\
المؤلف
Ibrahem,Mahmoud Saeed
هيئة الاعداد
باحث / محمود سعيد ابراهيم
مشرف / مـحمد عزالدين علي عزام
مشرف / محمد أسامة طه
الموضوع
Metraplant-E- Levonorgestrel -
تاريخ النشر
2014
عدد الصفحات
284.p:
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
أمراض النساء والتوليد
تاريخ الإجازة
1/1/2014
مكان الإجازة
جامعة عين شمس - كلية الطب - Obstetrics & Gynecology
الفهرس
Only 14 pages are availabe for public view

from 284

from 284

Abstract

Progesterone is a key hormone in regulating the female reproductive system, interacting at the level of the hypothalamus, the ovary, the uterus and the breast. Progesterone exerts effects on ovulation, endometrial differentiation, cervical mucus, breast differentiation and uterine contractility.
Progestins are available in a variety of formulations. Intrauterine delivery of progestin is an effective way to administer local treatment and bypass systemic side effects. Intrauterine drug delivery has the potential to treat many gynecologic conditions.
The levonorgestrel-releasing intrauterine system (LNG-IUS) is a safe, effective and acceptable form of contraception used worldwide. It also has a variety of noncontraceptive benefits including treatment for menorrhagia, endometriosis, and endometrial hyperplasia. The LNG-IUS has also been used in combination with estrogen for hormone replacement therapy and as an alternative to hysterectomy. Overall, the system is very well tolerated and patient satisfaction is quite high when proper education regarding possible side effects is provided. However, despite all of the obvious benefits of the LNG-IUS, utilization rates remain quite low in the developed countries, especially in the United States, because clinicians lack knowledge and skills and because the only current delivery system (Mirena®; Bayer HealthCare) is unavailable or costly in many countries.
Metraplant-E, which is used in this study, is a modified levonorgesrel-releasing intrauterine system from the old IUD “Metraplant”, modified by Azzam 2013, Metraplant-E design has a T-shaped frame containing Levonorgestrel and Ethylene Vinyl Acetate (EVA) as well as Barium Sulphate to make it radio-opaque, All the ”T” frame, the bulb of 20 mm length and sleeves contain: EVA, Levonorgestrel and Barium Sulphate. i.e. the whole system is containing Levonorgestrel which is different from either Mirena or Metraplant, which ensures more exposure of the endometrial surface to the system and hence expected more endometrial suppresion.
It consists of Levonorgestrel Hormone (60 mg), EVA ”Ethylene Vinyl Acetate” (120 mg) & Barium Sulphate (20 mg).
The FDA has approved EVA for use in humans for implanted and topical devices. EVA based devices are designed to slowly release drug compounds over a relatively long period of time.
Metraplant-E is designed without any coat membrane as in Mirena, which will help in more rise in Levonorgestrel level (higher initial release). The high initial release of LNG (reached more than 28µg/24H in Metraplant-E in this study of in-vitro release) may help in early stoppage of Bleeding in patients who suffer from menorrhagia. It’s also designed release rate more than 20µg/24H. that may allow it to be used as a contraceptive for more 5 years, furthermore the higher initial release just post application, may be benefit if used to treat Menorrhagia.
Another unique property of “Metraplant-E” & “Metraplant” that they’re the only LNG-IUS which have LNG in all parts of the system (vertical stem & horizontal sleeves). In Metraplant, there are 3 reservoirs for hormone one large reservoir on the vertical stem & 2 small reservoirs on the horizontal limbs. And in Metraplant-E, the whole body of the IUS made of both EVA & LNG. This point was a subject of interest during the early trials for studying the efficacy of the copper IUDs, Hence the Copper was included in the vertical stem and in the horizontal arms to provide a copper surface close to the uterine fundus.
The aim of this work was to study the In-Vitro release rate of Levonorgestrel from a new form of Levonorgestrel releasing device “Metraplant-E”, and to extract the hormone to evaluate its Levonorgestrel content.