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Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis

A drug and solid technology, applied in the field of solid drug formulations for the treatment of endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis, can solve problems such as adenomyosis

Pending Publication Date: 2020-06-05
ABBVIE INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some studies also suggest that women who have previously undergone uterine surgery may be at risk for adenomyosis

Method used

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  • Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis
  • Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis
  • Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome and adenomyosis

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0190] The preparation of the melt can be carried out in various ways. The mixing of the components can take place before, during or after the formation of the melt. For example, the components may be mixed and then melted, or mixed and melted simultaneously. The melt can also be homogenized in order to efficiently disperse the active ingredient. In addition, it may be expedient to melt the polymer first and then mix it into the active ingredient and homogenize it. Various additives may also be included in the melt, such as pH adjusters, glidants, disintegrants and / or fillers.

[0191] In certain embodiments, the solidified melt processed product is further ground, ground or otherwise reduced to particles. In some such embodiments, the melt processed product and each particle manufactured comprises a solid dispersion comprising the active ingredient and a pharmaceutically acceptable meltable binder. In some such embodiments, the melt processed product and each particle man...

example 1

[0212] Example 1: Formulations F1 and F2

[0213] Table 3 provides additional non-limiting examples of components of the disclosed formulations and the weight percent (w / w) of these components in the formulations. Compound A mentioned in the table below is the Compound A sodium salt and the corresponding weight percentages are provided in the salt form.

[0214] Table 3: Composition of formulations F1 and F2

[0215]

[0216] a Percentages given based on the weight of the uncoated tablet. Total percentages may not be 100% due to rounding.

[0217] Formulation F2 was tested for dissolution in 900 mL of pH 6.8 sodium phosphate using USP Apparatus II at 37°C and 50 rpm paddle speed. The dissolution profile of the formulation F2 tablet is shown in figure 2 middle.

example 2

[0218] Example 2: Study on the effect of anti-gelling agents on chemical stability

[0219] In order to study the impact of anti-gelling agent (pH regulator) on the chemical stability of compound A in the formulation, the preparation containing different compound A and anti-gelling agent sodium carbonate ratio is as follows:

[0220] Table 4. Composition of Exemplary Formulations

[0221]

[0222] 95 g of compound A, 9.5 g of anhydrous sodium carbonate, 7.66 g of polyethylene glycol 3350 and 7.66 g of crospovidone were weighed and pre-blended. After sieving through a 30 mesh screen, 1.6 g of silicon dioxide was added to the powder mixture and blended for an additional 5 minutes. Using Thermo Scientific TMPharma 11 twin screw extruder, melt granulation of the powder blend at 200-600mg / hr and 123-124°C with a screw speed of 400rpm. Granules were obtained by milling the off-white opaque extrudate at 5000 rpm using a Fitzmill using positive impact and a 0.033" circular scree...

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PUM

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Abstract

The present disclosure relates to pharmaceutical compositions comprising a gonadotropin-releasing hormone (GnRH) antagonist and methods of preparing and using such compositions. The disclosure also relates to methods of facilitating release of a GnRH antagonist from a pharmaceutical composition.

Description

[0001] related application [0002] This application claims priority to provisional application 62 / 547,410, filed August 18, 2017, provisional application 62 / 660,104, filed April 19, 2018, and non-provisional application PCT / US2018 / 043321, filed July 23, 2018 , all applications are hereby incorporated by reference in their entirety for all purposes. technical field [0003] The present invention relates to a pharmaceutical composition of elagolix or elagolix sodium or compound A or a pharmaceutically acceptable salt thereof, and a method for using the composition. Background technique [0004] Endometriosis is a disorder in which tissue normally present in the uterine cavity (ie, the endometrium) appears on the outside of the uterus, usually implanting on the peritoneal lining of the pelvic cavity. Endometriosis affects an estimated 1 in 10 women of reproductive age and causes pain, infertility and sexual dysfunction. The growth of endometrial tissue outside the uterine c...

Claims

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Application Information

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IPC IPC(8): A61K31/513A61K31/565A61K31/57
CPCA61K9/2009A61K9/2031A61K31/513A61P15/00A61P5/30A61K9/2018A61K9/1641A61K9/1611A61K9/2054A61K9/2027A61K9/2013A61P15/02
Inventor 邱怡虹龚豫川A.鲁格尔斯J.A.拜尔德K.克瓦利什C.D.欧文斯J.W.托马斯J.卡斯特利-哈利K.戈登M.C.斯纳贝斯A.M.索利曼O.A.弗罗尔斯R.贾因J.W-K.伍J.D.诺尔思H.帕拉奇P.M.佩罗索L.A.威廉斯祖卉胡越嵘
Owner ABBVIE INC
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