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Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis

A drug and composition technology, applied in the direction of medical preparations containing active ingredients, drug combinations, drug delivery, etc., can solve problems such as adenomyosis

Pending Publication Date: 2020-09-22
ABBVIE INC +1
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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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  • Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
  • Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis
  • Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0268] Example 1: Compound A monosodium salt forms a gel

[0269] To estimate the solubility of Compound A in water, various amounts of Compound A sodium salt were added to a fixed volume of 1.5 mL and equilibrated at 37°C; the concentration of Compound A in the solution was analyzed.

[0270] Table 2 lists the raw data and observations of the experiments, and figure 2 Concentrations are shown as a function of the amount of Compound A solid added. figure 2 The dashed line in is the theoretical concentration based on the weight of solids added and the volume of water. Such as figure 2 As shown in , the concentration of Compound A is in agreement with the simple calculation, reaching 100 mg solid / 1.5 mL. The deviation of the concentration from the theoretical line is caused by the volume expansion when a large amount of solute dissolves. Apart from that, although the concentration deviated from the theoretical line, the solution was still clear and no significant gelling ...

example 2

[0274] Example 2: In vitro release in the absence of anti-gelling agents

[0275] Immediate release formulations were prepared without anti-gelling agents. All ingredients except magnesium stearate were blended in a high shear granulator and granulated with purified deionized water. The granules were pan dried at 40°C and passed through a #20 US Standard Sieve and lubricated with magnesium stearate. Compound A mentioned in the table below is Compound A sodium salt.

[0276] Composition of formulations without antigelling agents

[0277] Element Quantity (mg / tablet) Compound A, sodium salt 207.3 Mannitol 304.0 pregelatinized starch 59.1 Povidone K 29 / 32 18.4 Magnesium stearate 11.2

[0278] Table 3 shows the dissolution profile of the uncoated tablets in pH 1.2 media.

[0279] Table 3: (RC2i; 200 mg; Lot No. 170123A-01 (GLIMS #39746))

[0280] time (minutes) Mean % (Standard Deviation) 15 15(0.5) 30 31(0.5...

example 3

[0281] Example 3: Formulations with anti-gelling agents

[0282] Table 4 provides additional non-limiting examples of components of the disclosed formulations and the weight percent (w / w) of these components in the final coated tablet. Compound A mentioned in the table below is Compound A sodium salt, and the corresponding amounts (mg / tablet) and weight percentages are provided in terms of the salt form.

[0283] Table 4. Composition of exemplary formulations.

[0284]

[0285] a Percentages given are based on the weight of the coated tablet. Total percentages may not be 100% due to rounding.

[0286] Table 4. Composition of Exemplary Formulations (continued)

[0287]

[0288] a Percentages given are based on the weight of the coated tablet. Total percentages may not be 100% due to rounding.

[0289] Table 4. Composition of Exemplary Formulations (continued)

[0290]

[0291] a Percentages given are based on the weight of the coated tablet. Total percentages...

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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 / 547,402 filed August 18, 2017, provisional application 62 / 660,102 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. [0003] joint research agreement [0004] The subject matter disclosed in this application was made by or on behalf of AbbVie Inc. and / or Neurocrine Biosciences, Inc., which were parties to a joint research agreement in effect on or before the effective filing date of this application, and such subject matter was made in Results of activities carried out within the scope of a joint research agreement. technical field [0005] The present invention relates to a pharmaceutical composition of Compound A and a pharmaceutically acceptable salt, and methods of using such compositions. Background technique [0006] Endometriosis is ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/513A61K31/565A61K31/57
CPCA61K9/2009A61K9/2018A61K9/2027A61K9/2059A61K31/513A61P5/30A61P15/00A61K9/2866A61K9/2846A61K9/1611A61K9/1623A61K9/1652A61K9/5015A61K9/0053A61K9/2054A61P15/02A61P15/08
Inventor J.贾延思K.C.斯潘塞G.A.麦克利兰A.V.斯蒂芬宁科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G.张D.梅茨格尔李艳霞T.R.朱邵溪O.A.弗罗尔斯R.贾因W-K.J.吴J.D.诺尔思H.帕拉奇P.M.佩罗索L.A.威廉斯
Owner ABBVIE INC
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