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Stable pharmaceutical composition comprising testosterone undecanoate

A technology of testosterone undecanoate and composition, applied in the field of testosterone ester injection composition, capable of solving problems such as high viscosity and injection force, inconvenient use, and low stability

Pending Publication Date: 2021-04-09
CHONG KUN DONG CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] However, the above-mentioned castor oil has disadvantages that it is inconvenient to use when injecting because of high viscosity and injection force, and has low stability

Method used

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  • Stable pharmaceutical composition comprising testosterone undecanoate
  • Stable pharmaceutical composition comprising testosterone undecanoate
  • Stable pharmaceutical composition comprising testosterone undecanoate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0040] Preparation of the compositions of Examples 1 to 9

[0041] Add testosterone undecanoate (hereinafter referred to as "TU"), castor oil, sesame oil, safflower oil or benzyl benzoate according to the combination in Table 1 below (benzyl benzoate, hereinafter referred to as "BB"), stirred at room temperature for 0.5 to 24 hours to prepare the compositions of Examples 1 to 9.

[0042] Table 1

[0043] (unit: mg)

[0044] Example testosterone undecanoate castor oil sesame oil safflower oil Benzyl Benzoate 1 - 800 - - - 2 - - 800 - - 3 - - - 800 - 4 100 1900 - - - 5 100 - 1900 - - 6 100 - - 1900 - 7 100 120 - - 200 8 100 - 120 - 200 9 100 - - 120 200

experiment example 1

[0046] Viscosity measurement experiment

[0047] The viscosity of the compositions of Examples 1 to 9 was measured by the following method.

[0048] 1) Viscometry: United States Pharmacopoeia (USP) 42Rotational rheometermethods-Method IV.Parallel plate (or parallel disk) rheometers

[0049]2) Diameter of viscometer disk: 25mm

[0050] 3) Distance from the upper disc: 1mm

[0051] 4) Absolute speed (sheer rate): 1-50 (1 / s)

[0052] 5) Temperature: 4°C, 15°C, 25°C, 30°C

[0053] 6) Sample volume: 0.65mL

[0054] The viscosities of Examples 1 to 3 containing only oil, measured by the method described above, are shown in Table 2 below.

[0055] Table 2

[0056] (unit: mPas, temperature: 4°C)

[0057]

[0058] As shown in above-mentioned table 2, the viscosity of embodiment 2 (safflower oil) and embodiment 3 (safflower oil) is respectively 154mPas and 129mPas value, and the viscosity of embodiment 1 (castor oil) is 3791mPas value, and embodiment 2 and implementation Comp...

experiment example 2

[0081] Injection force test

[0082] To a 5ml syringe with an internal diameter of 0.47 inch, fill 2.5cm of the composition of Examples 7 to 9, insert a 0.5 inch 27G or 29G needle, install it on Mecmesin's MutiTest-dV equipment, and utilize Mecmesin's BasicForce Gage 200 , the composition was pushed at a speed of 12mm / min and the injection force (Newton, N) was measured in the interval of 5-15mm, and the results were presented in Table 7 below.

[0083] Table 7

[0084] (unit: N)

[0085]

[0086]

[0087] As shown in Table 7 above, Example 8 containing sesame oil and Example 9 containing safflower oil showed lower injection force than Example 7 containing castor oil.

[0088] Therefore, the composition containing sesame oil and safflower oil can be injected with a low injection force, and thus, it can be seen that injection can be easily performed through a thin injection needle, and convenience in use can be increased when injecting.

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Abstract

The present invention relates to an injectable composition of testosterone ester for the treatment of testosterone deficiency. Particularly, the present invention relates to a pharmaceutical composition comprising testosterone undecanoate, which is capable of increasing the convenience for use in injection with the low viscosity and injection force, and has improved stability.

Description

technical field [0001] The present invention relates to a testosterone ester injection composition for treating testosterone deficiency. Specifically, it relates to a pharmaceutical composition containing testosterone undecanoate, in which ease of use during injection is enhanced by low viscosity and injection force, and stability is improved. Background technique [0002] Testosterone is the main androgen produced from the Leydig cells of the testes and is responsible for the normal growth, development, maintenance and secondary sexual characteristics of male sex organs. [0003] Testosterone deficiency is caused by insufficient secretion of testosterone and is characterized by a low concentration of testosterone in the serum. Testosterone deficiency may lead to male diseases, one of which is hypogonadism. Signs associated with male hypogonadism include erectile dysfunction, decreased libido, fatigue and loss of energy, depression, secondary degeneration of sexual characte...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K47/44A61K47/14A61K31/568A61P5/26
CPCA61K47/44A61K31/568A61K9/0019A61K47/14A61P5/26A61K47/06A61P5/24A61K47/02
Inventor 安炳基朴昭贤
Owner CHONG KUN DONG CORP
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