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Oral megestrol acetate suspension and preparation method thereof

A technology of megestrol acetate and suspension, which is applied in the field of medicine, can solve problems such as poor physical stability, and achieve the effects of increasing dissolution rate, improving efficiency, and shortening the preparation time

Pending Publication Date: 2021-08-20
TOT BIOPHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, poor physical stability during placement of oral suspensions has always been a problem, and a more simple and controllable method is needed to improve the dissolution rate in vitro

Method used

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  • Oral megestrol acetate suspension and preparation method thereof
  • Oral megestrol acetate suspension and preparation method thereof
  • Oral megestrol acetate suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] Material name Unit dose (mg / ml) Percentage (weight / volume) megestrol acetate 40.00 4％ polyethylene glycol 2000 180.00 18％ Sodium dodecyl sulfate 0.50 0.05％ sucrose 50.00 5％ xanthan gum 1.8 0.18％ sodium benzoate 2.00 0.2％ citric acid 2.44 0.244％ sodium citrate 0.17 0.017％ lemon zest 0.8 0.08％ purified water Appropriate amount Appropriate amount

[0071] Process Description:

[0072] Step 1 (preparation of the first solution)

[0073] Add part of the purified water into the stirring tank (M), add the prescribed amount of polyethylene glycol 2000, heat to 50°C, stir to dissolve, the stirring speed is 20rpm, and cool down to ≤35°C.

[0074] Add the prescribed amount of sodium lauryl sulfate, stir to dissolve.

[0075] Add the prescribed amount of megestrol acetate, stir to disperse evenly, and the stirring speed is 55rpm.

[0076] Step 2 (preparation of the second solution solution) ...

Embodiment 2

[0090] Xanthan gum and sucrose are pre-mixed in equal increments and then added to the suspension system (homogeneous 3600rpm, time 120 minutes)

[0091] Material name Unit dose (mg / ml) Percentage (weight / volume) megestrol acetate 40.00 4％ polyethylene glycol 2000 180.00 18％ Sodium dodecyl sulfate 0.50 0.05％ sucrose 50.00 5％ xanthan gum 1.8 0.18％ sodium benzoate 2.00 0.2％ citric acid 2.44 0.244％ sodium citrate 0.17 0.017％ lemon zest 0.8 0.08％ purified water Appropriate amount Appropriate amount

[0092] Process Description:

[0093] Step 1 (preparation of the first solution)

[0094] Add part of purified water into the stirring tank (M), add the prescribed amount of polyethylene glycol 2000, heat to 50°C, stir at 20rpm, and cool down to ≤35°C.

[0095] Add the prescribed amount of sodium lauryl sulfate, stir to dissolve.

[0096] Add the prescribed amount of megestrol acetate, stir and ...

Embodiment 3

[0111] Xanthan gum and sucrose are pre-mixed in equal increments and then added to the suspension system (homogeneous speed 3600rpm, time 90 minutes)

[0112]

[0113]

[0114] Process Description:

[0115] Step 1 (preparation of the first solution)

[0116] Add part of purified water into the stirring tank (M), add the prescribed amount of polyethylene glycol 2000, heat to 50°C, stir at 20rpm, and cool down to ≤35°C.

[0117] Add the prescribed amount of sodium lauryl sulfate, stir to dissolve.

[0118] Add the prescribed amount of megestrol acetate, stir and disperse evenly. Stirring speed 55rpm.

[0119] Step 2 (preparation of the second solution solution)

[0120] Add an appropriate amount of water into the stirring tank (N), heat to 40°C, add the prescribed amount of sodium benzoate, stir to dissolve, and the stirring speed is 20rpm.

[0121] Pre-disperse the prescription amount of xanthan gum and sucrose in equal increments before adding, then add the disperse...

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Abstract

The invention provides an oral megestrol acetate suspension and a preparation method thereof. The megestrol acetate suspension comprises the following components of 40.0 to 120.0 mg / ml of megestrol acetate, 100 to 300 mg / ml of a wetting agent, 0.05 to 0.5 mg / ml of a surfactant, 1.0 to 3.0 mg / ml of a suspending aid, 1.0 to 4.0 mg / ml of a pH regulator, 0.10 to 0.3 g / ml of a buffering agent or a deflocculating agent, 10.0 to 100.0 mg / ml of a sweetening agent, 1.0 to 3.0 mg / ml of a bacteriostatic agent, and a proper amount of a flavoring agent and purified water. The in-vitro dissolution speed of the prepared oral megestrol acetate suspension is obviously improved, and the problem of physical stability of the suspension is solved.

Description

technical field [0001] The invention relates to the field of medicine, in particular, the invention relates to an oral megestrol acetate suspension and a preparation method thereof. Background technique [0002] Megestrol acetate (MA) is a kind of progestogen drug, mainly used in the treatment of advanced breast cancer and advanced endometrial cancer, it can improve the appetite and cachexia of patients with advanced tumors, and it is effective for kidney cancer, prostate cancer and Ovarian cancer also has some curative effect. Megestrol acetate is a poorly soluble drug, and dissolution is the main step that limits the absorption of the drug in the body. Therefore, increasing the dissolution rate of the drug can significantly improve the absorption of the drug, thereby increasing the bioavailability. Various approaches are available to increase the bioavailability of megestrol acetate, as described in the following literature: [0003] Chinese invention patent CN104208072A...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/10A61K31/57A61K47/36A61K47/26A61P35/00
CPCA61K9/10A61K31/57A61K47/36A61K47/26A61P35/00
Inventor 曹恒杰陈小宝张维
Owner TOT BIOPHARM CO LTD
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