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Thermosensitive in-situ gel preparation for vaginal administration

A technology of vaginal administration and in-situ gel, which is applied in the field of temperature-sensitive in-situ gel preparations, in-situ gel sustained-release preparations and their preparations, achieving the effects of good safety, good redispersibility, and wide source of raw materials

Inactive Publication Date: 2012-07-04
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, after a comprehensive search of the literature, there is no relevant report on the temperature-sensitive thermosensitive in-situ gel based on the combination of poloxamer and suspending agent and its preparation method.

Method used

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  • Thermosensitive in-situ gel preparation for vaginal administration
  • Thermosensitive in-situ gel preparation for vaginal administration

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1 Preparation of Blank Gel I

[0036] An appropriate amount of xanthan gum was weighed and dissolved in pure water to obtain a stock solution of xanthan gum (0.5%, w / w). Weigh the components in corresponding proportions according to the table below, let stand at 4°C until the solid components are dissolved, and then stir evenly to obtain a uniform mixture, which is the blank gel I. The gelation temperature of this example is about 30-33°C. Wherein each component weight percent is as follows:

[0037] Reagent weight percentage (%) Poloxamer 407 16～17 Poloxamer 188 1 xanthan gum 0.1～0.2 Ethylparaben 0.2 water to sufficient amount

Embodiment 2

[0038] Example 2 Ornidazole thermosensitive in situ gel I

[0039] The experimental procedure is the same as that in Example 1. After the blank gel I is prepared, add an appropriate amount of ornidazole (through a 200 mesh sieve) and stir evenly. The gelation temperature of this example is about 32-34°C. The content of each ingredient in the prescription is shown in the table below:

[0040] Reagent weight percentage (%) Ornidazole 10 Poloxamer 407 (Pluronic F127) 16～17 Poloxamer 188 (Pluronic F68) 1 xanthan gum 0.1～0.2 Ethylparaben 0.2 water to sufficient amount

Embodiment 3

[0041] Example 3 Blank Gel II

[0042] The experimental procedure is basically the same as in Example 1, wherein during the preparation process, pure water is replaced by citric acid-sodium citrate (concentration: 30-50 mM) buffer solution with pH ~5. The gelation temperature of this example is about 34-37°C. Gels at this pH are particularly suitable for vaginal administration.

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Abstract

The invention belongs to the field of pharmaceutical preparations and relates to an in-situ gel sustained-release preparation which is used for vaginal administration and has high drug loading and a preparation method of the in-situ gel sustained-release preparation. The preparation is formed by an effective dose of drugs, a thermosensitive gel matrix material, a suspending agent and water or a buffer solution, wherein the drugs are suitable for vaginal administration, the thermosensitive gel matrix material is poloxamer, and the suspending agent is xanthan gum; and the suspending agent, i.e. the xanthan gum, does not affect the thermosensitivity of the preparation and can exert an excellent suspending effect on the drugs. The preparation has the advantages of simplicity in preparation, high drug loading, convenience in administration and little irritation, good safety, wide source of raw materials and low cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a temperature-sensitive in-situ gel preparation, in particular to an in-situ gel sustained-release preparation for vaginal administration with high drug loading and a preparation method thereof. Background technique [0002] In the treatment of gynecological diseases, vaginal administration is a very important route of administration. The advantage of this route of administration is that it can make the local concentration of the drug in the affected area high and the systemic side effects are small. At present, the commonly used vaginal drug dosage forms can be roughly divided into the following three categories: the first category is solid dosage forms, including vaginal suppositories, vaginal tablets, vaginal effervescent tablets, and vaginal capsules. Liquid-dissolved and dispersed drugs are most prone to uneven distribution in the vagina; the second category is semi-s...

Claims

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Application Information

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IPC IPC(8): A61K9/06A61K47/36A61K47/34A61K45/00A61P15/02A61P31/04A61P31/12A61P31/10A61P15/18A61P29/00A61P15/00
Inventor 刘瑜陆伟跃
Owner FUDAN UNIV
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