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Ethyl cellulose taste-masking microsphere with controllable drug release speed and preparation thereof

A technology of ethyl cellulose and microspheres, applied in the field of pharmacy, to achieve the effects of easy swallowing, high dosage flexibility, and controllable drug release rate

Pending Publication Date: 2020-06-30
SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although oral preparations are developing rapidly and their usage is increasing, it is of certain research value and challenge to diversify the preparations by combining the mouthfeel, the characteristics of the gastrointestinal tract and the properties of polymer materials.

Method used

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  • Ethyl cellulose taste-masking microsphere with controllable drug release speed and preparation thereof
  • Ethyl cellulose taste-masking microsphere with controllable drug release speed and preparation thereof
  • Ethyl cellulose taste-masking microsphere with controllable drug release speed and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1: The preparation method of ethyl cellulose microspheres is: take the carrier ethyl cellulose and dissolve it in a corresponding solvent, then add a certain amount of medicine to dissolve completely to obtain an oil phase, and drop the above oil phase into the mixture containing In the surfactant water phase, after emulsification and stirring, suction filtration, washing the product with deionized water, and drying to obtain ethyl cellulose microspheres. The dosage and conditions for the preparation of ethylcellulose microspheres of different drugs are shown in Table 1.

[0037] Table 1 Preparation conditions of ethylcellulose microspheres

[0038]

[0039]

Embodiment 2

[0040] Example 2: Take the ethylcellulose microspheres in Example 1, and measure their drug loading under corresponding detection methods. The detection methods and results are shown in Table 2, wherein the HPLC flow rate is 1mL / min.

[0041] Table 2 Detection method and drug loading capacity of ethyl cellulose microspheres

[0042]

Embodiment 3

[0043] Embodiment 3: Take the ethyl cellulose microsphere in embodiment 1 and add appropriate amount into drinking water to prepare as a sample that can be tasted. A group of 11 healthy adult volunteers aged 19-25 conducted a bitterness evaluation test, in which the corresponding API was used as a bitterness control. Volunteers were required to rinse their mouths with purified water, take an appropriate amount of samples and put them in their mouths, and turn their tongues back and forth until the solution was in full contact with the tongue coating. After 30 seconds, spit it out and rinsed their mouths with purified water several times. The volunteers’ opinions on the bitterness of AZI solutions with different concentrations were scored according to the bitterness scale, which consisted of four standards: 0=no taste, 1=slightly bitter, 2=medium bitterness and 3=strong bitterness.

[0044] Table 3 Evaluation of the bitterness of ethyl cellulose microspheres

[0045]

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Abstract

The invention provides an ethyl cellulose taste-masking microsphere with a controllable drug release speed and a preparation method thereof. The system of the ethyl cellulose taste-masking microspherecomprises one kind of ethyl cellulose or a mixture of more than one kind of ethyl cellulose with different molecular weights in a certain proportion and further comprises a hydrophobic drug. According to the invention, other excipients such as a pore-foaming agent are not used for regulating and controlling drug release, and the drug release speed is regulated and controlled by simply mixing thesame polymer of different models; drug release is delayed by forming a physical barrier, and bitterness perception is avoided, so a taste masking effect is achieved. The invention provides a prescription and a preparation method of the microsphere. While taste masking is achieved, drug release of the microsphere can be regulated and controlled according to needs, and the microsphere is large in drug loading capacity, high in flexibility, easy to divide dosage and swallow and applicable to research and development of children's preparations.

Description

technical field [0001] The invention relates to ethyl cellulose taste-masking microspheres with controllable drug release speed. The prescription design of the microspheres can regulate the drug release and achieve the taste-masking effect by forming a physical barrier, belonging to the field of pharmacy. Background technique [0002] Oral administration is the most commonly used route of drug delivery due to convenience, non-invasiveness, and low cost. Although oral preparations are developing rapidly and their usage is increasing, it is of certain research value and challenge to diversify the preparations by combining the mouthfeel, the characteristics of the gastrointestinal tract and the properties of polymer materials. In particular, the masking of bad taste and the regulation of drug release speed of oral drugs are the key to their curative effect. [0003] Microsphere is an encapsulated drug delivery system with promising application prospects. It can be prepared int...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K47/38A61K31/18A61K31/192A61K31/357A61K31/405A61K31/43A61K31/4422A61K31/451A61K31/496A61K31/546A61K31/55A61K31/7048A61K31/7052A61K45/00
CPCA61K9/1652A61K45/00A61K31/7052A61K31/7048A61K31/43A61K31/546A61K31/357A61K31/451A61K31/405A61K31/192A61K31/18A61K31/55A61K31/4422A61K31/496
Inventor 何淑旺张自强景亚军
Owner SHANDONG DYNE MARINE BIOTECHCAL PHARM HLDG CO LTD
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