Unlock instant, AI-driven research and patent intelligence for your innovation.

A mouth-dissolving film composition

A technology of composition and mouth-dissolving film, which is applied in the field of mouth-dissolving film composition and its preparation, can solve problems such as aggregation of active substances, affecting the mouthfeel and dissolution of the film, and poor treatment effect, so as to improve compliance and film-forming Good appearance and taste, uniform distribution of active ingredients

Active Publication Date: 2022-06-21
JIANGSU HENGRUI MEDICINE CO LTD
View PDF11 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are also some problems in the storage of film products. For example, after the film is stored for a long time, the active substances in it will aggregate, which will affect the taste and dissolution of the film, resulting in poor therapeutic effect.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • A mouth-dissolving film composition
  • A mouth-dissolving film composition
  • A mouth-dissolving film composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1: Ondansetron Oral Dissolving Film

[0048] The dosage of each prescription is shown in Table 1, and the prescription evaluation is shown in Table 2.

[0049] Table 1:

[0050]

[0051] The raw material of ondansetron was pulverized by a mechanical pulverizer (the aperture of the screen mesh was 0.5 mm). Place the prescribed amount of ondansetron in the main tank of the homogenizer, add poloxamer (not added in preparation D), absolute ethanol and water, and stir evenly. The polydextrose, the aqueous solution of polyoxyethylene and the aqueous solution of hydroxypropyl methylcellulose were added to the main tank, stirred in vacuum, and sheared at high speed for 15 minutes to obtain a glue solution. The glue liquid is scraped on a continuous coating machine, dried and formed, cut into a film with a specified area, and packaged and sealed.

[0052] Table 2:

[0053]

[0054] Based on the analysis of the dissolution time, mouthfeel, breaking force and 180...

Embodiment 2

[0055] Example 2: Entecavir Oral Dissolution Film

[0056] The dosage and evaluation of each prescription are shown in Table 3.

[0057] table 3

[0058]

[0059] Entecavir was dispersed in absolute ethanol. Add the aqueous poloxamer solution and stir until the entecavir is completely dissolved. Add maltitol, lemon essence, tartrazine, polydextrose, polyoxyethylene, and hypromellose aqueous solution to it and stir evenly. High-speed shearing and standing to obtain glue. The glue liquid is scraped on a continuous coating machine, dried and formed, cut into a film with a specified area, and packaged and sealed.

[0060] After experimental analysis, polydextrose can improve the mouthfeel and texture of the dissolving film.

Embodiment 3

[0061] Example 3 Dissolution test:

[0062] According to the dissolution test method (the fourth method of the four general rules of the Chinese Pharmacopoeia in 2015), take the film preparation 2*3cm obtained from the ondansetron mouth-dissolving film preparation A after being coated by a continuous coating machine, and fix it on a two-layer disc. Place the mesh plate in the lower part of the dissolution vessel, making it parallel to the rotating surface of the paddle bottom, with a distance of 25 ± 2 mm, for measurement, the dissolution temperature is 37 ± 0.5 °C, the volume of the dissolution medium is 900 ml, and the rotation speed is 50 rpm . The dissolution media were 0.1M hydrochloric acid solution, pH4.5 acetate buffer solution, pH6.8 phosphate buffer solution and purified water.

[0063] result (see figure 1 ): there is no obvious difference in the dissolution conditions of the ondansetron oral film-dissolving agent prepared by the present invention in the four medi...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention relates to an orally dissolving film composition. Specifically, the mouth-dissolving film composition of the present invention comprises an active ingredient, a film-forming polymer, polydextrose and a surfactant. The mouth-dissolving film composition of the invention has the advantages of good mouthfeel and uniform distribution of active ingredients, and the active ingredients do not aggregate after long-term storage.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an oral dissolving film composition and a preparation method thereof. Background technique [0002] Oral administration is the most common way of administering drugs, but different dosage forms are suitable for different users. Some dosage forms such as tablets and capsules are difficult to take for the elderly, children and some patients with dysphagia. Other preparations such as granules, oral liquids, dry suspensions, etc., some dosage forms of the same dose of drugs take a larger volume, which increases the difficulty of taking patients; the advantage of oral dissolving film preparations is that the specific surface area of ​​the preparation is larger. , can be quickly dissolved in the oral cavity, dispersed into a suspension of drugs and excipients, which is convenient for swallowing, without drinking water; the amount of excipients in the oral dissolving film is less, and the conte...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/70A61K47/36A61K47/10A61K47/38
CPCA61K9/7007A61K9/006A61K47/36A61K47/10A61K47/38
Inventor 钟月孙姣潘凯张辉刘凯
Owner JIANGSU HENGRUI MEDICINE CO LTD