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Soluble fentanyl, derivative buccal membrane preparation thereof and preparing method thereof

A soluble and derivative technology, applied in pharmaceutical formulations, drug combinations, organic active ingredients, etc., can solve the problems of slow onset of transdermal patch, difficult to last, and unsatisfactory clinical effects, and achieve improved bioavailability, drug Long-lasting, fast-acting results

Active Publication Date: 2015-09-30
LP PHARM (XIAMEN) CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injection, sublingual patch, sublingual spray, and oral patch have a rapid onset of effect, but are difficult to last, while transdermal patches have a slow onset of effect, and the clinical effect is not ideal. Most of the buccal and chewable tablets have Fentanyl enters the gastrointestinal tract through saliva, producing a first-pass effect

Method used

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  • Soluble fentanyl, derivative buccal membrane preparation thereof and preparing method thereof
  • Soluble fentanyl, derivative buccal membrane preparation thereof and preparing method thereof
  • Soluble fentanyl, derivative buccal membrane preparation thereof and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Preparation of Fentanylaskin Herbal Speed Film

[0048] prescription:

[0049]

[0050] step:

[0051] a. Fentney, sweet chrysanthemin, glycerin, lactose, mint, iron oxide red in order to dissolve in 200ml 80%ethanol solution;

[0052] b. Polyethylene pyrirol, hydroxytic cellulose, yellow gel in A solution in A solution, stir well, and leave it overnight to take off;

[0053] c. Put the B liquid evenly, the thickness of the wet film is about 300-400 μm, that is, each square meter is about 0.05mg of fentini, and it is dried at 70 ° C;

[0054] d. After drying, the unit is divided into a flat centimelate content.

Embodiment 2

[0055] Example 2 Preparation of Solubinating Fenye cheeks, cheeks, cheek -release membrane preparation

[0056] prescription:

[0057]

[0058] step:

[0059] a. Fentnib, hydroxylopyamyl cellulose K15m, sucrose, EuDragit L100, microcrystalline cellulose, triangular ethyl ester, lemon yellow mixed;

[0060] b. The hot -melt squeeze out of the film under 160 ° C, the thickness of the control membrane is 250 μm, and each square meter contains about 0.1mg fentini

[0061] c. Test its unit content.

experiment example 3

[0062] Experimental Example 3 Soluble Fenye mouth cheese speed soluble and medium -release dual -layer membrane preparation

[0063] prescription:

[0064] Quick soluble film prescription:

[0065]

[0066] Slow -release membrane prescription:

[0067]

[0068] Process:

[0069] a. Fentini, hydroxyl propyaline k15m, sucrose, EuDragit L100, microcrystalline cellulose, citric acid trigemone, lemon yellow mix well;

[0070] b. The hot -melt squeeze out of the film under 160 ° C, the thickness of the control membrane is 250 μm, and each square meter contains about 0.1mg fentini

[0071] e. Fascini, sweet chrysanthemidin, glycerin, lactose, mint, iron oxide red in sequence of 40ml 80%ethanol solution of the steamic solution

[0072] f. Polyethylene pyriardone, hydroxytic cellulose, yellow gel in the E solution, stir well, and let it go overnight to take off;

[0073] c. Put the F liquid evenly on the B film. The thickness of the wet membrane is about 300-400 μm, that is, each squar...

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Abstract

The invention discloses soluble fentanyl, a derivative buccal membrane preparation thereof and a preparing method thereof. The soluble fentanyl and the derivative buccal membrane preparation thereof can be instant fentanyl and a derivative buccal membrane preparation thereof, can be soluble slow-release fentanyl and a derivative buccal membrane preparation thereof and also can be instant and soluble slow-release fentanyl and a derivative buccal double-layer-membrane preparation. An instant membrane can be dissolved quickly at a buccal mucosa in one minute at the oral cavity, the fentanyl and a derivative thereof are released, and the clinical effect of efficient analgesia is achieved. A slow-release membrane slowly releases medicine within four hours in the oral cavity, and effective blood concentration is maintained for a long time. An instant-slow-release double-layer membrane has a quick effect, the medicine effect is durable, and continuous analgesia can be achieved.

Description

Technical field [0001] The invention is the field of drug preparations, which involves soluble fentanyl and its derivative mouth cheese membrane preparations and their preparation methods. Background technique [0002] Fantani and its analogs, such as Affiny, Carfenne, Lepfenne, Refencini, Schinsini, Tenfenne, etc., are high -efficiency opioid analgesic drugs.50-100 times for morphine.The effect of medicinal effect is similar to morphine. In addition to analgesic, it also has the effects of reducing heart rate, suppressing breathing, and reducing smooth muscle peristalsis.The addiction is smaller than morphine, and it is suitable for the analgesic of various pain and surgery, gynecology and other surgicals and during surgery.The side effects that can be observed in this type of opioids and Fentney are nausea, circulatory system disorders, constipation or itching and threatening life. ThereforeDraw to the body.However, due to the poor biological utilization of such drugs, oral mil...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4468A61P25/04
Inventor 苏艺杰蔡林辉凌榕槟朱海健叶英
Owner LP PHARM (XIAMEN) CO LTD
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