Desloratadine dry-mixed suspensoid and preparing method thereof

A technology of desloratadine and dry suspension, applied in the field of new dosage forms and preparation thereof, can solve the problems of easy deterioration, dispersible tablet volume can not be too large, thermodynamic instability and the like

Inactive Publication Date: 2004-06-30
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The dosage forms of desloratadine for clinical selection include tablets, dispersible tablets, and syrups. Tablets are a common dosage form. Absorption in the body must go through processes such as disintegration and dissolution before reaching the blood circulation through the gastrointestinal tract. Tablets In the production process, it is often difficult for the tablet to disintegrate and the drug to dissolve due to excipients, processes, etc., so that the drug cannot achieve the desired therapeutic effect
In addition, for children and patients with difficulty swallowing, tablets are difficult to accept
Though syrup overcomes the above-mentioned shortcoming of tablet, its production and transportation are in

Method used

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  • Desloratadine dry-mixed suspensoid and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: respectively use hydroxypropyl methylcellulose (HPMC), ethylcellulose (EC), aminoalkyl methacrylate copolymer E type (EUDRAGIT  E100) to screen the coating solution to finally determine the coating material. Coating weight gain 10%. Raw material coating screening

[0015] Test 1: HPMC 25g

[0016] Propylene glycol 10ml

[0017] Castor Oil 10ml

[0018] Polysorbate 80 10ml

[0019] Ethanol 500ml

[0020] Water 500ml Process: Weigh 25g HPMC, dissolve it with 500ml hot water, cool to room temperature to form a viscous solution, add 500ml ethanol, stir well, add castor oil, polysorbate 80, propylene glycol, stir well;

[0021] Test 2: EC 25g

[0022] Isopropanol 150ml

[0023] Ethanol 850ml Process: Weigh 25g EC, dissolve in 150ml isopropanol, 850ml

[0024] In ethanol, dissolve.

[0025] Test 3: EUDRAGITE100 25g

[0026] Ethanol 1000ml Process: Weigh 25g EUDRAGIT  E100, soluble

[0027] In 1000ml ethanol, it is a trans...

Embodiment 2

[0032] prescription

[0033] Uncoated Desloratadine 2.5g

[0034] Sucrose 212g

[0035] Mannitol 270g

[0036] Sodium Carboxymethyl Cellulose 10g

[0037] Sweet orange essence 0.5g

[0038] Xanthan Gum 5g

[0039] Sunset yellow 0.001g, 1000 bags in total Process: Pass the above ingredients through a 100-mesh sieve and mix well. Spray for coloring, dry and dispense.

Embodiment 3

[0041] prescription

[0042] Coated desloratadine raw material 2.5g

[0043] (calculated as desloratadine)

[0044] Sucrose 212g

[0045] Mannitol 270g

[0046] Sodium Carboxymethyl Cellulose 10g

[0047] Sweet orange essence 0.5g

[0048] Xanthan Gum 5g

[0049] Sedimentation volume ratio

[0050] The above experiments show that the taste of desloratadine produced by the present invention is obviously improved, and the raw materials are also extremely stable after being coated.

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Abstract

The present invention discloses a new dosage form of dichloroleitadine. It includes coated dichloroleitadine, and its content is 0.01-1%, and its coating material is methyl aminoalkyl acrylate copolymer type E and II acrylic resin. The dichloroleitadine raw material is sensitive to light heat and humidity, in order to ensure its stability, said raw material is coated so as to improve its non-stability, at the same time can hide its taste.

Description

technical field [0001] The invention discloses a new dosage form of desloratadine and a preparation method thereof. Background technique [0002] [0003] C 19 h 19 ClN 2 310.82 [0004] Desloratadine is a non-sedating long-acting tricyclic antihistamine, the active metabolite of loratadine, which can selectively block peripheral H 1 Receptors, inhibit the release of various allergic inflammatory chemical mediators, such as: inhibit mast cells and basophils from releasing histamine, prostaglandins, interleukins, etc., relieve allergic rhinitis or chronic idiopathic urticaria symptom. [0005] The dosage forms of desloratadine for clinical selection include tablets, dispersible tablets, and syrups. Tablets are a common dosage form. Absorption in the body must go through processes such as disintegration and dissolution before reaching the blood circulation through the gastrointestinal tract. Tablets In the production process, it is often difficult for the tablet to ...

Claims

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Application Information

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IPC IPC(8): A61K31/4545A61P37/08
Inventor 范敏华朱小平楼金芳穆斌
Owner HAINAN PULIN PHARMA
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