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Pharmaceutical capsule compositions containing loratadine and pseudoephedrine

A technique of pseudoephedrine and composition, applied in the field of oral medicine capsule composition, can solve problems such as poor wettability, unsatisfactory pseudoephedrine delivery mode and the like

Inactive Publication Date: 2004-08-11
YUHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this composition also suffers from poor wettability of loratadine at high pH conditions, which may lead to an unsatisfactory delivery mode of pseudoephedrine

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1: Preparation of Quick Release Pills Containing Loratadine and Pseudoephedrine Sulfate

[0035] A binder solution was prepared by dissolving 5.0 g of polyvinylpyrrolidone in 120 g of water. 25g loratadine, 180g pseudoephedrine sulfate, 25g microcrystalline cellulose, 75g low-substituted hydroxypropyl cellulose, 75g polyvinylpolypyrrolidone and 1.5g colloidal silicon dioxide were mixed and sieved by a 20-mesh sieve. Give mixed powder. While spraying the binder solution prepared above onto 250 g of sugar seeds in a centrifugal granulator, the mixed powder was dusted onto the sugar seeds in a centrifugal granulator to provide pellets. (Turntable speed: 140~200rpm, adhesive solution spraying speed: 2~20ml / min, air injection pressure: 1~2kg / cm 2 , air injection volume: 5 ~ 300L / min, powder spraying speed: 5 ~ 30g / min)

Embodiment 2 and 3

[0036] Examples 2 and 3: Preparation of Rapid Release Pellets Containing Loratadine and Pseudoephedrine Sulfate

[0037] The procedure of Example 1 was repeated except that the amounts of the components were changed as shown in Table 1 to obtain additional samples of rapid release pellets containing pseudoephedrine sulfate and loratadine.

[0038] Example 2

Embodiment 4

[0039] Embodiment 4: the preparation of the core pill containing pseudoephedrine sulfate

[0040] A binder solution was prepared by dissolving 20 g of hydroxypropyl cellulose in 480 g of water. 1200 g of pseudoephedrine sulfate and 3 g of colloidal silicon dioxide were mixed and sieved through a 20-mesh sieve to give a mixed powder. While spraying the binder solution prepared above onto 600 g of sugar seeds in the centrifugal granulator, the mixed powder was dusted on the sugar seeds in the centrifugal granulator to provide pellets. The pellets obtained were dried at 50°C until its water content was less than 2% as determined by a Kett-moisture analyzer to give core pellets containing pseudoephedrine sulfate.

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Abstract

The present invention relates to a pharmaceutical capsule composition for oral administration, which comprises rapid-release pellets (pellets A) containing loratadine and pseudoephedrine or a pharmaceutically acceptable salt thereof and extended-release pellets (pellets B) containing pseudoephedrine or a pharmaceutically acceptable salt thereof, wherein the pellets B are coated with a water-insoluble polymer and a wet-blocking agent.

Description

technical field [0001] The present invention relates to the medicine capsule composition containing loratadine and pseudoephedrine, more specifically, relate to oral medicine capsule composition, it comprises: Contain the quick release pill of loratadine and pseudoephedrine or its pharmaceutically acceptable salt (Pill A) and a sustained-release pellet (Pill B) containing pseudoephedrine or a pharmaceutically acceptable salt thereof, wherein the pellet B is coated with a water-insoluble polymer and a moisture barrier. Background technique [0002] Pseudoephedrine or a pharmaceutically acceptable salt thereof (eg, pseudoephedrine sulfate) is recognized by those skilled in the art as a sympathomimetic drug effective in the treatment of nasal congestion. Loratadine, a non-sedating antihistamine, is also known to be useful as an antiallergic agent for the treatment of seasonal allergic rhinitis symptoms such as sneezing and itching. Therefore, an oral dosage composition contain...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/50A61K9/52A61K9/54A61K31/445A61P11/06
CPCA61K9/5084A61K9/1635A61K9/1652A61K9/5078A61K9/5015A61K31/445A61K9/5026A61K9/1676A61K9/5047A61P11/02A61P11/06A61P37/08A61K31/135A61K2300/00
Inventor 赵恒範朴映準金贤洙
Owner YUHAN