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Pharmaceutical composition of piperazine derivatives

A composition and mixture technology, which is applied in the directions of drug combination, drug delivery, and pharmaceutical formulation, can solve problems such as microbial contamination, and achieve the effect of avoiding dissolution

Active Publication Date: 2009-07-08
UCB FARCHIM
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, once the seal of the container is broken and the pharmaceutical composition is fully used for a period of time, each time the container is used and their lid is opened or closed, these pharmaceutical compositions are continuously exposed to environmental or Risk of microbial contamination in humans

Method used

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  • Pharmaceutical composition of piperazine derivatives
  • Pharmaceutical composition of piperazine derivatives

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1. the preservative effect of cetirizine

[0041] Oral solutions and drops containing cetirizine are prepared. The composition is given in Table 1.

[0042] Table 1.- Cetirizine compositions

[0043] oral solution drops Cetirizine hydrochloride (mg) 1 10 70% sorbitol solution (mg) 450 - Glycerin (mg) 200 250 Propylene glycol (mg) 50 350 Sodium saccharin (mg) 1 10 Banana flavor (mg) 0.1754 - Sodium acetate (mg) 4.2 10 Acetic acid Add to pH5 Add to pH5 Purified water (ml) add to 1 add to 1

[0044] Preservative efficacy tests of antimicrobial agents were carried out according to the European Pharmacopoeia (chapter 5.1.3.). Oral solution and drop samples were incubated with bacterial and yeast suspensions Pseudomonas aeruginosa ATCC 9027, Escherichia coli ATCC 8739, Staphylococcus aureus ATCC6538, Candida albicans ATCC 10231 and Aspergillus niger ATCC 16404. The number of v...

Embodiment 2

[0051] Embodiment 2. the antiseptic effect of levocetirizine

[0052] Oral solutions and drops containing levocetirizine are prepared. The composition is given in Table 4.

[0053] Table 4.- Levocetirizine compositions

[0054] oral solution drops Levocetirizine hydrochloride (mg) 0.5 5 Maltitol-Lycarcin 80-55(mg) 400 - Glycerin 85% (mg) 235.2 294.1 Propylene glycol (mg) - 350 Sodium saccharin (mg) 0.5 10 Spices (Tutti frutti) with various fruit flavors (mg) 0.15 - Sodium acetate (mg) 3.4 5.7 Acetic acid (mg) 0.5 0.53 Purified water (ml) add to 1 add to 1

[0055] Preservative efficacy tests of antimicrobial agents were carried out according to the European Pharmacopoeia (chapter 5.1.3.). Oral solution and drop samples were incubated with bacterial and yeast suspensions Pseudomonas aeruginosa ATCC 9027, Escherichia coli ATCC 8739, Staphylococcus aureus ATC C6538, Candida albicans ATCC 10231...

Embodiment 3

[0061] Example 3. Antimicrobial Preservative Effect of Paraben on Cetirizine Aqueous Solution fruit

[0062] Oral solutions and drops containing cetirizine were prepared according to Example 1, but also containing a mixture of parabens (methylparaben / propylparaben in a weight ratio of 9 / 1) . The total amount of parabens was 0.15 mg / ml, 0.45 mg / ml, 0.75 mg / ml and 1.05 mg / ml. The antimicrobial preservation effect of these solutions and drops was determined according to the European Pharmacopoeia (Chapter 5.1.3.). The test results are given in Tables 7-14.

[0063] Table 7. Microorganism content in inoculated samples of oral solution containing 0.15 mg / ml paraben

[0064] time (days)

aeruginosa fake

Bacteria Escherichia coli

bacillus golden yellow grape

Staphylococcus white rosary

bacteria Aspergillus niger

Inoculum 5.5×10 5 4.6×10 5 4.0×10 5 3.7×10 5 2.3×10 6 0 5.1×10 5 4.5×10 5 3.0×10 5 4.0×10 5 4.1×10 6 ...

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Abstract

The present invention relates to liquid compositions comprising an active substance belonging to the family of substituted benzhydrylpiperazines and a reducing preservative.

Description

field of invention [0001] The present invention relates to liquid pharmaceutical compositions comprising active substances such as cetirizine, levocetirizine and elerelizine. Background of the invention [0002] A number of substances belonging to the family of substituted benzhydrylpiperazines are known to be substances with useful pharmacological properties. [0003] European Patent EP 58146 filed in the name of UCB, S.A. describes substituted benzhydrylpiperazines having the general formula, and pharmaceutically acceptable salts thereof: [0004] [0005] Among them, L stands for -OH or -NH 2 group, X and X' represent hydrogen atom, halogen atom, C 1 or C 4 Straight-chain or branched alkoxy group or trifluoromethyl group on the position, m is equal to 1 or 2, and n is equal to 1 or 2. [0006] Among these compounds, 2-[2-[4-[(4-chlorophenyl)phenylmethyl]-1-piperazinyl]ethoxy]acetic acid (also known as cetirizine) and its di The antihistamine properties of hydrochl...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/495A61K9/08A61K47/14A61P37/00
CPCA61K9/0048A61K31/495A61K9/0095A61K9/0043A61K47/14A61P37/08A61P43/00C07D487/04
Inventor D·法纳拉J·苏瓦尔特C·普兰M·迪勒斯
Owner UCB FARCHIM
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