Taste masked pharmaceutical compositions comprising bitter drug and pH sensitive polymer

A technology of polymers and compositions, which is applied in the field of preparation of taste-masking pharmaceutical compositions, and can solve problems such as unsatisfactory release and disadvantages

Inactive Publication Date: 2006-12-13
COUNCIL OF SCI & IND RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0030] Although the use of the polymer coating in the above-mentioned examples is effective in delaying the dissolution of the drug during chewing when in contact with saliva, it has disadvantages in the preparation of taste-masked liquid components for prolonged storage in contact with liquid media. aspect
Among the references mentioned above, none of the documents can meet the requirements of masking the bitter taste of the drug in pharmaceutical compositions such as suspensions and dry syrups. Suspension leaching, and cannot be released in the stomach after ingestion without affecting bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] Taste-masked microcapsules can be obtained by emulsification solvent evaporation technique. 3.50 g of ciprofloxacin were dispersed in a polymer solution containing 900 mg of polymer in 45 ml of a mixture of methanol and dichloromethane (1:1). The polymer has a monomer composition of 60% by weight methyl methacrylate, 25% by weight hydroxyethyl methacrylate and 15% by weight vinylpyridine. The nonionic surfactant Span 85 was added at 0.5% weight / weight (w / w) to facilitate the dispersion of ciprofloxacin in the polymer solution. Add the dispersed phase of ciprofloxacin dropwise into the light liquid paraffin bath under mechanical stirring. A constant mechanical stirring rate of 1000 rpm was maintained for 3-4 hours at room temperature. The solvent was evaporated and the microspheres obtained were isolated by filtration, washed with petroleum ether and dried under vacuum at 27° C. for 24 hours. The drug release profile of the prepared compositions was studied, and the r...

Embodiment 2

[0114] The taste-masked microcapsules of the bitter drug were obtained by microencapsulation by emulsification solvent evaporation technique. 2.35 g of ciprofloxacin were dispersed in a polymer solution containing 7.0 g of polymer in 40 ml of a mixture of methanol and dichloromethane (1:1). The polymer has a monomer composition of 60% by weight methyl methacrylate, 25% by weight hydroxyethyl methacrylate and 15% by weight vinylpyridine. Microencapsulation of ciprofloxacin with the pH sensitive polymer was accomplished using a method similar to that described in Example 1. The drug release profile of the prepared compositions was investigated and the results are listed in Table 2.

[0115] Table 2

Embodiment 3

[0117] Taste-masked microcapsules were obtained by microencapsulation by emulsified solvent evaporation technique. 2.0 g of clarithromycin was dissolved in a polymer solution containing 4.0 g of polymer in 40 ml of a mixture of methanol and dichloromethane (1:1). The polymer has a monomer composition of 60% by weight methyl methacrylate, 25% by weight hydroxyethyl methacrylate and 15% by weight vinylpyridine. The microencapsulation of clarithromycin and pH-sensitive polymer was accomplished using a method similar to that of Example 1. The drug release profile of the prepared compositions was investigated and the results are listed in Table 3.

[0118] table 3

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Abstract

The present invention discloses pharmaceutical compositions comprising of pH sensitive polymers used for taste masking highly bitter drugs. The pH sensitive polymer acts as a reverse enteric coating, which is soluble in the acidic pH range 1.0 to 3.0 normally found in the stomach but is insoluble in the pH range 3.5 to 7 thus inhibiting the release of the bitter drug at the pH of saliva and also at the pH of reconstitution medium in case of liquid orals.

Description

field of invention [0001] The present invention relates to a taste-masking composition comprising a bitter drug and a pH-sensitive polymer and a method for preparing the composition. The present invention also relates to a method for preparing a taste-masked pharmaceutical composition comprising a bitter drug and a pH-sensitive polymer. Background of the invention [0002] Although many delivery systems have been developed for different routes of administration, such as oral, parenteral, nasal, and transdermal, among others, the oral route remains the most attractive for drug delivery because it is a simple, convenient, non-invasive and common method of drug delivery. Most prescription drugs are designed for oral use because patients can self-administer them without hospitalization. Oral dosage forms can be designed according to the nature of the drug, the nature of the administration and the need for any particular action desired in the delivery system. Conventional oral...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16
CPCA61K9/1635
Inventor 莫汉·戈帕里克希纳·库尔卡尼阿尼奥帕·拉梅什·曼乔治
Owner COUNCIL OF SCI & IND RES
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