Pharmaceutical composition for improving palatability of drugs and process for preparation thereof
A composition and drug technology, applied in drug delivery, pharmaceutical formulations, antibacterial drugs, etc., can solve the problems of delayed drug release and inability to provide taste-masking effect, etc.
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Embodiment 1
[0085] Examples 1 and 2 disclose methods for preparing acid soluble / swellable polymers. As illustrated in Examples 3-9, time-dependent drug release was determined for the taste-masked pharmaceutical compositions given below. The samples were wetted in the dissolution medium taken from 900ml of medium and placed again in the dissolution vessel. The glass beaker used to wet the sample was flushed with excess dissolution medium prior to dissolution and the dissolution medium was placed again in the dissolution vessel.
[0086] The release of cefuroxime axetil from taste-masked granules was tested in 900 ml of 0.07N hydrochloric acid at 37±0.5°C using a USP type II apparatus rotating at 100 rpm. Samples were taken at 30, 60, 120, 180 and 240 minutes. Each withdrawn volume was replaced with fresh media to maintain sink conditions.
[0087] The release of ciprofloxacin hydrochloride from the taste-masked granules was tested in 900 ml of 0.01N hydrochloric acid buffer at 37±0.5°C ...
Embodiment 2
[0092] Acid-soluble or swellable polymers are synthesized by solution polymerization. The hydrophobic monomer, basic monomer and optional hydrophilic monomer are dissolved in dimethylformamide solvent. The polymer had the following monomer composition: 73% by weight methyl methacrylate, 18% by weight hydroxyethyl methacrylate and 9% by weight vinylpyridine. The azo initiator, azobisisobutyronitrile, was added to the monomer in dimethylformamide solution. The reaction mixture was purged with nitrogen to provide an inert atmosphere. Polymerization was accomplished by heating the reaction mixture to 65°C for 18 hours. The synthesized polymer was recovered by precipitation in a non-solvent (here water) and dried under vacuum at 45°C. The molecular weight of the synthesized polymer was determined by Waters Gel Permeation Chromatography, using a polystyrene type cross-linked copolymer (Styragel) column, with a polystyrene standard (Polysciences, USA) as a reference. The polymer ...
Embodiment 3
[0094] A taste-masked composition is obtained by dissolving the drug in an organic solvent solution of lipids and polymers, and obtaining microparticles containing the drug by microencapsulation in water and evaporation of the organic solvent.
[0095] Lipid-polymer solutions: Table 1 shows the compositions containing various lipid-polymer mixtures. The acid soluble polymer prepared in Example 1 was used as one of the pH dependent polymers in all compositions. The amount of solvent used was 7 ml of chlorinated hydrocarbons such as chloroform and dichloromethane. The amounts of lipids and polymers are shown in Table 1.
[0096] Taste-masked microparticles were obtained by emulsification solvent evaporation technique. Cefuroxime axetil was dissolved in the lipid-polymer solution prepared with the necessary amount of solvent. The lipid-polymer solution containing the drug was added dropwise into a distilled water bath under mechanical stirring. 0.1% by weight of polyvinyl alc...
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