Stabilised particles comprising 5-methyl-(6s)-tetrahydrofolate

A particle and methyl technology, applied in the field of small stabilized particles, which can solve problems such as unrealized taste masking

Inactive Publication Date: 2012-07-25
BAYER PHARMA AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the active agent is released relatively quickly from these particles and complete taste masking is not achieved

Method used

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  • Stabilised particles comprising 5-methyl-(6s)-tetrahydrofolate
  • Stabilised particles comprising 5-methyl-(6s)-tetrahydrofolate
  • Stabilised particles comprising 5-methyl-(6s)-tetrahydrofolate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0236] Preparation of Particles Containing Protective Agents

Embodiment 1A

[0237] Example 1A: / carnauba wax

[0238] 80 g carnauba wax (pharmaceutical grade) was dissolved in 1 kg n-heptane at 60° C. in a 2 liter double wall glass beaker while stirring at 400 rpm until a clear solution was obtained.

[0239] To this solution was slowly added 80 g of micronized To avoid clumping, the stirring rate was adjusted to 600 rpm. The mixture was cooled to 20°C at a cooling rate of 20°C / hour to obtain a drug containing microparticles coated with carnauba wax.

[0240] will contain micronized The particulates were filtered with cellulose acetate filters and glass filter units. The microparticles were then washed with 300 ml ethanol (96%) to remove n-heptane residues and unencapsulated

[0241] The filtered microparticles were transferred to a glass bowl and dried at 30°C for 2 hours.

[0242] The resulting batches of protected particles had the following particle sizes, containing The microparticles are coated with a protective agent.

[0243]...

Embodiment 1B

[0244] Example 1B: / carnauba wax

[0245] As described in Example 1A, using 40 g of micronized instead of 80g to prepare containing of particles.

[0246] The resulting batches of protected particles had the following particle sizes, containing The microparticles are coated with a protective agent.

[0247]

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Abstract

The present invention relates to small stabilised particles comprising a crystalline form of an alkaline earth metal salt of 5-methyl-(6S)-tetrahydrofolate and at least one protective agent. Such particles confer stability to the alkaline earth metal salt of 5-methyl-(6S)-tetrahydrofolate, and is conveniently incorporated in unit dosage forms, such as wafers.

Description

technical field [0001] The present invention relates to small stabilized granules comprising alkaline earth metal salt of 5-methyl-(6S)-tetrahydrofolate in crystalline form and at least one protective agent. The granules provide stability to the alkaline earth metal salt of 5-methyl-(6S)-tetrahydrofolate and facilitate incorporation into unit dosage forms such as wafers. Background technique [0002] In pregnant women, correction of low folate serum levels takes at least 2 months and reserves last only a few weeks. According to the recommendations of public health agencies, all women who are about to become pregnant should take 400 μg of folic acid per day to reduce the risk of birth defects (MMWR Morb. Mortal. Wkly. Rep. 1992; 41(RR-14): 1-7). Folate supplementation before discontinuous oral contraceptives or immediately after obtaining a positive pregnancy test may not be sufficient to maximize protection of the developing fetus. In addition, several studies of women tak...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/50A61K31/519A61K31/57A61K31/585A61K45/06
CPCA61K9/006A61K9/5015A61K47/44A61K47/42A61K31/519A61K31/57A61K9/0056A61K9/7007A61K47/36A61K47/32A61K31/585A61K45/06A61P3/02A61P15/00A61P15/18A61K2300/00
Inventor S·杰纳勒尔I·泰赖拜希A·丰克
Owner BAYER PHARMA AG
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