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Combination of vitamin d and 25-hydroxyvitamin d 3

A technology of 25-OHD3 and vitamins, which is applied in the direction of drug combination, transportation and packaging, and medical preparations containing active ingredients, and can solve problems that have not been studied

Inactive Publication Date: 2016-12-14
DSM IP ASSETS BV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

To our knowledge, the kinetics of dosing both vitamin D and 25-OH D3 in humans has not been previously studied

Method used

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  • Combination of vitamin d and 25-hydroxyvitamin d 3
  • Combination of vitamin d and 25-hydroxyvitamin d 3
  • Combination of vitamin d and 25-hydroxyvitamin d 3

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] Formulations & Clinical Trials

[0079] Preparation

[0080] Materials and methods

[0081] The 25-OH D3 spray-dried formulation is provided as a powder. Briefly, 25-OH D3 and DL-α-tocopherol were dissolved in oil of medium chain triglycerides and then emulsified into an aqueous solution of modified starch, sucrose and sodium ascorbate. The emulsion was atomized in a spray drier in the presence of silica. The resulting powder was collected at a water content (LOD) of less than 4% and sieved through 400 μm. Pack it and seal it in an aluminum bag, then store it in a dry place below 15°C, and use it within 12 months after its manufacture.

[0082] Three independent groups were made. In detail, a mixture consisting of:

[0083] 17.300kg water (WBI)

[0084] 13.460kg modified food starch (CAPSUL HS)

[0085] ·3.270kg sucrose

[0086] 0.730kg sodium ascorbate

[0087] Prepare an oil phase consisting of:

[0088] 0.550kg BERGABEST MCT oil 60 / 40

[0089] 0.049kg E...

Embodiment 2

[0122] Microarray data

[0123] The aim of the study was to test the effect of vitamin D3, 25-OH D3 and the combination of vitamin D3 and 25-OH D3 in a model of skeletal muscle atrophy using BalbC mice in which tail unloading results in animals unloading the hind limbs Skeletal muscle atrophy. This model was originally established in rats to simulate human spaceflight and is commonly used in other scientific fields to study loss of skeletal muscle mass or bone. The results are considered indicative of human conditions such as senile muscular atrophy (degenerative loss of skeletal muscle mass and strength during aging) or immobilization of skeletal muscle (eg after prolonged bed rest due to bone fractures, surgery or trauma).

[0124] method

[0125] For our study, nine-month-old BalbC female mice were randomly assigned at the beginning of the study into four groups of 10 animals each.

[0126] 1. Control group: hindlimb unloading (HU)

[0127] 2. Vitamin D3 group: HU+vit...

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PUM

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Abstract

We disclose compositions comprising Vitamin D (cholecalciferol and / or ergocalciferol) and 25-OH D3 (calcifediol), and use of those compositions to affect at least concentration, bioavailability, metabolism, or efficacy of vitamin D in a human. Forms and dosages of the composition, as well as processes for manufacturing a spray-dried formulation, are also disclosed.

Description

[0001] This application is a divisional application of the invention patent application "combination of vitamin D and 25-hydroxyvitamin D3" with the filing date of February 12, 2009 and the application number of 200980105261.7 (PCT / EP2009 / 051636). technical field [0002] The present invention relates to compositions comprising vitamin D (cholecalciferol and / or ergocalciferol) and 25-hydroxyvitamin D3 (ergocalcifediol), and said compositions for use in Use affecting at least the concentration, bioavailability, metabolism or potency of vitamin D. Background technique [0003] Vitamin D (eg, ergocalciferol and cholecalciferol) is a group of fat-soluble compounds defined by their biological activity. Vitamin D deficiency causes rickets in children and osteomalacia in adults. However, toxicity may occur after several months of chronic intake of more than 100 times the recommended daily allowance (ie, 5-15 μg or 200-600 IU vitamin D). For vitamin D, "the toxicity threshold is 5...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/593A61K31/59A61P1/00A61P1/12A61P1/16A61P21/00A23L33/155
CPCA61K31/593A23L33/155A61K9/16A61K31/592A61K45/06A23V2002/00A61K31/59A61K2300/00Y10T428/13A61P1/00A61P1/12A61P1/16A61P19/08A61P19/10A61P21/00A61P3/02A61P43/00
Inventor 尼尔·罗伯特·巴克布鲁诺·H·勒安伯格斯文·沃尔夫拉姆沃特·克雷豪伊丽莎白·斯达克林凯·尔本
Owner DSM IP ASSETS BV
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