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CN-122005460-A - Extrudate comprising vitamin A

CN122005460ACN 122005460 ACN122005460 ACN 122005460ACN-122005460-A

Abstract

The present invention relates to extrudates comprising vitamin a, in particular extrudates comprising a matrix and vitamin a palmitate. The matrix comprises or consists of octenyl succinate starch and dextrin. Such water-soluble or water-dispersible extrudates have excellent storage stability and may contain other components, such as other fat-soluble vitamins.

Inventors

  • Gihani Akcal
  • Andrea Purbarrero
  • Alan connolly
  • KIRCHEN STEFANIE
  • RIEGER HENRY
  • Simon sprett
  • URBAN KAI

Assignees

  • 帝斯曼知识产权资产管理有限公司

Dates

Publication Date
20260512
Application Date
20190314
Priority Date
20180315

Claims (14)

  1. 1. A water dispersible extrudate comprising a matrix and vitamin a palmitate, wherein the matrix comprises or consists of octenyl succinate starch and dextrin, wherein the weight ratio between octenyl succinate starch and dextrin is from 2:1 to 1:2.
  2. 2. The water-dispersible extrudate according to claim 1, wherein the extrudate is water-soluble or water-dispersible and preferably has a length of 50 to 2000 μιη.
  3. 3. The water-dispersible extrudate according to any one of the preceding claims, wherein the extrudate comprises at least one lipid-soluble antioxidant.
  4. 4. The water-dispersible extrudate according to any one of the preceding claims, wherein the extrudate comprises alpha-tocopherol and delta-tocopherol, and preferably comprises alpha-tocopherol, beta-tocopherol, gamma-tocopherol and delta-tocopherol.
  5. 5. The water-dispersible extrudate according to any one of the preceding claims, comprising: 1-2 wt.% vitamin A palmitate, based on the total weight of the extrudate and excluding any residual water, 0.001-0.02 Wt.% vitamin D3, based on the total weight of the extrudate and excluding any residual water, 8-15% By weight of dl-alpha-tocopheryl acetate, based on the total weight of the extrudate and excluding any residual water, At least 30% by weight of octenyl succinate starch, based on the total weight of the extrudate and excluding any residual water, -At least 30% by weight of dextrin, based on the total weight of the extrudate and excluding any residual water, and Preferably at least one antioxidant, Wherein the weight ratio between octenyl succinate starch and dextrin is 2:1 to 1:2, preferably 1:1.
  6. 6. A container comprising a plurality of water-dispersible extrudates according to any of claims 1-5.
  7. 7. The container of claim 6, wherein the container is a sachet, pouch or stick pack, and/or wherein each of the extrudates comprises at least 1 wt.% vitamin a palmitate based on the total weight of the water-dispersible extrudate and excluding any residual water.
  8. 8. A process for manufacturing a water-dispersible extrudate comprising at least one fat-soluble vitamin, the process comprising the steps of: -feeding a mixture of octenyl succinate starch and dextrin into a first barrel of an extruder -Injecting water into a second cartridge downstream of said first cartridge -Injecting said at least one fat-soluble vitamin into a third cartridge located downstream of said first cartridge and said second cartridge.
  9. 9. The process according to claim 8, wherein the weight ratio between octenyl succinate starch and dextrin is from 2:1 to 1:2, preferably from 1.5:1 to 1:1.5, most preferably 1:1.
  10. 10. The method of claim 8 or 9, wherein the extrudate comprises vitamin a palmitate.
  11. 11. The method according to any one of claims 8 to 10, wherein the mixture of vitamin a palmitate, vitamin D3, D1-alpha-tocopheryl acetate, and optionally at least one fat-soluble antioxidant is melted before being injected into the third cartridge, and wherein the third cartridge is preferably separated from the second cartridge by at least one cartridge.
  12. 12. Use of vitamin a palmitate for the manufacture of a water-dispersible extrudate, wherein the extrudate comprises octenyl succinate starch and dextrin.
  13. 13. Use according to claim 12, wherein the weight ratio between octenyl succinate starch and dextrin is from 2:1 to 1:2, preferably from 1.5:1 to 1:1.5, most preferably 1:1.
  14. 14. Use according to claim 12 or 13, wherein the water-dispersible extrudate is an extrudate according to any one of claims 1 to 5.

Description

Extrudate comprising vitamin A The application is a divisional application of a Chinese patent application 201980018737.7 (PCT/EP 2019/056448) with the application date of 2019, 3-14. Technical Field The present invention relates to the stability of oral dosage forms comprising vitamin a. Background The oral dosage form comprising vitamin a and other fat-soluble vitamins can be a liquid, tablet, capsule, powder or extrudate. Shelf life is an important feature of any vitamin supplement. Products with shelf lives of less than 6 months are not commercially valuable in many cases. Vitamin a is sensitive to oxygen. Thus, vitamin a extrudates typically require a large number of packages. Vitamin powders are sold in sachets or stick packs. This packaging system is also suitable for extrudates. Bags and stick pack packages typically contain only one dose. After eating, the empty bag is thrown away. This results in considerable wastage, especially if such containers contain a layer of aluminium foil. There is a need for an oral dosage form having all or at least some of the following characteristics: Source of vitamin A Contains other fat-soluble vitamins (besides vitamin A) Has good storage stability and long shelf life No need for expensive and unsustainable packaging materials Low production cost. Disclosure of Invention To reduce commodity costs, extrudates are produced rather than granules, tablets, capsules, etc. The extrudate can be produced continuously, thus reducing commodity costs. By providing a concentrated extrudate of relatively small volume, the cost of goods can be further reduced. Such extrudates require less packaging. This allows cost and waste to be reduced. Packaging costs can be further reduced by providing extrudates which themselves have high stability. If vitamin A palmitate is used as a source of vitamin A, the extrudate containing vitamin A will be more stable. Surprisingly, the stability can be further improved if vitamin a palmitate is embedded in a matrix consisting essentially of octenyl succinate starch and dextrin. Without wishing to be bound by theory, it has been hypothesized that vitamin a palmitate is less prone to crystallization than vitamin a acetate in a matrix consisting essentially of octenyl succinate starch and dextrin. There is a suggestion that vitamin a palmitate combines with the OH groups of the dextrins to help prevent crystallization. The stability of the extrudate comprising vitamin a can be further improved by adding a mixture comprising alpha-tocopherol, beta-tocopherol, gamma-tocopherol and delta-tocopherol. In a preferred embodiment, the extrudate of the present invention comprises 1-2 Wt.% vitamin A palmitate, based on the total weight of the extrudate and excluding any residual water, 0.001-0.02 Wt% of vitamin D3, based on the total weight of the extrudate and excluding any residual water, 8-15% By weight of dl-alpha-tocopheryl acetate, based on the total weight of the extrudate and excluding any residual water, At least 30% by weight of octenyl succinate starch, based on the total weight of the extrudate and excluding any residual water, -At least 30% by weight of dextrin, based on the total weight of the extrudate and excluding any residual water, and Preferably at least one antioxidant, Wherein the weight ratio between octenyl succinate starch and dextrin is 2:1 to 1:2, preferably 1:1. The method of making such an extrudate comprises the steps of: -feeding a mixture of octenyl succinate starch and dextrin into a first barrel of an extruder -Injecting water into a second cartridge downstream of said first cartridge -Injecting fat-soluble vitamins into a third cartridge downstream of the first cartridge and the second cartridge. Detailed Description The present invention relates to extrudates. In the context of the present invention, the term "extrudate" refers to solid particles that are preferably water-soluble or water-dispersible. The "water-soluble" or "water-dispersible" extrudate is placed in 2 dl water at 30 ℃ and stirred with a spoon at 60 rpm (revolutions per minute) for no more than 2 minutes, and disintegrates (fall aprt). In a preferred embodiment of the invention, "water-soluble" and "water-dispersible" refer to extrudates that disintegrate when placed in 2 dl water at 22 ℃ and stirred with a spoon at 60 rpm (revolutions per minute) for no more than 2 minutes. The extrudate of the present invention preferably has a length of 50 μm to 2000 μm, where "length" refers to the longest linear distance that can be measured. The definition of this length takes into account that the particles may have an irregular shape, such as the shape of a potato. In the case of a spherical extrudate, the diameter of the sphere corresponds to the length of the particle. Spherical extrudates are available, for example, by spheronization of cylindrical extrudates. In a preferred embodiment of the invention, the extrudate meets the specifications of 1000 μm > size > 2