Delivery system
11872316 ยท 2024-01-16
Assignee
Inventors
Cpc classification
A61K9/5026
HUMAN NECESSITIES
A61K9/5036
HUMAN NECESSITIES
A23V2002/00
HUMAN NECESSITIES
A61K9/5073
HUMAN NECESSITIES
A23P20/105
HUMAN NECESSITIES
A61K9/2886
HUMAN NECESSITIES
International classification
A61K9/28
HUMAN NECESSITIES
A23P10/30
HUMAN NECESSITIES
A23P20/10
HUMAN NECESSITIES
A61K9/48
HUMAN NECESSITIES
Abstract
The present invention relates to a new delivery system for nutritional ingredients (nutraceuticals). These nutritional ingredients are useful for gut and metabolic health in monogastric animals, especially in humans.
Claims
1. A particulate delivery system comprising coated particles adapted to deliver at least one nutraceutical to large intestines of a patient, wherein each of the coated particles consists of: (a) 10-85 wt. %, based on total weight of the delivery system, of a particulate solid core consisting of butyric acid and/or salts thereof as a nutraceutical, (b) 1-20 wt. %, based on total weight of the delivery system, of an inner coating having a substantially uniform thickness of 5 m to 20 m which covers the solid core, wherein the inner coating comprises at least one fermentable crosslinked biopolymer, and (c) 1-30 wt. %, based on total weight of the delivery system, of an outer coating having a substantially uniform thickness of 10 m to 30 m which covers the inner coating, wherein the outer coating is formed of a material resistant to stomach and small intestine conditions to thereby allow release of the at least one nutraceutical in the large intestines of the patient.
2. The particulate delivery system according to claim 1, wherein the at least one fermentable crosslinked biopolymer of the inner coating is selected from the group consisting of alginate, chitosan, pectin, cyclodextrin and gums.
3. The particulate delivery system according to claim 1, wherein the inner coating layer is crosslinked with Mg and/or Ca ions.
4. The particulate delivery system according to claim 1, wherein the outer coating is formed of a material selected from the group consisting of shellac, methacrylate copolymers and fats.
5. The particulate delivery system according to claim 1, wherein the inner coating has a substantially uniform thickness of 5 m to 10 m.
6. The particulate delivery system according to claim 1, wherein the outer coating has a substantially uniform thickness of 10 m to 20 m.
7. A process for producing the particulate delivery system according to claim 1, wherein the process comprises forming the coated particles by the sequential steps of: (a) producing the particulate solid core by a spray drying process; (b) spraying at least one fermentable uncrosslinked biopolymer onto the particulate solid core; (c) contacting the at least one fermentable uncrosslinked biopolymer with a crosslinker to form the inner coating which covers the solid core comprised of the at least one crosslinked biopolymer; (d) spraying the material resistant to stomach and small intestine conditions onto the inner coating to thereby form the outer coating of the particulate delivery system; and thereafter (e) drying the coated particles.
8. The process according to claim 7, wherein the steps (a)-(e) of the process are carried out batch-wise or continuously.
9. A product which comprises the particulate delivery system according to claim 1.
10. The product according to claim 9, wherein the product is a premix product, a dietary supplement product, a food product, a feed product, a personal care product or a pharmaceutical product.
Description
EXAMPLES
Example 1
(1) 30 g Na alginate (grinsted sodium alginate) are dissolved in 1500 g water at 50 C. with stirring. 3.2 g Ca chloride dihydrate is dissolved in 407 g water. 200 g Ca Propionate (Sigma-Aldrich) is filled in a fluid-bed processor (WFP mini, DMR, Wurster configuration). All coating steps were performed at a product temperature of about 40 C. The alginate solution is sprayed on the fluidized Ca propionate powder first. After spraying of the alginate solution, the feeding tube is briefly rinsed with water. The Ca chloride solution is sprayed on the inner coating at 40 C. for hardening. After the hardening solution, 400 g aqueos shellac preparation with a solids content of 25% (Marcoat 125N) is sprayed as outer coating. After spraying of the shellac, the product is dried in the fluid bed. 324 g coated granules were obtained.
(2) Composition of the final coated granulate was 60% Ca-propionate, 9% alginate, 1% Ca chloride and 30% shellac.
(3) Protection of propionate under stomach conditions was tested with 0.1N HCl at 37.5 C. using a USP-1 (SOTAX) apparatus. After 2 hours only 12% of the propionate was released.
Example 2: Comparative Example without Hardening the Inner Layer
(4) Ca-propionate was coated similar to example 1, skipping the hardening step (spraying of Ca chloride). Composition of the final coated granulate was 58% Ca-propionate, 7% Na alginate and 35% shellac.
(5) Protection of propionate under stomach conditions was tested with 0.1N HCl at 37.5 C. using a USP-1 (SOTAX) apparatus. After 2 hours 58% of the propionate was released.