Process of manufacturing a stable softgel capsule containing microencapsulated probiotic bacteria

Patent metadata

Field	Value
Publication number	US-9427012-B2
Application number	US-201113204979-A
Country	US
Kind code	B2
Filing date	Aug 8, 2011
Priority date	Aug 10, 2010
Publication date	Aug 30, 2016
Grant date	Aug 30, 2016

Abstract

A softgel capsule containing microencapsulated probiotic bacteria is manufactured such that the softgel capsule is stable for at least about 24 months at room temperature.

First claim

What is claimed is:

1. A process of manufacturing a softgel capsule containing microencapsulated probiotic bacteria comprising the steps of:
(a) providing microencapsulated probiotic bacteria with at least one coating comprising at least one vegetable lipid having a melting point of between about 35° C. and about 75° C.;
(b) suspending the microencapsulated probiotic bacteria in a suspending formulation to make a fill;
(c) mixing the fill at an intensity less than 3000 rpm and a temperature below 33° C. to make a mixed fill;
(d) reducing agglomerates of the microencapsulated probiotic bacteria in the mixed fill to make a de-agglomerated fill; and
(e) encapsulating the de-agglomerated fill in a softgel capsule,
wherein the integrity of the coating of the microencapsulated probiotic bacteria is maintained.

2. The process according to claim 1 , wherein the process is conducted while controlling exposure to oxygen.

3. The process according to claim 2 , wherein the softgel capsule containing microencapsulated probiotic bacteria is stable for at least about 18 months at room temperature.

4. The process according to claim 1 , wherein the agglomerates of the microencapsulated probiotic bacteria are reduced by milling the mixed fill at a temperature below about 33° C.

5. The process according to claim 1 , wherein the microencapsulated probiotic bacteria after encapsulation maintain an average particle diameter size of between about 150 to about 250 microns and less than about 550 microns.

6. The process according to claim 5 , wherein the microencapsulated probiotic bacteria after encapsulation maintain an average particle diameter size of about 200 microns and each microencapsulated probiotic bacteria has a particle diameter size less than about 500 microns.

7. The process according to claim 1 , wherein the at least one vegetable lipid is selected from the group consisting of polyglycerol ester, hydrogenated palm fat, glycerol dipalmitostearate, polyglyceryl-6-distearate, and combinations thereof.

8. The process according to claim 1 , wherein the suspending formulation comprises at least an oil, a suspending fat or an emulsifier.

9. The process according to claim 8 , wherein the suspending formulation comprises at least one oil and at least one material selected from the group consisting of suspending fats, emulsifiers, and combinations thereof.

10. The process according to claim 8 , wherein the at least one oil is selected from the group consisting of soya bean oil, canola oil, sunflower oil, macadamia oil, peanut oil, grapeseed oil, pumpkin seed oil, linseed oil, flaxseed oil, olive oil, maize oil, safflower oil, sesame oil, pine kernel oil, conjugated linoleic acid, almond oil, peach kernel oil, apricot kernel oil, walnut oil, rapeseed oil, raspberry seed oil, bilberry seed oil, cranberry seed oil, pomegranate seed oil and other fruit seed oils, seabuckthorn oil, chia oil, perilla oil, diaglycerol oil, vegetable derived sources of omega 3, fermented sources of eicosapentaenoic acid, fermented sources of docosahexaenoic acid, fermented sources of a combination of eicosapentaenoic acid, docosahexaenoic acid and other omega 3s, sources of gamma-linolenic acid and/or stearidonic acid, fractionated coconut oil, and combinations thereof.

11. The process according to claim 8 , wherein suspending fats are selected from the group consisting of monoglycerides of fatty acids, diglycerides of fatty acids, bees wax, glyceryl monostearate, glyceryl mono dioleate, fractionated palm oil derivatives, hydrogenated palm fat, hydrogenated soya oil derivatives, vegetable butters, medium chain triglycerides, and combinations thereof.

12. The process according to claim 8 , wherein emulsifiers are selected from the group consisting of lecithin, polysorbates, sorbitan mono oleates, and combinations thereof.

13. The process according to claim 1 , wherein the mixing is conducted at a temperature between about 15° C. and about 32° C.

14. The process according to claim 1 , wherein the reducing of agglomerates is performed with the de-agglomerated fill maintaining a temperature below about 33° C. and in a low humidity environment.

15. The process according to claim 1 , further comprising the step of:
(f) double drying the filled softgel capsule.

16. The process according to claim 15 , wherein the double drying is comprised of drying the capsules in a tumbler drier at forced ventilation, followed by drying the capsule on trays stacked inside drying cabinets, wherein the temperature is from about 18° C. to about 25° C. and the relative humidity is at about 8% to about 20%.

17. A probiotic softgel capsule made according to the process of claim 1 .

18. The probiotic softgel capsule according to claim 17 , wherein the process is conducted while controlling exposure to oxygen.

19. The probiotic softgel capsule according to claim 18 , wherein the softgel capsule is stable for at least about 24 months at room temperature.

20. A process of manufacturing a softgel capsule containing microencapsulated probiotic bacteria comprising the steps of:
(a) providing microencapsulated probiotic bacteria with at least one coating comprising at least one vegetable lipid having a melting point of between about 35° C. and about 75° C.;
(b) suspending the microencapsulated probiotic bacteria in a suspending formulation to make a fill;
(c) mixing the fill at an intensity less than 3000 rpm and a temperature below 33° C. to make a mixed fill;
(d) reducing agglomerates of the microencapsulated probiotic bacteria in the mixed fill to make a de-agglomerated fill; and
(e) encapsulating the de-agglomerated fill in a softgel capsule,
wherein the integrity of the coating of the microencapsulated probiotic bacteria is maintained, and
wherein the softgel capsule is stable for at least about 18 months at room temperature.

Assignees

• Valla Claudia
• Bertolami Rosa
• Rosina Giovanni
• Helson Karen
• Scherer Technologies Llc R P

Inventors

• Valla Claudia
• Bertolami Rosa
• Rosina Giovanni
• Helson Karen

Classifications

• A61P37/02

  Immunomodulators · CPC title

• A23P10/30 Primary

  Encapsulation of particles, e.g. foodstuff additives · CPC title

• A61P1/00

  Drugs for disorders of the alimentary tract or the digestive system · CPC title

• A23L33/115

  Fatty acids or derivatives thereof; Fats or oils · CPC title

• A23L33/135

  Bacteria or derivatives thereof, e.g. probiotics · CPC title