DOSAGE FORMS FOR THE DELIVERY OF A PROBIOTIC
Provided are compositions and methods for oral delivery to an infant of a composition containing Bifidobacterium . The composition may be pre-loaded into or placed directly onto an artificial nipple or pacifier and may also be applied directly to the skin of a caregiver and/or to one of the gums, teeth or cheek of the infant. The compositions of the invention are provided in soft gel fill, dissolvable or disintegrable tablet or powder or semisolid forms and are stable for at least 24 months when stored at 25° C. and 65% relative humidity.
1 . A method for oral delivery to an infant of a composition containing Bifidobacterium infantis wherein the composition is applied directly to the skin of a caregiver.
2 . A method of claim 1 wherein the composition further comprises a prebiotic.
3 . A method of claim 2 wherein the prebiotic is an oligosaccharide.
4 . A method of claim 2 wherein the prebiotic is a natural oligosaccharide.
5 . A method of claim 2 wherein the prebiotic is a synthetic molecule functionally equivalent to a natural oligosaccharide.
6 . A method of claim 5 wherein the prebiotic is lacto-N-tetraose (LNT) or 2′-fucosyllactose (2′-FL).
7 . A method of claim 1 wherein the composition is lactose free.
8 . A method of claim 1 wherein the composition further comprises an antioxidant.
9 . A method of claim 1 wherein the composition further comprises a vitamin, mineral or supplement.
10 . A method of claim 1 wherein the composition further comprises a food allergen.
11 . A method of claim 1 wherein the composition is contained in a soft gel.
12 . A method of claim 1 wherein the composition is a semisolid.
13 . A method of claim 1 wherein the composition is stable for at least 3 months when stored at 25° C. and 65% relative humidity.
14 . A method of claim 1 wherein the composition is stable for at least 6 months when stored at 25° C. and 65% relative humidity.
15 . A method of claim 1 wherein the composition is stable for at least 12 months when stored at 25° C. and 65% relative humidity.
16 . A method of claim 1 wherein the composition is stable for at least 24 months when stored at 25° C. and 65% relative humidity.
17 . A method of claim 1 wherein the composition is anhydrous.
18 . A method of claim 1 wherein the composition further comprises an ingredient suitable for skin in need of improving skin barrier function and/or moisturization.
19 . A method of claim 1 wherein the composition further comprises an ingredient suitable to soothe irritated skin or protect against skin irritation.
20 . A method for oral delivery to an infant of a composition containing Bifidobacterium infantis wherein the composition is applied via a caregiver's finger to one of the gums, teeth or cheek of the infant.
21 . A method for oral delivery to an infant of a composition containing Bifidobacterium infantis wherein the composition is applied to or pre-loaded into an artificial nipple or pacifier.
22 . A composition for oral delivery to an infant of a composition containing Bifidobacterium infantis wherein the composition is a dissolvable or disintegrable tablet.
23 . A composition of claim 22 further comprising one or more of a prebiotic, a food allergen and a vitamin, mineral or supplement.
24 . A composition of claim 22 wherein the composition is stable for at least 12 months when stored at 25° C. and 65% relative humidity.
25 . A composition of claim 22 wherein the composition is stable for at least 24 months when stored at 25° C. and 65% relative humidity.