[0020] The การเปิดเผยนี้ provides nutritional compositions and methods for
providing nutritional support. The nutritional compositions include a ส่วนประกอบไลปิด ซึ่งประกอบรวมด้วย DHA and ARA and are suitable for delivery to subjects suffering from nutritional deficiencies, such as preterm infants. The การเปิดเผยนี้ further provides an improved fortifier for
addition to human milk or infant formula. The fortifier ประกอบรวมด้วย a stable emulsion of DHA and ARA. The การเปิดเผยนี้ still further provides methods for providing nutritional support to subjects, such as preterm infants. A full and enabling disclosure of the การเปิดเผยนี้,
ที่รวมถึง the best mode thereof directed to one of ordinary skill in the art, is set forth in the
specification below.
[0021] Hereinafter, "enteral administration" includes, but is not limited to, feeding via nasogastric tube, orogastric feeding, intragastric feeding, or transpyloric administration.
"Enteral administration" may also include any other method known in the art for introducing a nutritional composition directly into the digestive tract other than via oral feeding.
[0022] The phrase "nutritional composition" includes nutritional supplements, human
milk fortifiers, infant formula fortifiers, and the like, but is not limited to the same. The nutritional compositions of the การเปิดเผยนี้ may be suitable for either enteral or oral administration. [0023] "Preterm infant" means a subject born before 37 weeks gestational age. The phrase "preterm infant" is used interchangeably with the phrase "premature infant."
[0024] "Low birth weight infant" means an infant born weighing less than 2500 grams (approximately 5 Ibs, 8 ounces).
[0025] "Very low birth weight infant" means an infant born weighing less than 1500 grams (approximately 3 Ibs, 4 ounces).
[0026] "Extremely low birth weight infant" means an infant born weighing less than 1000 grams (approximately 2 Ibs, 3 ounces).
[0027] "Infant" means a human subject ranging in age from birth to not more than about one year and includes infants from 0 ถึงประมาณ 12 months corrected. The phrase "corrected age" means an infant's chronological age minus the amount of time that the infant was born
premature. Therefore, the corrected age is the age of the infant if it had been carried to full term. The term infant includes low birth weight infants, very low birth weight infants, extremely low birth weight infants and preterm infants.
[0028] "Emulsion" means a mixture of two or more immiscible liquids ซึ่งประกอบรวมด้วย a dispersed phase and a continuous phase. In an emulsion, one liquid, called the dispersed phase, is
dispersed in the other liquid, called the continuous phase, bulk phase, or เอเควียส component.
[0029] "Unit dose" refers to a single package of a nutritional composition.
[0030] All percentages, parts and ratios as used herein are by weight of the total
composition, unless otherwise specified.
[0031] The nutritional composition of the การเปิดเผยนี้ may also be substantially free of any optional or selected ingredients described herein, provided that the remaining
nutritional composition still contains all of the required ingredients or features described herein. In this context, and unless otherwise specified, the term "substantially free" means that the
selected composition contains less than a functional amount of the optional ingredient, typically less than 0.1% by weight, and also, ที่รวมถึง zero percent by weight of such optional or
selected ingredient.
[0032] All references to singular characteristics or limitations of the การเปิดเผยนี้ shall include the corresponding plural characteristics or limitations, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.
[0033] All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.
[0034] The methods and compositions of the การเปิดเผยนี้, ที่รวมถึง components thereof, can ประกอบรวมด้วย, consist of, or consist essentially of the essential elements and limitations of the disclosure described herein, as well as any additional or optional ingredients,
components or limitations described herein or otherwise useful in nutritional compositions.
[0035] As used herein, the term "about" should be construed to refer to both of the
numbers specified in any range. Any reference to a range should be considered as providing support for any subset within that range.
[0036] The nutritional composition of the การเปิดเผยนี้ may provide nutritional
support to preterm and/or low-birth-weight infants or to any other patient with unmet nutritional needs. In บางรูปลักษณะ, the nutritional composition is designed to meet specific
nutritional needs of individual subjects, such as infants or preterm infants, in stable, unit-dose
liquid compositions standardized to a specified caloric content and/or as a concentrate to meet a subject's particular nutritional needs.
[0037] Furthermore, the การเปิดเผยนี้ provides a nutritional composition that is
useful to combat nutritional inadequacy in the provision of nutrients to those subjects relying on partial or total parenteral nutrition, thereby promoting healthy development of a subject.
Indeed, the nutritional composition provides effective amounts of nutrients, such as DHA or ARA, which will promote, for example, visual and neural development in an infant.
[0038] In บางรูปลักษณะ, the ส่วนประกอบไลปิด of the nutritional composition
ประกอบรวมด้วย a single fatty acid, such as a LCPUFA or a combination of LCPUFAs. LCPUFAs generally have a carbon chain length of at least 18. Suitable LCPUFAs for inclusion in the nutritional composition include, but are not limited to, w-3 or w-6 long-chain polyunsaturated acids, such as ARA (20:4n-6) and DHA (22:6n-3). In one embodiment, the ส่วนประกอบไลปิด ประกอบรวมด้วย DHA. In รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด of the nutritional composition ประกอบรวมด้วย both DHA and ARA. The preferred forms of DHA and ARA incorporated in the nutritional composition are free, non-esterified DHA and ARA.
[0039] The ส่วนประกอบไลปิด of the nutritional composition may ประกอบรวมด้วย between about
0.3% and about 5% w/w DHA in บางรูปลักษณะ. In a particular embodiment, the lipid
component ประกอบรวมด้วย at least about 0.32% DHA. In รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about 0.5% DHA. In บางรูปลักษณะ, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about 1% DHA. In further embodiments, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about
1.5% DHA. It still รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด of the nutritional composition ประกอบรวมด้วย at least about 2% DHA.
[0040] DHA may, in บางรูปลักษณะ, ประกอบรวมด้วย between about 15% and 30% w/w of the total ส่วนประกอบไลปิด. In รูปลักษณะอื่นๆ, DHA ประกอบรวมด้วย at least about 20% ถึงประมาณ 30% w/w of the ส่วนประกอบไลปิด. Still in further embodiments, DHA ประกอบรวมด้วย at least about 20% w/w of the ส่วนประกอบไลปิด. In still รูปลักษณะอื่นๆ, DHA ประกอบรวมด้วย 28% w/w of the ส่วนประกอบไลปิด. Indeed, the ส่วนประกอบไลปิด of the การเปิดเผยนี้ may be formulated with higher or lower amounts of DHA than are commonly known in the art. The nutritional
compositions formulated with a higher amount of DHA may provide additive and/or synergistic health benefits.
[0041] The source of DHA may be any source known in the art, such as, for example, marine oil, fish oil, single cell oil, egg yolk lipid, and brain lipid. The DHA can be in natural or refined form. Further, in one embodiment, the nutritional composition ประกอบรวมด้วย a source of DHA ซึ่งประกอบรวมด้วย DHASCO® and/or a fungal oil blend. In บางรูปลักษณะ, the nutritional
composition ประกอบรวมด้วย a source of DHA ซึ่งประกอบรวมด้วย LIPIL oil.
[0042] Likewise, in บางรูปลักษณะ, the nutritional composition may be formulated to deliver at least about 25 mg/kg/day of DHA to the subject. In บางรูปลักษณะ, the
7
nutritional composition may be formulated to deliver at least about 50 mg/kg/day DHA. In รูปลักษณะอื่นๆ, the nutritional composition may deliver at least about 60 mg/kg/day of DHA to the subject. And in บางรูปลักษณะ, the nutritional composition may be formulated to
deliver at least about 75 mg/kg/day of DHA to the subject. In further embodiments, the
nutritional composition is formulated to deliver at least about 100 mg/kg/day DHA. Accordingly, then, as many preterm infants weigh between about 500 g and 2000 g, the nutritional
composition may be formulated to deliver, for example, between about 12 mg and 200 mg of DHA per day. In บางรูปลักษณะ, the nutritional composition will ประกอบรวมด้วย between about
12 and about 200 mg of DHA per 100 ml...
[0043] The ส่วนประกอบไลปิด of the nutritional composition may ประกอบรวมด้วย between about
0.5% and about 5% w/w ARA. In one embodiment, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least
about 0.64% ARA.
[0020] The การเปิดเผยนี้ provides nutritional compositions and methods forproviding nutritional support. The nutritional compositions include a ส่วนประกอบไลปิด ซึ่งประกอบรวมด้วย DHA and ARA and are suitable for delivery to subjects suffering from nutritional deficiencies, such as preterm infants. The การเปิดเผยนี้ further provides an improved fortifier for addition to human milk or infant formula. The fortifier ประกอบรวมด้วย a stable emulsion of DHA and ARA. The การเปิดเผยนี้ still further provides methods for providing nutritional support to subjects, such as preterm infants. A full and enabling disclosure of the การเปิดเผยนี้, ที่รวมถึง the best mode thereof directed to one of ordinary skill in the art, is set forth in the specification below.[0021] Hereinafter, "enteral administration" includes, but is not limited to, feeding via nasogastric tube, orogastric feeding, intragastric feeding, or transpyloric administration. "Enteral administration" may also include any other method known in the art for introducing a nutritional composition directly into the digestive tract other than via oral feeding.[0022] The phrase "nutritional composition" includes nutritional supplements, humanmilk fortifiers, infant formula fortifiers, and the like, but is not limited to the same. The nutritional compositions of the การเปิดเผยนี้ may be suitable for either enteral or oral administration. [0023] "Preterm infant" means a subject born before 37 weeks gestational age. The phrase "preterm infant" is used interchangeably with the phrase "premature infant."[0024] "Low birth weight infant" means an infant born weighing less than 2500 grams (approximately 5 Ibs, 8 ounces).[0025] "Very low birth weight infant" means an infant born weighing less than 1500 grams (approximately 3 Ibs, 4 ounces).[0026] "Extremely low birth weight infant" means an infant born weighing less than 1000 grams (approximately 2 Ibs, 3 ounces).[0027] "Infant" means a human subject ranging in age from birth to not more than about one year and includes infants from 0 ถึงประมาณ 12 months corrected. The phrase "corrected age" means an infant's chronological age minus the amount of time that the infant was born premature. Therefore, the corrected age is the age of the infant if it had been carried to full term. The term infant includes low birth weight infants, very low birth weight infants, extremely low birth weight infants and preterm infants.[0028] "Emulsion" means a mixture of two or more immiscible liquids ซึ่งประกอบรวมด้วย a dispersed phase and a continuous phase. In an emulsion, one liquid, called the dispersed phase, is dispersed in the other liquid, called the continuous phase, bulk phase, or เอเควียส component.
[0029] "Unit dose" refers to a single package of a nutritional composition.
[0030] All percentages, parts and ratios as used herein are by weight of the total
composition, unless otherwise specified.
[0031] The nutritional composition of the การเปิดเผยนี้ may also be substantially free of any optional or selected ingredients described herein, provided that the remaining
nutritional composition still contains all of the required ingredients or features described herein. In this context, and unless otherwise specified, the term "substantially free" means that the
selected composition contains less than a functional amount of the optional ingredient, typically less than 0.1% by weight, and also, ที่รวมถึง zero percent by weight of such optional or
selected ingredient.
[0032] All references to singular characteristics or limitations of the การเปิดเผยนี้ shall include the corresponding plural characteristics or limitations, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made.
[0033] All combinations of method or process steps as used herein can be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.
[0034] The methods and compositions of the การเปิดเผยนี้, ที่รวมถึง components thereof, can ประกอบรวมด้วย, consist of, or consist essentially of the essential elements and limitations of the disclosure described herein, as well as any additional or optional ingredients,
components or limitations described herein or otherwise useful in nutritional compositions.
[0035] As used herein, the term "about" should be construed to refer to both of the
numbers specified in any range. Any reference to a range should be considered as providing support for any subset within that range.
[0036] The nutritional composition of the การเปิดเผยนี้ may provide nutritional
support to preterm and/or low-birth-weight infants or to any other patient with unmet nutritional needs. In บางรูปลักษณะ, the nutritional composition is designed to meet specific
nutritional needs of individual subjects, such as infants or preterm infants, in stable, unit-dose
liquid compositions standardized to a specified caloric content and/or as a concentrate to meet a subject's particular nutritional needs.
[0037] Furthermore, the การเปิดเผยนี้ provides a nutritional composition that is
useful to combat nutritional inadequacy in the provision of nutrients to those subjects relying on partial or total parenteral nutrition, thereby promoting healthy development of a subject.
Indeed, the nutritional composition provides effective amounts of nutrients, such as DHA or ARA, which will promote, for example, visual and neural development in an infant.
[0038] In บางรูปลักษณะ, the ส่วนประกอบไลปิด of the nutritional composition
ประกอบรวมด้วย a single fatty acid, such as a LCPUFA or a combination of LCPUFAs. LCPUFAs generally have a carbon chain length of at least 18. Suitable LCPUFAs for inclusion in the nutritional composition include, but are not limited to, w-3 or w-6 long-chain polyunsaturated acids, such as ARA (20:4n-6) and DHA (22:6n-3). In one embodiment, the ส่วนประกอบไลปิด ประกอบรวมด้วย DHA. In รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด of the nutritional composition ประกอบรวมด้วย both DHA and ARA. The preferred forms of DHA and ARA incorporated in the nutritional composition are free, non-esterified DHA and ARA.
[0039] The ส่วนประกอบไลปิด of the nutritional composition may ประกอบรวมด้วย between about
0.3% and about 5% w/w DHA in บางรูปลักษณะ. In a particular embodiment, the lipid
component ประกอบรวมด้วย at least about 0.32% DHA. In รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about 0.5% DHA. In บางรูปลักษณะ, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about 1% DHA. In further embodiments, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least about
1.5% DHA. It still รูปลักษณะอื่นๆ, the ส่วนประกอบไลปิด of the nutritional composition ประกอบรวมด้วย at least about 2% DHA.
[0040] DHA may, in บางรูปลักษณะ, ประกอบรวมด้วย between about 15% and 30% w/w of the total ส่วนประกอบไลปิด. In รูปลักษณะอื่นๆ, DHA ประกอบรวมด้วย at least about 20% ถึงประมาณ 30% w/w of the ส่วนประกอบไลปิด. Still in further embodiments, DHA ประกอบรวมด้วย at least about 20% w/w of the ส่วนประกอบไลปิด. In still รูปลักษณะอื่นๆ, DHA ประกอบรวมด้วย 28% w/w of the ส่วนประกอบไลปิด. Indeed, the ส่วนประกอบไลปิด of the การเปิดเผยนี้ may be formulated with higher or lower amounts of DHA than are commonly known in the art. The nutritional
compositions formulated with a higher amount of DHA may provide additive and/or synergistic health benefits.
[0041] The source of DHA may be any source known in the art, such as, for example, marine oil, fish oil, single cell oil, egg yolk lipid, and brain lipid. The DHA can be in natural or refined form. Further, in one embodiment, the nutritional composition ประกอบรวมด้วย a source of DHA ซึ่งประกอบรวมด้วย DHASCO® and/or a fungal oil blend. In บางรูปลักษณะ, the nutritional
composition ประกอบรวมด้วย a source of DHA ซึ่งประกอบรวมด้วย LIPIL oil.
[0042] Likewise, in บางรูปลักษณะ, the nutritional composition may be formulated to deliver at least about 25 mg/kg/day of DHA to the subject. In บางรูปลักษณะ, the
7
nutritional composition may be formulated to deliver at least about 50 mg/kg/day DHA. In รูปลักษณะอื่นๆ, the nutritional composition may deliver at least about 60 mg/kg/day of DHA to the subject. And in บางรูปลักษณะ, the nutritional composition may be formulated to
deliver at least about 75 mg/kg/day of DHA to the subject. In further embodiments, the
nutritional composition is formulated to deliver at least about 100 mg/kg/day DHA. Accordingly, then, as many preterm infants weigh between about 500 g and 2000 g, the nutritional
composition may be formulated to deliver, for example, between about 12 mg and 200 mg of DHA per day. In บางรูปลักษณะ, the nutritional composition will ประกอบรวมด้วย between about
12 and about 200 mg of DHA per 100 ml...
[0043] The ส่วนประกอบไลปิด of the nutritional composition may ประกอบรวมด้วย between about
0.5% and about 5% w/w ARA. In one embodiment, the ส่วนประกอบไลปิด ประกอบรวมด้วย at least
about 0.64% ARA.
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