GB2459657A

GB2459657A - Postnatal dietary supplement.

Info

Publication number: GB2459657A
Application number: GB0807735A
Authority: GB
Inventors: Ajit Lalvani; Kartar Singh Lalvani; Robert Peter Taylor
Original assignee: Individual
Current assignee: Individual
Priority date: 2008-04-29
Filing date: 2008-04-29
Publication date: 2009-11-04
Also published as: GB0807735D0

Abstract

A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, consists of betacarotene, vitamin D, vitamin E, vitamin C, vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin), vitamin B6, folic acid, vitamin B12, pantothenic acid, biotin, vitamin K, iron, magnesium, zinc, iodine, copper, selenium, calcium, omega-3 fish oil which includes DHA (docosahexaenoic Acid) and EPA (eicosapentaenoic Acid). Preferably the vitamins and minerals are provided in a tablet, and the fish oil is administered as a separate capsule.

Description

DESCRIPTION OF INVENTION

Title: Composition for postnatal health and lactation

TECHNICAL FIELD

This invention concerns a composition of biochemical constituents for use in the maintenance of postnatal health, and lactation.

BACKGROUND ART

Since 1990 in the U.K., there has been a steady increase in breast-feeding as women better understand the benefits for the baby in providing essential nutrients and antibodies that can impact their child's long term health. The specific requirements of thousands of women during breast-feeding has never been adequately addressed by the nutritional market, despite the clear scientific rationale, as many Dietary Reference Values (DRY' s) are officially increased for lactation.

The results of the infant feeding study (performed every 5 years by the U.K. Office for National Statistics) in 2005 showed that breastfeeding rates were 76% in the UK compared with 69% in 2000. This significant increase may be explained by the changing demographic age and educational profile of mothers.

The highest incidences of breast-feeding were found among mothers with high education levels, who were over 30 years old and first time mothers.

Milk production during breastfeeding places a large additional physical demand on a mother's body. Additional protein, fatty acids, vitamins and minerals must be supplied from the reserves and the diet. The quality of a mother's breast milk is, to a large extent, dependent on her nutritional intake. A high intake of DHA leads to DFIA rich milk, which is essential for the infant's neuronal development. When babies are fed on DHA rich breast milk it can help support their cognitive development, hand-eye co-ordination, psychomotor development and visual acuity.

During pregnancy, the growing foetus and placenta can increase certain maternal nutritional requirements. As it can be difficult to maintain this requirement through diet alone, supplementation is often recommended by midwives and health professionals to safeguard a mother's diet and replenish natural bodily stores, which are most depleted by the end of pregnancy, and following labour when there is additional blood loss.

This formulation has therefore been devised in order to provide specific follow on support during the postnatal period. It is also formulated to account for the need for a general postnatal supplement for 3-9 months following childbirth, to replace depleted nutrients and assist the body following pregnancy, even if the mother is not breast-feeding.

DISCLOSURE OF INVENTION

The invention concerns a pharmaceutical composition for postnatal health and lactation, that provides nutrients at meaningful and effective levels to safeguard a mothers diet during this period.

The following is the optimal formulation -Daily dosages of the following constituents, provided in 2 tablets per day: Betacarotene -2 mg Vitamin D3 -10 mcg Vitamin B -20 mg Vitamin C -70 mg Vitamin B 1 (Thiamine) -5 mg Vitamin B2 (Riboflavin) -2 mg Vitamin B3 (Niacin) -20 mg VitaminB6-10mg Folic Acid -400 meg Vitamin B 12 -6 mcg Pantothenic acid -6 mg Biotin-lSOmcg Vitamin K -70 meg Iron-16mg Magnesium -150 mg Zinc-15mg Iodine -140 meg Copper -1 mg Selenium -30 meg Calcium-700mg Plus, daily dosages of the following, provided in 1 capsule per day: Omega-3 Fish Oil -600 mg (which includes 3 00mg DFIA (Docosahexaenoic Acid) and 60mg EPA (Eicosapentaenoic Acid RDA / Active Levels: The following are the recommended dietary allowances for some of the constituents, and the reasons for the level chosen: Betacarotene -No RDA established but level within EU safe limits Vitamin D3 -200% -Preferred D3 form for healthy bone development. The official level that is recommended by the N.H.S. National Institute for Health and Clinical Excellence (NICE) for women whilst breast-feeding.

Vitamin E -200% -Higher the RDA level for increased antioxidant protection Vitamin C -117% -Higher the RDA level for increased antioxidant protection Vitamin B 1 (Thiamine) -214% -Water soluble vitamin any excess not required is excreted safely by the body Vitamin B2 (Riboflavin) -125% -Water soluble vitamin any excess not required is excreted safely by the body Vitamin B3 (Niacin) -111% -Water soluble vitamin any excess not required is excreted safely by the body Vitamin B6 -500% -Water soluble vitamin any excess not required is excreted safely by the body Folic Acid -200% -Water soluble vitamin any excess not required is excreted safely by the body Vitamin B 12 -600% -Water soluble vitamin any excess not required is excreted safely by the body Vitamin K -No RDA established but level within EU safe limits Iron -121% -Level needed to prevent anaemia in both mother and developing child.

Magnesium -50% -Level to help maintain healthy levels alongside dietary intake Zinc -100% -At full RDA level as fundamental to many bodily processes and cell division Iodine -93% -Levels help maintain healthy thyroid function Copper -Important trace element whose significance is often overlooked. Well within safe level for daily supplementation Selenium -No RDA established but level within EU safe limits Pantothenic acid -100% -At full RDA to help maintain healthy adrenal function Biotin -100% -At full RDA to help maintain healthy cell division Calcium -100% -The full RNI, to maintain healthy bones and growth Omega 3 Fish Oil -Oral intake levels are in line with research on brain and eye development Relevance of constituents Constituents are included for the following reasons: Betacarotene is converted to Vitamin A as required by the body. It is important for cellular development and immune system function Vitamin D3 is necessary for the absorption and utiisation of calcium.

Vitamin E is an important antioxidant transferred via breastmilk.

Vitamin C is all important for the formation of immune system cells and can help prevent free radical damage.

Vitamin 131 (Thiamine) is needed for a wide range of functions including carbohydrate metabolism and energy production and can improve glucose tolerance.

Vitamin B2 (Riboflavin) is involved in protein and energy metabolism.

Vitamin B3 (Niacin) is essential for carbohydrate metabolism and the circulatory system.

Vitamin B6 is needed for the production of red blood cells and antibodies Folic acid is required for a healthy nervous system and for blood formation. It functions in multiple coenzyme forms in acceptance, redox processing and transfer of one carbon units, including nucleotides and certain amino acids.

Vitamin B12 Maintains a healthy nervous system and contributes to energy release from food.

Pantothenic acid, also known as Vitamin B5, it is involved in cellular growth and metabolism.

Biotin is essential for protein and carbohydrate metabolism.

Vitamin K via breastmilk is especially important for babies to strengthen blood vessels and prevent excessive bleeding. Lack of Vitamin K can cause baemorrhaging and newborn infants are at high risk of Vitamin K deficiency.

Iron is vital for blood formation, and to help prevent anaemia in both mother and developing child.

Magnesium is required for strong bones in mother and child and is involved in many metabolic processes.

Zinc plays a role in hundreds of metabolic processes and is essential for processes such as nucleic acid synthesis, and essential for normal growth.

Iodine plays an important role in growth, development and the regulation of metabolism.

Copper is necessary for a range of processes, including protein and phospholipid synthesis.

Selenium is an important co-factor in antioxidant enzymes which help protect from free radical damage.

Calcium is vital for strong bones. The body has extra requirement when lactating in order to support nutritious breastmilk. Receiving a good supply of calcium in the diet is vital for strong bones and teeth, in addition to the health of the heart, muscles and nerves. Calcium plays an important role in tissue repair and the control of blood pressure and acidity. It is important for growing children, during pregnancy and breast feeding. Researchers found that lactating mothers who do not have enough calcium in their diet, put the bone structures around their teeth at risk. A high calcium diet when breastfeeding ensures healthy foetal bone development with minimised risk of bone loss in the mothers jaw.

Omega 3 Fish Oil Provides rich source of fatty acids DHA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid). Infants only have limited capability to synthesise these essential fatty acids, therefore most requirements must be obtained directly from the mother's milk.

DI-JA (Docosahexaenoic Acid) is the most important fatty acid required for healthy brain and eye development of the foetus. During breastfeeding the infants brain continues to take up DHA and 15% of brain growth occurs after birth. EPA (Eicosapentaenoic Acid) is required for optimum brain function and signalling and learning ability in later life.

DHA and EPA are especially vital during pregnancy and breast-feeding as they form the building blocks of the babys' eyes and brain. DHA is the most important fatty acid required for healthy brain and eye development of the foetus. Each capsule contains 60 mg EPA, which helps to maintain optimum brain function and cell signalling. Adults can obtain DHA and EPA through the conversion of the essential fatty acid alphalinoleic acid (ALA), from vegetable oils such as linseed but the conversion to DHA in particular is not vety efficient.

A more reliable and direct source is the consumption of either oily fish or fish oils with provide a good source of both DHA and EPA. The foetus is reliant on the mother for its DHA and EPA supply through placental transfer whilst in the womb or later via the mothers milk during breastfeeding. The DHA content of human milk is at least 30 times that of other mammals. After delivery, maternal DHA reserves are replaced slowly over a period of 5-6 months. In order to limit depletion of the mothers own reserves it is important that she consumes additional amounts of these fatty acids during both pregnancy and breastfee ding.

DHA is the predominant fatty acid in the central nervous system, found in the structural walls of brain cells. The foetal brain is made up of 60% fats of which 40% is DHA. There is a large increase in DHA uptake by the foetus and a corresponding increase in cerebal DHA content during the last trimester of pregnancy and the first post natal months. At birth, the baby's brain weight is about 70% of an adult's brain weight; 15% of brain growth occurs during infancy and the pre-school years. DHA is important throughout this period of development. DHA is found in even greater concentrations in the retina, where it contributes up to 60% of the fatty acid content. Research has shown that when the growing baby receives DHA from the third trimester onwards and during breastfeeding, circulating levels of DHA are higher, which can help to maintain healthy eye development and visual acuity (clarity of vision). The other Omega-3 fatty acid provided in the composition is EPA, which is required for optimal brain function and cell signaling (the process of communication between nerve cells) and becomes increasingly significant for children after birth in respect to areas such as learning ability and concentration. There are a growing number of studies that have positively correlated fatty acid supplementation of the maternal diet, with higher mental processing scores in the infant at four years old. DHA is important for development of the central nervous system and there is a growth spurt during the last trimester of pregnancy and the first postnatal months. At this time there is a large increase in uptake and cerebral DHA content and the foetus and newborn infant depend entirely on maternal supply of DHA. A high intake of DHA leads to DHA rich milk, which is essential for the infant neuronal development. When babies are fed DHA rich breast milk it can help support their cognitive development, hand-eye co-ordination, psychomotor development and visual acuity.

Suggested Daily Intake/Dosage: 2 tablets and 1 capsule per day with a main meal, with a full glass of water or cold drink.

Recommended Contra -Indications/Warnings: The formulation should be taken on a full stomach, with plenty of water.

Recommended to ensure maximum absorption of nutrients and to facilitate swallowing of tablet.

As the formulation contains vitamin K, if somebody is taking oral anticoagulants (e.g. warfarin) these tablets should not be taken except on the advice of a doctor. Vitamin K is not known to specifically interact with the action of aspirin or heparin.

Keep out of reach of children, because the tablets contains Iron which if taken in excess may be harmful to young children.

INDUSTRIAL APPLICABILITY

According to this invention, there is a pharmaceutical composition, or the use of that composition in the manufacture of a medicament, for combined, sequential or simultaneous administration, in any form, via any biological route, for use in the maintenance of postnatal health, and lactation. In its optimal embodiment the composition consists of a daily intake of 2 tablets that consist of: 2mg Betacarotene, lomcg Vitamin D3, 20mg Vitamin E, 70mg Vitamin C, 5mg Vitamin B 1 (Thiamine), 2mg Vitamin B2 (Riboflavin), 20mg Vitamin B3 (Niacin), 10mg Vitamin B6, 400mcg Folic Acid, 6mcg Vitamin B12, 6mg Pantothenic acid, lSOmcg Biotin, 70mcg Vitamin K, 16mg Iron, 150mg Magnesium, 15mg Zinc, l4Omcg Iodine, 1mg Copper, 3omcg Selenium, 700mg Calcium; plus 1 capsule that consists of: 600mg Omega-3 Fish Oil which includes 3 00mg DHA (Docosahexaenoic Acid) and 60mg EPA (Eicosapentaenoic Acid).

Claims

CLAIMS1. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of approximately 2mg Betacarotene, l0mcg Vitamin D3, 20mg Vitamin E, 70mg Vitamin C, 3mg Vitamin Bi (Thiamine), 2mg Vitamin B2 (Riboflavin), 20mg Vitamin B3 (Niacin), 10mg Vitamin B6, 400mcg Folic Acid, 6mcg Vitamin B12, 6mg Pantothenic acid, l5Omcg Biotin, 7omcg Vitamin K, 17mg Iron, 150mg Magnesium, 15mg Zinc, l4Omcg Iodine, 1mg Copper, 30mcg Selenium, 700mg Calcium, 600mg Omega-3 Fish Oil which includes 3 00mg DHA (Docosahexaenoic Acid) and 60mg EPA (Eicosapentaenoic Acid).
2. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of approximately 2mg Betacarotene, lOmcg Vitamin D3, 20mg Vitamin E, 70mg Vitamin C, 5mg Vitamin B 1 (Thiamine), 2mg Vitamin B2 (Riboflavin), 20mg Vitamin B3 (Niacin), 10mg Vitamin B6, 400mcg Folic Acid, 6mcg Vitamin B12, 6mg Pantothenic acid, 1 S0mcg Biotin, 70mcg Vitamin K, 16mg Iron, 150mg Magnesium, 15mg Zinc, l4Omcg Iodine, 1mg Copper, 30mcg Selenium, 700mg Calcium, 600mg Omega-3 Fish Oil which includes 300mg DI-IA (Docosahexaenoic Acid) and 60mg EPA (Eicosapentaenoic Acid).
3. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of: 1mg to 4mg Betacarotene, Smcg to l5mcg Vitamin D3, 10mg to 30mg Vitamin E, 35mg to 100mg Vitamin C, 3mg to 7mg Vitamin BI (Thiamine), 1mg to 3mg Vitamin B2 (Riboflavin), 10mg to 30mg Vitamin B3 (Niacin), 5mg to 15mg Vitamin B6, 200mcg to 600mcg Folic Acid, 3mcg to 9mcg Vitamin B12, 3mg to 9mg Pantothenic acid, 75mcg to 225mcg Biotin, 35mcg to lOOmcg Vitamin K, 8mg to 24mg Iron, 75mg to 225mg Magnesium, 7mg to 22mg Zinc, 7Omcg to 2lOmcg Iodine, 0.5mg to 1.5mg Copper, l5mcg to 45mcg Selenium, 400mg to 1000mg Calcium, 300mg to 900mg Omega-3 Fish Oil which includes 150mg to 450mg DHA (Docosahexaenoic Acid) and 30mg to 90mg EPA (Eicosapentaenoic Acid).
4. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of: 1mg to 4mg Betacarotene, 5mcg to l5mcg Vitamin D3, 10mg to 30mg Vitamin E, 35mg to 100mg Vitamin C, 3mg to 5mg Vitamin Bi (Thiamine), 1mg to 3mg Vitamin B2 (Riboflavin), 10mg to 30mg Vitamin B3 (Niacin), 5mg to 15mg Vitamin B6, 200mcg to 600mcg Folic Acid, 3mcg to 9mcg Vitamin B12, 3mg to 9mg Pantothenic acid, 75mcg to 225mcg Biotm, 35mcg to lOOmcg Vitamin K, 8mg to 24mg lion, 75mg to 225mg Magnesium, 7mg to 22mg Zinc, 7Omcg to 2lOmcg Iodine, 0.5mg to 1.5mg Copper, l5mcg to 45mcg Selenium, 400mg to 1000mg Calcium, 300mg to 900mg Omega-3 Fish Oil which includes 150mg to 450mg DHA (Docosahexaenoic Acid) and 30mg to 90mg EPA (Eicosapentaenoic Acid).
5. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of Betacarotene, Vitamin D3, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B12, Pantothenic acid, Biotin, Vitamin K, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Calcium, Omega-3 fatty acids 6. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising Betacarotene, Vitamin D3, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B12, Pantothenic acid, Biotin, Vitamin K, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Calcium, Omega-3 fatty acids.7. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), Smcg to l5mcg Vitamin D, 40mcg to lOOmcg Vitamin K, 400mg to 1000mg Calcium, in excess of 50mg EPA (Eicosapentaenoic Acid), and one or more of Betacarotene, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium.8. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, Vitamin K, more than 400mg Calcium, in excess of 50mg EPA (Eicosapentaenoic Acid), and one or more of Betacarotene, Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium.9. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, Vitamin K, more than 400mg Calcium, EPA (Eicosapentaenoic Acid), and one or more of: Betacarotene, Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folk Acid, Vitamin B 12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium.10. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), Smcg to l5mcg Vitamin D, 40mcg to lOOmcg Vitamin K, 400mg to 1000mg Calcium, and one or more of: Betacarotene, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Omega-3 fatty acids.11. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, Vitamin K, and more than 400mg Calcium, and one or more of: Betacarotene, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, Biotm, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Omega-3 fatty acids.12. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), Smcg to 1 Smcg Vitamin D, and 400mg to 1000mg Calcium and one or more of: Betacarotene, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Omega-3 fatty acids.13. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DFIA (Docosahexaenoic Acid), Vitamin D, and more than 400mg Calcium and one or more of: Betacarotene, Vitamin E, Vitamin C, Vitamin B 1 (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, Biotin, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, Omega-3 fatty acids.14. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), Smcg to l5mcg Vitamin D, 4Omcg to lOOmcg Vitamin K, 400mg to 1000mg Calcium, and in excess of 50mg EPA (Eicosapentaenoic Acid).15. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, Vitamin K, more than 400mg Calcium, and in excess of 50mg EPA (Eicosapentaenoic Acid).16. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DI-LA (Docosahexaenoic Acid), Vitamin D, Vitamin K, more than 400mg Calciutn, and EPA (Eicosapentaenoic Acid).17. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), 5mcg to l5mcg Vitamin D, 4Omcg to lOOmcg Vitamin K, and 400mg to 1000mg Calcium.18. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, Vitamin K, and more than 400mg Calcium.19. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising average daily dosages of 150mg to 450mg DHA (Docosahexaenoic Acid), Smcg to l5mcg Vitamin D, and 400mg to 1000mg Calcium.20. A pharmaceutical composition for postnatal health and lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising DHA (Docosahexaenoic Acid), Vitamin D, and more than 400mg Calcium.21. A claim according to any one of the previous claims in which the pharmaceutical composition does not comprise more than 3 00mg of amino acids in a protein or amino acid complex form.22. A claim according to any one of the preceding claims in which Vitamin D is used instead of Vitamin D3.23. A claim according to any one of the preceding claims in which DHA (Docosahexaenpoic acid) and EPA (Eicosapentaenoic acid) are used instead of Omega-3 fatty acids.24. A claim according to any one of the preceding claims in which flax seed oil or linseed oil is used instead of Omega-3 fatty acids.25. A pharmaceutical composition according to any one of the preceding claims for any use in postnatal health and lactation.26. A pharmaceutical composition according to any one of the preceding claims for any use other than postnatal health and lactation.27. A claim according to any one of the preceding claims in which the pharmaceutical composition includes one or more carriers or excipients.28. The use in the manufacture of a meclicament using a composition as described in Claims 1 to 27.29. A method of treatment of postnatal nutritional deficiencies and insufficient breat milk production, using a pharmaceutical composition as described in Claims 1to27.Amendments to the claims have been filed as followsCLAIMS1. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of (a) more than 400mg Calcium, (b) more than 250mg DHA (Docosahexaenoic Acid) and (c) Betacarotene, Vitamin D3, Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, Biotin, Vitamin K, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, EPA (Eicosapentaenoic Acid); in which the DHA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.2. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising of average daily dosages of(a) more than 400mg Calcium, (b) more than 250mg DHA (Docosahexaenoic Acid) and (c) Betacarotene, Vitamin D3, S...Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), S...Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, * Biotin, Vitamin K, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, EPA *** (Eicosapentaenoic Acid); in which the DHA (Docosahexaenoic Acid) and EPA * : (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.3. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of (a) more than 400mg Calcium, (b) more than 250mg DHA (Docosahexaenoic Acid) and (c) approximately 2mg Betacarotene, lOmcg Vitamin D3, 20mg Vitamin E, 70mg Vitamin C, 5mg Vitamin Bi (Thiamine), 2mg Vitamin B2 (Riboflavin), 20mg Vitamin B3 (Niacin), 10mg Vitamin B6, 400mcg Folic Acid, 6mcg Vitamin 1312, 6mg Pantothenic acid, lSOmcg Biotin, 7Omcg Vitamin K, 16mg Iron, 150mg Magnesium, 15mg Zinc, l4Omcg Iodine, 1mg Copper, 3Omcg Selenium, 60mg EPA (Eicosapentaenoic Acid); in which the DHA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.4. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comrpising of average daily dosages of (a) more than 400mg Calcium, (b) more than 250mg DHA (Docosahexaenoic Acid), and (c) approximately 2mg Betacarotene, lOnicg Vitamin D3, 20mg Vitamin E, 70mg Vitamin C, 5mg Vitamin B 1 (Thiamine), 2mg Vitamin B2 (Riboflavin), 20mg Vitamin B3 *:: (Niacin), 10mg Vitamin B6, 400mcg Folic Acid, 6mcg Vitamin B12, 6mg *. Pantothenic acid, lSOmcg Biotin, 7Omcg Vitamin K, 16mg Iron, 150mg *: Magnesium, 15mg Zinc, l4Omcg Iodine, 1mg Copper, 30mcg Selenium, 60mg *0** *:. EPA (Eicosapentaenoic Acid); in which the DHA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered : : separately from the other constituents. a *5. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of (a) more than 400mg Calcium, (b) more than 250mg DHA (Docosahexaenoic Acid) and (c) approximately 1mg to 4mg Betacarotene, 5mcg to l5mcg Vitamin D3, 10mg to 30mg Vitamin E, 35mg to 100mg Vitamin C, 3mg to 7mg Vitamin Bi (Thiamine), 1mg to 3mg Vitamin B2 (Riboflavin), 10mg to 30mg Vitamin B3 (Niacin), 5mg to 15mg Vitamin B6, 200mcg to 600mcg Folic Acid, 3mcg to 9mcg Vitamin B12, 3mg to 9mg Pantothenic acid, 75mcg to 225mcg Biotin, 35mcg to lOOmcg Vitamin K, 8mg to 24mg Iron, 75mg to 225mg Magnesium, 7mg to 22mg Zinc, 7omcg to 2lOmcg Iodine, 0.5mg to 1.5mg Copper, lsmcg to 45mcg Selenium, and 30mg to 90mg EPA (Eicosapentaenoic Acid); in which the DHA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.
6. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, comprising of average daily dosages of (a) more than 400mg Calcium, (b) more than 25 0mg DHA (Docosahexaenoic Acid), and (c) approximately 1mg to 4mg Betacarotene, 5mcg to l5mcg Vitamin D3, 10mg to 30mg Vitamin E, 35mg to :::: 100mg Vitamin C, 3mg to 7mg Vitamin Bi (Thiamine), 1mg to 3mg Vitamin *::* 82 (Riboflavin), 10mg to 30mg Vitamin B3 (Niacin), 5mg to 15mg Vitamin B6, 200mcg to 600mcg Folic Acid, 3mcg to 9mcg Vitamin B12, 3mg to 9mg :. Pantothenic acid, 75mcg to 225mcg Biotin, 35mcg to lOOmcg Vitamin K, 8mg to 24mg Iron, 75mg to 225mg Magnesium, 7mg to 22mg Zinc, 70mcg to : : 2lOmcg Iodine, 0.5mg to 1.5mg Copper, l5mcg to 45mcg Selenium, and 30mg * to 90mg EPA (Eicosapentaenoic Acid); in which the DFIA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.
7. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of (a) more than 400mg Calciwn, (b) more than 25 0mg D}-IA (Docosahexaenoic Acid) and (c) ten or more of: Betacarotene, Vitamin D3, Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic Acid, Vitamin B 12, Pantothenic acid, Biotm,, Vitamin K, Iron, Magnesium, Zinc, Iodine, Copper, Selenium, EPA (Eicosapentaenoic Acid); in which the DFIA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet or capsule that is administered separately from the other constituents.
8. A pharmaceutical composition that is specifically for lactation, for combined, sequential or simultaneous administration, in any form, via any biological route, consisting essentially of average daily dosages of (a) more than 400mg Calcium, (b) more than 25 0mg DHA (Docosahexaenoic Acid) and (c) five or more of Betacarotene, Vitamin D3, Vitamin E, Vitamin C, Vitamin Bi (Thiamine), Vitamin B2 (Riboflavin), Vitamin B3 (Niacin), Vitamin B6, Folic *:::: Acid, Vitamin B12, Pantothenic acid, Biotin, Vitamin K, Iron, Magnesium, * :* Zinc, Jo dine, Copper, Selenium, EPA (Eicosapentaenoic Acid); in which the : DFIA (Docosahexaenoic Acid) and EPA (Eicosapentaenoic Acid) are in a tablet I...:. or capsule that is administered separately from the other constituents.S:
9. A claim according to any one of the preceding claims in which Omega-3 fatty acids generally are used instead of DHA (Docosahexaenpoic acid) and EPA (Eicosapentaenoic acid).
10. A claim according to claim 9 in which the Omega-3 fatty acids come from Omega-3 Fish Oil.
11. A claim according to claim 10 in which the quantity of Omega-3 Fish Oil used is 600 mg (which includes 3 00mg DHA (Docosahexaenoic Acid) and 60mg EPA (Eicosapentaenoic Acid).
12. A claim according to any one of the preceding claims in which the quantity of Calcium is 400mg to 1000mg.
13. A claim according to any one of the preceding claims in which the quantity of Calcium is 700mg.
14. A claim according to any one of claims I to 13 in which the pharmaceutical composition does not comprise more than 3 00mg of amino acids in a protein or amino acid complex form.
15. A claim according to any one of claims 1 to 13 in which flax seed oil or : linseed oil is used instead of Omega-3 fatty acids. * ,u* * I **...
16. A claim according to any one of claims 1 to 13 for use in postnatal health :. and lactation. I,: :
17. A claim according to any one of claims 1 to 13 in which the pharmaceutical * composition includes one or more carriers or excipients.
18. The use in the manufacture of a medicament of a composition as described inClaims ito 17.