AN ORAL COMPOSITION CONTAINING BOVINE LACTOFERRIN FOR USE IN POSTPARTUM LACTATION SUPPORT.

Abstract

The invention relates to the use of bovine lactoferrin as a galactagogue active ingredient to correct lactation deficiency and / or support breast milk production in the postpartum period. Specifically, the invention concerns the use of bovine lactoferrin, derived from cow's milk, in an orally administered form to support lactation in the postpartum period.

Description

BOVINE FOR USE IN POSTPARTUM LACTATION SUPPORT AN ORAL COMPOSITION CONTAINING LACTOFERRIN TECHNICAL FIELD The subject of the invention is the treatment of lactation insufficiency in the postpartum period by bovine lactoferrin. galactagogue active ingredients for eliminating and / or supporting breast milk production It relates to its use as a component. In particular, the invention concerns bovine extract obtained from cow's milk. Lactoferrin is administered orally to support lactation in the postpartum period. It is intended for use in a practical form. PREVIOUS TECHNIQUE The postpartum period is the time after childbirth when the mother experiences physiological, hormonal, and psychological changes. It is a special period during which the mother's body tries to rebalance itself after pregnancy. During this process, the mother's body... Maintaining healing mechanisms and providing the milk necessary for newborn nutrition. It continues its production. Ensuring that lactation begins and continues adequately, It is critically important for the health of both mother and baby. Breast milk is essential for the growth and development of newborns. In addition to providing the necessary nutrients for development, it also supports immune system development. It contains numerous bioactive components that support breastfeeding during the postpartum period. Insufficient production affects not only nutrition but also the mother-baby bond. also in terms of establishing, continuing breastfeeding and supporting newborn health. This constitutes a significant problem. Lactation insufficiency is the most common cause of premature cessation of breastfeeding in the postpartum period. This is one of the common problems. Milk production is primarily regulated by the hormone prolactin. Milk production is regulated, and its release is supported by an oxytocin response. This hormonal... the mechanism functioning properly; the mother's general health status, postpartum recovery process, stress level, sleep patterns, nutritional status and baby's sucking It depends on numerous factors such as behavior, stress, fatigue, hormonal imbalance, and childbirth. subsequent physical and psychological burden, insufficient breast stimulation, frequent breastfeeding Situations such as the inability to perform this or the inability to effectively drain the milk negatively affect milk production. This can have an impact. As a result, there is a decrease in the amount of breast milk, and The mother may need additional feeding methods or supplements to increase milk production. In the relevant technical field, various galactagogue products are used to support lactation. Applications are used. Galactagogues increase or support milk production. active ingredients used for this purpose, herbal preparations, food supplements or pharmaceuticals They can be defined as products. Solutions that have been used for a long time in the relevant technical field. A significant portion are of plant origin. Specifically, fenugreek, moringa, milk thistle, and fennel. Cardius benedictus and similar herbal ingredients improve breast milk production during the postpartum period. It is commonly used in supplement products aimed at increasing muscle mass. These products generally Available in supplement forms including capsules, tablets, tea, syrup, or herbal extracts. It is presented. However, current herbal galactagogues have significant technical and safety limitations. Plant-derived ingredients often contain only the targeted active ingredient. It contains not only a large amount of metabolites, but also numerous secondary metabolites. This situation means that the product This makes it difficult to standardize the composition and creates effects between different production batches. This can vary in terms of level. The region where the plant grows, harvest time, Parameters such as the extraction method, the plant part used, and the production conditions are final. This can affect the active ingredient profile of the product. Therefore, the existing herbal ingredients... In galactagogues, establishing a predictable and reproducible dose-response relationship is crucial. Time is not possible. In addition, herbal galactagogues have undesirable side effects for both mother and baby. It can give birth. These types of components are foreign plant metabolites that can pass into breast milk. It can contain substances that can change the taste or smell of breast milk and affect newborns. It can pose a risk of sensitivity or allergic reactions. In addition, some herbal products... Ingredients may cause gastrointestinal discomfort, hormonal interactions, allergic reactions, or medications. It can exhibit side effects such as interactions between mother and newborn during the postpartum period. Because of the delicate physiological state, the safety profile of the galactagogue compound used And physiological compatibility is of great importance. Another limitation of plant galactagogues used in the relevant technical field is their presence in human milk. They are not naturally occurring proteins or components of breast milk. Therefore, the word 3 The topic is herbal remedies, lactation support, and the physiological equivalent of natural breast milk. Rather than providing it through a component found, traditional use or herbal effect It is based on expectations. This situation affects both mother and baby, especially during the postpartum period. more predictable, reliable, standardizable and physiologically compatible active in terms of This increases the need for components. A BRIEF DESCRIPTION OF THE INVENTION The subject of the invention is the resolution of lactation insufficiency occurring in the postpartum period. and / or galactagogue approaches used to support breast milk production It is related to the invention, particularly to the problems encountered in existing plant-derived galactagogue solutions. Standardization difficulties, risks of unwanted side effects, changes in the taste of breast milk. disadvantages such as the possibility of causing sensitivity or allergy risk in newborns It offers a usage approach aimed at reducing consumption. The invention includes oral supplements for providing lactation support during the postpartum period. It can be implemented in this way, is more predictable in terms of safety profile, and has a physiological profile. The aim is to ensure the use of a highly compatible active ingredient. In this way, current techniques for supporting breast milk production in the postpartum period as an alternative to traditional herbal remedies, more standardized and The aim is to demonstrate a feasible use of galactagogues. Another aim of the invention is to provide a solution during the postpartum period, which is considered a sensitive time for both mother and baby. providing lactation support through more controlled use of active ingredients The aim is to provide an opportunity. Thus, compared to the variable-content herbal preparations in the current technique, with a more distinct active ingredient profile and a usable solution suitable for oral administration. The aim is to support breast milk production. DETAILED DESCRIPTION OF THE INVENTION In this detailed explanation, the subject of the invention is the study of bovine lactoferrin in the postpartum period of the mother. In the treatment and / or prevention of lactation insufficiency, increasing breast milk production. galactagogue 4 formulated for oral administration to support and / or promote nutrition. It relates to its use as an effective active ingredient and is simply for a better understanding of the subject. This is explained with examples that will not create any limiting effect. In technical terms, the postpartum period refers to the time after childbirth when the mother is born. the physiological and hormonal recovery process begins, lactation starts and the mother This refers to the postpartum period during which milk production continues. This period is called lactation. where deficiency may occur and there is a need to support breast milk production It covers the time interval during which it can be heard. Lactation problems in the postpartum period can be caused by stress, fatigue, hormonal imbalance, and childbirth. subsequent inflammatory responses, insufficient stimulation of breast tissue, maternal general It occurs depending on numerous factors such as nutritional status and psychological factors. It can occur. The hormone prolactin plays an important role in regulating milk production. Milk secretion is supported by the oxytocin response. Therefore, in the postpartum period... the mother's physiological balance, immune response, inflammation level, and metabolic Supporting this condition is important for the sustainability of lactation. The scope of the invention is the use of bovine lactoferrin to support lactation in the postpartum period. This relates to its use for the purpose of iron binding. Bovine lactoferrin belongs to the transferrin family. It is a protein-structured glycoprotein exhibiting this characteristic. This bovine lactoferrin, preferably, It is obtained from cow's milk and contains lactoferrin, which is naturally found in human milk. lactation in the postpartum period due to structural and functional similarities It is considered a suitable active ingredient for use in support. Lactoferrin is a bioactive compound that occurs naturally in human milk, particularly colostrum. It is one of the proteins. Therefore, bovine lactoferrin is administered orally during the postpartum period. Its application, unlike existing plant galactagogues, is related to human milk biology. It allows for lactation support through a protein-based component. Bovine lactoferrin shows sequence similarity to human milk lactoferrin, indicating iron binding. Its glycoprotein structure and immunomodulatory, anti-inflammatory and antimicrobial properties Its balance-supporting properties mean that this component has physiological effects during lactation. This contributes to its use as a highly compatible support component. The contribution of bovine lactoferrin, used within the scope of this invention, to lactation support is demonstrated by a single... It occurs through multiple biological effects, not limited to a single mechanism. One of these biological effects is bovine lactoferrin, thanks to its iron-binding capacity. It contributes to the regulation of iron homeostasis. Iron homeostasis Supporting this helps maintain the mother's metabolic balance during the postpartum period. However, the iron-binding property of lactoferrin affects microorganisms. A microbial growth-suppressing environment by limiting access to free iron. This contributes to the formation of breast tissue, especially in the postpartum period. This is important in terms of controlling the microbial load in the environment. Another biological effect is that bovine lactoferrin also has anti-inflammatory and immunomodulatory properties. Its properties contribute to supporting lactation function in the postpartum period. It provides protection. Inflammatory processes, stress response, and immunity in the postpartum period. Changes in the system indirectly affect milk production. Lactoferrin its effects on balancing the inflammatory response and supporting the immune system, mammary gland helps epithelial cells function in a more favorable physiological environment. Thus, the biological processes related to milk production and milk secretion are as follows. It becomes possible to provide support. Another biological effect is that bovine lactoferrin affects mammary gland epithelial cells and milk production. It is an indirect supporting factor on its physiology. Mammary gland epithelial cells produce milk. These cells play a key role in the synthesis and secretion of its components. Lactoferrin Its antioxidant, immunomodulatory and tissue-supporting effects at the cellular level are in question. It contributes to maintaining the functional integrity of cells. In this context Bovine lactoferrin is important for maintaining milk production capacity, sustaining lactation, and It can be used to support milk production during the postpartum period. The invention relates to bovine lactoferrin, in a preferred application, to cows and / or cattle. It can be obtained from their milk. Bovine lactoferrin, which can be used within the scope of this invention; whole milk, skim milk, whey, milk whey, colostrum, or milk processing processes It can be isolated from the lactoferrin-containing fractions obtained as a result. Lactoferrin, suitable filtration, membrane separation, chromatographic purification, ion exchange chromatography, obtained using ultrafiltration, microfiltration, lyophilization or drying processes. 6 It is possible to do so. The bovine lactoferrin used in the invention is purified, partially... purified, concentrated, powdered, granulated or a suitable It is available in formulated form with a carrier. The invention includes bovine lactoferrin, naturally occurring bovine lactoferrin, and isolated bovine lactoferrin. purified bovine lactoferrin, colostrum-derived bovine lactoferrin, milk serum-derived bovine lactoferrin, whey-derived bovine lactoferrin, or food / pharmaceutical. It is available in the form of a usable bovine lactoferrin fraction. Additionally, bovine lactoferrin; apo-lactoferrin, holo-lactoferrin, or having different iron saturation levels. It can also be found in the form of lactoferrin. These forms have iron-binding capacity and They may differ in terms of biological activity and are intended for lactation support. It is possible to select the appropriate form for use. Within the scope of this invention, bovine lactoferrin provides lactation support in the postpartum period. It is included in a composition that can be administered orally. Oral The application form is safe, easy, and suitable for regular use by the mother during the postpartum period. It can be dosed and selected in a way that provides practical use. Within the scope of the invention Final product: tablet, film-coated tablet, chewable tablet, effervescent tablet, capsule, hard capsule. soft capsule, granules, pellets, powder, sachet, stick pack, oral solution, oral suspension, syrup, drops, oral spray, ready-to-drink liquid product, functional beverage, milk-based beverage, yogurt-like product The product can be prepared in the form of pudding, bar, gel, lozenge, or dietary supplement. Within the scope of this invention, bovine lactoferrin can be used as the sole active ingredient, or... with one or more excipients in a composition suitable for oral administration They can also be found together. These auxiliary components contribute to the stability of the product. its solubility, taste, odor, shelf life, bioavailability, ease of dosing, or These auxiliary components can be selected to improve user compliance. These pharmaceutical components... or carriers, fillers, binders, flow regulators suitable for food use, solvents, sweeteners, flavorings, stabilizers, preservatives, pH regulators, They can be selected from among emulsifiers, thickeners and coating agents. Excipients that can be used in solid oral forms include microcrystalline cellulose, lactose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, isomalt, starch, modified starch, calcium phosphate, magnesium stearate, silicon dioxide, hydroxypropyl methylcellulose, 7 Polyvinylpyrrolidone, croscarmellose sodium, crospovidon and similar pharmaceutical / food compatible products. Excipients may be present. In powder and sachet forms, maltodextrin, inulin, galactooligosaccharides, fructooligosaccharides, soluble fibers, natural flavorings, Sweeteners and flow regulators can be used. Excipients that may be used in liquid oral forms include purified water, glycerol, and plant-based ingredients. Glycerin, propylene glycol, natural fruit flavors, citric acid, sodium citrate, potassium sorbate, sodium benzoate, xanthan gum, pectin, guar gum, acacia gum, lecithin, and appropriate buffer. Systems may include the product in syrup, drop, or oral suspension forms. Thickeners and suspension agents are used to ensure homogeneity and ease of use. Agents and stabilizers can be used. Within the scope of this invention, bovine lactoferrin is used for maternal nutrition and physiological functions during the postpartum period. It is also formulated with additional active or supporting ingredients that can help meet their needs. These additional components include vitamins, minerals, amino acids, Proteins, prebiotics, probiotics, omega fatty acids, choline, inositol, folate, B group vitamins. vitamins, vitamin D, vitamin C, zinc, selenium, iron, iodine, calcium, magnesium and Similar micronutrients can be found. However, these components are different from bovine lactoferrin. without eliminating its primary use for postpartum lactation support They are considered as auxiliary or supportive components. The invention includes a composition, preferably in a form that does not contain plant galactagogue active ingredients. This method is being prepared. In this way, the multiple secondary problems encountered in existing herbal galactagogues are avoided. metabolic load, difficulty in standardization, potential for altering milk taste, and The risk of sensitivity in the baby due to foreign plant components is reduced. However, In some applications, a supplement selected to be compatible with bovine lactoferrin. The components can be used; however, the distinctive aspect of the invention is that lactation support is provided by bovine This is achieved via lactoferrin. The invention relates to a product containing bovine lactoferrin, used during lactation in the postpartum period. those experiencing milk deficiency, those wishing to support milk production, or those going through the breastfeeding process It can be used by mothers aiming to increase the continuity of their childbirth. Invention Its use can begin in the early postpartum period as well as during lactation. It can also be carried out in later periods as well. The application is daily, 8 This can be done periodically or as needed. Bovine lactoferrin The amount depends on the product form, the target daily dose, the mother's needs, and whether the product is a supplement. whether in food or pharmaceutical form and configured according to relevant regulatory requirements It is possible. In a preferred application of the invention, an oral product containing bovine lactoferrin is used postpartum. formulated for daily use to support breast milk production during this period. In another application, the product is used for lactation insufficiency in the postpartum period. It is used for protective or supportive purposes in mothers at risk. Another In practice, the product has galactagogue-like active ingredients in mothers experiencing decreased milk production. It is used as a component. This use is either alone or during breastfeeding. through counseling, proper nutrition, adequate fluid intake, and regular breastfeeding practices. This can be achieved in a supportive manner together. Within the scope of this invention, bovine lactoferrin is used in addition to lactation support during the postpartum period. It may also provide helpful benefits in supporting maternal health. Lactoferrin Its immunomodulatory and anti-inflammatory properties enhance the mother's immunity during the postpartum period. It contributes to supporting the balance of microbial growth. Its effect is limiting microbial proliferation. Reducing unwanted microbial load in breast tissue and lowering the risk of mastitis. It is supportive in this regard. It also has neuroprotective and anti-inflammatory properties. Due to its effects, it contributes to supporting general well-being in the postpartum period. It provides. The scope of protection of the invention is specified in the claims attached hereto, and these details are strictly adhered to. The explanation cannot be limited to those given for illustrative purposes. Because a technically skilled person... the person, without deviating from the main theme of the invention, in light of what has been described above, similar It is clear that these structures can emerge.

Claims

1. In the treatment of lactation insufficiency in mothers during the postpartum period and / or The bovine lactoferrin used in its prevention is characterized by the fact that it is a bovine... Lactoferrin, as the galactagogue active ingredient, increases breast milk production. formulated for oral administration to support and / or promote It is the fact that.

2. This is a use according to Claim 1, characterized by the isolation of the bovine lactoferrin in question. purified, partially purified, concentrated, lyophilized, It is found in powdered or granulated form.

3. A use according to claim 1 or 2, characterized by the fact that bovine lactoferrin is derived from naturally occurring bovine lactoferrin. lactoferrin, isolated bovine lactoferrin, purified bovine lactoferrin, colostrum whey-derived bovine lactoferrin, milk serum-derived bovine lactoferrin, whey It must contain at least one of the bovine lactoferrin groups.

4. A use according to any of claims 1 to 3, characterized by the following: the oral in question. The formula can be administered via this route in tablet, film-coated tablet, chewable tablet, or effervescent form. tablet, capsule, hard capsule, soft capsule, granules, pellets, powder, sachet, stick pack, oral solution, oral suspension, syrup, drops, oral spray, ready-to-drink liquid product, functional beverage, milk-based beverage, yogurt-like product, pudding, bar, gel, lozenge or It is in the form of a dietary supplement.

5. A use according to any of claims 1 to 4, characterized by being administered orally. The applicable composition may contain one or more pharmaceutically acceptable components. and / or contain auxiliary components suitable for food use.

6. This is a use case according to claim 5, characterized by the fact that the carrier of the auxiliary component in question is filler, binder, flow regulator, solvent, sweetener, flavoring, stabilizer, preservative, pH regulator, emulsifier, thickener, suspension agent or at least one of the coating agent groups.

7. A use according to claim 5 or 6, characterized by the fact that the auxiliary component is microcrystalline. 35 cellulose, lactose, maltodextrin, dextrose, mannitol, sorbitol, xylitol, isomalt, starch, modified starch, calcium phosphate, magnesium stearate, silicon dioxide, hydroxypropyl 10 methylcellulose, polyvinylpyrrolidone, croscarmellose sodium, or crospovidon It is the presence of at least one member from the group.

8. A use according to claim 5 or 6, characterized by the fact that the auxiliary component is pure water, glycerol, vegetable glycerin, propylene glycol, natural fruit flavor, citric acid, sodium citrate, potassium sorbate, sodium benzoate, xanthan gum, pectin, guar gum, acacia It must contain at least one of the following: gum, lecithin, or buffer system group.

9. A usage according to any of the previous requests, and its characteristic is; bovine lactoferrin is a vitamin, mineral, amino acid, protein, prebiotic, probiotic, and omega compound. fatty acids, choline, inositol, folate, B vitamins, vitamin D, vitamin C, zinc, one or more of the following selected minerals: selenium, iron, iodine, calcium, or magnesium. It is present together with a supporting component.