Oil-based vitamin b12 suspension for oral administration across various age groups

Abstract

The invention relates to an oil-based suspension of vitamin B12 formulated for oral administration, primarily intended for infants but also suitable for children, adults, and elderly individuals. The suspension comprises vitamin B12 uniformly distributed within a vegetable oil matrix and is free from additives, stabilizers, and emulsifiers, including lecithin.

Description

[0001] Title of the Invention:

[0002] Oil-Based Vitamin B12 Suspension for Oral Administration Across Various Age Groups

[0003] Summary of the Invention:

[0004] This invention provides a liquid suspension that retains its original properties over time without breaking down, altering, or losing its effectivenessEllt is formulated as an oil-based vitamin B12 suspension for oral administration, suitable across various age groups, including infants, children, adults, and the elderly

[0005] The suspension comprises vitamin B12 uniformly distributed in a vegetable oil matrix and is free from additives, stabilizers and emulsifiers, including lecithinElThe formulation does not require preservatives®

[0006] The stability and microbial resistance of the suspension are a direct result of the hydrophobic characteristics of the oil matrix, which limits the water content to <01'2% to levels incompatible with microbial pro life rati on^The oil also shields the dispersed vitamin B12 particles from oxidative degradation by limiting exposure to environmental oxygen®

[0007] The product may comprise vegetable oils such as sunflower, coconut, palm, olive, soybean, corn, canola, avocado, grapeseed, and / or rapeseed oil®ln certain embodiments, the oil-based vitamin B12 suspension may further comprise one or more additional active ingredients selected from vitamins, probiotics, prebiotics, and postbioticsSThese optional components are dissolved or dispersed in the same oil matrix and do not require the inclusion of stabilizers, emulsifiers, or preservatives®The additive-free nature of the formulation is maintained except for the defined active substancesSThe suspension can be administered via multiple methods, including droppers, syringes, or pipettes, thus ensuring flexibility for different users and applications!?]

[0008] Background of the Invention:

[0009] Vitamin B12 is crucial forvarious biological functions, including neurological development, red blood cell production, DNA synthesis, and immune system support®Deficiency in B12 can impair immune function, heightening susceptibility to infections and chronic inflammation®

[0010] Delivering a stable and bioavailable form of vitamin B12, particularlyfor sensitive populations such as infants, presents significant challenges®Aqueous solutions are prone to microbial contamination and degradation, often requiring preservatives that are not ideal for infant use® Hence, there is a need for an improved, preservative-free vitamin B12 formulation®

[0011] Figures:

[0012] Figure 1 : Process flow Detailed Description of the Invention:

[0013] Preparation and Homogenization Process for Vitamin B12 Oil Suspension:

[0014] To begin the process, the mixing tank is filled with the specific amount of vegetable oil required for the batch!?]

[0015] Vitamin B12 particle size reduction is achieved by preparing a premix of vitamin B12 in a small portion of oil taken from the mixing tank^30 ml of oil is measured into a brown glass jar, and the required amount of vitamin B12 crystalline is addedBA stirring magnet is placed in the jar, and the jar is sealed tightly

[0016] The jar is positioned 20 mm off-center on a magnetic stirrer to promote wobbling movement, aiding in breaking down the vitamin B12 crystalline into a uniformly distributed suspension!?] Stirring is performed at 750 rpm for at least 12 hours and up to 48 hours, verified to produce a homogeneous suspension without differences between the minimum and maximum stirring times!?]

[0017] The dispersion technique, involving controlled mechanical stirring and off-center vortex generation, ensures uniform particle distribution and prevents localized aggregation or sedimentation, thus maintaining product consistency over time!?]

[0018] After stirring, the premix is carefully poured back into the mixing tank, which is then filled with nitrogen to prevent oxidationBHomogenization is performed with a centrally mounted paddle at 65 rpm for at least 15 minutesIWertical baffles are used to enhance mixing efficiency and ensure uniform dispersion before filling and final packaging!?]

[0019] Formulation Composition:

[0020] The vitamin B12 may be present as cyanocobalamin, methylcobalamin, or hydroxocobalamin, in low or high concentrations!?]

[0021] The oil suspension comprises vegetable oils selected from:

[0022] Sunflower oil

[0023] Coconut oil

[0024] Palm oil

[0025] Olive oil

[0026] Soybean oil

[0027] Corn oil

[0028] Canola oil

[0029] Avocado oil

[0030] Grapeseed oil

[0031] Rapeseed oil The selected vegetable oils exhibit low water content and minimal oxygen solubility, creating an optimal medium to sustain the chemical stability of sensitive water-soluble vitamins such as vitamin B12®

[0032] The suspension contains no additives, no stabilizers, and no emulsifiers, including no lecithin®

[0033] Broader Applications:

[0034] While primarily intended for infants, the formulation can also be used for:

[0035] • Children and Adults: Offered at appropriate dosages®

[0036] • Delivery Systems: o Oral Droppers (for infants and young children) o Oral Syringes (for accurate dosing, particularly in medical settings) o Pipettes (providing another option for accurate dosing at home)

[0037] Stability and Microbial Resistance:

[0038] The oil-based formulation retains its original properties overtime®By maintaining a water content of <0H2% and creating a hydrophobic environment, the formulation effectively prevents bacterial, fungal, and yeast proliferation, thereby eliminating the requirement for chemical preservatives®Furthermore, the oil matrix serves as a barrier to oxygen diffusion, preserving the chemical integrity of vitamin B12®

[0039] Examples:

[0040] Example 1 :

[0041] 0®5 g of cyanocobalamin is dispersed in 25,000 g of sunflower oil® Packaged in 10 mL bottles with droppers®The formulation remains stable at room temperature for at least 24 months without preservatives, due to its water content of <032% and protective oil matrix®

[0042] Example 2:

[0043] OHB g of hydroxocobalamin is mixed into 150 g of coconut oilSPackaged in 5 mL pipettes for pediatric useSThe suspension is stable and maintains bioavailability without the need for preservatives, owing to its oil-based composition and <02% water content®

Claims

Claims:1: A liquid suspension for oral administration comprising vitamin B12 uniformly distributed in a vegetable oil, wherein the suspension is free from additives, stabilizers, and emulsifiers, including lecithin.2: The suspension according to claim 1, wherein the water content is <0.2%.3: The suspension according to claim 1 or 2, which maintains a shelf life of at least 24 months at ambient temperature without requiring preservatives.4: The suspension according to any one of claims 1 to 3, wherein the vitamin B12 is selected from cyanocobalamin, methylcobalamin, or hydroxocobalamin.5: The suspension according to any one of claims 1 to 4, wherein the vegetable oil is selected from sunflower oil, coconut oil, palm oil, olive oil, soybean oil, corn oil, canola oil, avocado oil, grapeseed oil, or rapeseed oil.6: A method of administering vitamin B12 to a person, comprising orally delivering a pre-measured dose of the liquid suspension according to any one of claims 1 to 5, using a dropper, syringe, or pipette.7: The suspension according to any one of claims 1 to 6, further comprising one or more additional active ingredients selected from vitamins, probiotics, prebiotics, and postbiotics.

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