Innovative formulation for cardiac support supplements using molecular-level mixing technology

Abstract

The invention relates to an formulation for cardiac support supplements and the method of its preparation by using molecular-level mixing technology. The method involves preparing molecular-level emulsions of alpha-lipoic acid, acetyl L-carnitine, and coenzyme Q10, followed by spray drying to produce a homogeneous powder premix. This approach ensures precise dosage control, enhanced bioavailability, and improved stability, making it a valuable advancement in the field of nutraceutical and pharmaceutical formulations.

Description

[0001] Innovative Formulation for Cardiac Support Supplements Using Molecular-Level Mixing Technology

[0002] Technical Field:

[0003] The present invention relates to the field of pharmaceutical and nutraceutical formulations. Specifically, it pertains to an innovative method for preparing homogeneous powder premixes of cardiac support supplements using advanced molecular-level mixing technology. This technology can be applied to various industries including pharmaceuticals, nutraceuticals, food, and cosmetics where precise and consistent mixing of ingredients is crucial.

[0004] Keywords:

[0005] Molecular-Level Mixing Technology, Cardiac Support Supplements, Alpha-Lipoic Acid, Acetyl L-Carnitine, Coenzyme Q10, Raw Material Mixing, Emulsion, Spray Drying, Bioavailability, Stability, Homogeneous Powder Premix

[0006] Background Art:

[0007] Conventional mixing methods for preparing powder premixes often result in heterogeneous mixtures with significant variations in particle size, ingredient distribution, and stability. These limitations lead to inconsistent product quality, reduced efficacy, and compromised stability of active ingredients. Traditional techniques struggle to uniformly incorporate microgram ingredients with macrogram ingredients, resulting in issues in dosage precision and bioavailability. Cardiac support supplements, which often include active ingredients like alpha- lipoic acid (ALA), Acetyl L-camitine (ALC), and Coenzyme Q10 (CoQlO), face significant challenges due to their diverse physicochemical properties. These challenges necessitate a more precise and efficient mixing technology that ensures uniform distribution, stable formulations, and high product quality at the molecular level.

[0008] Mixing powders composed of ALA, ALC, and CoQlO for cardiac support supplements presents several challenges:

[0009] 1. Alpha-Lipoic Acid (ALA): o Hygroscopic Nature: ALA is hygroscopic, meaning it readily absorbs moisture from the environment, leading to clumping and degradation. o Stability: ALA can be unstable under certain conditions, particularly when exposed to light and heat. o Compatibility: The acidic nature of ALA may interact with other compounds, affecting their stability and bioavailability.

[0010] 2. Acetyl L-Carnitine (ALC): o Hygroscopic Nature: ALC also absorbs moisture, leading to potential degradation or clumping. o Chemical Reactivity: ALC can be reactive, especially with acidic or basic substances, leading to degradation. o Thermal Sensitivity: ALC is sensitive to high temperatures, which can degrade the compound during the mixing process if not properly controlled. yme Q10 (CoQlO): Low Solubility: CoQlO is lipophilic and poorly soluble in water, making it challenging to ensure even distribution in a powder mix. Particle Size: CoQlO particles are often larger compared to ALA and ALC, leading to separation and settling issues in the final product. Stability: CoQlO is sensitive to light and oxygen, requiring careful handling and packaging to maintain its efficacy. on Challenges in Mixing: Uniform Distribution: Ensuring that each molecule is uniformly distributed throughout the mixture can be difficult due to differences in particle size, density, and solubility. Moisture Control: Controlling the moisture content during mixing and storage is essential to prevent degradation and clumping. Stability: Maintaining the stability of all three compounds during the mixing process and throughout the product's shelflife requires careful consideration of environmental factors like temperature, light, and humidity. Interaction: Potential chemical interactions between the compounds can affect their stability and efficacy.

[0011] Disclosure Of The invention:

[0012] • Summary of the Invention:

[0013] The invention discloses a novel formulation for cardiac support supplements utilizing molecular-level mixing technology. This method involves the preparation of molecular-level emulsions of ALA, ALC, and CoQlO, followed by spray drying to produce a homogeneous powder premix. This approach ensures precise dosage control, enhanced bioavailability, and improved stability of the active ingredients.

[0014] • Detailed Description:

[0015] The innovative formulation process using molecular-level mixing technology comprises the following steps:

[0016] 1 Molecular Dispersion: o Alpha-Lipoic Acid (ALA): 300 mg of ALA is dissolved in water and a small amount of ethanol. This step addresses the hygroscopic nature and ensures proper dispersion of ALA at the molecular level. o Acetyl L-Carnitine (ALC): 500 mg of ALC is dissolved in water. This step ensures uniform dispersion and addresses the reactivity and thermal sensitivity of ALC. o Coenzyme Q10 (CoQlO): 200 mg of CoQlO is dissolved in a mixture of ethanol and oil. This step ensures proper dispersion of the lipophilic CoQlO and addresses its solubility challenges.

[0017] 2 Emulsion Integration: o The individual emulsions of ALA, ALC, and CoQlO are combined into a single, homogeneous emulsion mixture. This integration ensures uniform distribution and interaction of the ingredients at the molecular level, overcoming the challenges of differing solubility and particle sizes.

[0018] 3. Spray Drying: o The emulsion mixture is subjected to spray drying, a process that involves atomizing the emulsion into fine droplets and rapidly drying them to form a homogenous powder. This step preserves the molecular-level homogeneity achieved during mixing and produces particles of uniform size, preventing separation and settling issues. 4 Resulting Product: o The final product is a fine, homogeneous powder premix with uniform particle size, enhanced bioavailability, and improved stability. This process minimizes the exposure of sensitive ingredients like CoQlO to light and oxygen, thereby preserving their stability and efficacy over the product's shelf life.

[0019] 5. Consistent Assay Results: o Efficacy assays conducted on premixes prepared using “Mixing Technology at The Molecular Level” Technology show significantly reduced variation in ingredient concentrations, with variations of less than 5% compared to up to 20% in conventional methods.

[0020] • Applications:

[0021] This innovative formulation can be applied to a wide range of cardiac support supplements and other nutraceuticals requiring homogeneous powder mixtures. It is particularly beneficial for formulations where precise dosage control and stability are critical. The molecular-level mixing technology can also be adapted for use in pharmaceuticals, food, and cosmetic industries to improve the homogeneity and quality of various products.

[0022] Overcoming the Challenge with “Mixing Technology at The Molecular Level” Technology: The process involved:

[0023] 1. Alpha-lipoic acid: 300 mg dissolved in water and a small amount of ethanol.

[0024] 2. Acetyl L-carnitine: 500 mg dissolved in water.

[0025] 3. Co-enzyme Q10: 200 mg dissolved in a mixture of ethanol and oil.

[0026] Table.1 Premix composition

[0027] These solutions were individually emulsified, combined to form a homogeneous emulsion, and subjected to spray drying. The result was a uniform powder premix with improved homogeneity and stability. • Advantages of the New Formula:

[0028] 1. Enhanced Homogeneity: o The molecular-level mixing technology ensures that all active ingredients are uniformly distributed at the molecular level, overcoming the challenges of differing solubility and particle sizes.

[0029] 2. Improved Bioavailability: o By achieving a homogenous mixture, the bioavailability of each component is significantly enhanced, ensuring that the body can absorb and utilize the active ingredients more efficiently.

[0030] 3. Stability: o The process minimizes the exposure of sensitive ingredients like CoQlO to light and oxygen, thereby preserving their stability and efficacy over the product's shelflife.

[0031] 4. Dosage Precision: o The technology allows for precise control over the amount of each ingredient in the final product, ensuring consistent and accurate dosages in every batch.

[0032] 5. Particle Size Uniformity: o The spray drying process produces particles of uniform size, preventing separation and settling issues and ensuring a consistent product.

[0033] 6. Moisture Control: o The technology effectively manages the hygroscopic nature of ALA and ALC, preventing clumping and degradation caused by moisture absorption. Brief Description of Drawings:

[0034] Figure 1: Preparation Concept of “Mixing Technology at The Molecular Level” Technology

[0035] (a) Emulsion Formation and Integration: This part of the figure illustrates the preparation of multiple-ingredient emulsions. Separate core material solutions (red and yellow) and a wall material solution, which is an emulsifying agent, (purple) are individually prepared and then combined in a beaker. The individual ingredients are dispersed into emulsions using specialized emulsification techniques, ensuring each ingredient is uniformly distributed at the molecular level. The combined emulsion represents a homogeneous mixture ready for the next step.

[0036] (b) Spray Drying Process: This part of the figure depicts the spray drying process. The homogeneous emulsion mixture is fed into a spray dryer where it is atomized into fine droplets and exposed to a hot air stream. The rapid evaporation of the water phase results in the formation of solid particles or powder, which are then collected. This process preserves the molecular-level homogeneity achieved during the mixing and emulsion integration stages.

[0037] Conclusion:

[0038] Molecular-level mixing technology addresses the limitations of conventional mixing methods, which often result in non-homogeneous mixtures with varying particle sizes and densities due to the disparity in solubility of different ingredients. These inconsistencies affect bioavailability, stability, and final product quality. Molecular-level mixing technology provides a precise, efficient, and scalable solution for preparing homogeneous powder premixes at the molecular level. This novel formulation enhances bioavailability, stability, and consistency, making it a valuable innovation for the nutraceutical and pharmaceutical industries.

Claims

Claims:

1. A method for preparing a homogeneous powder premix for cardiac support supplements using molecular-level mixing technology, comprising: o Dissolving alpha-lipoic acid, acetyl L-carnitine, and coenzyme Q10 in appropriate solvents to form individual emulsions. o Integrating the individual emulsions into a single, homogeneous emulsion mixture. o Subjecting the homogeneous emulsion mixture to spray drying to form a homogenous powder. o Producing a final product with uniform particle size, enhanced bioavailability, and improved stability.

2. The method of claim 1, wherein alpha-lipoic acid is dissolved in water and a small amount of ethanol.

3. The method of claim 1, wherein acetyl L-carnitine is dissolved in water.

4. The method of claim 1, wherein coenzyme Q10 is dissolved in a mixture of ethanol and oil.

5. The method of claim 1, wherein the spray drying step atomizes the emulsion into fine droplets and rapidly dries them to form a homogeneous powder.

6. A homogeneous powder premix produced by the method of claim 1, exhibits uniform particle size, enhanced bioavailability, and improved stability.

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