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Method for a supplemental dietary composition having a multi-phase dissolution profile

a technology of dietary composition and dissolution profile, which is applied in the direction of drug composition, dispersed delivery, metabolic disorder, etc., can solve the problems of not only addressing the problem of but also presenting a problem in terms of bioavailability, and nothing in the u.s. pat, so as to increase the rate of dissolution of poorly-soluble compounds

Inactive Publication Date: 2007-08-30
MULTI FORMULATIONS LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] The present invention relates to a method and composition for achieving a multi-phasic rate of dissolution comprising administering to a mammal a composition comprising a series of decreasingly fine-milled and unprocessed supplemental dietary ingredients, wherein the fine-milled and unprocessed supplemental dietary ingredients are of like molecules. The plurality of dissolution rates of the composition is the result of the rates of dissolution corresponding to the specific ingredient types and degree of micronization for each ingredient. An aspect of the present invention is to provide an increase in the rate of dissolution of poorly-soluble compounds as compared to conventional unprocessed oral dosage formulations. A further aspect of the present invention is to provide a substantially immediate dissolution of the compositional ingredients in a first phase.

Problems solved by technology

This not only presents a problem in terms of bioavailability but also in terms of reducing or preventing toxicity and irregular absorption in the intestinal tract (Shekunov BY, Chattopadhyay P, Seitzinger J, Huff R. Nanoparticles of poorly water-soluble drugs prepared by supercritical fluid extraction of emulsions.
Therefore, it is a challenge to make these compounds, which will be used in a biological system, e.g., orally ingested by a human, such that they will be more readily bioavailable and at desired rates of dissolution.
For Example, U.S. Pat. No. 6,905,707 entitled “Controlled Release Arginine Alpha Ketoglutarate” discloses a controlled release formulation “characterized by protecting the active ingredients from chemical degradation in a patient's gastrointestinal tract and releasing the active ingredients in a controlled manner.” However, nothing in U.S. Pat. No. 6,905,707 addresses the problem associated with the rate of dissolution of poorly-soluble compounds.

Method used

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  • Method for a supplemental dietary composition having a multi-phase dissolution profile

Examples

Experimental program
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Effect test

example 1

In Powdered Form

[0082] A dietary supplement comprising the following ingredients per serving is prepared for consumption one time per day per individual:

[0083] about 2.0 ng of fine-milled Glycine, about 2.0 g of regular Glycine, about 5.0 ng of fine-milled L-Arginine, about 5.0 g of regular L-Arginine, about 3.0 ng of fine-milled Calcium-KIC, about 3.0 g of regular Calcium-KIC, about 2.0 g of Maltodextrin, about 1.5 g of Citric Acid, about 80 g of Dextrose, about 0.5 g of Sodium Citrate, about 0.3 g of Sodium Gluconate, about 0.4 g of Polyvinylyrolidone, about 0.1 g of Modified Food Starch, about 0.4 g of Syurp Solids, about 0.03 g of Gum Acacia , about 0.05 g of Silicon Dioxide, about 0.027 g of Acesulfame-Potassium, and about 0.01 g FD&C Red #40.

[0084] Preferably, the nutritional composition is consumed in accordance with the following directions:

[0085] Directions: As a dietary supplement, take one serving (35 g) of product before a high-intensity workout. Mix in a shaker cup...

example 2

[0090] A dietary supplement comprising the following ingredients per serving is prepared for consumption one to four times per day per individual.

[0091] about 7.5 g Leucine, about 0.0004 g fine-milled Leucine, about 0.05 g Calcium-KIC, about 0.45 g Hydroxyprpoyl Cellulose, about 1.75 g Microcrystalline Cellulose, about 0.18 g Croscarmellose Sodium, about 0.03 g Calcium Carbonate, about 0.12 g Vegetable Stearine, about 0.06 g Magnesium Stearate, about 0.06 g Silica, about 0.03 g Magnesium Silicate, about 0.306 g Coating [Polyvinyl Alcohol, Polyethylene Glycol, Talc, Titanium Dioxide, Riboflavin, Soy Lecithin, Polysorbate 80, Hydroxypropyl methylcellulose, Colorings], about 0.001 g Lysine Ketoisocaproic Acid and about 0.0004 g Sweeteners.

[0092] Preferably, the nutritional composition is consumed in accordance with the following directions:

[0093] Directions: As a dietary supplement, take 1 serving (6 caplets) first thing in the morning. On workout days, take 1 serving immediately be...

example 3

[0094] A dietary supplement comprising the following ingredients per serving is prepared for consumption one to four times per day per individual.

[0095] about 2.0 g regular Creatine-Ethyl Ester HCI, about 0.001 g fine-milled Creatine-Ethyl Ester HCI, about 0.1 g Creatine Alpha-ketoglutarate and about 0.1 g Alpha-lipoic Acid.

[0096] Preferably, the nutritional composition is consumed in accordance with the following directions:

[0097] Directions: As a dietary supplement, take two servings per day, e.g., one serving (2 caplets) in the morning and one serving (2 caplets) in the afternoon. Consume 10 8 oz. Glasses of water daily. To maximize results, use in conjunction with weight training.

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Abstract

The present invention relates to a method and composition for achieving a multi-phasic dissolution prolife through the process of fine-milling to increase the rate of dissolution of ingredients. The ingredients to be fine-milled are ingredients suitable for use in supplemental dietary compositions.

Description

RELATED APPLICATIONS [0001] The present application is related to and claims benefit of priority to U.S. Provisional Application No. 60 / 776,325, entitled “Compositions and method for increasing the rate of bioavailability of supplemental dietary ingredients” filed Feb. 23, 2006, the disclosure of which is hereby fully incorporated by reference.FIELD OF THE INVENTION [0002] The invention relates to the process of particle milling (micronization) for the purposes of producing a supplemental dietary composition characterized by a multi-phase dissolution profile. Based upon the resultant particle dimensions the ultimate rate of dissolution is affected, wherein the combination of multiple differently sized ranges of dimensioned particles achieves a multi-phased, multiple-term of dissolution of like particles. An aspect of the present invention is to provide an increase in the rate of dissolution of poorly-soluble compounds as compared to conventional oral dosage formulations. Another asp...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/20A23L5/30A23L33/00
CPCA23L1/30A23L1/3002A23L1/304A23L1/3051A23L1/3053A23L2/52A23V2002/00A61K9/0095A61K9/14A61K9/20A61K9/2072A61K31/122A61K31/185A61K31/197A61K31/198A61K31/205A61K31/385A61K31/4045A61K31/455A61K31/555A61K31/715A61K33/24A61K33/42A61K36/185A61K36/53A61K36/539A61K36/752A61K36/76A61K36/84A61K36/889H01L21/28273H01L29/42324H01L29/788H01L29/7884Y10S514/923A61K2300/00A23V2200/20A23V2250/0606A23V2250/7046A23V2200/326A23V2200/316A23V2250/06A23V2250/0644A23V2250/21A23L33/10A23L33/105A23L33/16A23L33/175A23L33/18H01L29/40114A61P21/06A61P25/20A61P3/02A61P43/00
Inventor HEUER, MARVINCLEMENT, KENCHAUDHURI, SHANRAMSBOTTOM, JAMES
Owner MULTI FORMULATIONS LTD
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