U.S. patent application number 16/827529 was filed with the patent office on 2020-10-29 for stable liquid formulations for pharmaceuticals and supplements.
The applicant listed for this patent is David Johnson, Max Spielberg. Invention is credited to David Johnson, Max Spielberg.
Application Number | 20200338200 16/827529 |
Document ID | / |
Family ID | 1000004942464 |
Filed Date | 2020-10-29 |
United States Patent
Application |
20200338200 |
Kind Code |
A1 |
Spielberg; Max ; et
al. |
October 29, 2020 |
Stable liquid formulations for pharmaceuticals and supplements
Abstract
A liquid composition comprising: a primary component being an
Active Pharmaceutical Ingredient (API), a nutritional supplement,
or combinations thereof: a base; and a preservative blend is
provided along with a method of making said composition.
Inventors: |
Spielberg; Max; (Beverly
Hills, CA) ; Johnson; David; (Beverly Hills,
CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Spielberg; Max
Johnson; David |
Beverly Hills
Beverly Hills |
CA
CA |
US
US |
|
|
Family ID: |
1000004942464 |
Appl. No.: |
16/827529 |
Filed: |
March 23, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15912785 |
Mar 6, 2018 |
10596266 |
|
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16827529 |
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62580648 |
Nov 2, 2017 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61K 36/9066 20130101;
A61P 11/14 20180101; A61K 47/46 20130101; A61K 36/074 20130101;
A61K 35/644 20130101; A61K 36/88 20130101; A61K 47/12 20130101;
A61K 36/35 20130101; A61K 47/26 20130101; A61K 36/9068 20130101;
A61K 36/235 20130101; A61K 36/736 20130101; A61K 9/0095
20130101 |
International
Class: |
A61K 47/46 20060101
A61K047/46; A61K 9/00 20060101 A61K009/00; A61K 36/88 20060101
A61K036/88; A61K 35/644 20060101 A61K035/644; A61K 36/736 20060101
A61K036/736; A61K 36/35 20060101 A61K036/35; A61P 11/14 20060101
A61P011/14; A61K 36/235 20060101 A61K036/235; A61K 47/26 20060101
A61K047/26; A61K 36/9068 20060101 A61K036/9068; A61K 47/12 20060101
A61K047/12; A61K 36/9066 20060101 A61K036/9066; A61K 36/074
20060101 A61K036/074 |
Claims
1. A liquid composition comprising: a primary component being an
Active Pharmaceutical Ingredient (API), a nutritional supplement,
or combinations thereof: a base; a preservative blend comprising
either, Organic Cultured Dextrose, Organic Elderberry (16:1 Fruit
Powder) Organic Compliant Citric Acid Organic Turmeric Root Powder
Organic Fennel Seed Powder Organic Ginger Root, in a ratio of
1:0.8-1.0:0.55-0.65:0.40-0.54:0.05-0.09:0.05-0.09 or Organic
Cultured Dextrose Organic Elderberry (16:1 Fruit Powder) Organic
Compliant Citric Acid Organic Echinacea Purpurea Herb (6:1), in a
ratio of 1:0.60-0.70:0.55-0.65:0.35-0.44.
2. The composition of claim 1 wherein the preservative blend is
2-5% w/w of the composition.
3. A method of preparing a liquid composition comprising the steps
of: Providing components of a preservative blend comprising either
Organic Compliant Citric Acid Organic Turmeric Root Powder Organic
Fennel Seed Powder Organic Ginger Root, or Organic Cultured
Dextrose Organic Elderberry (16:1 Fruit Powder) Organic Compliant
Citric Acid Organic Echinacea Purpurea Herb (6:1), and combing them
into an herbal pre-mix, blend into a small amount of the base and
heat between 180-200 degrees Fahrenheit, to create the pre-mix
containing the herbal ingredients; combining the pre-mix and mix
with the remainder of the agave/honey (the majority of the
formula), which was heated to about 100.degree. F. degrees until
the pre-mix is homogenous and becomes one product; cooling the
combined mixture to room temperature and introduce flavors once at
room temperature; placing the combined cooled room temperature
product containing flavors (pre-mix and remainder of formula); and
mixing to form a uniform composition.
Description
INDEX TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. Non-provisional
patent application Ser. No. 15/912,785 Filed Mar. 6, 2018 which is
a non-provisional of, and claims benefit to U.S. Provisional Patent
Application Ser. No. 62/580,648 filed Nov. 2, 2017 the disclosures
of which are incorporated herein by reference in their
entirety.
SUMMARY OF THE INVENTION
[0002] The present invention relates to novel stabilization of
liquid pharmaceutical and nutritional supplements.
[0003] In one embodiment, the present invention is a liquid
composition comprising: [0004] a primary component being an Active
Pharmaceutical Ingredient (API), a nutritional supplement, or
combinations thereof: [0005] a base; [0006] a preservative blend
comprising either, Organic Cultured Dextrose, Organic Elderberry
(16:1 Fruit Powder)
[0007] Organic Compliant Citric Acid
[0008] Organic Turmeric Root Powder
[0009] Organic Fennel Seed Powder
[0010] Organic Ginger Root, in a ratio of
1:0.8-1.0:0.55-0.65:0.40-0.54:0.05-0.09:0.05-0.09 or
[0011] Organic Cultured Dextrose
[0012] Organic Elderberry (16:1 Fruit Powder)
[0013] Organic Compliant Citric Acid
[0014] Organic Echinacea Purpurea Herb (6:1), in a ratio of
1:0.60-0.70:0.55-0.65:0.35-0.44.
[0015] In one embodiment, the present invention provides the
preservative blend is 2-5% w/w of the composition.
[0016] In one embodiment, the present invention is a liquid
composition consisting of: [0017] a primary component being an
Active Pharmaceutical Ingredient (API), a nutritional supplement,
or combinations thereof: [0018] a base; [0019] a preservative blend
comprising either, Organic Cultured Dextrose, Organic Elderberry
(16:1 Fruit Powder)
[0020] Organic Compliant Citric Acid
[0021] Organic Turmeric Root Powder
[0022] Organic Fennel Seed Powder
[0023] Organic Ginger Root, in a ratio of
1:0.8-1.0:0.55-0.65:0.40-0.54:0.05-0.09:0.05-0.09 or
[0024] Organic Cultured Dextrose
[0025] Organic Elderberry (16:1 Fruit Powder)
[0026] Organic Compliant Citric Acid
[0027] Organic Echinacea Purpurea Herb (6:1), in a ratio of
1:0.60-0.70:0.55-0.65:0.35-0.44.
[0028] In one embodiment, the present invention is a method of
preparing a liquid composition as described herein comprising the
steps of:
[0029] Providing components of a preservative blend comprising
either Organic Compliant Citric Acid
[0030] Organic Turmeric Root Powder
[0031] Organic Fennel Seed Powder
[0032] Organic Ginger Root, or
[0033] Organic Cultured Dextrose
[0034] Organic Elderberry (16:1 Fruit Powder)
[0035] Organic Compliant Citric Acid
[0036] Organic Echinacea Purpurea Herb (6:1), [0037] and combing
them into an herbal pre-mix, blend into a small amount of the base
and heat between 180-200 degrees Fahrenheit, to create the pre-mix
containing the herbal ingredients;
[0038] combining the pre-mix and mix with the remainder of the
agave/honey (the majority of the formula), which was heated to
about 100.degree. F. degrees until the pre-mix is homogenous and
becomes one product;
[0039] cooling the combined mixture to room temperature and
introduce flavors once at room temperature;
[0040] placing the combined cooled room temperature product
containing flavors (pre-mix and remainder of formula); and
[0041] mixing to form a uniform composition.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0042] The present invention relates to novel stabilization of
liquid pharmaceutical and nutritional supplements.
[0043] Although the examples provided herein are nutritional
supplements, it is contemplated that any Active Pharmaceutical
Ingredient (API) or nutritional supplement ingredient is formulated
according to the invention disclosed herein and will produce a
stable composition with desired shelf life.
[0044] In one embodiment, the present invention includes the
process of blending an herbal pre-mix with a small amount of the
base (in this case, agave or honey) and heating at a high
temperature (about 180-200 degrees Fahrenheit), subsequently mixing
the pre-mix with the remainder of the formula, which has been
heated to be at a lower temperature (about 100.degree. F.). By
heating the pre-mix and base and the remainder of base separately
and at different temperatures, the novel process will reduce the
froth and prevent flavor changes. This is the first time such a
system has been used.
[0045] In one embodiment, the present invention includes using
approximately 80-90% solid base (in this case, 84% solid agave or
honey depending) with combination of cultured dextrose and citric
acid in order to not have to put in a non-organic, synthetic
preservative systems. This allows the present invention to have a
certified organic base without any synthetic preservative systems.
This is the first time this combination of high percentage solid
base, citric acid and cultured dextrose has been used.
[0046] In formulations practice, it is known that often two or more
preservatives are provided. Sometimes they are provided for
specific preserving characteristics. However, there are
preservative systems that are utilized with various components
having beneficial synergistic affects even thought the exact
mechanism of the beneficial synergistic affects is not clearly
understood. This is true in the present formulation whereby a
synergistic system has been discovered, demonstrated effective, yet
is operating in a mechanism not fully understood.
[0047] In the present invention, particular ratios have been
discovered whereby a plurality of components in the ratios herein,
provide the desired effect.
[0048] Initial formulas were exactly the same, except the agave was
around 60-70% solid and they did not have cultured dextrose. These
formulas did not have an effective preservation system, and failed
stability testing.
Manufacture
[0049] In one embodiment, the present invention is performed using
the following steps:
[0050] Providing organic herbal extracts and combing them into an
herbal pre-mix, blend into a small amount of the base (here, agave
or honey depending) and heat between 180-200 degrees Fahrenheit, to
create the pre-mix containing the herbal ingredients.
[0051] Although the examples demonstrate Agave and Honey as the
base, the term "base" as used herein includes components having
similar viscosities and characteristics including, but not limited
to tapioca syrups, fruit syrups, maple syrups, elderberry syrup,
combinations of bases, and the like.
[0052] As is known, Agave will break down at 320.degree. F. and
will even begin to change at 210.degree. F., therefore
180-200.degree. F. is one ideal temperature range to extract the
herbal ingredients into the agave/honey without hurting them or the
agave/honey. The present invention contemplates temperature for
other types of syrups with similar consistencies at similar
temperatures.
[0053] Combining the pre-mix and mix with the remainder of the
agave/honey (the majority of the formula), which was heated to
about 100.degree. F. degrees until the pre-mix is homogenous and
becomes one product.
[0054] Cooling the combined mixture to room temperature and
introduce flavors once at room temperature.
[0055] Placing the combined cooled room temperature product
containing flavors (pre-mix and remainder of formula) and mix into
a mixer.
[0056] It has been discovered that separately handling the pre-mix
and remainder of formula separately, prevents flavor changes and
froth. This then helps reduce and prevent sheer and flavor changes
as the sheer and flavor changes are caused by warming at a high
temperature. Heating the herbal pre-mix is necessary to blend the
herbal ingredients into the base.
Sample Formulations
TABLE-US-00001 [0057] FORMULA 1 AGAVE COUGH SYRUP Organic Agave
Syrup 4.6 g Organic Acerola 29 mg (containing 34% naturally
occurring Vitamin C) Proprietary Blend: 27 mg Organic Elderberry
Fruit Powder (16:1), Organic Fennel Extract, Organic Turmeric,
Organic Ginger Root.
TABLE-US-00002 FORMULA 2 HONEY COUGH SYRUP Organic Honey 6.3 g
Organic Echinacea 15 mg Organic Elderberry Fruit Powder (16:1) 25
mg Organic Acerola 75 mg (containing 34% naturally occurring
Vitamin C)
TABLE-US-00003 FORMULA 3 AGAVE TEETHING SYRUP Organic Agave Syrup
4.6 g Organic Acerola 29 mg (containing 34% naturally occurring
Vitamin C) Proprietary Blend: 25 mg Organic Elderberry Fruit Powder
(16:1), Organic Turmeric, Organic Reishi Mushroom.
TABLE-US-00004 Agave Cough Syrup Percentage Composition Mg per
Formulation serving Percentage Organic Agave Syrup 2894.28
96.4761172% Organic Acerola (34% Vitamin C) 30.88 1.0254118%
Organic Cultured Dextrose 24.26 0.8085000% Organic Elderberry (16:1
Fruit Powder) 21.00 0.7000000% Organic Compliant Citric Add 14.45
0.4816700% Organic Cherry Flavor 11.13 0.3709677% Organic Reishi
Mushroom Powder 2.00 0.0666667% Organic Turmeric Root Powder 2.00
0.0666667% Total: 3,000.00 100.000000%
TABLE-US-00005 Honey Cough Syrup Percentage Composition Mg per
Formulation: serving Percentage Organic Honey 4,530.88 90.6176871%
Purified Water 285.71 5.7142857% Organic Acerola (34% Vitamin C)
78.75 1.5750000% Organic Cultured Dextrose 40.43 0.8085000% Organic
Elderberry (16.1 Fruit 25.00 0.5000000% Powder) Organic Compliant
Citric Acid 24.08 0.4816700% Organic Echinacea Purpurea Herb 15.00
0.3000000% (6:1) Organic Compliant Lemon Flavor 0.14 0.0028571%
Total: 5,000.00 100.000000%
TABLE-US-00006 Agave Teething Syrup Mg per Formulation: serving:
Percentage Organic Agave Syrup 2,892.18 96.4094505% Organic Acerola
(34% Vitamin C) 30.88 1.0294118% Organic Cultured Dextrose 24.26
0.8085000% Organic Elderberry (16:1 Fruit Powder) 21.00 0.7000000%
Organic Compliant Citric Acid 14.45 0.4816700% Organic Cherry
Flavor 11.13 0.3709677% Organic Turmeric Root Powder 2.00
0.0666667% Organic Fennel Seed Powder 2.00 0.0666667% Organic
Ginger Root 2.00 0.0666667% Total: 3,000.00 100.000000%
Preservative Efficay Testing
USP Preservative Efficay
TABLE-US-00007 [0058] Agave Cough Syrup Inoculum ATCC Test
Organisms Level (CFU/g) Number Escherichia coli 4.9 .times.
10.sup.5 8739 Pseudomonas aeruginosa 6.0 .times. 10.sup.5 9027
Staphylococcus aureus 5.0 .times. 10.sup.5 6538 Candida albicans
2.6 .times. 10.sup.5 10231 Aspergillus (niger) 3.1 .times. 10.sup.5
16404 brasiliensis
Method
[0059] The sample was challenged against the five individual
microorganisms listed above following the USP <51>
guidelines. Pure culture challenge yields specific data on each
microorganism employed in the study.
[0060] The sample was initially tested for aerobic bacteria, yeast,
and mold following the USP <51> guidelines. This initial
screen is imperative to ensure the product does not contain any
microorganisms prior to beginning the inoculations. No organisms
were found in the sample during the initial screen.
Effectiveness Standards
[0061] Bacteria: Not less than 1.0 log reduction from the initial
count at 14 days, and no increase from the 14 days' count at 28
days. Yeast and Molds: No increase from the initial calculated
count at 14 and 28 days. Upon reinoculation, the same effectiveness
standards apply.
TABLE-US-00008 Test E. P. S. C. A. Interval coli aeruginosa aureus
Albicans brasiliensis 0 hours 1.8 .times. 10.sup.5 2.8 .times.
10.sup.4 6.7 .times. 10.sup.5 2.0 .times. 10.sup.3 2.2 .times.
10.sup.4 1 Week 210 260 190 <10 2.2 .times. 10.sup.3 2 Weeks
<10 <10 <10 <10 30 4 Weeks <10 <10 <10 <10
<10 All results in the table are reported as CFU/g
[0062] Study Conclusion The sample has PASSED the test. The actual
data collected from the study at each testing interval is listed on
the following page.
USP Preservative Efficay
TABLE-US-00009 [0063] Honey Cough Syrup Inoculum ATCC Test Organism
Level (CFU/g) Number Escherichia coli 4.9 .times. 10.sup.5 8739
Pseudomonas aeruginosa 6.0 .times. 10.sup.5 9027 Staphylococcus
aureus 5.0 .times. 10.sup.5 6538 Candida albicans 2.6 .times.
10.sup.5 10231 Aspergillus (niger) 3.1 .times. 10.sup.5 16404
brasiliensis
Method
[0064] The sample was challenged against the five individual
microorganisms listed above following the USP <51>
guidelines. Pure culture challenge yields specific data on each
microorganism employed in the study.
[0065] The sample was initially tested for aerobic bacteria, yeast,
and mold following the USP <51> guidelines. This initial
screen is imperative to ensure the product does not contain any
microorganisms prior to beginning the inoculations. No organisms
were found in the sample during the initial screen.
Effectiveness Standards
[0066] Bacteria: Not less than 1.0 log reduction from the initial
count at 14 days, and no increase from the 14 days' count at 28
days. Yeast and Molds: No increase from the initial calculated
count at 14 and 28 days. Upon reinoculation, the same effectiveness
standards apply.
TABLE-US-00010 Test E. P. S. C. A. Interval coli aeruginosa aureus
albicans brasiliensis 0 hours 5.1 .times. 10.sup.5 1.3 .times.
10.sup.5 9.7 .times. 10.sup.5 1.2 .times. 10.sup.5 2.4 .times.
10.sup.4 1 Week 120 86 5.2 .times. 10.sup.4 10 1.9 .times. 10.sup.4
2 Weeks <10 <10 <10 <10 2.1 .times. 10.sup.3 4 Weeks
<10 <10 <10 <10 850 All results in the table are
reported as CFU/g
[0067] Study Conclusion The sample has PASSED the test. The actual
data collected from the study at each testing interval is listed on
the following page.
USP Preservative Efficay
TABLE-US-00011 [0068] Agave Teething Syrup Inoculum ATCC Test
Organism Level (CFU/g) Number Escherichia coli 4.9 .times. 10.sup.5
8739 Pseudomonas aeruginosa 6.0 .times. 10.sup.5 9027
Staphylococcus aureus 5.0 .times. 10.sup.5 6538 Candida albicans
2.6 .times. 10.sup.5 10231 Aspergillus (niger) 3.1 .times. 10.sup.5
16404 brasiliensis
Method
[0069] The sample was challenged against the five individual
microorganisms listed above following the USP <51>
guidelines. Pure culture challenge yields specific data on each
microorganism employed in the study.
[0070] The sample was initially tested for aerobic bacteria, yeast,
and mold following the USP <51> guidelines. This initial
screen is imperative to ensure the product does not contain any
microorganisms prior to beginning the inoculations. No organisms
were found in the sample during the initial screen.
Effectiveness Standards
[0071] Bacteria: Not less than 1.0 log reduction from the initial
count at 14 days, and no increase from the 14 days' count at 28
days. Yeast and Molds: No increase from the initial calculated
count at 14 and 28 days. Upon reinoculation, the same effectiveness
standards apply.
TABLE-US-00012 Test E. P. S. C. A. Interval coli aeruginosa aureus
albicans brasiliensis 0 hours 1.7 .times. 10.sup.5 2.4 .times.
10.sup.4 5.6 .times. 10.sup.5 1.2 .times. 10.sup.3 2.5 .times.
10.sup.4 1 Week 300 190 190 <10 805 .times. 10.sup.3 2 Weeks
<10 <10 <10 <10 40 4 Weeks <10 <10 <10 <10
<10 All results in the table are reported as CFU/g
[0072] Study Conclusion The sample has PASSED the test. The actual
data collected from the study at each testing interval is listed on
the following page.
[0073] The following represents the blend of ingredients
demonstrative of one embodiment of the novel preservative
system:
Preservative Blend 1
[0074] Organic Cultured Dextrose
[0075] Organic Elderberry (16:1 Fruit Powder)
[0076] Organic Compliant Citric Acid
[0077] Organic Turmeric Root Powder
[0078] Organic Fennel Seed Powder
[0079] Organic Ginger Root
[0080] In one embodiment, these are combined in a ratio of
1:0.8-1.0:0.55-0.65:0.40-0.54:0.05-0.09:0.05-0.09.
Preservative Blend 2
[0081] Organic Cultured Dextrose
[0082] Organic Elderberry (16:1 Fruit Powder)
[0083] Organic Compliant Citric Acid
[0084] Organic Echinacea Purpurea Herb (6:1)
[0085] In one embodiment, these are combined in a ratio of
1:0.60-0.70:0.55-0.65:0.35-0.44.
[0086] The blend is used at 2-5% w/w of the final formulation. As
evidenced by the USP testing disclosed herein, formulations
utilizing this stability system have demonstrated stability.
[0087] While the invention has been described in its preferred form
or embodiment with some degree of particularity, it is understood
that this description has been given only by way of example and
that numerous changes in the details of construction, fabrication,
and use, including the combination and arrangement of parts, may be
made without departing from the spirit and scope of the
invention.
* * * * *