Theracurmin

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Theracurmin®

Curcumin has been being researched all over the world because of its high functionality and efficacy, however it always retains the key challenges in bioavailability.
Theravalues has been tackling the issue through trial and error process and finally succeeded in developing Theracurmin®with a 27 times higher absorption capacity by employing the patented technology to produce stable sub-micron particles. Theracurmin® shows stabilized dispersion ability in water as well as heat resistance and is accepted and esteemed globally as a functional food raw material.

セラクルミン®はウコンの主成分を飛躍的に高吸収化した素材です。 セラクルミン®はウコンの主成分を飛躍的に高吸収化した素材です。

Turmeric?

Turmeric is a perennial plant of ginger family and widely spread in South and South
East Asian countries. It is commonly used as a spice, flavoring agent, food preservative,
and coloring agent, and known as a key ingredient of curry powder.

Long history of Turmeric use
The medicinal use of this plant has been documented in Ayurveda
(Indian traditional medicine) for over 6000 years and used as herbal remedy
for Arthritis, Cancer, Cardiac and other medical conditions.
The turmeric has migrated
into China as an element of Chinese herbal remedy and been used as an anti-depressant.

Curcumin?

Curcumin is a polyphenol derived from the rhizome of the plant Curcuma Longa, commonly called turmeric and is used as a spice, flavoring agent, food preservative, and coloring agent in general.

Curcumin is well known for its effect of anti-inflammatory and anti-oxidant amongst medical and health science institutes all over the globe. A great number of researches are being conducted by a variety of medical and science institutes.

Development of high bioavailable curcumin

Development of high bioavailable curcumin

Curcumin is always facing a fatal issue, the poor bioavailability. When orally ingested, most of the curcumin is excreted without being absorbed in the small intestine.
Theravalues have been struggling to resolve the issues of curcumin and finally succeeded in developing Theracurmin® with a 27 times higher absorption capacity based on the patented technology.
In the clinical study, Theracurmin® demonstrates 27 times higher bioavailability than ordinary curcumin powder. The unique technology has enabled to produce sub-micron particles, which demonstrate a stabilized dispersion ability in water as well as heat resistance.
Theracurmin® is considered as an efficient solution to enjoy the benefits of curcumin for the people all over the world.

クルクミン粒子を細粒化+凝集を防ぐ表面処理=吸収性を大幅に改善 仮説に基づく腸管吸収のイメージ図 クルクミン粒子を細粒化+凝集を防ぐ表面処理=吸収性を大幅に改善 仮説に基づく腸管吸収のイメージ図

  • 従来のクルクミン 顕微鏡写真 従来のクルクミン 顕微鏡写真
  • セラクルミン® 顕微鏡写真 セラクルミン® 顕微鏡写真
  • 水への分散比較 従来のクルクミン粉末 セラクルミン® 水への分散比較 従来のクルクミン粉末 セラクルミン®

Improvement of absorption of curcumin

Successfully confirmed 27 times higher bioavailability than the ordinary curcumin powder through the clinical study by 30mg single administration to human subjects.

血中動態 用量依存性 血中濃度AUC 0-6hr Sasaki H, et al: Biol Pharm Bull. 34(5): 660-665, 2011. 血中動態 用量依存性 血中濃度AUC 0-6hr Sasaki H, et al: Biol Pharm Bull. 34(5): 660-665, 2011.

The key to the solution of contemporary diseases “chronic inflammation”

The recent researches have extended our understandings of “chronic inflammation” and it became obvious that chronic inflammation builds the basis of many contemporary diseases, such as diabetes, cancer and autoimmune disorder.
Chronic inflammation is developing without noticing and exacerbates many physiological and pathological diseases, therefore it is called “Silent Killer”.
In the today’s lifestyle, more than 70% of cause of death amongst people over 60 are diseases due to chronic inflammation.

Curcumin and chronic inflammation

It is well known that chronic inflammation is caused by the continuous activation of NF-κB and curcumin is one of the natural ingredients to inhibit the activation of NF-κB. By this anti-inflammatory efficacy through diminishing the activated NF-κB , curcumin is thought to prevent lifestyle related diseases and bring in a healthy aging life to the people. Because of those potential benefits, it has been studied further by many research institutes all over the world even now.
Theravalues is initiating many clinical researches for chronic inflammation related diseases with collaborations with many academic and educational organizations in Japan as well as overseas.

NF-κB:
NF-κB (nuclear factor kappa-light-chain-enhancer of activated B cells) is a protein complex that controls transcription of DNA, cytokine production and cell survival. Improper regulation of NF-κB is considered as a cause of many diseases, such as cancer, inflammatory and autoimmune diseases, viral infection and improper immune development

Clinical studies with Theracurmin® for chronic inflammation relates diseases

We Theravalues have been conducting clinical studies of Theracurmin® with Universities and Research Institutes at home and abroad.

慢性炎症 メタボリックシンドローム肥満、糖尿病、高脂血症、慢性腎疾患、NASH 動脈硬化 虚血性心疾患 脳血管疾患 自己免疫疾患 リウマチ 潰瘍性大腸炎 神経変性疾患 後天性心疾患 パーキンソン病 がん 増殖 血管新生 転移 慢性炎症 メタボリックシンドローム肥満、糖尿病、高脂血症、慢性腎疾患、NASH 動脈硬化 虚血性心疾患 脳血管疾患 自己免疫疾患 リウマチ 潰瘍性大腸炎 神経変性疾患 後天性心疾患 パーキンソン病 がん 増殖 血管新生 転移 肝機能(高輪メディカルクリニック) 運動・疲労回復(筑波大学) 中心血圧改善(筑波大学) 糖尿病(京都医療センター) COPD(京都医療センター) 動脈硬化(筑波大学) 運動・疲労回復(筑波大学) 心不全(京都医療センター) 中心血圧改善(筑波大学) 変形性膝関節症 (京都医療センター) 膵臓がん(京都大学) 肺がん(埼玉医科大) 進行性悪性腫瘍(MD Anderson) 治療抵抗性癌: 悪液質 認知症・アルツハイマー(UCLA)

Safety of Theracurmin®

In vitro and in vivo

Theracurmin has been confirmed its safety by Mutagenicity test (in vitro), Ames test and Chromosomal Aberration test.

Repeated dose Toxicity test (rat, 13 weeks)

The safety dosage level per day is assayed 1,500mg/day/kg by 90day repeated test

Clinical Study

Through double blind Randomized Controlled Trials, Theracurmin is confirmed as safe for long term (12 weeks, 180mg of curcumin per day) administration and excess (four weeks, 900mg of curcumin per day) administration test by human.

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Toxicity Data
Test Ames test Subacute toxicity study Subchronic toxicity study Chromosome aberration test Micronucleus assay Test
Test
Detail
Salmonella spp.
(4 strains)

E.Coli

Dose (as curcumin)
0,187.5,375,750,1500 mg/kg
Period: 2 weeks
Period : 2 weeks
Dose (as curcumin)
0,375,750,1500 mg/kg
Period: 13 weeks
Period: 13 weeks
In vitro chromosome aberration test in Chinese hamster lung cells Male sprague-dawley rats bone marrow micronucleus assay
Result Negative No toxicological findings observed by oral administration No toxicological findings observed by oral administration Negative Negative
Safety Assessment by Clinical Study in Healthy Volunteers
Test Safety test with excessive dosage Long term safety test with standard dosage
Test
Detail
Tested dosage (as curcumin): 900 mg/q.d./p.o.
(5 x of standard dosage*)
Period: 4 weeks
Tested dosage (as curcumin): 180 mg/q.d./p.o.
(standard dosage*), 12 weeks.
Period: 12 weeks
Result THERACURMIN® was proved its safety in this study. THERACURMIN® was proved its safety in this study.

    

q.d.: Once a day
p.o.: Oral intake
ADI: Acceptable Daily Intake (3mg/kg)
*Standard dosage: 180mg/day (as curcumin) = ADI(3mg/kg) x 60kg (average adult body weight)

Stability of Theracurmin®

Theracurmin® is in the form of sub-micron particles with enhanced stability when dispersed in water, as well as against light and heat. In addition, there is no bitterness and almost no taste or smell.

Stably dispersed and dissolved in water, therefore it can be used in various beverage products.
Showed high stability in photostability test, therefore it is compatible with
transparent containers.
Showed stable survival rate during thermal stability test at 95⁰C and 120 ⁰C ,
therefore can be used under pasteurization conditions for beverage and food.

Comparison in curcumin dispersion

  • Photostability test

    *500Langley is equivalent to the UV of two summer days

  • Thermal stability test