Boroflex Capsule

Calcium Fructoborate Capsules

Each serving per capsule contains:

Calcium Fructoborate equivalent to elemental Boron 6 mg

Ingredients:

Calcium Fructoborate, Bulking Agent [INS 460 (i)], Anticaking Agent [INS 553 (iii)], Antisticking Agent [INS 470 (i)], Ingredient of capsule shell [INS 464], Synthetic food colour [INS 102] & [INS 171]

Nutritional Information

* % RDA calculated as per ICMR Guidelines, 2020 for sedentary work men.

** % RDA values calculated as per FSSAI Labeling and Display Regulation 2020 for average adult.

# % RDA not established.

Capsule

6 mg (elemental Boron)

BoroflexTM is a Natural-identical form Calcium Fructoborate

100% Vegan and non-genetically modified (Non-GMO)

4.1 Therapeutic indication

Helps for bone and joint health.

4.2 Posology and method of administration

NUTRACEUTICAL

Target Consumer Group: Adults

Recommended usage: One capsule twice a day

Not to exceed the recommended daily dose.

Capsule should be swallowed whole & not to be opened, chewed or crushed.

4.3 Contraindications

Don't take this preparation if you are allergic to it or any ingredients contained in this preparation.

4.4 Special warnings and precautions for use

• It is Nutraceutical and Not for Medicinal Use.
• Allergen Information: Allergen free.
• This product is not intended to diagnose, treat, cure or prevent any disease.
• This product is not to be used as a substitute for a varied diet.

4.5 Drugs interactions

Boron is not known to have any clinically relevant interactions with medications.

• Fructoborates have positive synergic interactions with calcium, magnesium, zinc, iron, and copper.
• The amount of fructoborate should be increased when the amount of iodine, fluoride, and silicon from the body increases as well.
• Antagonism: Fructoborates are antagonized by silicon as orthosilicic acid, by iodine, and by fluoride.

4.6 Use in special populations

Pregnant / lactating women, children & people with medical conditions should consult a Healthcare Professional before use.

4.7 Effects on ability to drive and use machines

No effect anticipated. There isn’t specific research directly linking boron supplementation to driving performance.

4.8 Undesirable effects

Generally recognized as safe (GRAS certified) by United States Food and Drug Administration (FDA). Generally well-tolerated; possible mild side effects include gastrointestinal discomfort, headaches, or skin reactions.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to:medico@zuventus.com

Website: https://www.zuventus.com/drug-safety-reporting

By reporting side effects, you can help provide more information on the safety of this medicine.

5.1 Pharmacodynamic properties

Boron is a trace element found in various foods and available as a dietary supplement. It plays essential roles in the metabolism of plants, animals, and humans, and recent research suggests it may have been significant for the evolution of life on Earth. The World Health Organization recognizes boron as "probably essential" for humans. In food and beverages, boron appears as inorganic borates or as mono- or di-sugar-borate esters, such as calcium fructoborate.

Calcium fructoborate (CaFB) is a plant-based boron compound that enters cells via sugar transporters (GLUTs), facilitating the absorption of fructoboric acid. It acts as a catalyst for CO2 hydration, enhancing buffering capacity at physiological pH. CaFB modulates various cell signaling pathways, influencing inflammatory mediators and transcription factors, and exhibits antioxidant properties by reducing reactive oxygen species (ROS). Compared to traditional boric acid, CaFB has more complex mechanisms of action, including the formation of sugar borate esters (SBEs) that interact with key amino acids. SBEs are considered conditionally essential nutrients, potentially influencing metabolic processes and disorders like arthritis and diabetes. Additionally, CaFB demonstrates anti-inflammatory effects by regulating cytokine production and lowering inflammatory markers. Importantly, it exists as a non-toxic boron reservoir, allowing safe biological activity inside and outside cells. Overall, CaFB's diverse mechanisms distinguish it from conventional boron compounds.

5.2 Boron and Bone Health

Clinical studies suggest that boron may help reduce osteoarthritis symptoms by inhibiting inflammation. It plays a crucial role in bone growth and formation, potentially influencing osteoblast and osteoclast activity, serum steroid hormone levels, and calcium metabolism. Boron deficiency has been linked to abnormal limb development, delayed growth plate maturation, and decreased bone strength. Supplementation has shown to improve bone strength measures in animal studies.

Boron and Calcium Metabolism: Research indicates that boron deprivation leads to increased urinary excretion of calcium and magnesium and decreased levels of key hormones in postmenopausal women. Boron may positively influence calcium and vitamin D metabolism, reducing the risk of osteoporosis. A study found that 6 mg of boron supplementation per day for 60 days raised serum vitamin D levels by about 20% in vitamin D-deficient subjects. Additionally, a trial with female athletes and sedentary women showed that 3 mg/day of boron for 10 months reduced serum phosphorus and increased magnesium levels, potentially enhancing bone mineral density.

Boron and Arthritis: Lower boron intake has been associated with higher rates of arthritis. Studies have shown a negative correlation between soil boron levels and arthritis incidence. In areas with daily boron intakes of 1.0 mg or less, arthritis rates range from 20% to 70%, while in areas with 3–10 mg intake, rates drop to 0%–10%. A double-blind study indicated that 6 mg/day of boron significantly improved joint conditions and reduced pain in osteoarthritis patients after 8 weeks of supplementation compared to a placebo.

Stimulates Osteogenesis: Promotes osteoblast differentiation and reduces superoxide formation. Boosts testosterone, increases muscle mass, improves calcium absorption, and maintains bone density. Enhances the bioavailability of sex hormones and Vitamin D. Anti-oxidant Action: Acts as an anti-inflammatory by inhibiting oxidative bursts and improving free radical scavenging. Inhibits collagenase enzymes, protecting skin, joints, and bones.

Safety and Efficacy: Improves osteoarthritis symptoms and reduces inflammatory markers. Reduces knee discomfort and improves joint flexibility. Improves inflammatory and cardiovascular biomarkers. It reduces the use of painkillers.

Overall, boron appears to play a beneficial role in bone health, calcium metabolism, and potentially in reducing arthritis symptoms.

5.3 Pharmacokinetic properties

Absorption

Boroflex is water soluble and highly bioavailable. Most ingested boron is hydrolyzed to boric acid within the gastrointestinal tract. Fructoborates are absorbed in the small intestine. The body absorbs about 85%–90% of ingested boron.

Our bodies have no capability to synthesize them from fructose and boric acid. Studies have shown that Calcium Fructoborate (CaFB) absorbed from the gastrointestinal tract to the bloodstream in an intact form and time-dependent manner. Study results show that CaFB can be detected intact in blood following oral administration. Thus, it has been confirmed that CaFB could:

(a) have a distinct purpose and bioactivity of its own or

(b) serve as a controlled-release supply of Boron that does not convert back to Boric acid in tissues and blood

Some studies have identified three types of B-containing molecules of CaFB in aqueous solutions (the speciation of fructoborates is highlighted in Fig. 2): Free Boric Acid (5%), Diester (85%) and Monoester complex (10 %).

Figure: FBE speciation in the human metabolism

Subsequently, Fructoborate species may possess a biological role such as functioning as a coenzyme or cofactor (Fig.).

Metabolism of Fructoborates in enzymatic system

The biological and clinical benefits observed thus far for CaFB suggest that B-containing sugars are indeed unique and extraordinary participants in the realm of B-containing molecules. Studies have shown that CaFB is a good adjuvant in the treatment of osteoporosis, possibly the best in dietetic prevention of osteoporosis based on the large study group.

Storage

Fructoborates have been found in mice bone, heart, brain, liver, and muscle.

Excretion

In animal metabolism (mice), fructoborates are metabolized initially in fructoboric acid and then in boric acid and excreted mainly through urine.

6.1 Animal Toxicology or Pharmacology

Not available

Calcium fructoborate is a natural identical product with molecular composition Ca[(C₆H₁₀O₆)2B]2°4H₂O, identical with the calcium fructoborate molecule found in nature.

Sugar–borates (SBs) are mono- or di-sugar–borate esters (SBEs) comprised of one or two monosaccharide molecules linked to a boron (B) atom.

Using liquid- and solid-state 11B and 13C nuclear magnetic resonance (NMR) spectroscopy, the fructoborate anion structure was defined (figure-1).

Fructoborate anion structure

Three basic types of boron-containing molecules are found in aqueous solutions of Boroflex: free boric acid, the diester complex, and the monoester complex. The relative molar concentrations of these 3 types of boron-containing molecules were found to be approx. 5%, 85%, and 10 %, respectively.

8.1 Incompatibilities

None

8.2 Shelf-life

Refer on pack.

8.3 Packaging information

1 Blister strip of 10 capsules

1 x 10 N Capsules

8.4 Storage and handing instructions

Store below 30°C. Protect from light & moisture.

Keep out of reach of children

• Pregnant or nursing mothers, children, and people with medical conditions must consult a physician before taking this supplement
• Generally well-tolerated; possible mild side effects include gastrointestinal discomfort, headaches, or skin reactions.
• Long-term high doses may lead to toxicity, so adherence to recommended doses is crucial.
• Inform your healthcare provider about any medications or supplements you are currently taking, as CaFB may interact with certain drugs, especially those affecting bone health or hormone levels.
• Regular follow-up appointments with your healthcare provider are recommended to assess your response to the supplement and make necessary adjustments.
• Keep track of any changes in your symptoms, especially concerning bone and joint health.

27^th September 2024