December 11, 2019
Health

FDA-Approved Herbanext ‘Tawa-Tawa’ Food Supplement Now Available; Nationwide Launch August 21

Highlights:

— The Food and Drug Administration (FDA) has approved — and granted a Certificate of Product Registration (CPR) — to the Herbanext Laboratories, Inc.’s Tawa-Tawa Capsule Food Supplement.

— Herbanext went through years of research assisted by the Department of Science and Technology (DOST) with over Php8 million used to acquire high-tech machines.

— Philip S. Cruz, founder/president of Herbanext says another research study on Tawa-Tawa will start in 2019 to uncover more details about its medicinal properties.

— The Herbanext food supplement’s not a medicine, it has no approved therapeutic value.

— Various research studies showed Herbanext’s Tawa-Tawa standardized extract has no toxic or poisonous effect and, thus, it has no ill effect on people’s health.

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By EDD K. USMAN, Twitter @edd1819, Instagram @bluestar0910, Facebook: SDN — Science, Digital & Current News

FINALLY, after a long process, a standardized “tawa-tawa” herbal food supplement for dengue is now in the market.

That’s at least in some selected pharmacies, for now, in Iloilo, Negros, Laguna, and Cavite.

Its plastic container identifies it as “Tawa-Tawa (Euphorbia hirta) Standardized Extract” under the Daily Apple brand of Herbanext Laboratories, Inc.

Secretary Fortunato T. de la Peña relayed this to SDN — Science and Digital News, saying its manufacturer has supplied or released the dengue-fighting green-colored capsules to some drug stores in the four provinces.

He received the information from DOST VI Regional Director Rowen R. Gelonga.

De la Peña learned that Herbanext will release the Tawa-Tawa Standardized Extract herbal supplements nationwide on August 21. “We expected that from all the plants in our ‘Tuklas LunasTM’ (formerly Drug Discovery and Development Program).”

Related story: DOST Continues Battle vs. Dengue, Says Herbal Supplement Out August 12

Philip S. Cruz, founder and president of Herbanext, confirmed this on Tuesday, August 13, to SDN — Science and Digital News.

1 a 1 Herbanext Philip Cruz

Herbanext Founder and President Philip S. Cruz speaks in a DOST forum in the past. He established the company in 2001. (Photo: Herbanext)

Cruz said Herbanext released last week 4,000 bottles of the food supplement, each bottle with 30 capsules. (That’s 120,000 capsules in total.)

The 18-year-old Herbanext has “a 2,500 m2 cGMP-certified and Halal-accredited manufacturing plant in Bago City, Occidental,” creating a product portfolio that includes “a wide range of nutraceutical products, healthy beverages, and functional foods all utilizing locally grown medicinal herbs.”

The company is “the first and only dedicated extraction and spray-drying facility for medicinal herbs in the country.”

“Considering the gravity of the current dengue epidemic, the good safety profile presented by the product, and the CPR granted by FDA, Herbanext has decided to make the product available to the market by August 21 as a food supplement with no label claims,” Cruz said.

“FDA” is Food and Drug Administration; “CPR” stands for Certificate of Product Registration.

The company applied for the tawa-tawa food supplement’s CPR with the FDA in 2018 and “granted on April 24, 2019.”

The tawa-tawa product of the Filipino company is now being sold at Daily Apple stores and selected local pharmacies with SRP (suggested retail price) of Php15 per capsule (Php450 per bottle).

Generika drug stores, which sells generic medicines, will distribute the product nationwide.

1 a 1 Herbanext spray

Some of the herbal extracts of Herbanext. (Photo: Herbanext)

“The recommended dosage is 1 to 2 capsules 3x daily for adults, to be taken before meals. Capsule contents may be dissolved in a small amount of water or milk and consumed as such if desired.

“A maximum of 5-7 days of consumption of the product is recommended,” the Herbanext top executive said.

Herbanext plans to release some 3,500 bottles of the food supplement for dengue during the official launch of the product on August 21, as it targets 10,000 bottles for September. Generika has wide distribution reach with its 830 stores across the country.

The company developed the tawa-tawa extract capsules through a grant from the Tuklas LunasTM Program of the DOST being implemented by its Philippine Council for Health Research and Development (DOST-PCHRD).

Herbanext Laboratories is the first private company accepted in the DOST-PCHRD’s TuklasLunasTM Program to participate in the government’s drug discovery research in collaboration with the academe.

Herbanext cited the popularity of tawa-tawa or gatas-gatas, which is known to have antiviral and anti-thrombocytopenic (platelet increasing activity).

1 a 1 Herbanext facility

High-tech facility of Herbanext. (Photo: Herbanext)

Cruz added that the herbal plant “remains the most popular traditional remedy for dengue in the Philippines. Its traditional use of treating the symptoms of dengue can be traced back centuries.”

A researcher and inventor, Cruz in 2015 received a Ten Outstanding Young Men (TOYM) award. The DOST also bestowed him several awards.

Like in many parts of the country, the dengue epidemics is “a recurring problem in Western Visayas.”

The problem had prompted the Herbanext founder to start a research aimed at developing “a standardized tawa-tawa extract capsule in 2013.”

Another reason, apparently, for embarking on the research is that tawa-tawa until now has not been accepted in the mainstream because of the lack of scientific data that supports its safety, efficacy, and proper dosing.

Add to this that its “traditional practice of preparing a decoction from fresh plants is not practical in urban centers where the supply of the fresh herb is scarce and heavy metal contamination is a real concern.”

Cruz recalled that Herbanext commissioned pre-clinical studies from 2013 to 2015 under the Research Center for Natural and Applied Science (RCNAS) of the University of Santo Tomas (UST), with the objective of establishing the product’s safety and its efficacy as an anti-thrombocytopenic agent.

1 a 1 Herbanext supplement pic 1

Image courtesy of Herbanext.

“Results of the acute toxicity study indicate that the spray-dried tawa-tawa extract is virtually non-toxic with no evidence of organ abnormalities even a very high dose of 10 g/kg.

“This dosage is equivalent to an 8 kg. child consuming around 250 capsules of tawa-tawa extract a day.

“Dose-response studies, on the other hand, demonstrated that the spray-dried extract is able to retain the desired bio-activity of the herb even after processing, having efficacy at a wide dosage range,” Cruz said.

He also cited a cytotoxicity screening that the University of the Philippines-Disease Molecular Biology and Epigenetics Laboratory (UP-DMBEL) conducted showing the “tawa-tawa extract did not produce nephrotoxicity and hepatotoxicity in in-vitro cell models.”

The Herbanext founder did not stop his work on the popular herb. He continued through the support of the PCHRD headed by Executive Director Dr. Jaime Montoya under its initiative dubbed Drug Discovery and Health Products, which was renamed to Tuklas LunasTM.

So, from 2015 lasting until 2019, Cruz and his research team deep-dived “on the identification and quantification of key bio-active compounds in tawa-tawa, and several other popular Philippine medicinal herbs, and developed protocols for the manufacturing of standardized dosage forms.”

Cruz said another research on tawa-tawa is in the pipeline for this year to be conducted by the University of San Agustin-Center for Natural Drug Discovery Development (USC-CND3) in Iloilo in partnership with Herbanext.

DOST will also fund the new study aimed at “identifying the specific compounds responsible for (tawa-tawa’s) platelet increasing properties.”

“It is estimated that another 3-5 years of research and clinical studies are still needed before the product can comply with the drug standards of the Food and Drug Administration (FDA),” said Cruz. (SDN)

All images/pictures courtesy of Herbanext.

 

Frequently Asked Questions (from Herbanext):

Herbanext

Is the consumption of tawa-tawa safe?

Tawa-tawa is a popular herbal medicine not only in the Philippines but also in many other countries in the tropics where it is used to treat a variety of diseases, including respiratory ailments (cough, coryza, bronchitis, and asthma), female disorders, worm infestations in children, dysentery, jaundice, pimples, gonorrhoea, digestive problems, and tumors. The herb is considered safe for both adults and children in many traditional healing systems in the world. In the acute toxicity study conducted by researchers at UST-RCNAS on the spray-dried tawa-tawa of Herbanext, the extract did not produce toxicity even at a high dose of 10 g/kg based on rat model after 2 weeks. This result was consistent with the findings in a study conducted in India in 2016 where 10 g/kg did not product any sign of toxicity. Extrapolated, this means that 500 grams (around 1,500 capsules) of the extract will not cause acute toxicity to a 50 kg adult.

In a 90-day sub-chronic toxicity study conducted in Malaysia in 2013, no toxicity was detected on rats at a dose of 1.0 mg/kg/day. There was no significant change in food and water consumptions, body weight change, haematological and biochemical parameters, relative organ weights, and gross findings compared to the control group.  A recent in vitro nephrotoxicity and hepatotoxicity screening conducted on tawa-tawa extract at the Disease Molecular Biology and Epigenetics Laboratory (National Institute of Molecular Biology and Biotechnology) at UP Diliman also confirm the safety of the extract. Because tawa-tawa is normally consumed for only 3-5 day for treating dengue cases based in Philippine traditional practice, the risk of side effects is nil.

Is tawa-tawa really effective for dengue?

The efficacy of tawa-tawa and its active constituents against dengue is well supported, and has been documented in a substantial number of studies ranging from in silico (computer-generated) simulations, in vitro (against infected cell cultures), and in vivo (in mice and people) models. It is hypothesized that there are two possible mechanisms by which tawa-tawa extracts work against dengue virus: as an anti-thrombocytopenic (prevents loss of platelets or increases platelet count), and an antiviral agent. An in silico study on quercetin, one of tawa-tawa’s active compounds was able to show that the compound inhibited the activity of several viral proteins involved in replication, even at minute concentrations. This was further supported by an in-vitro study on viral cultures of dengue, wherein the compound was able to stop viral multiplication.

One of the main clinical studies done on tawa-tawa, performed in India, was able to show that 70% of patients (out of a population of 125 patients) recovered from the symptoms of dengue (increased platelet count, relief from fever) after administration with tawa-tawa infusion (in addition to oral rehydration), as opposed to the group that was simply given the basic treatment protocol for dengue symptoms (i.e. oral rehydration).

In terms of its anti-thrombocytopenic properties, tawa-tawa has been shown to increase platelet count in rat experimental models. Compared to its active compound quercetin, which has been researched on in many studies and is well understood as an antiviral compound, the compounds responsible anti-thrombocytopenic activity of tawa-tawa are not as clearly identified, despite its clear efficacy in mice and people. This is subject to further investigation to understand the molecular mechanism by which tawa-tawa functions in this manner.

What is a “spray-dried extract”? What does “standardized mean”?

An extract is an herbal preparation containing the active ingredient of a substance in concentrated form. After concentration, the extract undergoes spray-drying, which is a rapid drying method taking only a few seconds. This helps preserve the active components of tawa-tawa.

Spray-drying is the same process used for making coffee powder and powdered milk, except that it is done at lower drying temperature for medicinal plant extracts.

Standardization, on the other hand, is a process whereby various laboratory tests and assay procedures are applied for the evaluation of raw material, intermediate product, and finished product, so as to confirm the presence of the desired compounds.

For the tawa-tawa capsules, the spray-dried extract is standardized for the presence of selected markers, particularly certain flavonoids which are believed to be responsible for the antiviral and antithrombocytopenic activity of tawa-tawa. One of these compounds being laboratory tested in the Herbanext tawa-tawa capsule is quercetin.

What is its difference of capsules made from extract vs those made from powdered herbs?

It takes 5 grams of tawa-tawa powder to produce 1 gram of tawa-tawa extract. Because extracts are concentrated, dosing is lesser and thereby improving patient compliance. Being readily soluble in water (unlike powdered tawa-tawa), extracts will be absorbed by the body faster. The tawa-tawa extract is also tested multiple times by chromatographic tests from receipt of raw material to the final product. This allows the detection of adulterants and guarantees the presence of desired active compounds.

When should I take tawa-tawa? How should I use it?

The recommended dosage for a 50-100 kg adult for standardized tawa-tawa extract is 6 capsules a day, to be equally divided into 3 doses to be taken 15 minutes before each meal (2 capsules at 3 times per day). For smaller bodyweights, maintain a dosage of around 1 capsule every 10 kg, to be divided equally 3 times per day. Contents of the capsule may be dissolved in water or milk if desired. Consumption is maintained for 3-5 days until the platelet count normalizes.

Tawa-tawa is not intended to be consumed as a preventive or prophylactic measure against dengue. Instead, tawa-tawa, is taken to aid in the recovery from dengue infection. Tawa-tawa has mild diuretic action so it is important to drink the capsules with a full glass water.

If I use tawa-tawa capsules, do I still need to go to a health center?

Yes, it is strongly advised that patients seek proper hospital care to monitor platelet count and other important blood parameters. These tests are important to determine the severity of the infection. Dengue causes leakage of plasma so it is important to maintain adequate hydration. Severe dehydration can lead to Dengue Shock Syndrome which can be fatal.

Why is tawa-tawa extract more expensive than powdered tawa-tawa?

Tawa-tawa extract is in concentrated form, providing a significantly higher content of active ingredient. Compared to capsulized powdered tawa-tawa leaves which just undergo drying and grinding, the manufacture of tawa-tawa extract undergoes multiple steps including extraction, concentration, sterilization, spray-drying, standardization, and compounding. The manufacturing process follows pharmaceutical standards and the product is tested for quality multiple times.

Can I just prepare tawa-tawa decoction by myself?

If you have a ready supply of fresh tawa-tawa, you can certainly prepare a fresh decoction every day and this will be equally effective.  Many instructions can be found in the internet on how to do this. Just make sure that your source of tawa-tawa is clean. If you are living in an urban area, collecting tawa-tawa from the surroundings is not recommended as the plant is known to accumulate heavy metals.

Tawa-tawa, based on animal studies and traditional use, has antipyretic activity and can help manage the symptoms of fever. It is important in this regard to consume just the right amount as excessive quantities can cause hypothermia.

How long is the shelf life of the product? Where can I buy the Daily Apple Tawa-tawa capsule?

The standardized tawa-tawa extract has a shelf life of 2 years. The product is currently available online (www.dailyapplestore.com) and in its outlets in Quezon City, Bacolod, Cebu, Davao, and General Santos.

The product will be available in selected local pharmacies starting on August 21 and will be distributed nationwide by Generika Drugstore. Please check www.herbanext.com for a complete list of stores.

Definition of Terms: 

  1. Toxicity — The quality or state of being toxic — or poisonous. (Merriam-Webster Dictionary)
  2. Cytoxicity — The potential of a compound to cause death. (ScienceDirect.com)
  3. Nephrotoxicity — Being poisonous to the  kidney (Merriam-Webster Dictionary)
  4. Hepatotoxicity — A state of toxic damage to the liver. (Merriam-Webster Dictionary)
  5.  Thrombocytopenia (Thrombocytopenic) — Is a condition in which you have a low blood platelet count (MayoClinic.org)
  6. Decoction —  the extraction of the water-soluble substances of a drug or medicinal plants by boiling (Collins Dictionary)
  7. Efficacy —  Tability, especially of a medicine or a method of achieving something, to produce the intended result: 2. the quality of being effective. (Cambridge Dictionary)
  8. Antiviral —  An agent that kills a virus or that suppresses its ability to replicate and, hence, inhibits its capability to multiply and reproduce. (Medicinenet.com)
  9. Dosage —  the amount of medicine that you should take at one time. (Cambridge Dictionary)
  10. Food supplements — Foodstuffs intended as a supplement to the regular diet and which are a concentrated source of nutrients. (Anses.fr/en) (But are not considered food)
  11. Protocol — A system of rules that explain the correct conduct and procedures to be followed in formal situations. A plan for a scientific experiment or for medical treatment. (Merriam-Webster)

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