The Mucilin Difference

The Mucilin® Difference

Psyllium husk Fiber

A Note from Chairman & CEO
Paradigm Pharmaceuticals Inc., New York

Dear Customer,

We are proud to introduce Mucilin® in the U.S. which we manufacture at our pharmaceutical plant and which we sell in many other countries as a pharmaceutical product, approved by their regulatory authorities.

As a pharma-grade product, Mucilin® stands apart from nearly all Psyllium husk products sold in the U.S.

From raw materials to the final product, Mucilin® is manufactured under the same strict production and quality control standards as for our blood pressure, cholesterol, liver, epilepsy and other medications in the plant.

We go to such lengths for several reasons.

We believe that a product that’s taken by the patient for serious medical conditions should be produced with great care and tested for its efficacy and safety like any medicine. This natural and soluble fiber is indicated for habitual constipation and bloating. Many doctors in Asia prescribe Mucilin® to patients who have undergone colorectal surgery. This natural fiber is also taken for other clinically demonstrated benefits, such as for lowering cholesterol and improving heart health.

A Psyllium husk product should be treated as a drug also because taking it improperly can cause serious injury, such as choking, and damage to the liver in patients suffering from other indications. The US FDA itself requires that manufacturers put this warning on their product labels.

There is another, important reason for adopting pharma-like standards: Psyllium husk—which is culled from the seed of the plant known as Plantago ovata, native to India and the neighboring region— varies in quality from crop to crop. It must be selected and processed to a uniform standard —like the active ingredient in any medicine.

The raw husk contains mineral and microbial contaminants which it inherits from the soil and the ambient environment. And not all husk expand equally when mixed with a fluid—it’s the husk’s ability to form a smooth and soft bulk that’s vital to the product’s efficacy as the fiber passes through the gastrointestinal tracks, scraping and clearing the colon.

It is also important for maximum efficacy that the Psyllium husk product doesn’t contain any seeds, which do not expand in a fluid. There are many cheap products in the market with powdered seeds which make the drink grainy and clumpy, and some brown-speckled in appearance. The U.S. FDA has established that for a Psyllium husk product to be a source of soluble fiber it must contain only the husk, and that the husk should account for 95% of the product’s content, the rest being other ingredients, such as flavoring excipients. Mucilin® meets this U.S. FDA standard—and more.

Regulatory authorities in the U.S. and Europe periodically revise Quality and Safety standards for all medicines, prescription as well as non-prescription drugs. Psyllium husk products included. Mucilin® meets the latest standards for quality and safety—swelling index, foreign matter, yeast and mold—established by US Pharmacopeia (USP 41) and the British Pharmacopeia (BP2019).

Our in-house specifications for quality are even stricter, so much so that few suppliers of Psyllium fiber can meet them. We process the fiber to meet our own stringent standards. For instance, we reduce its moisture content to the lowest possible to eliminate the risk of microbial contamination during the shelf-life of the product, as the fiber is easily susceptible to absorbing ambient moisture and attracting bacteria.

We test each batch of Mucilin® to ensure it meets US and European and our own quality and safety standards before we release it for sale.

If you are taking a Psyllium husk product, ask your manufacturers and suppliers if they meet USP 41 and BP2019 standards of quality.

Mucilin® has been sold as a drug for more than two decades in Asia, and it is approved as a drug in five countries by their FDAs. Although regulatory approval is not yet required in the U.S. for Psyllium husk products, we are proud of the endorsement in other countries attesting to the efficacy and safety of our Mucilin®.

Yours sincerely,

A.K.Naj
Chairman and CEO


RATING PSYLLIUM HUSK QUALITY

PSYLLIUM HUSKS ARE GRADED ACCORDING TO PURITY AND PARTICLE SIZE

Psyllium husk, also known as Ispaghula and Isabgol, is the husk of the seeds of the plant Plantago ovata, (genus Plantago), native to India and its neighboring countries. As a plant product, the husk quality can vary from crop to crop.

CROP QUALITY

Quality of Psyllium husk depends on the crop: a healthy crop produces seeds that are robust in size (2.1 to 2.8 mm thick)and bright rose white in color; a poor crop yields brownish seeds (1.5 mm thick), which contain high percentage of impurities.

High quality Psyllium husk has greater swelling properties and in liquid forms a smooth, jello-like bulk; the poor quality is coarse and brown in color and forms a clumpy mass with impurities.

There are nearly 40 species of Psyllium, but the husk from Plantago ovate, also known as “blonde Psyllium”, is the best and has the highest fiber content.

US FDA STANDARDS

Psyllium has become a synonymous term to describe all Psyllium husk products. Not all contain only the Psyllium husk; they have both the husk and the seed. The seed mainly contains proteins and other nutrients, but they have little use for the intended purpose of the product because they don’t expand like the husk to act as bulk laxative in the gastrointestinal tracks to sweep the colon clean

According to the US FDA guidelines, the source of soluble fiber is the husk alone—not the seed—and the regulatory agency has established a minimum purity specification of no less than 95% husk as a qualifying criterion for eligible source of soluble fiber from Psyllium.

The Mucilin® Standard

  • We use Psyllium husk that expands minimum of 40 times its weight when mixed with a liquid, the near maximum index of the best of the husk.
  • We process the husk to reduce its natural moisture content to significantly less than the 8% present in the husk of most finished products.
  • We use Psyllium husk with stringent limits on microbial and other contaminants.