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LDN FILLERS If your Low Dose Naltrexone comes from a compounding pharmacy and arrives as a liquid, then you’re getting pure naltexone powder dissolved in distilled water. This is probably the “purest” way to ingest naltrexone. You don’t need to worry about fillers. BUT -- If you get your LDN in any other form, you're swallowing filler. A “filler” is an inert, inactive ingredient that accompanies every dose of naltrexone you take. If you make your own LDN -- If you make LDN by crushing ReVia (pronounced REV-yah) or another commercially manufactured 50mg naltrexone tablet, you're still injesting filler, because each tablet is comprised of about 16% Naltrexone and 84% filler. What kind of filler is in your tablet? This depends on the manufacturer. Here are the main manufacturers: Barr Labs – Barr manufactures naltrexone under the brand name ReVia for the US and Canadian markets. This tablet contains 50mg naltrexone and these inactive ingredients: lactose monohydrate, colloidal silicone dioxide, magnesium stearate, crospovidone, microcrystalline cellulose, purified water, Opadry beige (coloring). [Information from Barr Labs phone representative.] Bristol Myers Squibb – BMS manufactures naltrexone under the brand name ReVia in markets other than the US and Canada. As of 2002, their 50 mg tablets contain 50 mg of naltrexone hydrochloride, plus these inactive ingredients (filler): lactose, microcrystalline cellulose, crospovidone, silicon dioxide, magnesium stearate, and pale yellow Opadry (colouring). [Information from a 2002 leaflet by Australian Prescription Products Guide.] Mallinckrodt – makes a 50mg naltrexone pill called Depade. This tablet contains 50mg naltrexone, plus these inactive ingredients (filler): crospovidone, hydropropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethelene glycol, polysorbate 80, silicone dioxide, titanium dioxide, yellow iron oxide, and red iron oxide. [Information from Mallinckrodt website.] [Historical Note: The original ReVia was made by Dupont. The inactive ingredients were: lactose, microcrystalline cellulose, crospovidone, silicon dioxide, magnesium stearate, and pale yellow Opadry (colouring). In 2001, Bristol Myers Squibb acquired DuPont Pharmaceuticals. In April 2002, BMS sold the ReVia brand-name rights in the US and Canada to Barr Laboratories. BMS continues to market ReVia outside of the US and Canada.] If your LDN is made by a compounding pharmacy – Ask your pharmacist how it is made. 1. Some compounders make LDN by crushing commercially manufactured 50mg tablets and putting the powder into capsules. Because the amount of powder that goes into each capsule is not enough to fill the capsule, most pharmacies add additional filler. If this is how you get your LDN, you can find out which commercially manufactured tablet is being used and what kind of additional filler is being added. 2. Other compounders don’t crush 50mg tablets; instead, they use pure naltrexone powder (purchased in bulk from pharmaceutical companies), which they mix with filler. From these pharmacists, you can learn what kind of filler you are taking. Here are some of the most common fillers used by compounding pharmacists: LACTOSE: Lactose is a naturally-occurring simple carbohydrate, or sugar, found only in the milk of mammals. For this reason, it is also commonly referred to as “milk sugar.” Lactose has long been used as a soluble filler in the manufacture of orally administered pharmaceuticals. It is safe, stable, inexpensive, and has a fast dissolution rate. Pharmaceutical- grade lactose powder is highly pure, and specifically produced to meet government standards of safety and purity. Lactose is easily tolerated by most patients. However, if you are lactose-intolerant (that is, if milk products give you nausea, diarrhea, abdominal cramping, bloating, or flatulence), you might want to try another filler. Note: Dr Bihari asks his patients to use lactose, unless they have an adverse reaction… not because he believes lactose is better than other fillers, but because he began his study of LDN with lactose, and he wants his records to be consistent. ACIDOPHILOUS – (pronounced Ah-SID-uh-FILL-us) – is lactic bacteria, or one-celled micro-organisms, used by the body to promote immunity and proper nutrition. Sold over the counter as a nutritional supplement and digestive aid, Acidophilus is sometimes used as a treatment for diarrhea and constipation. It is commercially available as powder, tablets, capsules or liquid. Lactose-intolerant patients sometimes switch to Acidophilus filler in their LDN capsules. AVICEL – a brand name for microcrystalline cellulose. Avicel has been used safely and effectively for 35 years in the food and pharmaceutical industries. Virtually inert, it is not absorbed into the system, and will not interfere or interact with other nutrients, vitamins or minerals. Avicel is made of wood which has been purified and powdered into extremely tiny particles -- between 0.000039 and 0.0001560 of an inch of pure fiber, with the consistency of a very fine face powder. Avicel is the filler used by Skip’s Pharmacy in Boca Raton. For a fun history of Avicel, “Let Us Have Nothing To Eat,” CLICK HERE. CALCIUM CARBONATE – a mineral that occurs naturally in limestone, marble and coral. Crushed to a fine, flavorless, odourless powder, it is a natural food additive, and the most common ingredient in calcium supplements and antacids. Calcium is absorbed by the small intestine and is used by the body to build bone tissue. Calcium supplements are generally well tolerated, but in some patients may cause constipation, bloating, gas and flatulence. People with kidney stones, hypercalcemia, sarcoidosis, hyperparathyroidism, hypervitaminosis D or cancer should not take calcium carbonate. People taking calcium supplements are usually advised to take them with food. There has been some concern among LDN users that calcium carbonate is occasionally packed too tight in the capsule, which can cause a slow-release reaction, rather than the desired fast- release. Any questions about filler should be referred to your doctor or your pharmacist. -- Last updated 1/7/06
[Note: The information provided on this site is intended for educational and informational purposes only. Gazorpa.com is not engaged in rendering medical service or advice, and the information provided is not a substitute for a professional medical opinion. If you have a medical problem, please contact a qualified health professional.] |