FAQs about INDREPTA
Q. What steps were undertaken to assure full potency of ingredients in Indrepta?
A. Expiration dates on each lot of ingredient were checked. Each ingredient was analyzed by HPLC (high-performance liquid chromatography) to identify the quantity and purity of each component of the ingredient. Specific assays were used to measure the active ingredient. Microbiology testing was also performed, as well as tests for heavy metals and other contaminants. Small overages of each ingredient were added during manufacture to ensure that capsules were not shorted due to incomplete mixing.
Q. How will you ensure quality of Indrepta from batch to batch?
A. Each lot of each ingredient will be reviewed as outlined above. Also we insisted that each ingredient used in Indrepta is standardized to an active component to ensure batch to batch consistency. Without such standardization there would be no way to ensure consistency.
Q. Are supplements regulated?
A. Yes. The Food and Drug Administration (FDA) controls which supplements can be used and the quantity allowed. Facilities that prepare supplements must be FDA licensed and inspected, and must prepare supplements according to Good Manufacturing Practices (GMP). Each manufacturer has its own scientists who review each formulation according to FDA guidelines to ensure its safety.
Q. What’s involved in creating a new supplement?
A. Finding a manufacturer that can be trusted is key. We made it clear to prospective manufacturers that we’d expect third party testing of the supplement, we required final approval on the source of each ingredient and that we were unwilling to accept substitute ingredients. Many manufacturers are unwilling to work under these conditions or with small organizations who cannot place very large orders. We require a custom formulation and intend to allow our laboratory research and patient input to drive changes in future orders. It was important to find a manufacturer genuinely interested in helping patients to achieve this flexibility. We worked with our manufacturer for many months to refine the specifications for the formulations, to calculate overages and capsule sizes, to get the Supplement Facts prepared and to handle the details of the label design and printing and correct bottles. Two contracts were drafted, negotiated and signed.
Q. Is it safe to combine the supplements in Indrepta?
A. Combining dietary polyphenols happens naturally whenever you eat a variety of fruits and vegetables. Indrepta ingredients are combined naturally by people who are high consumers of fruits and vegetables. Increasing evidence demonstrates that combining multiple polyphenols is more effective to increase CFTR function than high doses of any single molecule.
Q. Are the doses of ingredients in Indrepta safe?
A. We used amounts of ingredients well below limits tested to be safe in humans for each ingredient. Combining multiple dietary polyphenols allows us to use less of any single ingredient, and better reflects dietary polyphenol mixtures that could be achieved through a daily diet of a wide variety of fruits and vegetables.
Q. Could too much dietary polyphenols be inhibitory of CFTR?
A. Evidence suggests that inhibitory concentrations (measured as inhibition of chloride conductance in cell culture) are not achievable through oral supplementation.
Q. Why doesn’t Indrepta contain genistein?
A. Although we feel that in moderate amounts, use of the soy isoflavone genistein is safe, genistein is a phytoestrogen and many people, especially males, object to the use of phytoestrogens. For this reason, genistein was never considered as an Indrepta ingredient. However, CF is currently a progressive disease, and for this reason potentially effective compounds deserve consideration. Benefits and side effects must be carefully weighed. Anyone who is interested can purchase genistein separately. For some mutations, combining Indrepta and genistein may be very effective.
Q. When will ingredients of Indrepta be released?
A. A release document for Indrepta was prepared ahead for publication on the date that the product is made available. Ingredients are also listed on every bottle.
Q. What if I have difficulty swallowing pills?
A. Indrepta can be stirred into applesauce if you prefer to take it this way.
Q. When does Indrepta expire?
A. Two years from the manufacture date. So the first lot expires October, 2018.
Q. What is Indrepta C?
A. Indrepta C is designed as a supplement for cystic fibrosis patients with a nonsense mutation. Read the release notes for more details.