Tacrolimus – an Effective Immunosuppressant API for a Number of Inflammatory Disorders

Tacrolimus – an Effective Immunosuppressant API for a Number of Inflammatory Disorders

Immunosuppressant, OTC and Compounding Product

tacrolimusTacrolimus CAS No: 104987-11-3

Tacrolimus is an immunosuppressant that has been primarily used to help transplant patients accept their new organs. However, there’s more to this macrolide API than meets the eye. By inhibiting the production of T cells within the body, tacrolimus can be used to help a variety of inflammatory diseases, most notably eczema and vitiligo. Recently, there’s been more research conducted in how tacrolimus reacts with inflammatory bowel diseases, with positive results shown in clinical studies.

Organ Transplant Protection

Tacrolimus has been shown to inhibit interleukin-2, which means there are fewer available T cells to attack foreign bodies in an organ transplant patient. In addition to major organ transplants (e.g., heart, kidney, lungs, etc.), it’s also effective for bone marrow, limb transplants, and skin grafts. As stem cell research develops, it will likely become a key component to helping patients receive donations without harmful side effects to the body. Its success with organ transplants has even inspired researchers to apply the API to those with pulmonary arterial hypertension. Discovered in 1984 and approved by the FDA for liver transplants 10 years later, this API has come a long way since it began as a fermented soil sample in Japan.

Skin Diseases

Tacrolimus can be given in oral form as well as a topical treatment for skin conditions. While inflammation is a critical process in the body to fend off potentially harmful irritants, tacrolimus helps to balance out an overactive immune system. The API will again interfere with the natural production of T Cells within the body to reduce the itching, redness, burning, and swelling of a skin condition. Often used to counteract the worst effects of eczema and Kimura’s disease, it has recently proven itself effective against vitiligo. Patients who had not already responded to prior treatment, Tacrolimus was shown across a variety of studies to be exceptionally effective in cephalic regions of the body — particularly in the face.

Inflammatory Bowel Disorders

While still in clinical trials as of the writing of this article, Tacrolimus could be a potential solution for inflammatory bowel disorders such as ulcerative proctitis and ulcerative colitis. A recent study that compared Tacrolimus to a placebo was ended early because Tacrolimus was proven effective to aid in the remission of the inflammation. What was so encouraging about this study was that the patients tested had previously been resistant to prior treatments. It may even be used as a potential aid for Chrohn’s disease, especially if the termination of steroids in the patient triggers a relapse.

Vital Statistics

Tacrolimus has been linked to lymphoma when used to treat skin disorders. While the risk of cancer was classified as a ‘small excess’, it’s worth noting for prescribers. While some researchers have associated tacrolimus with skin thinning, other studies have not shown an increased risk of thinning even after prolonged use of tacrolimus. Patients who have used a cyclosporine (e.g., Gengraf, Sandimmune, etc.) or are allergic to hydrogenated castor oil must alert their doctor. This API can safely be used in combination with other transplant aids, such as steroids or mycophenolate. Potential side effects with the transplant version include headache, shaking, and stomach irritation. In the topical version, side effects may include burning or itching at the site of application.

LGM Pharma

LGM Pharma is an innovation-driven API company, involved in the distribution of quality cGMP pharma ingredients to leading pharmaceutical companies. We specialize in streamlining the API supply chain management throughout all development and commercial stages while providing complete technical capabilities, expert regulatory support as well as other value-added services.

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