DRUG PRODUCT FORMULATIONS
Current TEMPOL Formulations
Matrix Biomed, Inc. has developed five (5) formulations with the active ingredient TEMPOL: MTS-01, MTS-02, MTS-10, MBM-01, and MBM-02. MTS-01 is a topical gel formulation of TEMPOL being developed for the prevention of hair loss (alopecia) induced by whole brain radiotherapy for the treatment of brain cancer and for radiation-induced skin damage secondary to radiation treatment of a variety of cancers. MTS-02 is a water-based gel formulation of TEMPOL being developed for the prevention of radiation-induced proctitis in patients with prostate cancer. MTS-10 is a water-based mouthwash formulation of TEMPOL being developed for the prevention of oral mucositis caused by radiation therapy for the treatment of cancer. MBM-01 is a liquid formulation of TEMPOL being developed for the prevention of oral mucositis and other cisplatin and radiation induced toxicities where the patients ability to swallow has been compromised. MBM-02 is a gelatin capsule being developed for the prevention various chemotherapeutic induced toxicities in which the patient is able to swallow a gelatin capsule.
The MTS-01 drug product is a topical gel containing 70 mg/mL of TEMPOL (7% w/w) plus water, ethanol, and hydroxypropyl cellulose. The composition of MTS-01 to be used for clinical trials for indications such as the prevention of radiation dermatitis.
The drug product MTS-02 contains 70 mg/mL TEMPOL (7% w/w) formulated as an aqueous gel with propylene glycol, methyl and propyl parabens, glycerin, buffers, and hydroxyethyl cellulose. The product is packaged in a single use 60-mL syringe containing 50 grams of gel for rectal administration.
The drug product MBM-01 is a TEMPOL solution that is an orange-colored, aqueous solution containing 7% TEMPOL along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils. The placebo contains the same excipients as the active product plus FD&C Yellow #6 for color matching. The composition of MBM-01 is currently the subject of our clinical trials preventing toxicities associated with chemotherapy and radiation.
The drug product MBM-02 is a TEMPOL Capsule, 200 mg. The TEMPOL Capsules are a Swedish orange opaque, hard gelatin capsule, size 00 filled with 200 mg of TEMPOL drug product powder.