U.S. application Ser. No. 08/960,149 filed on Oct. 29, 1997, the disclosure of which is herein incorporated by reference, describes a method of generating molecular iodine in the stomach of a human or animal using an iodine reductant and an iodine oxidant. One reductant/oxidant pair identified as one of the preferred embodiments in this invention is iodide and iodate. One reason that iodide and iodate are preferred is that both of these compounds are used separately as food additives and both have GRAS (generally regarded as safe) status in the U.S. The literature describes the stability of iodide and iodate individually but there are no published reports of the stability of these two compounds in combination. In fact, these two chemicals in an appropriate medium can react rapidly with each other to yield molecular iodine.
This invention describes methods and compositions to stabilize an oral pharmaceutical composition that generates molecular iodine in situ wherein the active agents in said compositions are iodide and iodate. Methods for preparation of said stabilized pharmaceutical compositions are also described. It is a further objective of this invention to set forth the conditions and materials necessary to formulate a stable dosage form of iodide and iodate in the presence of accepted pharmaceutical excipients. It is a further objective of this invention to identify methods and compositions that comply with the strict stability objectives embodied in published regulatory guidelines of the FDA.
Regulatory bodies in different territories around the world have published guidelines that define requirements that must be met to manufacture and distribute a new pharmaceutical agent for human and animal use. In the U.S. the Food and Drug Administration (FDA) regulates drugs. Stability testing is a mandated aspect of the FDA drug development process and is required for manufacture and distribution of drugs.