DelSite seeks US OK for nasal delivery polymer
US Food and Drug Administration for an excipient used for drug
delivery - called GelSite - used to formulate vaccines, proteins
and peptide drugs that are delivered across mucosal surfaces, such
as the nasal cavity.
Under US law a DMF - which can over an active pharmaceutical ingredient (API), inactive excipient or even some elements of packaging - is filed with the FDA. Once reviewed and approved, the DMF can be cited by companies seeking to make use of the technology it describes. This does away with the need for each licensee of the technology to file a dossier covering its use in finished products.
It can contain confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of a drug product.
DelSite's DMF is for the manufacturing of the GelSite polymer and its use in nasal and other mucosal applications. The company, a subsidiary of US firm Carrington Laboratories, is developing a nasal formulation for influenza vaccinations based on the delivery system, and is initially targeting the H5N1 bird flu strain that some fear could cause the next flu pandemic in humans.
The DMF will also cover use of the polymer in DelSite's GelVac delivery system for powdered drugs. Dry powder formulations delivered nasally provide several potential advantages, including better stability, room temperature storage, no need for preservatives and no need for needles. Nasal immunization induces both systemic and mucosal immune responses.
Bill Yates, president of DelSite, said: "By filing the DMF, we now can streamline future regulatory filings and this will be beneficial to collaborators and commercial or governmental partners."
In May, DelSite announced results of a Phase I clinical trial involving 15 healthy volunteers that demonstrated that GelVac was safe and well tolerated and that doses were consistently and reproducibly delivered to the nasal cavity.
It is based on the GelSite polymer, a naturally sourced, high molecular weight ionic polysaccharide excipient that exhibits distinct chemical and functional properties. GelSite(R) polymer is capable of in situ gelation, ie changing from a liquid or a powder to a gel upon contact with body fluids.
The GelSite polymer is manufactured by Sabila Industrial, a subsidiary of Carrington located in Costa Rica.
