Background:
The oral drug delivery segment is the largest segment in the drug delivery market
with more than a 52% market share. It is valued at roughly $50 billion and is
expected to reach $92 billion by 2016. This increase represents an annual growth rate
of 11.3%. The majority (84%) of most marketed drug products in the U.S. and
Europe are oral dosage forms.
Statement of Problem:
Although oral drug delivery can potentially be problematic for certain drugs (i.e., first
pass effect, poor solubility, poor absorption, degradation in the stomach, etc.), oral
formulations are still less expensive to produce as they do not need to be
manufactured under sterile conditions. Furthermore, many people prefer oral dosages
over the pain and discomfort associated with injections. The inventors have
discovered a novel spray drying process, which can incorporate more than one drug
and can also be used to deliver a customized release profile tailored to a variety of
systems. This invention also combines the benefits of several techniques (ex. spray
drying, coating, self-emulsifying) while minimizing each technique’s limitations to
convey more therapeutic benefits for patients.
Potential Solution:
The present invention relates to the development of modified multi-layered
microstructures of active pharmaceutical agent, which can be administrated orally.
Multi-layered microstructures are prepared by dual channel (spray gun) spray dryer
which enables simultaneous drying of inner core or droplets embedded into outer
layer or matrix of excipients to enable various combination of formulation to enhance
active pharmaceutical agent’s bioavailability by enhanced absorption in the
gastrointestinal tract. The present invention can be applied for oral delivery of a larger
group of active pharmaceutical agents (i.e., small molecules, proteins, peptides),
enabling the delivery of more than one active pharmaceutical agent with enhanced
absorption of the active pharmaceutical agents in the gastrointestinal tract.
Furthermore, this method has applicability to enteric-coated self-emulsifying
microstructures and can be used to produce specific drug release profiles (i.e.,
pulsatile, controlled release, immediate release). The inventors claim that their
present invention (Enteric coated self emulsifying multi-layered microparticles) by
spray drying may have applications in treating a variety of cancers by improved oral
delivery.
Commercialization Status:
This technology is currently in the pre-clinical development stage, and R&D was
funded at FAMU by the Florida Government for James & Esther King Biomedical
Research Program “Technology Transfer Feasibility (TTF) Grants. Already, the
development of the DIM-P (novel anti-cancer agent) was formulated in enteric coated
self-emulsified micro-particles as Spray BIO-Max DIM-P and was evaluated for in-
vitro performance, pharmacokinetics in rats as well as dogs, toxicology on normal
mice and anti-cancer therapeutic potential in different lung tumor models. We are
seeking collaborative partners or licensees in the Biotechnology and/or
Pharmaceutical Industries to take these developments into commercialization
Brochure
