TFF Pharmaceuticals’ Technology Generates Superior Inhalational Dry Powder Formulations for Pulmonary Drug Delivery
September 26 2024 - 7:00AM
TFF Pharmaceuticals, Inc (Nasdaq: TFFP) (the “Company” or “TFF
Pharmaceuticals”), a clinical-stage biopharmaceutical company
focused on developing and commercializing innovative drug products
based on its patented Thin Film Freezing (TFF) technology platform,
announces positive preclinical data published in the Journal of
Drug Delivery Science and Technology further validating the
Company’s TFF technology as superior approach to formulate dry
powders for pulmonary drug delivery. The study demonstrates the
superiority of TFF inhalational dry powders over jet-milling and
spray-drying technologies in a rat model, with enhanced uniform
drug distribution in the lungs, lower airway-to-lung distribution
ratio, and rapid disaggregation of particles of the TFF powder and
subsequent particle movement of the resulting TFF nanoaggregates.
In the newly published study, voriconazole dry
powder formulations for inhalation were prepared by three different
methods: jet-milling, spray-drying, and Thin Film Freezing. The TFF
processed voriconazole dry powder, consisting of brittle, easily
shearable nanoaggregates, exhibited the most homogeneous
distribution in lung tissue, with the lowest airway-to-lung
voriconazole deposition ratio (1.27), followed by spray-dried
(1.76) and jet-milled (2.73) powders. This enhanced distribution is
attributed to the smaller particle size after disaggregation and
rapid movement of particles on the liquid surface. The results
suggest that TFF inhalational dry powders may enhance treatment
efficiency and reduce toxicity for lung diseases, further
supporting Thin Film Freezing as a promising technology to
formulate dry powders for pulmonary drug delivery. “This is our
first head-to-head comparison of TFF powder to powders made by
other technologies, administered by inhalation to animals and
characterized using mass spectrometry imaging to assess lung drug
distribution. We are extremely pleased to confirm our hypothesis
that Thin Film Freezing technology leads to the most homogeneous
distribution of the drug in the lung,” said Dr. Robert O. Williams
III, Co-inventor of TFF technology and Professor at The University
of Texas at Austin College of Pharmacy.
“These data, which examine formulations of
voriconazole manufactured using different particle engineering
technologies, suggest that the TFF dry powder technology for
inhalation provides clear advantages over jet-milling and
spray-drying methods,” said Dr. Harlan Weisman, TFF Pharmaceuticals
Chief Executive Officer. “It is gratifying to have the continued
support of the scientific community for our approach, and to have
ongoing validation of our science. The more rapid and uniform
distribution of TFF generated dry powders in the lung with their
lower airway to lung deposition ratio differentiate our
inhalational products from products generated by other technologies
and provide the opportunity to increase efficacy and lower risk of
toxicities.”
ABOUT TFF PHARMACEUTICALS’ THIN FILM
FREEZING (TFF) TECHNOLOGYTFF Pharmaceuticals’ proprietary
Thin Film Freezing (TFF) technology allows for the transformation
of both existing compounds and new chemical entities into dry
powder formulations exhibiting unique characteristics and benefits.
The TFF process is a particle engineering process designed to
generate dry powder particles with advantageous properties for
inhalation, as well as parenteral, nasal, oral, topical and ocular
routes of administration. The process can be used to engineer
powders for direct delivery to the site of need, circumventing
challenges of systemic administration and leading to improved
bioavailability, faster onset of action, and improved safety and
efficacy. The ability to deliver therapies directly to the target
organ, such as the lung, allows TFF powders to be administered at
lower doses compared to oral drugs, reducing unwanted toxicities
and side effects. Laboratory data suggest the aerodynamic
properties of the powders created by TFF can deliver as much as 75%
of the dose to the deep lung. TFF does not introduce heat, shear
stress, or other forces that can damage more complex therapeutic
components, such as fragile biologics, and instead enables the
reformulation of these materials into easily stored and
temperature-stable dry powders, making therapeutics and vaccines
more accessible for distribution worldwide. The advantages of TFF
can be used to enhance traditional delivery or combined to enable
next-generation pharmaceutical products.
ABOUT TFF PHARMACEUTICALS
TFF Pharmaceuticals, Inc. is a clinical-stage
biopharmaceutical company engaging patented rapid freezing
technology to develop and transform medicines into potent dry
powder formulations for better efficacy, safety, and stability. The
company’s versatile TFF technology platform has broad applicability
to convert most any drug, including vaccines, small and large
molecules, and biologics, into an elegant dry powder highly
advantageous for inhalation, or for topical delivery to the eyes,
nose and the skin.
SAFE HARBOR
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Such forward-looking statements in this press
release include, but are not limited to, statements by the Company
relating to the expected benefits of its patented TFF technology
platform over jet-milling and spray-drying methods,.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that could cause actual results to
differ materially, including (i) the risk that further testing may
not be consistent with the data to date demonstrating the
superiority of the TFF technology platform over jet-milling and
spray-drying methods, (ii) the risk that the Company may not be
able to obtain additional working capital with which to continue
its current operations and clinical trials as and when needed,
(iii) success in early phases of pre-clinical and clinical trials
do not ensure later clinical trials will be successful; (iv) no
drug product incorporating the TFF platform has received FDA
pre-market approval or otherwise been incorporated into a
commercial drug product, (v) the Company has no current agreements
or understandings with any large pharmaceutical companies for the
development of a drug product incorporating the TFF Platform, and
(vi) those other risks disclosed in the section “Risk Factors”
included in the Company’s Quarterly Report on Form 10-Q filed with
the SEC on August 14, 2024.. The Company cautions
readers not to place undue reliance on any forward-looking
statements. The Company does not undertake and specifically
disclaims any obligation to update or revise such statements to
reflect new circumstances or unanticipated events as they occur,
except as required by law.
Investor Relations Contact:Core IRJason
Nelsoninvestorinfo@tffpharma.com
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