Post by peter on Nov 30, 2016 6:59:30 GMT -5
In addition to insulin, the Technosphere® technology
platform has also been used to deliver
salmon calcitonin (sCT) and parathyroid hormone
(PTH) by inhalation in healthy volunteers.
Both of these peptide drugs are approved for the
treatment of osteoporosis, a disease that affects
an estimated 10 million Americans and remains a
threat for 55% of people over the age of 50 years.
Most sCT products are injectables, but one
nasal product, Miacalcin®, is also currently available.
One sc PTH product, Forteo® is currently
marketed. Clearly, the ability to administer these
drugs by inhalation would enhance patient compliance
and contribute to an improved quality of
life. Additionally, the rapid-onset pharmacokinetic
profile observed with Technosphere®/Insulin is
expected to be ideal for the delivery of both sCT
4 and PTH 5 (see figure 9).
In a clinical pharmacokinetic study,
Technosphere®/PTH powder was administered
to 11 healthy volunteers using the MedTone™
inhaler. Each subject received three doses of
Technosphere®/PTH (400,800, and 1600 IU)
and an sc injection of PTH alone as a control.
Systemic PTH concentrations were measured
over a period of five hours. Two of the three test
groups (800 and 1600 IU PTH) demonstrated significant
peak PTH plasma levels that were above
those required to achieve clinical efficacy.5
The relative bioavailability of inhaled PTH compared
with sc injection was 48%.
SUMMARY
The Technosphere® technology platform is a
novel inhalation system for the non-invasive
administration of peptide therapeutics that currently
require injection. Formulations using this
system, including Technosphere®/Insulin and
Technosphere®/PTH, have the potential to offer
patients freedom from injections and an
enhanced quality of life.
A sharp peak in the pharmacokinetic profile
that mimics endogenous plasma levels is certainly
beneficial in the delivery of insulin, and is
also likely to be beneficial in the delivery of
other therapeutic proteins and hormones.
However, the application of Technosphere®
technology is not limited to proteins and peptides.
Initial research has indicated that formulations
of small-molecule therapeutics for the treatment
of pain and nausea, among other indications,
could be effective in delivering rapid relief.
Furthermore, while the focus is pulmonary
delivery, research has also demonstrated that
proteins (including insulin) can be stabilised
against degradation when formulated with
Technosphere® particles. This property may
prove invaluable in the development of fragile
protein or vaccine therapeutics that would not
otherwise be feasible.
Together, the assets associated with
Technosphere® technology have the potential to
provide impressive drug delivery solutions across
a wide variety of therapeutic areas encompassing
a number of diverse disease states.
platform has also been used to deliver
salmon calcitonin (sCT) and parathyroid hormone
(PTH) by inhalation in healthy volunteers.
Both of these peptide drugs are approved for the
treatment of osteoporosis, a disease that affects
an estimated 10 million Americans and remains a
threat for 55% of people over the age of 50 years.
Most sCT products are injectables, but one
nasal product, Miacalcin®, is also currently available.
One sc PTH product, Forteo® is currently
marketed. Clearly, the ability to administer these
drugs by inhalation would enhance patient compliance
and contribute to an improved quality of
life. Additionally, the rapid-onset pharmacokinetic
profile observed with Technosphere®/Insulin is
expected to be ideal for the delivery of both sCT
4 and PTH 5 (see figure 9).
In a clinical pharmacokinetic study,
Technosphere®/PTH powder was administered
to 11 healthy volunteers using the MedTone™
inhaler. Each subject received three doses of
Technosphere®/PTH (400,800, and 1600 IU)
and an sc injection of PTH alone as a control.
Systemic PTH concentrations were measured
over a period of five hours. Two of the three test
groups (800 and 1600 IU PTH) demonstrated significant
peak PTH plasma levels that were above
those required to achieve clinical efficacy.5
The relative bioavailability of inhaled PTH compared
with sc injection was 48%.
SUMMARY
The Technosphere® technology platform is a
novel inhalation system for the non-invasive
administration of peptide therapeutics that currently
require injection. Formulations using this
system, including Technosphere®/Insulin and
Technosphere®/PTH, have the potential to offer
patients freedom from injections and an
enhanced quality of life.
A sharp peak in the pharmacokinetic profile
that mimics endogenous plasma levels is certainly
beneficial in the delivery of insulin, and is
also likely to be beneficial in the delivery of
other therapeutic proteins and hormones.
However, the application of Technosphere®
technology is not limited to proteins and peptides.
Initial research has indicated that formulations
of small-molecule therapeutics for the treatment
of pain and nausea, among other indications,
could be effective in delivering rapid relief.
Furthermore, while the focus is pulmonary
delivery, research has also demonstrated that
proteins (including insulin) can be stabilised
against degradation when formulated with
Technosphere® particles. This property may
prove invaluable in the development of fragile
protein or vaccine therapeutics that would not
otherwise be feasible.
Together, the assets associated with
Technosphere® technology have the potential to
provide impressive drug delivery solutions across
a wide variety of therapeutic areas encompassing
a number of diverse disease states.
