U.S. patent application number 10/650349 was filed with the patent office on 2005-03-03 for multiple drug delivery system & method.
Invention is credited to Gelder, Steven K..
Application Number | 20050045197 10/650349 |
Document ID | / |
Family ID | 34217134 |
Filed Date | 2005-03-03 |
United States Patent
Application |
20050045197 |
Kind Code |
A1 |
Gelder, Steven K. |
March 3, 2005 |
Multiple drug delivery system & method
Abstract
A device for drug delivery, including at least two different
juxtaposed layers of edible matter, each layer having a dosage
level of medication and the layers alternate dosage level.
Inventors: |
Gelder, Steven K.; (Santa
Monica, CA) |
Correspondence
Address: |
MACCORD MASON PLLC
300 N. GREENE STREET, SUITE 1600
P. O. BOX 2974
GREENSBORO
NC
27402
US
|
Family ID: |
34217134 |
Appl. No.: |
10/650349 |
Filed: |
August 28, 2003 |
Current U.S.
Class: |
131/270 |
Current CPC
Class: |
A61K 9/0056 20130101;
A24B 15/16 20130101; A23G 3/368 20130101; A61K 9/209 20130101; A23G
3/54 20130101; A61K 9/2072 20130101 |
Class at
Publication: |
131/270 |
International
Class: |
A24F 047/00 |
Claims
1. A device for drug delivery, comprising: at least two different
juxtaposed layers of edible matter, wherein each layer has a dosage
level of medication and the layers alternate dosage level
2. The device of claim 1, wherein the at least two different
juxtapose layers of edible matter are more than two layers of
edible matter and wherein the layers alternate dosage levels.
3. The device of claim 1, wherein the drug is one that satisfies a
nicotine addiction and wherein alternating doses mimic a smoker's
nicotine uptake when smoking a cigarette.
4. The device of claim 1, further including a support device for
hand-control or manipulation of the device.
5. The device of claim 4, wherein the support device is larger than
a normal candy support device in order to satisfies a cigarette
user's tactile needs.
6. The device of claim 4, wherein the support device is a lollipop
stick.
7. The device of claim 1, further including a chewable core,
wherein the core has at least one dose level of the drug.
8. The device of claim 7, wherein the chewable core is selected
from the group consisting of gum, taffy, caramel, and combinations
thereof.
9. The device of claim 1, wherein an outer-layer drug is an
anti-side-effect drug directed toward alleviating side-effects of
an inner-layer drug.
10. The device of claim 9, wherein the inner-layer drug is a
chemotherapeutic drug.
11. A method for delivering a drug, the method steps comprising:
providing a drug delivery device as in claim 1.
12. The method of claim 11, wherein the dosage levels progress from
low dosage to high dosage, high dosage to low dosage, and
combinations thereof.
13. A method for aiding in the cessation of a chemical addiction,
the method steps comprising: providing a device as in claim 1,
having at least two dosage levels of an addictive drug
substitute.
14. The method of claim 13, further comprising: providing a series
of multiple-dosage devices as in claim 1, wherein each device has
at least two doses, the first available dose being higher than the
next available dose, and each successive device in the series has
the first available dose at the about same concentration as the
core in the prior device in the series.
15. The method of claim 14, wherein the chemical addiction is an
addiction to nicotine and the drug is nicotine or nicotine
substitute.
Description
BACKGROUND OF THE INVENTION
[0001] (1) Field of the Invention
[0002] The present invention relates generally to pharmacology and,
more particularly, to smoking cessation methods and aids.
[0003] (2) Description of the Prior Art
[0004] Cigarette smoking has been associated with lung cancer,
heart disease, and other ailments, including birth defects.
Unfortunately, addiction to cigarette smoking is difficult to break
because the user has both a chemical addiction to the nicotine
delivered via the cigarette and a psychological addiction to the
hand to mouth motion. In addition, the nicotine levels delivered
via a cigarette are not constant, but rather are delivered as
multiple spiking doses. The most successful solution to break
cigarette use will then be one that emulates most closely the
delivery of nicotine, both chemically and mechanically, by a
cigarette.
[0005] Studies have shown that smokers using nicotine gum, patch,
nasal spray, inhaled nicotine, or nicotine sublingual tablets are
about 1.5 to 2 times more likely to stop smoking than smokers using
no cessation aid, and evidence suggests that bupropion may be even
more effective (see, Silagy et al., Cochrane Database Syst. Rev.,
No. 2, p.CD000146 (2000)). However, each of the existing smoking
cessation aids has drawbacks, and none has proven fully effective.
Additionally, resolution of nicotine addiction requires that the
addict gradually reduce the dosage over time. Prior art embodiments
have accomplished this by providing devices at different doses of
nicotine, such that the user can switch to devices with
progressively lower dose over time.
[0006] Cigarette smoking involves a hand-to-mouth ritual that may
be repeated over 70,000 times per year. Since smoking cessation
requires giving up a highly ingrained habitual motion as well as
giving up nicotine, an effective smoking cessation aid should
address the behavioral components of smoking as well as providing
nicotine replacement therapy. A smoking cessation aid should give
the smoker the comfort of an oral and tactile ritual, while at the
same time supplying nicotine. However, a smoking cessation device
that is too similar to a conventional cigarette and provides oral
sensations and tactile stimuli that too closely mimic tobacco
smoking may not be ideal. A smoker using such a device might find
it too easy to relapse into cigarette smoking (see, e.g., Schneider
et al., Addiction, 91:1293-1306 (1996)). Thus, a smoking cessation
aid that provides the synergistic combination of nicotine plus oral
and tactile stimuli, while not too closely approximating a
conventional tobacco cigarette, seems most desirable.
[0007] Various smoking cessation aids have been developed,
including nicotine gum (see, e.g., U.S. Pat. No. 3,845,217);
nicotine transdermal patch (see, e.g., U.S. Pat. No. 4,915,950);
nicotine nasal spray (see, e.g., AU 664 41); nicotine inhaler (see,
e.g., U.S. Pat. Nos. 4,920,989 and 4,953,572); and
sustained-release bupropion hydrochloride (see, e.g., Jorenby et
al., N. Engl. J. Med., 340:685-91(1999)). Other examples of smoking
cessation aids include nicotine nose drops (see, e.g., U.S. Pat.
No. 4,579,858); nicotine lozenges (see, e.g., U.S. Pat. Nos.
4,806,35 and 5,549,906); smoke-free cigarettes (see, e.g., U.S.
Pat. Nos. 4,284,089, 4,676,259, 4,736,755, 4,813,437, 5,284,163,
and 6,041,789); compositions comprising nicotine metabolites (see,
e.g. U.S. Pat. No. 5,869,505); and drinkable nicotine solutions
(see, e.g., WO 99/55371).
[0008] Certain devices developed to facilitate smoking cessation
provide the nicotine and oral stimulation, but no repetitive
hand-to-mouth motion is required to use these aids. These aids
include chewing gums, tablets and lozenges.
[0009] Chewing gum was an early carrier employed to deliver
nicotine or other drugs. U.S. Pat. No. 4,276,890 issued to Fichera
Jul. 7, 1981 describes the use of chewing gum for the delivery of a
chemical to aid in the cessation of smoking. U.S. Pat. No.
4,753,800 issued to Mozda Jun. 28, 1988 describes the use of
chewing gum to deliver nicotine and other drugs, but not
specifically for the purpose of aiding in the cessation of
smoking.
[0010] Tablets and lozenges are another embodiment of a drug
delivery device applied to smoking cessation. U.S. Pat. No.
6,248,760 issued Jun. 19, 2001 to Wilhelmsen for Tablet Giving
Rapid Release of Nicotine for Transmucosal Administration teaches a
tablet embodiment. U.S. Pat. No. 6,280,761 issued Aug. 28, 2001 to
Santus for Nicotine lozenge teaches the use of a lozenge for
delivery of nicotine.
[0011] Aids that provide nicotine, oral stimulation, and repetitive
hand-to-mouth motion for use include suckers or lollipops and an
inhalation tube. U.S. Pat. No. 5,058,544 issued Sep. 17, 1991 to
Mascarelli, et al. for Cigarette Substitute provides an edible
portion having a small amount of a nicotine composition sufficient
to satisfy the desires of the cigarette smoker. Preferably, the
edible portion would be shaped in the form of a conventional
lollypop, which would preferably have a hard semi-hard candy.
[0012] PUBLICATION US20020059939 for Device and method for the
cessation of smoking teaches an oral device providing a tubular
chamber used to intake liquid/gas and the delivery of nicotine for
the cessation of smoking.
[0013] These prior art devices do not teach the incorporation of a
step-down dosage level regimen within a device that satisfies the
hand-to-mouth behavior and oral stimulation. A step-down regimen
with only single dosage level devices require the user to abandon
the current dosage level and abruptly move to the next lower level.
This can cause the recrudesence of withdrawal symptoms.
[0014] Devices with a plurality of doses have been described. U.S.
Pat. No. 6,358,060 issued Mar. 19, 2002 to Pinney et al. for
Two-stage transmucosal medicine delivery system for symptom relief
describes a delivery system provided in chewing gum form or lozenge
form and provides an initial dose of medicine capable of achieving
a rapid pharmacological effect and a second dose of medicine for a
prolonged effect. U.S. Pat. No. 6,344,222 issued Feb. 5, 2002 to
Cherukuri, et al. for Medicated chewing gum delivery system for
nicotine teaches a chewing gum delivery system that has nicotine, a
gum base and a buffer system with an improved release rate for the
nicotine. The delivery system is capable of delivering initial and
second doses of a craving reduction active or other actives (e.g.,
nicotine), the combination of which rapidly reduces cravings, or
provides some other pharmacological effect, and provides the
pharmacological effect or protection from such cravings over a
prolonged period of time beyond the initial dose. These prior art
devices, while incorporating multiple doses within a device, do not
satisfy the hand-to-mouth motion.
[0015] Each of these prior art embodiments has drawbacks associated
with them. Nicotine patches may irritate the skin, and some smokers
are dissatisfied with the lack of rapid nicotine absorption from
the patch. Nicotine nasal sprays may irritate the nose and throat.
More importantly, none of these smoking cessation aids simulates
the tactile sensations or hand-to-mouth behaviors that form an
integral part of the smoker's addiction. Patches provide no oral or
tactile stimulus; gum, lozenges, and drinkable solutions stimulate
only the mouth, and nasal sprays stimulate only the airways. These
aids lack the important synergistic combination of nicotine, oral
stimulation, variable dose, and hand-to-mouth behaviors that
smokers' desire. Although the inhalation tube and lollypop do
satisfy these needs, these prior art devices do not teach the
incorporation of a step-down dosage level regimen within a single
device. A step-down regimen with only single dosage level devices
require the user to abandon the current dosage level and abruptly
move to the next lower level. This abrupt change in dosage can
cause withdrawal symptoms. Prior art single-dose lollipop
embodiments, while satisfying the chemical and psychological
dependencies, lack the dosage step-down that appears necessary for
users to progress to lower dosages and eventual resolution of the
addiction.
[0016] Therefore, a need exists for a smoking cessation aid that
combines the nicotine, oral stimulation, variable dose, and
hand-to-mouth behaviors that smokers desire, and provides a series
of multiple-dose devices with overlapping doses such that an addict
can move to progressively lower doses without abrupt lowering the
dose.
SUMMARY OF THE INVENTION
[0017] The present invention is directed to a multiple-dosage level
device that provides nicotine or nicotine equivalent, variable
dose, repetitive hand-to-mouth motion, and oral stimulation to aid
in the cessation of smoking.
[0018] Accordingly, one aspect of the present invention is to
provide a device for the cessation of an addiction, including a
lollypop with hard candy exterior and chewable core, wherein
exterior has a first dose level and core has a second dose
level.
[0019] Another aspect of the present invention is to provide a
device for the induction of tachyphylaxis, comprising: A lollypop
with hard candy exterior and chewable core, wherein exterior has a
first dose level and core has a second dose level.
[0020] Another aspect of the present invention is to provide a
method for cessation of chemical addiction, comprising: providing a
series of multiple-dosage devices, wherein each device has at least
2 doses, the first available dose being higher than the next
available dose, and each successive device in the series has the
first available dose at the about same concentration as the second
available dose of the prior device in the series.
[0021] Still another aspect of the present invention is to provide
a method for the induction of tachyphylaxis, comprising: providing
a series of multiple-dosage devices, wherein each device has at
least 2 doses, the first available dose being lower than the next
available dose, and each successive device in the series has the
first available dose at the about same concentration as the second
available dose of the prior device in the series.
[0022] These and other aspects of the present invention will become
apparent to those skilled in the art after a reading of the
following description of the preferred embodiment when considered
with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] FIG. 1 is a cross-sectional view of a lollipop constructed
according to the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] In the following description, like reference characters
designate like or corresponding parts throughout the several views.
Also in the following description, it is to be understood that such
terms as "forward," "rearward," "front," "back," "right," "left,"
"upwardly," "downwardly," and the like are words of convenience and
are not to be construed as limiting terms.
[0025] Referring now to the drawings in general, the illustrations
are for the purpose of describing a preferred embodiment of the
invention and are not intended to limit the invention thereto. As
best seen in FIG. 1, the device is configured as a lollipop,
generally referenced as 10, having an edible portion 11 and a
support 12. The edible portion is comprised of a hard candy shell
15 and a gum interior 20. The hard candy shell can be of a variety
of shapes, including cylindrical, spherical, orthogonal, and the
like, without departing from the invention. The dimensions of the
lollipop are such that the lollipop will feel comfortable in the
user's mouth, generally the same diameter or cross-section as
currently available hard candies or lozenges. The support 12 is of
a dimension that satisfies the user's tactile needs. By way of
example, it may be equivalent to a typical lollipop stick, or may
be larger, such as the dimensions of a cigarette.
[0026] The lollipop contains a pharmaceutical chemical having at
least two dose levels, a first dose level in the candy shell and a
second dose level in the gum interior. In the case of a device for
the resolution of cigarette addiction, the chemical is nicotine,
including nicotine derivatives, at doses ranging from high doses
designed to satisfy heavy nicotine-intakers to a low dose of no
nicotine.
[0027] In the cases of devices to break addiction, the doses would
start with the higher dose externally and progress to lower doses
internally. A range of devices with close or overlapping dosages
would be provided.
[0028] A multiple-dosage level device provides gradual step-down,
allowing the user to progress from a higher dose to a lower dose
within the same device. The immediate chemical craving would be
satisfied by the higher, first dose. Over time, the user would
become habituated to the second, lower dose, such that when the
user moved to the next lower dosage device, in which the first dose
is the same concentration as the second dose of the previous level,
the user would be accustomed to the initial dosage level.
[0029] Use of a lollipop that incorporates nicotine in such a
step-down dose would also satisfy the psychological or habitual
addictions associated with cigarette smoking.
[0030] More than 2 levels of a chemical may also be provided, for
example by stratifying the candy shell or incorporating the
multi-level chewing gums as described in the prior art U.S. Pat.
Nos. 6,358,060 and 6,344,222 and incorporated herein by reference
in their entirety.
[0031] The present invention provides a controlled release of
predetermined levels of a pharmaceutical over time. By stratifying
the hard candy shell into different layers, and alternating the
levels of a drug, spiking dosages can be delivered. Alternatively,
the drug itself can be varied between strata, thereby delivering
combinations of drugs. More specifically, a first drug can be
delivered in a stratum and a second drug can be delivered in the
next-most interior stratum. The drug can be a pharmaceutical agent
or a non-pharmaceutical agent, including sweeteners such as sugar,
corn syrup, aspartame, saccharin, and the like.
[0032] Other benefits of the present invention include increased
compliance by otherwise recalcitrant users, such as children and
mental patients. The present invention would be of great use in
mental patients, or other persons without the capacity to endure
the slight discomfort associated with abrupt changes in medication.
Compliance would be higher in these persons if using the present
invention than if using prior art embodiments. The device would be
especially effective when sequentially administering multiple drugs
to these users. In these embodiments, the internal core need not
necessarily be chewable gum, but can be any candy, including hard
candy, taffy, caramel, and the like. The nature of the internal
core can be modified to satisfy the requirements of the specific
application.
[0033] A specific example embodiment, not intended as a limitation,
is the use of the device for the administration of cancer
chemotherapeutic drugs to young children. Certain chemotherapeutics
induce nausea, and therefore an anti-nausea drug is frequently
administered prior to administration of the chemotherapeutic to
reduce the nausea. In the specific embodiment, an anti-nausea drug
can be incorporated in the exterior shell, and the chemotherapeutic
drug into the internal chewable core. In this application, a child
would received the anti-nausea agent while eating the exterior
shell, preferably slowly enough for the drug to be in effect when
the child started chewing the chewable core and started receiving
the chemotherapeutic drug. The chewable core need not necessarily
be chewing gum, but can be any chewable candy or substance, such as
taffy, caramel, and the like.
[0034] The present invention includes a device for drug delivery,
including at least 2 different juxtaposed layers of edible matter,
each layer having a dosage level of medication and the layers
alternate dosage level. The at least two different juxtapose layers
of edible matter may be more than two layers of edible matter and
the layers have variable dosage levels.
[0035] Variable dosage levels results in spiking delivery of the
drug. Alternating or varying delivery permits the user to maintain
the device in his/her mouth, yet have variable levels of drug
delivery. This variable delivery more closely mimics actual
cigarette smoking, and can break the hand-to-mouth motion or habit
because the user can gradually reduce manipulation of the device,
while receiving variable doses of the drug.
[0036] Thus using the present invention in an embodiment that uses
a drug that satisfies nicotine addiction provided with alternating
doses closely mimic a smoker's nicotine uptake when smoking a
cigarette. To further emulate smoking, the device can further
include a support device for hand-control or manipulation of the
device. This support permits removing the device from the mouth,
for example if the user needs to adjust the intake of the drug. The
support device can be a normal candy support, such as a lollipop
stick, or may be larger than a normal candy support device, in
order to satisfies a cigarette user's tactile needs
[0037] A device according to the present invention also preferably
has a chewable core, wherein the core has at least one dose level
of the drug. The chewable core can be a chewabel candy, such as
gum, taffy, caramel, and the like.
[0038] In one embodiment, the outer-layer drug is an
anti-side-effect drug directed toward alleviating side-effects of
an inner-layer drug. For example, if the inner-layer drug is a
chemotherapeutic drug that causes nausea, the outer-layer drug can
be an anti-nausea agent.
[0039] A method for using the device to deliver a drug includes
providing a device with multiple doses. A series of devices can
also be provided, wherein the dosage levels are staged between
devices, providing an incremental change of dosage levels, wherein
the incremental levels progress from low dosage to high dosage,
high dosage to low dosage, and combinations thereof. For example, a
drug that causes severe side effects and is otherwise useless may
be useful if the body can adapt to the side-effects. Such an
adaptation can potentially be achieved by incrementally increasing
the dose levels from a very low starting dose. After the curative
effective is achieved, the drug administration can be stopped, for
the dosage can be tapered down to prevent withdrawal symptoms. In
the case of a chemical addiction, a method for resolving the
addiction includes providing a device according to the present
invention having at least 2 dosage levels of an addictive drug
substitute. For greater efficacy, a series of multiple-dosage
devices can be provided, wherein each device has at least 2 doses,
the first available dose being higher than the next available dose,
and each successive device in the series has the first available
dose at the about same concentration as the core in the prior
device in the series. Thus, a series of multiple-dosage devices
would have high (H) and low (L) drug dosage levels: H1L1, H2L2,
H3L3, H4L4, HnLn, Hn+1Ln+1, Hn+2Ln+2. Hn+2 can be similar to, less
than, or higher than Ln+1. Hn+2 can be higher than Ln+1 such that
the user feels satisfied by the slightly higher dose of Hn+2 than
by the low dose of Ln+1.
[0040] In the case of chemical addiction to nicotine, the devices
would contain nicotine or a nicotine substitute. The nicotine
addiction can be from the nicotine inhaled from smoking tobacco,
such as from cigarettes, pipes or cigars, or from oral tobacco
products, such as chewing tobacco, snuff, and the like.
[0041] A preferred embodiment of the present invention is a device
for the administration of a drug. The device includes an edible
drug delivery device with a flavored exterior and a chewable core.
The drug in the flavored exterior and core can be the same,
similar, or different drugs. The device can be used to deliver a
drug for the purposes of medical treatment, or for the purposes of
stopping a chemical addiction.
[0042] For example, the drug in the flavored exterior can be at
least one anti-side-effect agent directed towards alleviating the
effects of the drug in the at least one inner layer. For example,
the inner drug may be a chemotherapeutic agent that causes nausea,
and the otherefore the outer layer drug is an anti-nausea drug.
[0043] The flavored exterior can be a hard candy. The drug may be
stratified in the hard candy shell into different layers, and the
levels of the drug are alternated in the different layers,
resulting in delivery of variable or spiking dosages to the
user.
[0044] The core has at least one drug, which can be a second dose
level. For example, the chewable core for a device directed towards
cessation of nicotine addiction contains nicotine or nicotine
substitutes at a second dose level. The core can be a chewable
candy, such as gum, taffy, caramel, and the like.
[0045] The device may also include a support, such as a typical
lollipop stick, or may be larger, such as the dimensions of a
cigarette or cigar.
[0046] The device can be directed toward the cessation of a
chemical addiction, including nicotine addiction, such as from
smoking or chewing tobacco products. In the embodiment for the
cessation of nicotine addiction, the flavored exterior contains
nicotine at a first dose level and the chewable core contains
nicotine at a second level. The nicotine is preferably stratified
in the hard candy shell into different layers, and the levels of
the drug are alternated, resulting in delivery of spiking dosages.
The device for the cessation of smoking preferably includes a
support, such as a typical lollipop stick, or may be larger, such
as the dimensions of a cigarette or cigar, such that manipulation
of the support satisfies the user's tactile needs.
[0047] Certain modifications and improvements will occur to those
skilled in the art upon a reading of the foregoing description. By
way of example, as an alternative to the foregoing description of
preferred embodiments, the device can be used to induce
tachyphylaxis, that is, a decreased response to a drug given over a
period of time so that larger doses are required to produce the
same response, in cases where tachyphylaxis is desired. Induction
of tachyphylaxis can be used, for example, to protect against
accidental overdoses, or in homeopathy to stimulate a patient's
weakened response. By using a system of multiple-dosage,
overlapping-dose devices, tachyphylaxis can be induced while
minimizing the effects of increasing dosage.
* * * * *