Education and demonstration – Means for demonstrating apparatus – product – or surface... – Display panel – chart – or graph
Reexamination Certificate
1998-09-03
2002-03-19
Page, Thurman K. (Department: 1615)
Education and demonstration
Means for demonstrating apparatus, product, or surface...
Display panel, chart, or graph
C424S434000, C424S449000, C514S343000, C514S813000
Reexamination Certificate
active
06358060
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a two-stage medicine delivery system and method for making the two-stage medicine delivery system, wherein an initial dose of medicine is capable of achieving a rapid pharmacological effect, whereas a second dose achieves a prolonged pharmacological effect. The invention also is directed to an improved methodology for symptom relief, such as relief from cravings attributable to withdrawal (e.g., nicotine withdrawal).
The term “medicine”, as used herein, is not limited to substances which relieve pain, disease and/or infection. To the contrary, the term “medicine” encompasses virtually any therapeutic substance which can be effectively applied using the system of the present invention to achieve some desired result. Similarly, the term “lozenge” as used herein is not limited to products that are hard and have a flat, diamond-like shape, but rather encompasses any candy-like source of a therapeutic substance irrespective of its shape, such as gum. The term “lozenge” includes those substitutes by which medicine may be transmucosally delivered to the user.
Most conventional medicine delivery systems have limitations which make them less than ideal. One limitation relates to the speed of delivery. Few medicine delivery systems can provide a pharmacological effect within five minutes of use, much less within one to three minutes of use, and then provide sustainable (or on-demand) delivery for over 30 minutes. The delay in pharmacological effect is especially problematic in situations where the patient takes the medication in response to a stimulus. Examples of such situations include patients who take the medication in response to heart palpitations, diabetics who take the medication in response to noticeable glucose variations, addicts who take craving-reduction medicine in response to cravings, patients who take medication in response to panic attacks, and those seeking to stop smoking and experiencing a craving for a cigarette. In those patients, dangerous complications could arise if the medication is delivered ineffectually or at too fast of a rate.
Another limitation relates to variations in concentration of medicine achieved in the user's bloodstream. Few, if any, medicine delivery systems can provide substantially constant concentrations of medicine in the bloodstream. It is desirable, however, to provide a substantially constant concentration which remains at or near the level of pharmacological effect (LPE). Concentrations below the LPE may have little, if any, effect on the symptoms which the patient wishes to alleviate. Thus, when a medicine delivery system provides such low concentration, it is doing little, if anything, to alleviate the patient. Similarly, concentrations of medicine above the LPE typically are unnecessary, and can produce side-effects or reactions to the medication. There is consequently a need for a medicine delivery system which provides an initial dose of medicine sufficient to rapidly achieve a medicine concentration in the user's bloodstream at or near the LPE and which thereafter provides another more prolonged dose capable of maintaining the concentration of medicine in the user's bloodstream substantially constant at or near the LPE.
Conventional oral delivery systems fail to provide the foregoing combination of doses and the desirable results associated therewith. Typically, the conventional oral delivery system has a delay of 1-3 hours before reaching the LPE. Thereafter, it is unable to maintain a substantially constant concentration at or near the LPE. Instead, the desired pharmacological effect is achieved over a period of time by exceeding the concentration associated with the LPE, followed by a rapid decline in concentration below the LPE.
A typical curve CC representing the concentrations achieved by such an oral delivery system is illustrated in FIG.
1
. The illustrated strategy disadvantageously exposes the patient to an over-dosage, as indicated by the portion of the concentration curve CC which appears far above the LPE line. The resulting overdosage tends to produce toxic side-effects or reactions to the medication.
In addition, the concentration curve CC remains below the LPE line for a significant period of time after the medication is taken. The length of this delay may vary and is affected by the speed of ingestion. This represents a potentially unacceptable delay in the desired pharmacological effect. This delay is particularly unacceptable where the medicine is used to reduce cravings. In those situations, the delay may be long enough that the patient succumbs to the craving. Smokers, for example, might smoke before the orally taken medicine can produce a reduction in the nicotine craving.
The concentration curve CC also drops below the LPE line after the over-dosage. This likewise represents a period of time between dosages where the patient is not receiving the benefit of the desired pharmacological effect.
Although the period of time between pills can be decreased in an attempt to reduce the magnitude of the overdosages, this becomes inconvenient to the patient and greatly increases the likelihood that the patient will not comply with the dosage requirements and therefore will not receive the full benefit of the desired pharmacological effect. In order to avoid non-compliance, the medicine delivery system should minimize the amount of activity required of the patient.
An additional problem with conventional oral medicine delivery systems which require stomach absorption of the medicine is the highly volatile enzymatic environment of the gastro-intestinal system. This environment can alter the medicine and reduce or eliminate its effectiveness.
In order to provide more immediate pharmacological effects, hypodermic injection has been used as a medicine delivery system. Such injection techniques, however, fail to provide constant concentrations of the medicine in the blood over prolonged periods of time.
FIG. 2
illustrates a typical concentration curve CC′ which represents the concentration of medicine in the blood over time when a conventional hypodermic injection technique is used. The concentration curve CC′ demonstrates how the initial dosage actually exceeds the LPE necessary to achieve the desired pharmacological effect. The hypodermic injection technique therefore exposes the patient to an over-dosage. This over-dosage, in turn, increases the likelihood of side-effects and adverse reactions. Another disadvantage associated with the conventional hypodermic injection technique is that it fails to provide a prolonged period of time during which the concentration remains at or near the LPE. Instead, the concentration curve CC′ reaches a peak soon after injection and progressively diminishes over time.
Yet another disadvantage associated with conventional hypodermic injection techniques is the pain associated with such injection techniques. Some patients are extremely disturbed by the notion of hypodermic injection. This limits the number of patients which will use the injection technique. Even the patients which do elect to use the hypodermic injection technique may be less likely to comply on a regular basis with dosage requirements when faced with the unpleasantness of frequent injections. In many cases, the injection technique requires medical personnel, privacy, and/or a stationary place to perform the injection. When all three requirements are present, the injection technique is extremely inconvenient to the patient.
Another conventional technique for delivering medicine involves an intravenous drip. The intravenous drip is capable of providing a rapid pharmacological effect and can be programmed to dispense medicine at a rate which achieves a substantially constant concentration of medicine in the blood, at or near the LPE. A typical curve CC″ representing the concentrations achieved by the intravenous drip technique is illustrated in FIG.
3
.
The intravenous drip, however, requires trained medical personnel to sup
Cone Edward J.
Gitchell Joseph
Henningfield Jack E.
Pinney John M.
Shiffman Saul
Joynes R.
JSR LLC
Liniak, Berenato, Longacre & White LLC
Page Thurman K.
LandOfFree
Two-stage transmucosal medicine delivery system for symptom... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Two-stage transmucosal medicine delivery system for symptom..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Two-stage transmucosal medicine delivery system for symptom... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2826353