Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1987-06-08
1989-12-05
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424439, 424441, A61K 968
Patent
active
048851736
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND
1. The Field of the Invention
The present invention is related to methods and compositions for use in systemically delivering potent pharmacological agents having cardiovascular activities to patients in a dose-to-effect manner. More particularly, the present invention is directed to methods and compositions for noninvasive administration of precise doses of potent pharmacological agents having cardiovascular functions (such as vasodilating, calcium channel blocking, beta-blocking, seritonin receptor blocking, angina blocking, anti-hypertensive, and cardiac stimulating properties) and renal vascular functions (such as increasing urine output).
2. The Prior Art
The proper functioning of a person's cardiovascular system determines to a large extent the quality of life that person will enjoy. There have been significant advances in recent years in understanding the complex mechanisms which control the cardiovascular system. This had led to the development of a host of potent new drugs available for clinical use in treating cardiovascular conditions such as congestive heart failure, hypertension, angina, ventricular and atrial fibrillation, and related conditions, and current expectations are that additional potent drugs will continue to become available in the future.
For example, the physician has at his disposal a vast array of hypotensive drugs useful for treating high blood pressure. Blood pressure ("BP") is the product of two hemodynamic factors, cardiac output ("CO") and total peripheral resistance ("TPR"): or TPR, or both.
It is believed that beta-blockers, such as esmolol, nadolol, pindolol, and timolol, reduce blood pressure by decreasing the heat rate or cardiac output. Some beta-blockers, such as atenolol and metoprolol, are known as cardioselective beta-blockers because they have a greater affinity for the beta.sub.1 adrenoceptors that predominate in the heart than for the beta.sub.2 receptors that predominate in the bronchi and peripheral vasculature. The cardioselective nature of these beta-blockers is lost if too great a dose is administered.
All beta-blockers, however, if administered in excess, may result in impaired pulmonary function, wheezing, and asthmatic attacks. In addition, there may be serious adverse cardiovascular effects from the use of beta-blockers, such as bradycardia (abnormally slow heart rate), profound hypotension, and even precipitation of severe congestive heart failure. Adverse central nervous system ("CNS") effects of beta-blockers include dizziness, fatigue, mental depression, and in some cases hallucinations; short-term memory impairment and vertigo have also been observed. There may also be adverse gastrointestinal ("GI") reactions, such as diarrhea and nausea.
As a result, it will be appreciated that while beta-blockers have a very valuable place in cardiac treatment, it is critical that the appropriate dosage be given to a patient in order to avoid the dangers and problems caused by overdosing or underdosing.
Other hypotensive drugs, such as nitroprusside and hydralazine, reduce blood pressure by lowering the total peripheral resistance by direct vasodilation. These drugs are particularly potent and are usually given in an emergency or when other hypotensive treatments have failed. Even slight overdoses of this type of hypotensive drug may result in headache, tachycardia, nausea, and diarrhea, and may even precipitate angina pectoris or ventricular arrhythmia.
Still other hypotensive drugs, such as prazosin, are alpha.sub.1 -blockers which are also capable of reducing blood pressure by lowering the total peripheral resistance as a result of vasodilating effects. An overdose of prazosin may result in headache, drowsiness, palpitation, nausea, and even fainting.
Labetolol is a unique hypotensive drug which combines the features of alpha-blockers with beta-blockers. Blood pressure is reduced due to a decrease in systemic vascular resistance, but usually without a substantial reduction or increase in heart rate, cardiac output, or stroke volume. Unfortunate
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Hague Brian
Stanley Theodore H.
Page Thurman K.
University of Utah
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