Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
2000-10-19
2002-09-17
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C424S434000, C424S435000, C424S436000, C424S464000, C424S468000, C514S183000
Reexamination Certificate
active
06451848
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to compositions and methods comprising morphine gluconate for eliciting an analgesic or anesthetic response in a mammal.
BACKGROUND OF THE INVENTION
The compound morphine or (−)7,8-didehydro-4,5&agr;-epoxy-17-methylmorphinan-3,6&agr;-diol, is a phenanthrene derivative that exhibits the following general structure:
Structure A (see page before claims)
Morphine is a centrally acting narcotic analgesic that acts as an agonist primarily at mu, kappa and perhaps delta receptors in the central nervous system. By acting on these receptors, morphine causes analgesia and anesthesia as a result of a receptor-mediated central action on pain perception, together with a receptor-medicated modulatory effect on the central transmission of noxious sensation. Some side effects caused by morphine include drowsiness, respiratory depression and euphoria.
Various morphine compositions are known in the pharmaceutical arts. For example, morphine sulfate is one of the most commonly prescribed morphine compositions. Other morphine compositions such as morphine tartrate and morphine lactate are disclosed in U.S. Pat. No. 5,880,132 issued to Hill and U.S. Pat. No. 5,378,474 to Morella et al. for the treatment and prevention of pain or nociception. Some polar compositions of morphine including morphine-3-glucuronide and morphine-6-glucuronide are disclosed in U.S. Pat. No. 5,629,011 to Illum. While these references discuss different pharmaceutical compositions of morphine, none disclose morphine gluconate or a chemically modified equivalents thereof.
Morphine has been used for a variety of clinical indications. Some examples of such indications include analgesia, for treatment of acute and chronic pain, anesthesia during surgery and to allay anxiety during acute pulmonary edema.
Several delivery routes have been utilized for administering morphine. These routes include oral, injectable, buccal and intranasal administration. For example, oral and injectable morphine sulfate are commonly prescribed for cancer pain. Oral and injectable morphine sulfate are available from Abbott Pharmaceuticals Inc., USA.
Other more desirable delivery routes have been investigated. For example, intranasal delivery of morphine has shown potential for rapid onset and duration of action. Further, intranasal administration offers minimal delays in absorption, is not as invasive as intravenous delivery and achieves therapeutically effective amounts of the drug in plasma. For example, intranasal delivery of morphine is disclosed in U.S. Pat. No. 5,629,011 to Illum and U.S. Pat. No. 4,464,378 to Hussain for the treatment of chronic and acute pain. The entire disclosure of U.S. Pat. No. 5,629,011 and U.S. Pat. No. 4,464,378 is herein incorporated by reference. While these references discuss the benefits of intranasal delivery of morphine, there is no consideration of using morphine gluconate or chemical equivalent thereof as an analgesic or anesthetic.
Based on the foregoing, there is a need for effective morphine compositions and methods for eliciting analgesic and anesthetic responses. The morphine compositions and methods of the present invention include morphine gluconate or chemical equivalent thereof.
SUMMARY OF THE INVENTION
The present invention provides a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof.
In one embodiment, the present invention provides a pharmaceutical composition which includes a therapeutically effective amount of morphine gluconate or chemical equivalent thereof for eliciting an analgesic or anesthetic response in a mammal.
It another embodiment, the present invention provides a method of making a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof by mixing morphine sulfate with sodium gluconate to yield morphine gluconate or chemical equivalent thereof.
In yet another embodiment, the present invention provides a method for eliciting an analgesic or anesthetic response in a mammal which includes administering a therapeutically effective amount of a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof to the mammal that is sufficient to elicit analgesia or anesthesia.
In still yet another embodiment, the present invention provides a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof, prepared by mixing morphine sulfate with sodium gluconate to yield morphine gluconate or chemical equivalent thereof.
The present invention also relates to a method for eliciting an analgesic or anesthetic response in a mammal comprising nasally administering a therapeutically effective amount of a pharmaceutical composition which includes morphine gluconate or chemical equivalent thereof to the mammal in combination with a nasal delivery system.
REFERENCES:
patent: 4464378 (1984-08-01), Hussain
patent: 5198209 (1993-03-01), Zhou et al.
patent: 5202128 (1993-04-01), Morella et al.
patent: 5330766 (1994-07-01), Morella et al.
patent: 5378474 (1995-01-01), Morella et al.
patent: 5508043 (1996-04-01), Krishnamurthy
patent: 5629011 (1997-05-01), Illum
patent: 5728695 (1998-03-01), Harrison et al.
patent: 5730997 (1998-03-01), Lienhop et al.
patent: 5756483 (1998-05-01), Merkus et al.
patent: 5830892 (1998-11-01), Baker
patent: 5877316 (1999-03-01), Haworth et al.
patent: 5880132 (1999-03-01), Hill
patent: 5885999 (1999-03-01), Elliott
patent: 5942251 (1999-08-01), Merkus
patent: 82/03768 (1982-11-01), None
Banker and Rhodes, eds.,Modern Pharmaceutics, Chapter 2, pp. 23-74, Marcel Dekker Inc., New York, 1979.
Behl Charanjit R.
Romeo Vincent D.
Sileno Anthony P.
Nastech Pharmaceutical Company Inc.
Page Thurman K.
Tran S.
Woodcock & Washburn LLP
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