Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1998-10-21
2001-03-27
Kishore, Gollamudi S. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S427000, C424S430000, C424S434000, C424S435000, C424S436000, C424S486000, C514S256000
Reexamination Certificate
active
06207172
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition for the delivery of a pharmaceutical agent to a patient. The invention also relates to methods of making a composition for the delivery of a pharmaceutical agent.
BACKGROUND OF THE INVENTION
The delivery of pharmaceutical agents to patients can be difficult when the pharmaceutical agent to be delivered is highly lipophilic and/or poorly water soluble. For example, one common method of delivering or administering a pharmaceutical agent is by subcutaneous injection. In order to subcutaneously inject a pharmaceutical agent into a patient, the pharmaceutical agent is typically dissolved in or mixed with a solvent, most preferably water. If the pharmaceutical agent can not be dissolved in or mixed with an acceptable solvent such as water, it cannot be administered subcutaneously. Similar problems are seen when a pharmaceutical agent is to be administered to a patient orally in a solution. Because many pharmaceutical compounds are highly lipophilic and/or poorly water soluble, there is a need for compositions that can be used to deliver these pharmaceutical agents.
SUMMARY OF THE INVENTION
The present invention provides a composition for the delivery of a pharmaceutical agent to a patient, the composition comprising polyethylene glycol having a weight-average molecular weight in the range of about 1,300 to about 9,000, an aqueous solution containing from about 5% (w/v) to about 20% (w/v) polyvinylpyrrolidone with respect to the entire solution, the polyvinylpyrrolidone having a weight-average molecular weight in the range of about 2,000 to about 30,000, and a pharmaceutical agent.
In one embodiment of the invention, the polyethylene glycol has a weight-average molecular weight in the range of about 1,300 to about 4,800.
In a preferred embodiment of the invention, the polyethylene glycol has a weight-average molecular weight in the range of about 3,000 to about 4,800.
In another preferred embodiment of the invention, the polyvinylpyrrolidone is about 20% (w/v) of the aqueous solution.
In another preferred embodiment of the invention, the polyvinylpyrrolidone has a weight-average molecular weight of about 10,000.
In one embodiment of the invention, the pharmaceutical agent is highly lipophilic or poorly water soluble.
In another embodiment of the invention, the aqueous solution is water.
In still another embodiment of the invention, the aqueous solution is a biologically compatible buffer having a pH in the range of about 1.0 to about 7.4.
In a more preferred embodiment of the invention, the biologically compatible buffer is a phosphate buffer.
In another preferred embodiment of the invention, the polyethylene glycol is present in the composition in an amount that is in the range of about 20% to about 70% by volume of the composition.
In a more preferred embodiment of the invention, the polyethylene glycol is present in the composition in an amount that is in the range of about 40% to about 60% by volume of the composition.
In a most preferred embodiment of the invention, the polyethylene glycol is present in the composition in an amount that is about 50% by volume of the composition.
In a preferred embodiment, the aqueous solution is present in the composition in an amount that is in the range of about 20% to about 70% by volume of the composition.
In a more preferred embodiment, the aqueous solution is present in the composition in an amount that is in the range of about 40% to about 60% by volume of the composition.
In a most preferred embodiment, the aqueous solution is present in the composition in an amount that is about 50% by volume of the composition.
Also provided is a method of making a pharmaceutical composition, the method comprising melting solid polyethylene glycol having a weight-average molecular weight in the range of about 1,300 to about 9,000, adding a pharmaceutical agent to the molten polyethylene glycol to form a polyethylene glycol/pharmaceutical agent combination, and combining the polyethylene glycol/pharmaceutical agent combination with an aqueous solution of polyvinylpyrrolidone, the polyvinylpyrrolidone having a weight-average molecular weight in the range of about 2,000 to about 30,000.
Also provided is a method of making a pharmaceutical composition, the method comprising combining a pharmaceutical agent with solid polyethylene glycol having a weight average molecular weight in the range of about 1,300 to about 9,000 to form a polyethylene glycol/pharmaceutical agent combination, and combining the polyethylene glycol/pharmaceutical agent combination with an aqueous solution of polyvinylpyrrolidone, the polyvinylpyrrolidone having a weight-average molecular weight in the range of about 2,000 to about 30,000.
In a preferred embodiment of the methods of making a pharmaceutical composition, the polyethylene glycol has a weight-average molecular weight in the range of about 1,300 to about 4,800.
In a more preferred embodiment of the methods of making a pharmaceutical composition, the polyethylene glycol has a weight-average molecular weight in the range of about 3,000 to about 4,800.
In a preferred embodiment of the methods of making a pharmaceutical composition, the polyvinylpyrrolidone is about 20% (w/v) of the aqueous solution.
In a preferred embodiment of the methods of making a pharmaceutical composition, the polyvinylpyrrolidone has a weight-average molecular weight of about 10,000.
In a preferred embodiment of the methods of making a pharmaceutical composition, the pharmaceutical agent is highly lipophilic or poorly water soluble.
In a preferred embodiment of the methods of making a pharmaceutical composition, the aqueous solution is water.
In a preferred embodiment of the methods of making a pharmaceutical composition, the aqueous solution is a biologically compatible buffer having a pH in the range of about 1.0 to about 7.4.
In a preferred embodiment of the methods of making a pharmaceutical composition the buffer is a phosphate buffer.
In a preferred embodiment of the methods of making a pharmaceutical composition the polyethylene glycol is present in the composition in an amount that is in the range of about 20% to about 70% by volume of the composition.
In a preferred embodiment of the methods of making a pharmaceutical composition the polyethylene glycol is present in the composition in an amount that is in the range of about 40% to about 60% by volume of the composition.
In a most preferred embodiment of the methods of making a pharmaceutical composition, the polyethylene glycol is present in the composition in an amount that is about 50% by volume of the composition.
In a preferred embodiment of the methods of making a pharmaceutical composition, the aqueous solution is present in the composition in an amount that is in the range of about 20% to about 70% by volume of the composition.
In a preferred embodiment of the methods of making a pharmaceutical composition, the aqueous solution is present in the composition in an amount that is in the range of about 40% to about 60% by volume of the composition.
In a preferred embodiment of the present invention, the aqueous solution is present in the composition in an amount that is about 50% by volume of the composition.
In a preferred embodiment of the methods, the composition is autoclaved, freeze dried, or extruded.
DETAILED DESCRIPTION OF THE INVENTION
The present invention relates to a composition that can be used to deliver a pharmaceutical agent to a patient. The term “patient” means all animals including humans. Examples of patients include humans, cows, dogs, cats, goats, sheep, and pigs.
A pharmaceutical agent is a chemical compound that when administered to a patient has a biological effect on the patient. Examples of pharmaceutical agents include, but are not limited to, compounds given to a patient to treat cancer, AIDS, inflammation, diabetes, high blood pressure, atherosclerosis, Altzheimer's disease, bacterial or viral infection, high cholesterol, depression, obesity, emesis, dementia, stroke, restenosis, and ce
Ando Howard Yoshihisa
Rose Steven Edward
Ashbrook Charles W.
Atkins Michael J.
Crissey Todd M.
Kishore Gollamudi S.
Warner-Lambert & Company
LandOfFree
Composition for the delivery of a pharmaceutical agent to a... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Composition for the delivery of a pharmaceutical agent to a..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Composition for the delivery of a pharmaceutical agent to a... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2460469