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Drug delivery compositions suitable for intravenous injection
| Details |
Inventors: Yiv, Seang H.; Tustian, Alex K.;
Assignee: Elan Corporation plc (Dublin, IE)
Primary Examiner: Kishore; Gollamudi S.
Assistant Examiner:
Attorney, Agent or Firm: Synnestvedt & Lechner LLP
The present invention provides drug delivery compositions in both concentrated and diluted forms for use as vehicles in the administration of various active agents. The drug delivery compositions are primarily designed for use with lipophilic, amphipathic, and sparingly water soluble active agents, preferably drugs. The drug delivery compositions are to be administered to an animal to effect uptake of the active agent. The primary mode of administration is by intravenous, intra-arterial, intrathecal, intraperitoneal, intraocular, intra-articular, intramuscular or subcutaneous injection. The concentrated drug delivery compositions are formulated with a phospholipid component, a component selected from propylene glycol or certain polyethylene glycol compounds, a high HLB surfactant, and the drug component, with water and/or an oil component optional. The concentrated drug delivery compositions can be diluted with an aqueous fluid to form an oil-in-water microemulsion composition. |
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DETAILED DESCRIPTION OF THE INVENTION The present invention provides for drug delivery compositions that are suitable for the preferred intravenous and intra-arterial administration modes.
The compositions contain the active agent, generally a therapeutic drug compound, dissolved within the components of the composition.
The compositions are characterized by having a relatively small particle size in their diluted forms so that the compositions can be filter sterilized.
The compositions are stable in their diluted forms, and can thus be stored at refrigerated or freezing temperatures without concomitant loss of active agent activity or drug delivery composition performance.
The present invention also provides methods for preparing the drug delivery compositions, and methods for administering the drug delivery compositions to an animal.
The drug delivery compositions of the present invention are specifically adapted for use with active agents, referred to herein also as "drugs.
" The active agents suitable for use in this invention are either lipophilic or amphipathic.
Lipophilic active agents are those materials that have an octanol:water partition coefficient (at room temperature, generally about 23.
degree.
C.
) of greater than 10:1, more preferably greater than 50:1, and even more preferably greater than 100:1.
Examples include steroids, benzodiazepines, such as diazepam, carmustine (BCNU), paclitaxel (available as Taxol.
RTM.
from Bristol-Myers Squibb Oncology), and the like.
Amphipathic materials may not be soluble in octanol or water to any significant extent.
If they are somewhat water soluble, their solubility should be low enough that the volume of aqueous buffer needed to administer an efficacious amount of drug intravenously should be greater than about 1 mL/Kg body weight, or about 1 00 mL for a 70 Kg adult human.
Amphipathic materials useful in the present invention are soluble in polar organic solvents such as chloroform, ethylacetate, C.
sub.
1-3 alcohols, or dimethyl formamide (DMF), and have a relative solubility in any one of these solvents compared to water of at least 5:1, preferably at least 10:1, and more preferably at least 50:1
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Nonmetallic Processes 
