United States Patent:  6,090,368

Assignee:  The Board of Governors for Higher Education, State of Rhode Island and (Providence, RI)

Filed:  March 3, 1998

A pharmaceutical composition of a water soluble drug admixed with an aqueous bioadhesive cellulosic polymer containing microcrystalline particles. When sprayed (via a conventional spray device) into the nose, drug molecules are retained in contact with the nasal membrane. The drug composition comprises ketorolac tromethamine in an aqueous nasal polymeric spray formulation that without the addition of any permeation enhancer will promote drug absorption and provides absolute drug bioavailability greater than 90%.

SUMMARY OF THE INVENTION

The present invention provides a pharmaceutical nasal spray composition containing ketorolac tromethamine that provides a therapeutic blood level comparable to that of its injection. In particular, the present invention alleviates many of the problems associated with the present treatment of pain, especially in the case of migraine headache.

Ketorolac tromethamine is carried in a fluid medium which is especially formulated to transport the drug for intranasal administration. Preferably, ketorolac tromethamine is admixed with polymeric bioadhesives selected from the group consisting of cellulosic materials, polyacrylics, gums, cyclodextrins, chitosans, hyaluronates, albumins and phosphlipids.

Although the preferred embodiment will be described in reference to ketorolac tromethamine, it is believed that other drugs suitable for purposes of the invention including other non-narcotic analgesic and anti-inflammatory drugs as well as other salts/complexes or free acid.

Claim 1 of 3 Claims

1. A pharmaceutical nasal spray consisting of:

an effective amount of ketorolac based analgesic admixed with a phospholipid or a bioadhesive polymer selected from the group consisting of polyacrylics, cellulosics, gums, cyclodextrins, chitosans, hyaluronates and albumins said spray when administered intranasally having a therapeutic blood level compared to that of the same spray when injected.

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