Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1992-05-11
2001-09-04
Peselev, Elli (Department: 1623)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S023000, C514S024000, C514S210030, C514S247000, C514S613000, C524S788000
Reexamination Certificate
active
06284744
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention is directed to the use of hyaluronic acid (“HA” herein), or a water soluble salt thereof such as sodium hyaluronate, in a readily flowable medium, as a carrier for direct introduction of medicaments such as antibiotics to the peritoneal cavity for enhanced and effective healing following surgical trauma. The invention is particularly directed to preventing or minimizing interperitoneal infections. Many mammalian surgical procedures involve invasion of the peritoneal cavity. They occur with attendant introduction of bacteria. The current procedure has been to close the surgical opening following completion of the surgical procedure with contemporaneous or subsequent combatting of bacteria with intravenous antibiotic treatment. Treatment may last for periods ranging from five to seven days. During this period of time, scar tissue or adhesions can develop along with other discomforting effects such as localized pain, obstruction of the bowel and the like.
Sera has been relied on to carry the intravenously introduced antibiotic to the situs of the trauma. Sera does a poor job, however, because bacteria retards sera flow and is present in the incision area in high concentration combatting the efficacy of the antibiotic. It would be more effective, faster and more efficient if the antibiotic could be introduced directly to the peritoneal cavity at the time of surgery or for short periods thereafter. The difficulty, however, is that no vehicle currently is known which would allow direct administration to the peritoneal cavity without attendant almost immediate loss, i.e. within an hour, of the introduced antibiotic through the wall of the cavity by absorption or other means.
SUMMARY OF THE INVENTION
According to the present invention, hyaluronic acid is utilized in solution, in a pharmaceutically acceptable media, typically a sterile, readily flowable isotonic aqueous solution, as a carrier for medicaments, typically antibiotics, to enable direct application within the peritoneal cavity of an effective amount of such antibiotic from a time beginning at surgery and, if necessary, for a longer period of time, to enable localized treatment to combat or inhibit infection. Preferred, however, and most convenient, is to administer the carrier as a single application at the conclusion of the surgical procedure just prior to closing, with the solution applied to the site of the infection and adjacent tissue, with enough solution used so that the intraperitoneal circulation within the cavity, as a consequence of migration, will occur. Thus, direct coating of the surfaces of the peritoneal cavity are assured and less infection and discomfort and more rapid and complete healing will occur.
The hyaluronic acid solution of the instant invention is provided in a sterilized, easily pourable solutions having an equivalent hyaluronic acid concentration of at least about 0.4% by weight based on the weight of the solution of hyaluronic acid, or a water soluble salt thereof, said solution having a viscosity of 25° C. within a range of 500 to 10,000 centipoise, preferably from about 500 to about 6,000 centipoise. The hyaluronic acid, or salt thereof, employed in the invention preferably has a molecular weight of from about 500,000 or less to about 2.5 million or more, preferably from about 1 to about 1.5 million. In the practice of the invention, the hyaluronic acid solution and the medicament is applied topically to the peritoneal cavity to provide an effective amount of medicament to a mammal responsive to the medicament for a period of time beginning at the time of surgery along, if desired, with continuing application for a period of time sufficient to inhibit or prevent infection. It is preferred to administer the solution in a single application, such as by lavage, at the conclusion of the surgical procedure just prior to closing. In practice of the instant invention, the combat of infection is localized to the peritoneal cavity, enhancing control of infection and the speed of healing.
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The Merck Index, 10thEd. M. Windholz et al, Eds. pp. 335, 499 and 1075-1076 (1983).*
O. Boudoris, et al., “Effet synergique due Dextran 70 a 32% et d'un antibiotique dans la prevention des adherences peritoneals”,Journal of Clinical Pharmacology(1992): 160-164.
Dunn, et al., “The Adjuvant Effect of Peritoneal Fluid in Experimental Peritonitis,”Annals of Surgery(1984): 37-43.
Cohn, Z.A. and Morse, S.I., “Interactions Between RabbitPolymorphonuclear Leucocytesand Staphylococci,”Journal of Experimental Medicine110 (1959) : 419-443.
Hirsch, J.G. and Church, A.B., “Studies of Phagocytosis of Group A Streptoccocci byPolymorphonuclear LeucocytesIn Vitro,”The Journal of Experimental Medicine111 (1960) : 309-322.
Jenkin, C. and Benacerraf, J., “In Vitro Studies on the Interaction Between Mouse Peritoneal Macrophages and Strains of Salmonella andEscherichia Coli,”The Journal of Experimental Medicine(1960) : 403-417.
Roberts, R.B., “The Interaction In Vitro Between Group B Meningococci and RabbitPolymorphonuclear Leukocytes,”The Journal of Experimental Medicine(1967) : 795-817.
Howard, et al., “Surgical Infectious Disease” 2nd ed., p. 160, Appleton and Lange, East Norwalk, Conn., 1988.
Gere S. diZerega, et al.;The Peritoneum; cover page (1 page), publisher page (1 page), table of contents (3 pages), pp. 1-25, pp. 26-56, p. 91, pp. 156-158, pp. 158-160, pp. 195-199, pp. 307-308, pp. 308-309, pp. 274-306, pp. 307-369, conclusions pp. 22, 23, 93, 203, 264, 300 and 356, and index pp. 371-378.
Harold Ellis; “The Cause And Prevention of Postoperative Intraperitoneal Adhesions”; (1971); pp. 497-511.
Kathleen Rodgers, et al.; Draft “Reduction of Intraperitoneal Abscess Formation After Administration of Antibiotics In Hyaluronic Acid”; (yet to be published); pp. 1-28.
Christie Parker & Hale LLP
Peselev Elli
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