Claims for Patent: 5,051,408

Summary for Patent: 5,051,408

Title:	Inulin compositions in gamma polymorphic form
Abstract:	A process for preparing gamma inulin comprising the steps of (a) recrystallizing crude inulin from water at a temperature below 37.degree. C. to obtain a suspension, (b) heating the suspension at a temperature of from about 25.degree. to 45.degree. C. for about 1-3 days, (c) further heating the suspension at a temperature of about 40.degree. to 55.degree. C. for about 0.5 to 1.5 hours, and (d) isolating insoluble gamma inulin from the suspension. A composition comprising particles of inulin or an inulin derivative in the gamma polymorphic form is characterized in that the particles have a low rate of solution in aqueous media above 30.degree. C., particularly above 37.degree. C. The composition is effective as the active component of an immunotherapeutic preparation for activation of the alternative pathway of complement, or for antitumor treatment.
Inventor(s):	Cooper; Peter Dodd (Monash, AU)
Assignee:	The Australian National University (Acton, AU)
Application Number:	07/501,752
Patent Claims:	1. A composition comprising particles of inulin, wherein said particles are in the gamma polymorphic form and are virtually insoluble in aqueous media at 37.degree. C. 2. A composition according to claim 1, wherein said inulin has a molecular weight greater than 8,000. 3. A composition according to claim 1, comprising particles of gamma inulin, wherein the gamma inulin has a molecular weight in the range of from about 8,000 to about 16,000 and is virtually insoluble in water at 37.degree. C. 4. A composition according to claim 3, wherein said gamma inulin is in the form of a stable pure suspension of particles <1 .mu.m in diameter. 5. An immunotherapeutic preparation for activation of the alternate pathway of complement (APC) in a human or animal body, which comprises as the active component thereof particles of inulin in the gamma polymorphic form, wherein said particles are virtually insoluble in aqueous media at 37.degree. C.; and a pharmaceutically acceptable diluent or carrier. 6. A preparation according to claim 5, wherein said active component comprises particles of gamma inulin. 7. A preparation according to claim 5, wherein said carrier or diluent is a sterile, aqueous vehicle. 8. A preparation according to claim 7, wherein said aqueous vehicle is an isotonic solution. 9. A preparation according to claim 5 in a form suitable for injection. 10. A preparation according to claim 5 in a form suitable for oral, rectal, vaginal, topical, nasal or ocular administration. 11. A preparation according to claim 5, further comprising a second active component which is an immune modulator. 12. A preparation according to claim 4, wherein said immune modulator is a vaccinating antigen, an antigenic peptide sequence, or an anti-iodiotype immune globulin. 13. A preparation according to claim 11, wherein said immune modulator is an interleukin or an interferon or tumor necrosis factor or other lymphokine, or thymocyte stimulator or other thymus stimulating hormone, a muramyl peptide or other microbial component or whole microbial component or whole microbe, or an endotoxin. 14. A method for the activation of the alternative pathway of complement (APC) in a human or animal body, which comprises administering to the human or animal body an effective amount for said activation of an immunotherapeutic preparation according to claim 5. 15. A method for enhancement of an immune response in a human or animal body to which has been administered an immune modulator which comprises administering to the human or animal body an effective amount for said enhancement of an immunotherapeutic preparation according to claim 5. 16. A method for enhancement of the effect of administration of a vaccinating antigen, an antigenic peptide sequence, or an anti-idiotype immune globulin, in a human or animal body which comprises administering as an adjuvant an effective amount for said enhancement of an immunotherapeutic preparation according to claim 5.

Details for Patent 5,051,408

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	BAYGAM, GAMASTAN S/D	immune globulin (human)	Injection	101134	01/11/1944		2008-09-24
Grifols Therapeutics Llc	GAMMAKED (KENDRION), GAMUNEX-C	immune globulin injection (human) 10% caprylate/chromatography purified	Injection	125046	08/27/2003		2008-09-24
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	05/21/2004		2008-09-24
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	03/26/2007		2008-09-24
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAGAM	immune globulin intravenous (human)	Injection	125062	07/11/2014		2008-09-24