Patent
Production of a viable, storable worm egg suspension
| العنوان: | Production of a viable, storable worm egg suspension |
|---|---|
| Patent Number: | 9,017,700 |
| تاريخ النشر: | April 28, 2015 |
| Appl. No: | 12/594074 |
| Application Filed: | March 31, 2008 |
| مستخلص: | The present application describes a novel, advantageous purification method which guarantees the embryonation capability and the viability of a worm egg suspension. The T. suis worm eggs are first treated in a non-embryonated condition in a sulfuric acid solution at about =ph 2. Bacteria and viruses are thereby killed successfully. The germination number of yeasts and fungi is reduced. In a second step, the pH-value is increased and an orally tolerated preservative is added. Yeasts and fungi are thereby killed successfully. The suspension medium used in the second purification step can then be used as a culture medium for additional production (embryonation) and storage. |
| Inventors: | Wilhelm, Rudolf (Bischweier, DE); Roepstorff, Allan Kund (Rodovre, DK); Kapel, Christian Moliin Outzen (Rungstedt Kyst, DK) |
| Assignees: | Dr. Falk Pharma GmbH (Freiburg, DE) |
| Claim: | 1. A process for the preparation of a non-pathogenic pharmaceutical preparation of a storable suspension of viable parasitic Trichuris suis eggs for oral administration comprising: obtaining viable eggs from Trichuris suis; subjecting said eggs to sulphuric acid treatment at a pH of ≦2 for a period of 2 to 8 hours; adjusting the pH to ≧4 by adding a suitable base; and adding a pharmacologically acceptable preservative, wherein after the ingestion of the suspension of eggs by a human, a sufficient number of helminths develop which result in a stimulation of regulatory human T-cells. |
| Claim: | 2. The process as claimed in claim 1 , characterized in that the preservative is selected from the group consisting of sorbic acid, benzoic acid, salts of these acids, p-benzoic acid esters, propylene glycol, and a combination of these preservatives. |
| Claim: | 3. The process as claimed in claim 2 , characterized in that one or more preservatives selected from the group consisting of sorbic acid at a concentration of from 0.01 to 0.2%, benzoic acid at a concentration of from 0.1 to 0.3%, p-hydroxy-benzoic acid esters at a concentration of from 0.02 to 0.3% by weight, propylene glycol at a concentration of from 5 to 20% by weight and a combination of the abovementioned preservatives in the abovementioned concentration ranges is added. |
| Claim: | 4. The process as claimed in claim 1 , characterized in that further pharmaceutically acceptable additives are added to the suspension. |
| Claim: | 5. The process as claimed in claim 1 , characterized in that the acid treatment is brought about by addition of sulfuric acid. |
| Current U.S. Class: | 4242/691 |
| Patent References Cited: | 6764838 July 2004 Weinstock et al. 2005/0118655 June 2005 Weinstock et al. 1 530 972 May 2005 WO 2007/076868 July 2007 |
| Other References: | Ichhpujani et al (Medical Parasitology 3rd edition, Jaypee Brother Medical Publishers Ltd, India. Revised 2005). cited by examiner PCT International Preliminary Report on Patentability for International Patent Application PCT/EP2008/002542 mailed Nov. 19, 2009—English translation. cited by applicant Boes, J., et al., “Embryonation and infectivity of Ascaris suum eggs isolated from worms expelled by pigs treated with albendazole, pyrantel pamoate, ivermectin or piperazine dihydrochloride”, Veterinary Parasitology, Feb. 28, 1998, pp. 181-190, vol. 75, No. 2-3. cited by applicant Elliott, D. et al., “Helminthic parasite exposure protects mice from colitis”, Digestive and Liver Disease, May 2000, p. A26, vol. 32, Supplement 1. cited by applicant Hunter, M. M., et al., “Review article: Helminths as therapeutic agents for inflamatory bowel disease”, Alimentary Pharmacology & Therapeutics, Jan. 15, 2004, pp. 167-177, vol. 1, No. 2, Blackwell Scientific Publications, Ltd., Cambridge, Great Britain. cited by applicant Reddy, A., et al., “The use of Trichuris suis and other helminth therapies to treat Crohn's disease”, Parasitology Research, Apr. 2007, vol. 100, No. 5, pp. 921-927, Springer Verlag, Berlin, Germany. cited by applicant Summers. Robert W., et al., “Trichuris suis seems to be safe and possibly effective in treatment of inflammatory bowel disease”. American Journal of Gastroenterology, Sep. 2003, vol. 98, No. 9, pp. 2034-2041. cited by applicant Summers, Robert W., et al., “Trichuris suis therapy in Chrohn's disease”, GUT, Jan. 2005, vol. 54, No. 1, pp. 87-90. cited by applicant PCT Search Report and Written Opinion for International Patent Application PCT/EP2008/002542 mailed Mar. 7, 2008. cited by applicant |
| Primary Examiner: | Graser, Jennifer |
| Attorney, Agent or Firm: | Curatolo Sidoti Co., LPA Curatolo, Joseph G. Sidoti, Salvatore A. |
| رقم الانضمام: | edspgr.09017700 |
| قاعدة البيانات: | USPTO Patent Grants |
| الوصف غير متاح. |