Claims for Patent: 10,568,957

Summary for Patent: 10,568,957

Title:	Rotavirus vaccine compositions and process for preparing the same
Abstract:	Invention provides novel rotavirus vaccine compositions comprising rotavirus antigens, stabilizers and buffers. The buffers in the invention are pre-mixed in the rotavirus vaccine compositions to neutralize the high acidic pH of the stomach without requiring separate administration of an antacid before vaccine administration. Vaccine compositions with buffers of the invention are stable liquid rotavirus vaccine formulations for oral administration.
Inventor(s):	Vadrevu; Krishna Mohan (Hyderabad, IN), Prasad; Sai Devarajulu (Hyderabad, IN)
Assignee:	Bharat Biotech International Ltd. (Hyderabad, IN)
Application Number:	14/396,691
Patent Claims:	1. A liquid vaccine formulation comprising: a rotavirus antigen of strain 116E; and a combination buffer system, wherein the combination buffer system is a mixed buffer system comprising ammonium acetate, ammonium bicarbonate and di-ammonium orthophosphate buffer. 2. The vaccine formulation of claim 1, wherein the mixed buffer is present at a concentration range of 0.01 M to 2 M. 3. The vaccine formulation of claim 2, wherein the mixed buffer is present at a concentration of 0.5 M. 4. The vaccine formulation of claim 1, wherein the dose volume is 1 ml, which is sufficient to neutralize the acidity of the gastric environment, wherein said vaccine formulation is capable of eliciting protective immune response against infections caused by rotavirus infections. 5. The vaccine formulation of claim 1, wherein the formulation is stable for at least two years at 2.degree.-8.degree. C. 6. The vaccine formulation of claim 1, wherein the formulation is stable for at least 6 months at 25.degree. C. 7. The vaccine formulation of claim 1, further comprising a sugar. 8. The vaccine formulation of claim 7, wherein the sugar comprises from 20% to 75% sucrose. 9. The vaccine formulation of claim 7, wherein the sugar comprises up to 10% lactose. 10. The vaccine formulation of claim 7, wherein the sugar comprises up to 1% trehalose. 11. The vaccine formulation of claim 1, further comprising an albumin. 12. The vaccine formulation of claim 7, wherein the albumin comprises human serum albumin. 13. The vaccine formulation of claim 7, wherein the albumin comprises up to 10% lactalbumin hydrolysate. 14. A liquid vaccine formulation comprising: a rotavirus antigen; and a buffer comprising ammonium acetate, ammonium bicarbonate, and di-ammonium orthophosphate buffer. 15. The vaccine formulation of claim 14, wherein the rotavirus antigen comprises an antigen of rotavirus strain 116E. 16. The vaccine formulation of claim 14, wherein the buffer comprises a concentration of from 0.01 M to 2 M. 17. The vaccine formulation of claim 14, wherein the buffer comprises a concentration of about 0.5M. 18. The vaccine formulation of claim 14, which has a pH from 7 to 8.5. 19. The vaccine formulation of claim 14, which is stable for at least two years at 2.degree.-8.degree. C. 20. The vaccine formulation of claim 14, which is stable for at least 6 months at 25.degree. C. 21. A liquid vaccine formulation comprising: a rotavirus antigen; and a magnesium hydroxide carbonate buffer system, wherein the vaccine has a pH from 10 to 10.5. 22. The vaccine formulation of claim 21, wherein the rotavirus antigen comprises an antigen of rotavirus strain 116E. 23. The vaccine formulation of claim 21, wherein the buffer system comprises magnesium hydroxide carbonate dihydrate at a concentration of from 0.01 M to 0.5 M. 24. The vaccine formulation of claim 21, wherein the buffer system comprises magnesium hydroxide carbonate dihydrate at a concentration of about 0.1M. 25. The vaccine formulation of claim 21, which is stable for at least two years at 2.degree.-8.degree. C. 26. The vaccine formulation of claim 21, which is stable for at least 6 months at 25.degree. C. 27. The vaccine formulation of claim 1, which comprises a dose volume of between 0.5 ml to 2.0 ml. 28. The vaccine formulation of claim 27, wherein the dose volume is 1.0 ml. 29. The vaccine formulation of claim 27, wherein the dose volume is 2.0 ml. 30. The vaccine formulation of claim 1, which comprises a dose volume sufficient to neutralize the acidity of the gastric environment. 31. The vaccine formulation of claim 1, which is capable of eliciting a protective immune response against infections caused by rotavirus. 32. The vaccine formulation of claim 14, which comprises a dose volume of between 0.5 ml to 2.0 ml. 33. The vaccine formulation of claim 32, wherein the dose volume is 1.0 ml. 34. The vaccine formulation of claim 32, wherein the dose volume is 2.0 ml. 35. The vaccine formulation of claim 14, which comprises a dose volume sufficient to neutralize the acidity of the gastric environment. 36. The vaccine formulation of claim 14, which is capable of eliciting a protective immune response against infections caused by rotavirus. 37. The vaccine formulation of claim 21, which comprises a dose volume of between 0.5 ml to 2.0 ml. 38. The vaccine formulation of claim 37, wherein the dose volume is 1.0 ml. 39. The vaccine formulation of claim 37, wherein the dose volume is 2.0 ml. 40. The vaccine formulation of claim 21, which comprises a dose volume sufficient to neutralize the acidity of the gastric environment. 41. The vaccine formulation of claim 21, which is capable of eliciting a protective immune response against infections caused by rotavirus.

Details for Patent 10,568,957

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	October 21, 1942		2033-04-23
Takeda Pharmaceuticals U.s.a., Inc.	BUMINATE, FLEXBUMIN	albumin (human)	Injection	101452	March 03, 1954		2033-04-23
Central Laboratory Of The Netherlands Red Cross Blood Transfusion Service	N/A	albumin (human)	Injection	101993	September 07, 1979		2033-04-23
Csl Behring Ag	ALBURX	albumin (human)	Injection	102366	July 23, 1976		2033-04-23
Grifols Biologicals Llc	ALBUTEIN	albumin (human)	Injection	102478	August 15, 1978		2033-04-23