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US4168303A Expired / Lapsed US ⏱️ 0.0 years remaining

Lyophilized native gamma globulin preparation for intravenous administration

Assignee: Tanabe Pharma Corp
•
Filing: 1978-06-07
•
Granted: 1979-09-18
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Expires: 1998-06-07
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Abstract

Abstract Freeze-drying of an aqueous solution of human native gamma globulin having an anticomplementary activity of 20 (C'H50) or less in the presence of 0.06 to 0.26 part by weight of a neutral inorganic salt for 1 part by weight of the gamma globulin gives an immunoactive lyophilized native gamma globulin preparation which has undergone neither increase in anticomplementary activity nor deterioration in antibody activity during the freeze-drying and is safe for use in intravenous administration.

Inventors

  • 👤 Masayuki Nishida
  • 👤 Sadao Yabushita
  • 👤 Shigeru Fujita
  • 👤 Toshiyuki Saki

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-11-05 05:48
CPC Classifications
C; C07; C07K; C07K16/00; C07K16/06; Y; Y10; Y10S; Y10S530/00; Y10S530/827; Y10S530/829; Y10S530/83; Y10S530/831

Claims Analysis

Total Claims: 10
Claim 1
Independent Claim 51 words
A lyophilized native gamma globulin preparation for intravenous administration consisting essentially of a human native gamma globulin which has undergone no modification having an anticomplementary activity of 20 (C'H50) or less and 0.06 to 0.26 (inclusive) part by weight of sodium chloride for 1 part by weight of the gamma globulin.
Claim 2
Dependent Claim 51 words
A lyophilized native gamma globulin preparation for intravenous administration consisting essentially of a human native gamma globulin which has undergone no modification having an anticomplementary activity of 20 (C'H50) or less and 0.06 to 0.26 (inclusive) part by weight of sodium chloride for 1 part by weight of the gamma globulin.
Claim 3
Dependent Claim 35 words
The lyophilized native gamma globulin preparation for intravenous administration according to claim 1, wherein 0 to 0.3 part by weight of human serum albumin is incorporated for 1 part by weight of the gamma globulin.
Claim 4
Dependent Claim 36 words
The lyophilized native gamma globulin preparation for intravenous administration according to claim 1 or 2, wherein 0 to 0.5 part by weight of a diluent is incorporated for 1 part by weight of the gamma globulin.
Claim 5
Dependent Claim 18 words
The lyophilized native gamma globulin preparation for intravenous administration according to claim 3, wherein the diluent is mannitol.
Claim 6
Dependent Claim 60 words
A process for producing a lyophilized native gamma globulin preparation for intravenous administration, which comprises freeze-drying an aqueous solution of human native gamma globulin which has undergone no modification having an anticomplementary activity of 20 (C'H50) or less in the presence of 0.06 to 0.26 part by weight of sodium chloride for 1 part by weight of the gamma globulin.
Claim 7
Dependent Claim 60 words
A process for producing a lyophilized native gamma globulin preparation for intravenous administration, which comprises freeze-drying an aqueous solution of human native gamma globulin which has undergone no modification having an anticomplementary activity of 20 (C'H50) or less in the presence of 0.06 to 0.26 part by weight of sodium chloride for 1 part by weight of the gamma globulin.
Claim 8
Dependent Claim 36 words
The process according to claim 5, wherein the freeze drying is carried out in the presence of 0.1 to 0.3 part by weight of human serum albumin for 1 part by weight of the gamma globulin.
Claim 9
Dependent Claim 37 words
The process according to claim 5 or 6, wherein the freeze drying is carried out in the presence of 0 to 0.5 part by weight of a diluent for 1 part by weight of the gamma globulin.
Claim 10
Dependent Claim 11 words
A process according to claim 7, wherein the diluent is mannitol.

References Cited (Backward Citations)

US2793203A Cited
US3966906A Cited
US3466368A Cited
US3903262A Cited
DE2606118A1 Cited
US4027010A Cited
US4021540A Cited
US4087519A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1982-09-17 1983-03-19 1983-09-18 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 1986-09-17 1987-03-19 1987-09-18 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 1990-09-17 1991-03-19 1991-09-18 $7700.00 Window Closed / Lapsed

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