Vaccine stabilizer containing L-glutamic acid and L-arginine

• US 4,337,242 A
• Filed: 03/10/1981
• Issued: 06/29/1982
• Est. Priority Date: 02/05/1980
• Status: Expired due to Term

• Current Assignee: Merck & Co., Inc.
• Original Assignee: Merck & Co., Inc.
• Inventors: Markus, Henry Z., McAleer, William J.
• Primary Examiner(s): Rose, Shep K.
• Application Number:
  US06/242,195
• Time in Patent Office: 476 Days
• Field of Search: 424/89, 435/235-239
• US Class Current: 424/202.1
• CPC Class Codes: A61K 2039/525 Virus
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 47/183 Amino acids, e.g. glycine, EDTA or aspartame
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/42 Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein oligopeptides having up to five amino acids A61K47/183; polyamino acids A61K47/34
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• CPC Class Codes: C12N 2760/18434 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: Y02A 50/30 Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

An improved stabilized liquid live viral vaccine contains a live virus, partially hydrolyzed gelatin, a monosaccharide or disaccharide, a cell culture medium, L-glutamic acid, L-arginine and sufficient physiologically acceptable acidic buffer to maintain the pH at from about 6.0 to about 6.5.

Claims

1. A liquid vaccine comprising an inactivated or attenuated virus and a stabilizer consisting essentially of on a parts by weight basis from about 1.5 to about 2.1 parts partially hydrolyzed gelatin having a molecular weight of about 3,000, from about 7.0 to about 13.0 parts of a monosaccharide or disaccharide from about 0.4 to about 0.6 parts of an in vitro cell culture medium, from about 0.35 to about 0.7 part L-glutamic acid, from about 0.75 to about 1.3 parts L-arginine, and an amount of a physiologically acceptable acidic buffer effective to maintain the pH to from about 6.0 to about 6.5.

2. A vaccine according to claim 1 wherein the disaccharide is sucrose.

3. A vaccine according to claim 1 wherein the buffer is phosphate buffer.

4. A vaccine according to claim 1 wherein the virus is measles, mumps, rubella, varicella, polio, hepatitis, herpes simplex type 1, herpes simplex type 2, or combinations thereof.

5. A vaccine according to claim 1 wherein the stabilizer consists essentially of on a parts by weight basis of about 1.8 parts partially hydrolyzed gelatin having a molecular weight of about 3,000, about 10.0 parts of a monosaccharide or disaccharide, about 0.5 part of an in vitro cell culture medium, about 0.5 part L-glutamic acid, about 1.0 part L-arginine, and an amount of a physiologically acceptable acidic buffer effective to adjust the pH to from about 6.0 to about 6.5.

6. A vaccine according to claim 5 wherein the disaccharide is sucrose.