Biologically stable interferon compositions comprising thimerosal

• US 4,847,079 A
• Filed: 07/27/1987
• Issued: 07/11/1989
• Est. Priority Date: 07/29/1985
• Status: Expired due to Fees

• Current Assignee: Schering Corporation (Merck & Co., Inc.)
• Original Assignee: Schering Corporation (Merck & Co., Inc.)
• Inventors: Kwan, Henry K. H.
• Primary Examiner(s): Hazel, Blondel
• Application Number:
  US07/077,957
• Time in Patent Office: 715 Days
• Field of Search: 424/85.4, 424/85.5, 424/85.6, 424/85.7
• US Class Current: 424/85.7
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/195 having an amino group
• CPC Class Codes: A61K 31/305 Mercury compounds
• CPC Class Codes: A61K 38/212 IFN-alpha
• CPC Class Codes: A61K 38/38 Albumins
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• 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

Abstract

Stable pharmaceutical compositions comprising interferon and thimerosal which are substantially resistant to microorganism contamination and growth are disclosed.

Claims

1. A biologically and physically stable pharmaceutical solution substantially resistant to microorganism contamination and growth comprising 2×

10³ to 5×

10⁸ I.U. alpha interferon, 0-2 mg human albumin, 5-25 mg glycine, 0.005 to 1.0 mg thimerosal, and a compatible buffer system to maintain the pH at 6.5 to 8.0 per milliliter of solution.

2. A pharmaceutical solution of claim 1 comprising 1×

10⁴ to 2×

10⁸ I.U. alpha interferon/ml.

3. A pharmaceutical solution of claim 2 wherein the pH is maintained at 7.0 to 7.4.

4. A pharmaceutical solution of claim 3 comprising 1 mg human albumin/ml and 20 mg glycine/ml.

5. A pharmaceutical solution of claim 4 comprising 0.02 to 0.05 mg thimerosal/ml.

6. A pharmaceutical solution of claim 5 wherein the alpha interferon is alpha-2 interferon.

7. A biologically stable lyophilized pharmaceutical composition substantially resistant to microorganism contamination and growth, for reconstitution with water, comprising 2×

10³ to 5×

10⁸ I.U. alpha interferon, 0-2 mg human albumin, 5-25 mg glycine, 0.005 to 1.0 mg thimerosal and a compatible buffer system to maintain the pH of the reconstituted solution at 6.5 to 8.0 for each milliliter of water that will be added later during reconstitution.

8. A pharmaceutical composition of claim 7 comprising 1×

10⁴ to 2×

10⁸ I.U. alpha interferon per milliliter of water to be added later during reconstitution.

9. A pharmaceutical composition of claim 8 wherein the buffer is chosen so that the pH of the reconstituted solution is maintained at pH 7.0 to 7.4.

10. A pharmaceutical composition of claim 9 wherein 1 mg human albumin and 20 mg glycine are added per milliliter of water to be added later during reconstitution.

11. A pharmaceutical composition of claim 10 wherein 0.02 to 0.05 mg thimerosal is added per milliliter of water to be added later during reconstitution.

12. A pharmaceutical composition of claim 11 wherein the alpha interferon is alpha-2 interferon.