TH73258B - A liquid interferon formulation stabilized by HSA free. - Google Patents

Abstract

DC60 (23/07/47) describes a stable HSA-free liquid pharmaceutical mixture composed of interferon (IFN) compounds whose formulations are solutions containing buffers, surfactants. skin isotonics and antioxidants. is recombinant IFN-Human Beta Described a pharmaceutical composition of a stabilized HSA-free liquid containing interferon (IFN), in which the formulation is a solution containing inclusions, buffers, surfactants. isotonics and antioxidants. Preferably, ether pheron is recombinant. IFN-Human Beta Drug Patent

Claims (3)

Disclaimer (all) which will not appear on the announcement page: Edit 10/10/2018 Page 1 of 3 pages Disclaimer 1. Pharmaceutical components that are HSA-free stabilized liquids that are composed of Including with Interferon-Beta (interferon-beta) (IFN-beta), where the above constituents are solvents containing buffers, surfactants, isotonic substances. And anti-oxidation substances Where the anti-oxidation agent is methionine ------------------------------------ -------------------------------------------------- -------------- 1. Pharmaceutical components that are HSA-free stabilized liquids that form Combined with interferon-beta (IFN-beta), where the constituents are buffer-containing solvents, surfactants, isotonic substances. And anti-oxidation substances Where the anti-oxidant is methionine 2. Mixture according to claim 1 where such interferon is IFN-Beta 3. Mixture of any preceding claim, where IFN-Beta is a human IFN-beta compound 4. Mixture of any previous claim. Where the buffer sounds There are sufficient amounts to maintain the pH of the mixture. Within plus or minus 0.5 units of the specified pH, where the nominal pH is approximately 3.0 to approximately 5.0 5. Mixture of any previous claim, where such pH is 3.5 plus or minus 0.2 6. Mixture of Any preceding claim where such pH is 4.5 plus or minus 0.2 7. Any mix of preceding claim. Where the buffer sounds It is available in concentrations of approximately 5.mM to 500 mM. 8. Mixture of any precedent claim. Where the buffer sounds It is said to exist at a concentration of approximately 10 mM. 9. Mixture of any previous claim. Where is the buffer? Cetate Buffer 1 0. Mixture of any previous claim. Where isotonic substances The hit is mannitol 1. 1. Mixture of any previous claim. Where isotonic substances The hit is there. Concentrate approximately 0.5 mg / ml to approximately 500 mg / ml 1 2. Mixture of any previous claim. Where isotonic substances The hit is there. In a concentration of approximately 55 mg / ml 1 3. Mixture of any previous claim Where the surfactant Such skin can be selected from Pluronic R F77, Pluronic F87, Pluronic F88 and Pluronic F68. 1 4. Mixture of any previous claim. Where the surfactant The skin is Pluronic F68 1. 5. Mixture of any previous claim. Where the surfactant Such skin is available at a concentration of approximately 0.01 mg / ml to approximately 10 mg / ml 1 6. Mixture of any previous claim. Where the surfactant Such skin is present at a concentration of approximately 1mg / ml. 1 7. Mixture of any previous claim. Where the antagonists That oxidation is methionine 1. 8. Mixture of any previous claim. Where the antagonists Such oxidation exists in Concentrate approximately 0.01 to approximately 5.0 mg / ml 1 9. Mixture of any previous claim. Where the antagonists Such oxidation exists in Concentrate approximately 0.1 mg / ml 2 0. Mixture of any previous claim. Where Interphia Such ron is available in a concentration of approximately 10 micrograms / ml. Up to approximately 800 micrograms / ml 2 1. Mixture of any previous claim. Where Interphia It is available at a concentration of approximately 44 88 or 264 mg / ml. 2. 2. Mixture of any previous claim. Where the mixture is That is, a solution of aquarius 2 3. Mixture of any preceding claim That also includes Antibacterial agent 2 4. Mixture of any preceding claim Where the substance stops The bacterium is benzyl alcohol. 2. 5. Mixture of any previous claim. Where the substance stops Such bacteria exist at Concentration of approximately 0.1% to approximately 2.0% 2 6. Mixture of any previous claim. Where the substance stops Such bacteria exist at 0.2 or 0.3% concentration. 2 7. Method for the preparation of HSA-free stabilized liquid pharmaceutical mixtures pursuant to claim 1-26, whereby the method consists of the calculated number additions of the. Surfactant Anti-oxidant and isotonic substances down Buffered solution and Then add the interferon (IFN) 2 8. The container is tightly sealed in aseptic and suitable condition. For preservation before use Contains pharmaceutical ingredients The liquid under any claim from Article 1 to 26 2. 9. Vessel of claim 28, where such container is Prefilled syringe For single dose entry 3 0. Container of claim 28, where such container is Vial 3. 1. Container of claim 28, where the container is Automatic injection cartridge 3 2. Container of claim 30 or 31, where the container as Said for the entry into the design Single or multiple dose 3 3.Pre-Dosage Kit for Multi-Dose Mixture Pharmaceutical according to any of the Claims from 23 to 26, where the prefabricated kits are included with the first container of the chemical mixture Pharmaceuticals according to any of the claims 1 to 22, and the second cartridge containing a solution of Bacteria inhibitors