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Suspension formulation of interferon

a technology of suspension and interferon, which is applied in the direction of peptide/protein ingredients, implants, prostheses, etc., can solve the problems of difficult design of protein formulations that are stable at elevated temperature for a long time, and the patient is not easily tampered with by the patient, etc., and achieves the effects of reducing the risk of infection, and improving the safety of patients

Inactive Publication Date: 2006-11-23
INTARCIA THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The invention is about a new way to make interferon, which is a medication used to treat certain disorders. The new way involves using a special vehicle made of polymer and solvent that has viscous fluid properties. The interferon is mixed into this vehicle and is stabilized using certain chemicals. The result is a suspension formulation that is stable for at least three months when stored under certain conditions. The invention also includes a method to treat interferon-responsive disorders by giving the suspension formulation to patients.

Problems solved by technology

The injectable form of IFN-ω is currently in Phase II clinical studies for Hepatitis C. This injectable form is solution-based and is not formulated for sustained delivery.
Implantable drug delivery devices once inserted in the patient are not easily tampered with by the patient.
Generally speaking, protein formulations that are stable at elevated temperature for a long duration, e.g., weeks, months, or a year, are difficult to design.
Unfortunately, proteins are typically only marginally stable in aqueous formulations for a long duration.
However, there is the challenge of delivering particle formulations from an implantable drug delivery device at a controlled flow rate.

Method used

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Examples

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example 1

[0045] A bulk solution of IFN-ω was obtained as a frozen solution having a concentration of approximately 5 mg / ml. The IFN-ω solution was dialyzed against 25 mM citrate solution (pH 6.0). Sucrose and methionine in citrate solution were added to the dialyzed IFN-ω to make final IFN-ω:sucrose:methionine:citrate in a ratio of 1:2:1:1.77. The solution was spray dried as described above. The average particle size was 4-5 μm. The spray solution and spray dried particles were analyzed using RP-HPLC. The first two bars of FIG. 3 show percent main peak for the spray solution and spray dried particles of this example. Percent main peak refers to the fraction of IFN-ω detected that is in a monomeric form and does not appear to be chemically degraded in any form

example 2

[0046] A bulk solution of IFN-ω was obtained as a frozen solution having a concentration of approximately 5 mg / ml. The IFN-ω solution was dialyzed against 25 mM citrate solution (pH 6.0). Sucrose and methionine in citrate solution were added to the dialyzed IFN-ω to make final IFN-ω:sucrose:methionine:citrate in a ratio of 1:2:1:2.15. The solution was spray dried as described above. The average particle size was 4-5 μm. The spray solution and spray dried particles were analyzed using RP-HPLC. The second two bars of FIG. 3 show percent main peak for the spray solution and spray dried particles of this example.

example 3

[0047] A bulk solution of IFN-ω was obtained as a frozen solution having a concentration of approximately 5 mg / ml. The IFN-ω solution was dialyzed against 25 mM citrate solution (pH 6.0). Sucrose and methionine in citrate solution were added to the dialyzed IFN-ω to make final IFN-ω:sucrose:methionine:citrate in a ratio of 1:2:1:2.2 at IFN-ω concentration of 3.3 mg / mL. The solution was spray dried as described above. The spray dried particles were evaluated using RP-HPLC and SEC at various timepoints during storage. The results are shown in Tables 3 and 4 below.

TABLE 3SECRP-HPLCProteinMonomerMain PeakContentTemperatureTime(Standard(Standard(Standard(° C.)(months)Deviation)Deviation)Deviation)A (n = 15)0100.00 (0.01) 96.26 (0.39)16.11 (0.21)B (n = 3)40199.85 (0.00)96.99 (0.19)16.47 (0.07)C (n = 3)40299.90 (0.01)95.85 (0.01)16.16 (0.22)D (n = 3)40399.93 (0.02)96.45 (0.35)16.51 (0.22)E (n = 3)40699.88 (0.00)95.24 (0.12)17.01 (0.13)F (n = 3)25699.93 (0.01)96.20 (0.10)17.14 (0.14)G (n ...

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Abstract

A suspension formulation of interferon includes a non-aqueous, single-phase vehicle including at least one polymer and at least one solvent, the vehicle exhibiting viscous fluid characteristics, and an interferon contained in a particle formulation dispersed in the vehicle. The particle formulation includes a stabilizing component comprising one or more stabilizers selected from the group consisting of carbohydrates, antioxidants, and amino acids. The suspension formulation is characterized in that less than 10% of the interferon degrades over 3 months under an accelerated storage condition.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority from U.S. Provisional Application No. 60 / 650,226, filed Feb. 3, 2005, the content of which is incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] The invention relates to delivery of interferon at controlled rates over extended periods of time. [0003] Interferons are a group of glycoprotein cytokines produced by cells in response to various stimuli, such as exposure to virus, bacterium, parasite, or other antigen. Interferons have antiviral, immunomodulatory, and antiproliferative activities. Interferons are classified as Type I or Type II. Interferons classified as Type I bind to a common receptor called the Interferon Type I or α-β receptor and are produced by leukocytes, fibroblasts, or lymphoblasts in response to virus or interferon inducers. Interferon Type I includes interferon alpha (IFN-α), interferon beta (IFN-β), and interferon omega (IFN-ω), but IFN-ω has limited homology to hu...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/21A61K9/14
CPCA61F2250/0068A61K9/0004A61K9/0019A61K9/0024A61K38/21A61K9/1617A61K9/1623A61K9/1694A61K9/19A61K9/10A61P31/12A61P37/02A61P43/00
Inventor AYER, RUPAL A.DENNIS, PAULADESJARDIN, MICHAEL A.LAM, STANLIU, KUIMATSUURA, JAMES E.NARAYANAN, LATHAROHLOFF, CATHERINE M.ZAMORA, PAULINE C.
Owner INTARCIA THERAPEUTICS INC
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