Human interferon beta API Manufacturers

General Description:

Human interferon beta, identified by CAS number 74899-71-1, is a notable compound with significant therapeutic applications. Human interferon beta is a polypeptide used in the management of relapsing forms of Multiple Sclerosis (MS), and was initially approved by the FDA in 1992. Multiple Sclerosis is a devastating neurodegenerative disease that is usually progressive and significantly debilitating with a profound impact on the quality of life. Interferon beta is currently being studied as a possible treatment for COVID-19, which results from infection with the novel 2019 SARS-CoV-2 virus. Interferon-beta has been used in the past in clinical studies with other coronaviruses due to its demonstrated activity against the virus causing Middle Eastern Respiratory Syndrome (MERS). It is therefore a potential drug candidate for SARS-CoV-2 based on viral genetic similarity.

Indications:

This drug is primarily indicated for: This drug is indicated to treat relapsing forms of Multiple Sclerosis (MS) in adults, which includes clinically isolated syndrome, relapsing-remitting disease, as well as active secondary progressive disease. Its use in specific medical scenarios underscores its importance in the therapeutic landscape.

Metabolism:

Human interferon beta undergoes metabolic processing primarily in: Data regarding the metabolism of beta interferon is not readily available in the literature. This metabolic pathway ensures efficient processing of the drug, helping to minimize potential toxicity and side effects.

Absorption:

The absorption characteristics of Human interferon beta are crucial for its therapeutic efficacy: Beta interferon has a bioavailability of about 30% after subcutaneous or intramuscular administration, demonstrating peak serum concentrations within several hours of a dose. Peak interferon beta-1b concentrations are achieved between 1-8 hours post-dose, measuring about 40 IU/mL. After injection, it is absorbed mainly by the lymphatic route. Prescribing information for interferon beta-1b indicates a bioavailability of 50%. Concentrations of beta interferon are detectable in the circulation 1-2 to days after administration. The drug's ability to rapidly penetrate into cells ensures quick onset of action.

Half-life:

The half-life of Human interferon beta is an important consideration for its dosing schedule: The mean terminal elimination half-life of interferon-beta varies from 8 minutes to about 4 hours. This determines the duration of action and helps in formulating effective dosing regimens.

Route of Elimination:

The elimination of Human interferon beta from the body primarily occurs through: Beta interferon is excreted by hepatic and renal pathways, with renal pathways accountable for about 40% of its clearance. Understanding this pathway is essential for assessing potential drug accumulation and toxicity risks.

Volume of Distribution:

Human interferon beta is distributed throughout the body with a volume of distribution of: The average state volume of distribution for beta interferon is 0.25 L/kg to 2.88 L/kg. Another reference mentions a volume of distribution of 120 L. Beta interferon is distributed throughout the body after extravasation across the vascular wall into the tissue after injection. It likely does not cross the blood-brain barrier, and it is unclear whether beta interferon crosses the placenta. This metric indicates how extensively the drug permeates into body tissues.

Clearance:

The clearance rate of Human interferon beta is a critical factor in determining its safe and effective dosage: Average serum clearance in a pharmacokinetic study of beta-interferon 1b ranged from 9.4 mL/min•kg-1 to 28.9 mL/min•kg-1. Another study revealed a clearance ranging between 0.3 to 1.4 L/h/kg. It reflects the efficiency with which the drug is removed from the systemic circulation.

Pharmacodynamics:

Human interferon beta exerts its therapeutic effects through: Interferon-beta has antiviral and immunomodulatory effects. It reduces demyelination, the main component of Multiple Sclerosis pathophysiology, reducing the clinical frequency of MS attacks and slowing disease progression. In vitro studies have shown that beta interferon reduces the replication of certain coronaviruses in lung tissue. Retrospective studies using combinations of and beta interferon showed improved survival against MERS-CoV, the virus that causes Middle Eastern Respiratory Syndrome (MERS). The drug's ability to modulate various physiological processes underscores its efficacy in treating specific conditions.

Mechanism of Action:

Human interferon beta functions by: Part of the pathophysiology of MS is immune cell activation in addition to degradation of the blood–brain barrier (BBB), resulting in both neural demyelination and axon injury. Immunomodulating drugs such as interferon-beta decrease the inflammation that results in demyelination of nerves. Binding of interferon-beta to type 1 interferon receptors induces a series of beneficial transcriptional JAK/STAT pathway changes. This decreases antigen presentation as well as the proliferation of inflammatory T-cells, reducing the inflammation associated with MS. It also changes the expression of cytokine and matrix metalloproteinase (MMP). This mechanism highlights the drug's role in inhibiting or promoting specific biological pathways, contributing to its therapeutic effects.

Toxicity:

Classification:

Human interferon beta belongs to the None, classified under the direct parent group Peptides. This compound is a part of the Organic Compounds, falling under the Organic Acids superclass, and categorized within the Carboxylic Acids and Derivatives class, specifically within the Amino Acids, Peptides, and Analogues subclass.

Categories:

Human interferon beta is categorized under the following therapeutic classes: Amino Acids, Peptides, and Proteins, Anti-Infective Agents, Biological Factors, Experimental Unapproved Treatments for COVID-19, Immunologic Factors, Intercellular Signaling Peptides and Proteins, Interferon Type I, Interferons, Peptides, Proteins. These classifications highlight the drug's diverse therapeutic applications and its importance in treating various conditions.

Experimental Properties:

Further physical and chemical characteristics of Human interferon beta include:

• Hydrophobicity: -0.427
• Isoelectric Point: 9.02
• Molecular Weight: 40036.0