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Capsid assembly modulator solid formulation

A solid, solid dispersion technology that can be used in pill delivery, antiviral agents, drug combinations, etc., to solve problems such as reduced therapeutic effectiveness, inability to adhere to dosage regimens, and emergence of viral resistance

Inactive Publication Date: 2021-10-26
JANSSEN SCI IRELAND UC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] High pill burden increases the risk of patients not taking their full dose and thus failing to adhere to the prescribed dosage regimen
As such, the effectiveness of treatment is reduced, which also leads to the emergence of viral resistance
Increased problems associated with this pill burden, where patients must take a combination or combination of different antiviral agents

Method used

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  • Capsid assembly modulator solid formulation
  • Capsid assembly modulator solid formulation
  • Capsid assembly modulator solid formulation

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0103] Example 1: New formulations according to the invention

[0104] The quantitative and qualitative composition of Compound A 400 mg / g spray-dried powder (G028) is provided in Table 5 below.

[0105]

[0106] The quantitative and qualitative composition of Compound A 400mg / g spray-dried powder (G028) is provided in Table 6 below.

[0107]

[0108] The qualitative and quantitative compositions of Compound A 100-mg (G030) oral tablet and 100-mg (G031 ) oral tablet are provided in Table 7 below. The tablet contains compound A and stabilizer in a weight ratio of 1:1.5.

[0109] Table 7: Qualitative and Quantitative Composition of Compound A 100-mg Oral Tablets (G030) and (G031)

[0110]

[0111]

[0112] a plant grade

example 2

[0113] Example 2: Phase 1, open-label study in healthy adult subjects to evaluate the biological activity of Compound A Utilization

[0114] A Phase 1 open-label study was conducted to assess the safety, tolerability and pharmacokinetics (PK) of Compound A following single-dose oral administration in the fasted or fed state. Whole plasma PK profiles were determined.

[0115] Study 1 assessed the exposure of G020 (a 10 mg / mL aqueous suspension of a crystalline form of Compound A), and G009 (a 100-mg tablet containing Compound A and Exposure of an amorphous solid dispersion of HPMC as a stabilizer). Study 2 assessed the exposure of G024 (a 100-mg tablet containing an amorphous solid dispersion of Compound A with HPMC-AS as a stabilizer in a 1:3 by weight ratio) in 2 independent trials. The groups (n=13, n=10) were fasted, and one group was fed. Study 2 also evaluated G030 (a 100-mg tablet containing an amorphous solid dispersion of Compound A with HPMC-AS as a stabilizer ...

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Abstract

The present disclosure is directed to solid oral dosage forms of a capsid assembly inhibitor for the treatment of hepatitis B virus infection.

Description

technical field [0001] The present disclosure relates to solid oral dosage forms of capsid assembly inhibitors for the treatment of hepatitis B virus infection. Background technique [0002] Chronic hepatitis B virus (HBV) infection is a persistent, potentially progressive, necroinflammatory liver disease associated with chronic HBV infection. Worldwide, about 240-400 million people are chronically infected with HBV, and chronic HBV infection is the main cause of global severe liver disease and liver-related death (Hepatitis B Factsheet [hepatitis B factsheet], World Health Organization [World Health Organization] , 2013; Hoofnagle JH et al, Management of Hepatitis B: Summary of a Clinical Research Workshop [Management of Hepatitis B: Summary of a Clinical Research Workshop], Hepatology [Hepatology], 2007, 45(4): 1056- 1075; EASLClinical Practice Guidelines: Management of chronic hepatitis B virus infection [EASL clinical practice guidelines: management of chronic hepatitis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/40A61K9/20
CPCA61K9/2054A61K31/40A61K9/146A61P31/00A61K9/1652A61P31/20
Inventor M·B·S·安内C·E·巴尔迈因M·延森斯O·伦茨A·辛格J·斯诺伊斯J·J·范登博舍F·A·R·范迪克D·J·W·弗斯特雷特
Owner JANSSEN SCI IRELAND UC
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