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Pharmaceutical composition comprising cabotegravir

A technology of composition and injection composition, which is applied in the direction of drug delivery, active ingredients of heterocyclic compounds, active ingredients of hydroxyl compounds, etc., to achieve the effect of exhibiting particle size stability and realizing resuspension

Pending Publication Date: 2022-07-22
VIIV HEALTHCARE UK LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patient non-adherence is a known problem with these complex HIV regimens and can lead to the emergence of multi-drug resistant strains of HIV

Method used

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  • Pharmaceutical composition comprising cabotegravir
  • Pharmaceutical composition comprising cabotegravir
  • Pharmaceutical composition comprising cabotegravir

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0265] Example 1: Composition of the invention

[0266]

[0267]

[0268] table 3

[0269] Table 3 shows exemplary pharmaceutical compositions of the invention (in these examples, the pharmaceutical compositions are also described as "suspensions"), prepared using the following method.

[0270]A formulation was prepared by dissolving 9.5 g of Poloxamer 338 (BASF), 5.0 g of mannitol (Roquette Freres) and 8.7 g of PEG3350 (Clariant) in 164.2 g of water for injection (WFI) and filtering the solution through a 0.2 μm filter vehicle. The formulation vehicle was added to cabotevir (free acid) to prepare a 400 mg / ml crude suspension. The crude suspension was circulated with stirring at 73-145 ml / min through a wet bead mill (Netzsch MiniCer) containing 0.30 mm YTZ beads (Nikato Corp) set at 29.7 Hz until reaching, as measured by laser diffraction, reached Desired median particle size of 0.2 to 1.0 μm. The wet bead mill was cooled to maintain a temperature between 1°C and 2...

Embodiment 2

[0271] Reality Example 2: Stability of Compositions Containing Cabotevir, Poloxamer 338 and PEG3350

[0272] A formulation was prepared by dissolving 7.5 g Poloxamer 338 (BASF), 5.7 g mannitol (Roquette Freres) and 7.5 g PEG3350 (Clariant) in 166.7 g water for injection (WFI) and filtering the solution through a 0.2 μm filter vehicle. The formulation vehicle was added to 100 g of cabotevir (free acid) to make a 400 mg / ml coarse suspension. The coarse suspension was circulated at 73-145 ml / min through a wet bead mill (Netzsch MiniCer) containing 0.30 mm YTZ beads (Nikato Corp) set at 29.7 Hz, while stirring, until the desired 0.25 μm was reached. median particle size. The wet bead mill was cooled to maintain a temperature between 1°C and 25°C. The milled suspension was filled into Type I glass vials, flushed with nitrogen, stoppered (FM457 stopper) and sealed. The resulting suspension was terminally sterilized by gamma irradiation at a minimum dose of 25 kGy. Table 4 sho...

Embodiment 3

[0282] Example 3: 400 mg / mL Cabotevir and Poloxamer 338 or 407

[0283] An injectable suspension containing about 400 mg / mL of cabotevir is prepared with Poloxamer 407 or 338. Mannitol was also added as a tonicity agent. The formulation vehicle was prepared by dissolving 7.0 g Poloxamer 338 and 3.5 g mannitol in 177.0 g WFI (Suspension 4), or 7.5 g P407 (BASF) and 4.7 g mannitol (Roquette Freres) was dissolved in 175.3 g of WFI (Suspension 3) and the solution was filtered through a 0.2 μm filter. The formulation vehicle was added to 100 g of cabotevir (free acid) to prepare a 400 mg / ml crude suspension. The crude suspension was circulated with stirring at 73-145 ml / min through a wet bead mill (Netzsch MiniCer) containing 0.30 mm YTZ beads (Nikato Corp) set at 29.7 Hz until the desired average of about 0.2 μm was reached particle size. The wet bead mill was cooled to maintain a temperature between 1°C and 25°C. The suspension was filled into Type I glass vials, flushed w...

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Abstract

The present invention relates to human immunodeficiency virus (HIV) treatments. In particular, the present invention relates to a pharmaceutical composition comprising Cabotegravir or a pharmaceutically acceptable salt thereof, polyethylene glycol and poloxamer, which can be used as a long-acting HIV treatment.

Description

[0001] Field of Invention [0002] The present invention relates to human immunodeficiency virus (HIV) therapy. In particular, the present invention relates to the long-acting treatment of HIV. Background technique [0003] Patients with HIV infection often undergo complex treatment regimens that involve taking multiple pills at regular intervals each day. Patient non-adherence is a known problem with these complex HIV treatment regimens and can lead to the emergence of multidrug-resistant strains of HIV. [0004] The use of long-acting parenterals has been established in clinical practice for decades, especially in the fields of contraception, antipsychotics and opiate addiction. More recently, long-acting parenteral formulations for the treatment and prevention of HIV have been explored. Long-acting injectables have been proposed as a way to overcome the problem of non-adherence in HIV treatment regimens. Long-acting injectable formulations are in clinical development, a...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/20A61K47/26A61K47/34A61K31/4985A61K31/5365A61P31/18A61K39/00C07K16/10
CPCA61K31/4985A61P31/18A61K9/0019A61K9/2031A61K47/26A61K47/34A61K31/77A61K31/047A61K31/517A61K31/519A61K31/541A61K31/52A61K2300/00A61K47/10
Inventor N.阿哈文K.楚E.韦尔苏伊森
Owner VIIV HEALTHCARE UK LTD
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