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Ophthalmic formulations of methotrexate

A technology of methotrexate and enhancer, applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, inorganic non-active ingredients, etc.

Pending Publication Date: 2022-04-29
ALDEYRA THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Use of anti-inflammatory drugs or immunosuppressants may benefit subjects at higher risk of PVR

Method used

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  • Ophthalmic formulations of methotrexate
  • Ophthalmic formulations of methotrexate

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0192] Example 1: Preparation of Composition and Evaluation by Silicone Oil

[0193] Water is placed in a suitable container, and each ingredient as appropriate for the formulation, eg, surfactants, buffers, bulking agents, methotrexate, etc., is added and dissolved in solution one at a time. The pH was adjusted to 7.4 ± 0.2 by adding 1M sodium hydroxide or HCl. Water was added to make up to the desired final volume.

[0194] Two grades of silicone oil were used: Dimethicone 1,000 cps (Sigma Aldrich, UK) and 5,000 cps (Mistral industrial chemicals, UK) The effect of formulation composition on the travel time of methotrexate through silicone layers of different viscosities and amounts was investigated.

[0195] 1. Test two heights of silicone oil: place 0.5cm or 1cm of oil on top of 2mL of LPBS buffer to confirm the best height to use.

[0196] 2. Place a drop of formulation (-50 mg) on ​​top of the silicone layer.

[0197] Time taken (cm / min) for the API (formulation dropl...

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Abstract

The present disclosure provides formulations of methotrexate for ocular administration, including intravitreal administration, and the use of the formulations for the treatment of proliferative vitreoretinopathy (PVR), intraocular lymphoma (e.g., PVRL), and intraocular inflammation.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Application Serial No. 62 / 900,060, filed September 13, 2019, and U.S. Provisional Application Serial No. 63 / 044,288, filed June 25, 2020, which The entire disclosure is incorporated herein by reference in its entirety. Background technique [0003] Proliferative vitreoretinopathy (PVR) is a clinical syndrome that occurs after rhegmatogenous retinal detachment, such as that caused by a retinal rupture (eg, retinal tear or retinal hole) and its surgical repair. The pathogenesis of PVR involves the release of cells into the vitreous cavity (extraretinal cells), where they replicate and form periretinal fiber membranes on the inner and / or outer surfaces of the retina, causing retinal shortening and retinal traction. PVR is characterized by intraretinal fibrosis and decreased elasticity, leading to traction elevation of the retina and subsequent...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/519A61K9/00A61K9/50
CPCA61K31/519A61K9/0048A61K47/26A61K47/10A61K9/0051A61K47/02A61K47/34A61K9/0019A61P27/02A61P35/00
Inventor D·埃利奥特S·G·马哈塔P·萨尔波特达T·斯特雷耶夫斯基
Owner ALDEYRA THERAPEUTICS