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Pharmaceutical compositions for the treatment of ophthalmic conditions

A composition, vegetable oil technology, applied in the direction of drug combination, drug delivery, active ingredients of hydroxyl compounds, etc.

Active Publication Date: 2020-08-25
罗得技术公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the design of biocompatible, stable and serializable emulsion formulations remains a challenge

Method used

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  • Pharmaceutical compositions for the treatment of ophthalmic conditions
  • Pharmaceutical compositions for the treatment of ophthalmic conditions
  • Pharmaceutical compositions for the treatment of ophthalmic conditions

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0172] Example 1: Feasibility of preparing an emulsion of sesame oil in water by homogenization in the presence of surfactants

[0173] In this example, the feasibility of preparing an emulsion of sesame oil in water by homogenization in the presence of surfactants is explored.

[0174] A model surfactant formulation was prepared comprising 7% polyoxyethylene 40 stearate (EF3) and 0.3% tyloxapol (EF4). The surfactant concentrations used in the model formulations were chosen to span a range of suitable dosage concentrations for ophthalmic use. Surfactants with similar lipophile-lipophile balance (HLB) values ​​were chosen: HLB of polyoxyethylene 40 stearate was 16.7; HLB of tyloxapol was 12.9.

[0175] Surfactants and sesame oil were added to 80% bulk water for injection (WFI) and mixed using a magnetic stir plate for approximately 30 minutes to form EF3 and EF4 formulations (Table 1).

[0176] Table 1. EF3 formulations and EF4 formulations

[0177] Reagent, %(w / w)...

Embodiment 2

[0180] Example 2: Effect of Surfactants on Emulsions of Sesame Oil in Water Suitable for Ophthalmology

[0181] In this example, the optimum pH and osmolarity ranges of the compositions were evaluated.

[0182] A model formulation containing 7% polyoxyethylene 40 stearate (PE3) and 0.3% tyloxapol (PE4) was prepared. Surfactant and sesame oil (1.5%) were added to the 80% batch of WFI and mixed using a magnetic stir plate. Once the mixture appears homogeneous, the sample is diluted to the desired volume and the pH and osmolarity of the solution are measured. The pH was adjusted to 6.8-7.0 using 1 N NaOH. The osmolarity of the samples was adjusted to 270-310 mOsm / L using NaCl. The results are shown in Table 2 below.

[0183] Table 2. Optimization of pH and osmolarity during homogenization

[0184]

[0185]

[0186] The amount of NaOH needed to adjust the pH was small and caused little osmolarity increase in either the PE3 formulation or the PE4 formulation. Neither 1....

Embodiment 3

[0188] Example 3: Preparation of Sesame Oil Emulsions in Water Using Surfactants with Various HLBs

[0189] In this example, emulsion formulations PE1-PE10 were prepared as shown in Table 3. These samples were prepared using the method described in Example 1 (homogenization at 3000 rpm for 15 minutes).

[0190] Table 3. Emulsion Formulations

[0191]

[0192]

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Abstract

The invention provides emulsion compositions comprising at least one cannabinoid compound, and methods for making the same. The emulsion compositions are stable, well tolerated and are capable of delivering therapeutically effective amounts of cannabiniods to target sites, including sites on the surface of and / or within an eye. Also provided are methods of using the compositions to provide ocularneuroprotection and / or to treat ophthalmic conditions such as glaucoma.

Description

technical field [0001] The present invention provides pharmaceutical compositions comprising at least one cannabinoid compound, methods of their use and methods of their preparation. In one embodiment, the pharmaceutical compositions of the present invention are useful in the treatment of ophthalmic disorders such as glaucoma. In certain embodiments, the pharmaceutical composition is an emulsion composition that is stable, well tolerated, and capable of delivering a therapeutically effective amount of a cannabinoid to a target site, including the surface of the eye of a mammal (e.g., a human) and / or internal parts. Also provided are methods of using the compositions to provide ocular neuroprotection, thereby treating or preventing ophthalmic conditions such as glaucoma. Background technique [0002] The prevalence of neuropathic ophthalmic conditions is a major public health concern. For example, glaucoma is one of the leading causes of blindness worldwide. In the United...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/352A61K9/00A61K9/10A61K9/107A61K31/00
CPCA61K47/10A61K9/107A61K47/44A61K31/352A61P27/06A61K31/07A61K31/355A61K31/5377A61K47/26A61K9/0048A61K9/1075A61K9/10A61K9/0019A61K31/353A61P27/04A61P29/00A61K9/0014A61K9/06A61K47/02
Inventor 张平武胡珍泽陶媛媛
Owner 罗得技术公司