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Ophthalmic formulation

A technology for ophthalmic and ophthalmic compositions, applied in the field of ophthalmic compositions, can solve problems such as insufficient effect

Active Publication Date: 2020-05-15
PANOPTES PHARMA GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, in order to treat dry eye, artificial tears are administered to supplement tears, and chondroitin sulfate, glutathione, hyaluronic acid, fibronectin, epidermal growth factor (EGF), etc. are administered to relieve subjective symptoms, but the effect is not enough

Method used

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  • Ophthalmic formulation
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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0108] Example 1 - Binding of PP-001 to Albumin

[0109] To analyze the binding of PP-001 to HSA (human serum albumin), a Thermo Scientific(TM) rapid equilibrium dialysis (RED) assay was performed. Different PP-001 formulations were applied to the donor side of the device, and 50 mM phosphate buffer, pH 7.4, was used as the acceptor medium. The time required to reach equilibrium in dialysis was determined to be 5 hours. The formulation was incubated at 23°C, 300 rpm to allow the unbound fraction to permeate through the dialysis membrane into the receptor buffer compartment. After equilibrating for 5 hours, the unbound fraction was determined by analyzing the amount of PP-001 in each compartment by HPLC / DAD.

[0110] To investigate the non-specific binding of PP-001 to the RED Device Insert, a 0.05 mg / mL solution of PP-001 in 50 mM phosphate buffer pH 7.4 was used as a control sample. The PP-001 concentration in the acceptor compartment was 82% greater than the PP-001 concen...

example 2-P

[0126] Example 2 - PP-001 / albumin eye drop formulation

[0127] PP-001 drug (150 mg) was suspended in a mixture of water (21.0 g) and 1M NaOH aqueous solution (482 μL), and the mixture was stirred at 700 rpm for 0.5-3 hours at room temperature (20-25 °C), and then 20 % albumin in water (7.5 mL). Stirring was continued for 1-2 hours at room temperature. The pH and osmolarity of the solution were adjusted to 7.4 and 270-330 mOsm / kg, respectively, by the slow (dropwise) addition of 1 M aqueous HCl and 26% aqueous NaCl (575 μL). The yellowish, nearly clear mixture was stirred for a further 15 minutes and then filtered using a 0.2 μm sterile filter.

[0128] Such as figure 1 As shown, the formulation comprising 3 mg / mL PP-001 and 50 mg / mL albumin had excellent comfort in the tested patient group.

[0129] Example 3 - Physicochemical Properties of PP-001 / Albumin Eye Drops Prepared as in Example 2

[0130] pH 7.39

[0131] 276mOsm / kg

[0132] >98% PP-001 bound to albumin

example 4-P

[0133] Example 4- Eye Irritation / Comfort Test of PP-001 / Albumin Eye Drops

[0134] The PP-001 eye drop formulation containing albumin was mixed with PP-001 eye drop containing HPMC, PVP and glycerol as excipients and commercially available cyclosporin eye drop Compare. Apply one drop to one eye. All formulations contained 3 mg / mL PP-001. The emulsion formulation contains 0.1% cyclosporine. The comfort of the different formulations was rated according to the following comfort scores:

[0135] 1: comfortable (such as isotonic saline)

[0136] 2: Very slight temporary sensation

[0137] 3: Slight burning or foreign body sensation

[0138] 4: Burning or stinging sensation

[0139] 5: Intense burning or tingling or redness

[0140] Volunteers rated PP-001 formulations in HPMC, PVP, and glycerol as burning and stinging, and formulations containing 5% or 20% albumin as comfortable and non-irritating to the eyes. All tested placebo formulations resulted in the same comfort ...

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Abstract

The present invention provides an ophthalmic composition comprising an active pharmaceutically compound non-covalently bound to albumin. The composition of the present invention is useful for treatment of ophthalmic diseases and disorders.

Description

technical field [0001] The present invention relates to ophthalmic compositions comprising a pharmaceutically active compound non-covalently bound to albumin. The compositions of the present invention are useful in the treatment of ophthalmic diseases and conditions. Background technique [0002] Many eye diseases have no early symptoms. They may be painless and may not change vision until the disease is quite advanced. [0003] Dry eye disease occurs when tear production decreases or tears evaporate too quickly due to decreased tear quality. Without adequate lubrication, the eyes can become dry, gritty, dry, burning, red, or watery. [0004] In addition to their desired effects, eye lubricants may have some unwanted effects. Although not all of these side effects are likely to occur, they may require medical attention if they occur. More or less common side effects are blurred vision, eye redness or discomfort or other irritation that was not present before this medici...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/42A61K31/381A61P27/02
CPCA61K9/0048A61K31/381A61K31/4709A61K38/13A61K47/42A61P27/02A61K9/08A61K9/06A61K47/643
Inventor S·斯佩尔F·奥本玛
Owner PANOPTES PHARMA GMBH
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