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Ophthalmic preparation

An ophthalmic composition and weight technology, which is applied in the direction of medical preparations containing non-active ingredients, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems that cannot be solved well, the cost of preparations becomes higher, and preparations Storage and use troubles and other issues

Pending Publication Date: 2020-12-01
SYNCORE BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The use of chelating agents makes the formulation cost higher
However, even adding the hydralazine hydrochloride aqueous solution of the chelating agent still cannot avoid the problem of discoloration of the solution, which brings great troubles to the storage and use of the preparation
This problem has not been well resolved

Method used

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  • Ophthalmic preparation
  • Ophthalmic preparation
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment ： Embodiment 1

[0054] Examples: Example 1: Formulations can be prepared by stepwise addition of ingredients.

[0055] In an embodiment, a method for preparing an ophthalmic composition formulation comprises: first adding an appropriate amount of buffer solution to an appropriate amount of purified water under stirring. Purified water is preferably filled into containers of suitable size to accommodate the volume of the final formulation. Buffer solutions can be prepared separately or can be purchased commercially. In one non-limiting embodiment, the buffer solution is an acetate buffer solution. In one non-limiting embodiment, the acetate buffer solution comprises sodium acetate, acetic acid and purified water. In an exemplary embodiment, the pH of the acetate buffer solution is about 4.2 to 4.6. In a specific embodiment, the pH of the buffer is 4.2. As a non-limiting example, an acetate buffer solution can be prepared by adding 1.75 g of sodium acetate and 18.6 mL of acetic acid 2N into...

Embodiment 2

[0064] Example 2: The stability of the disclosed formulation was tested by accelerating the chemical or physical changes of the drug by increasing the storage temperature.

[0065] Eight hydralazine hydrochloride formulations of formulation a-formulation h in Example 1 were filled into glass sample vials. Formulations were stored at 40°C and 50°C to evaluate storage under accelerated chemical or physical changes of the drug. Measure the pH, osmolality (Osmol / kg) and content (%) of the solution active ingredient when the time is zero and one, two, three, four weeks, and observe the appearance and color of the solution.

[0066]The results are shown in Table 3 to Table 10, the initial solution of the hydralazine hydrochloride preparations of formula f, formula g and formula h has changed color at room temperature. After four weeks of storage at 40°C, formula a, formula b, formula c, formula d and formula e can all remain colorless, clear and transparent. After three weeks of s...

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Abstract

The invention relates to an ophthalmic preparation composition to provide a stable hydralazine topical preparation for the treatment of ocular diseases and illness conditions. The composition contains0.02%-2% by weight of a hydralazine pharmaceutically active drug, wherein ethylene dinitrilotetra-acetic acid radical ions used for chelating metal ions are basically not contained. The invention also relates to a method of preparing the above ophthalmic composition.

Description

technical field [0001] The present disclosure provides ophthalmic formulations and methods of treating the eye. Background technique [0002] Hydralazine is a known antihypertensive drug that produces a hypotensive effect by relaxing the vasodilator effect of vascular smooth muscle. More specifically, hydralazine alters calcium metabolism, thereby interfering with calcium mobilization within vascular smooth muscle, thereby affecting the onset or prolongation of the contractile state of vascular smooth muscle ( Drug Instructions). [0003] In addition to medicinal uses for lowering blood pressure, US Patent 8,088,773, incorporated herein by reference, teaches the use of hydralazine for the treatment of non-neovascular or dry age-related macular degeneration. Age-related macular degeneration is a chronic disease that is the leading cause of vision loss in people over the age of 60 in developed countries. The disease is mainly divided into dry and wet forms. The dry type r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/502A61K47/14A61P27/02
CPCA61K9/0048A61K31/502A61K47/14A61P27/02A61K9/08A61K47/02A61K47/10A61K47/186
Inventor 林书毅
Owner SYNCORE BIOTECH
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