Gentle preservative compositions for self-preserving solutions

Abstract

Compositions are described which are useful in preserving any topically applied solution. Compositions including one or more cationic polysaccharides in solution in an amount effective to preserve contact lenses are also described, as well as methods of making and using such solutions.

Description

technical field

[0001] The invention relates to the application of one or more cationic polysaccharides in the preparation of flexible antiseptic systems. More specifically, the present invention relates to the use of compositions comprising one or more cationic polysaccharides to provide flexible preservation of ophthalmic solutions and medical devices. Background technique

[0002] Currently, the widely used contact lenses fall into two categories: hard and soft. Rigid or rigid corneal lenses are formed from polymerized acrylate materials such as polymethylmethacrylate (PMMA). Gels, hydrogels, or soft lenses are polymerized from monomers such as 2-hydroxyethyl methacrylate (HEMA), or in the case of extended wear lenses, silicon-containing monomers or macromers Polymerized. Both hard and soft contact lenses are exposed to a broad spectrum of microorganisms during everyday wear and become contaminated relatively quickly. Both hard and soft contact lenses require daily cl...

Examples

Embodiment 1

[0028] The preparation of embodiment 1 test solution

[0029] Sample solutions for testing were prepared according to the recipes listed in Table 1 below.

[0030] Table 1

[0031] Element

weight%

the solution

1

2

3

4

sodium borate

boric acid

EDTA

Polymer JR 30M

pH

Osmolarity (mOsm / Kg)

0.135

1.000

0.05

0.02

7.0-7.4

180-220

0.160

1.400

0.05

0.02

7.11

235

0.160

1.400

0.05

0.01

7.11

230

0.160

1.400

0.05

0.005

7.11

232

[0032] Table 1 - continued

[0033] Element

weight%

the solution

5

6

7

8

sodium borate

boric acid

EDTA

Polymer JR 30M

Polymer JR 400

pH

Osmolarity (mOsm / Kg)

0.160

1.400

0.10

0.02

0

7.03

...

Embodiment 2

[0036] Example 2 ISO / FDA Microbial Preservative Efficacy Testing of Test Solutions with 5 FDA / ISO Challenge Microorganisms

[0037] Using 5 kinds of FDA / ISO challenge microorganisms, namely 3 kinds of bacteria and 2 kinds of fungi, the test solutions prepared according to the above-mentioned Example 1 were subjected to ISO / FDA microbial preservative efficacy tests respectively. Acceptance criteria established for bacteria required at least a 3.0 log reduction in the number of viable bacteria per milliliter recovered at 14 days. After 14 days of re-challenge, the concentration of bacteria should have decreased by at least 3.0 logs by 28 days. Acceptance criteria established for yeast and fungi require that the number of viable yeast and fungi recovered per milliliter remain at or below the initial concentration within ±0.5 logs of experimental error within 14 days. After 28 days, the concentrations of fungi and yeast should remain at or below post-rechallenge within experiment...

Embodiment 3

[0042] The preparation of embodiment 3 preservative system

[0043] Sample solutions for testing were prepared according to the preservative system formulations listed in Table 3 below.

[0044] table 3

[0045] Element

technical field

[0001] The invention relates to the application of one or more cationic polysaccharides in the preparation of flexible antiseptic systems. More specifically, the present invention relates to the use of compositions comprising one or more cationic polysaccharides to provide flexible preservation of ophthalmic solutions and medical devices. Background technique

[0002] Currently, the widely used contact lenses fall into two categories: hard and soft. Rigid or rigid corneal lenses are formed from polymerized acrylate materials such as polymethylmethacrylate (PMMA). Gels, hydrogels, or soft lenses are polymerized from monomers such as 2-hydroxyethyl methacrylate (HEMA), or in the case of extended wear lenses, silicon-containing monomers or macromers Polymerized. Both hard and soft contact lenses are exposed to a broad spectrum of microorganisms during everyday wear and become contaminated relatively quickly. Both hard and soft contact lenses require daily cl...

Examples

Embodiment 1

[0028] The preparation of embodiment 1 test solution

[0029] Sample solutions for testing were prepared according to the recipes listed in Table 1 below.

[0030] Table 1

[0031] Element

weight%

the solution

1

2

3

4

sodium borate

boric acid

EDTA

Polymer JR 30M

pH

Osmolarity (mOsm / Kg)

0.135

1.000

0.05

0.02

7.0-7.4

180-220

0.160

1.400

0.05

0.02

7.11

235

0.160

1.400

0.05

0.01

7.11

230

0.160

1.400

0.05

0.005

7.11

232

[0032] Table 1 - continued

[0033] Element

weight%

the solution

5

6

7

8

sodium borate

boric acid

EDTA

Polymer JR 30M

Polymer JR 400

pH

Osmolarity (mOsm / Kg)

0.160

1.400

0.10

0.02

0

7.03

...

Embodiment 2

[0036] Example 2 ISO / FDA Microbial Preservative Efficacy Testing of Test Solutions with 5 FDA / ISO Challenge Microorganisms

[0037] Using 5 kinds of FDA / ISO challenge microorganisms, namely 3 kinds of bacteria and 2 kinds of fungi, the test solutions prepared according to the above-mentioned Example 1 were subjected to ISO / FDA microbial preservative efficacy tests respectively. Acceptance criteria established for bacteria required at least a 3.0 log reduction in the number of viable bacteria per milliliter recovered at 14 days. After 14 days of re-challenge, the concentration of bacteria should have decreased by at least 3.0 logs by 28 days. Acceptance criteria established for yeast and fungi require that the number of viable yeast and fungi recovered per milliliter remain at or below the initial concentration within ±0.5 logs of experimental error within 14 days. After 28 days, the concentrations of fungi and yeast should remain at or below post-rechallenge within experiment...

Embodiment 3

[0042] The preparation of embodiment 3 preservative system

[0043] Sample solutions for testing were prepared according to the preservative system formulations listed in Table 3 below.

[0044] table 3

[0045] Element