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Ophthalmic compositions with omega-3 fatty acids

A technology of fatty acids and mixtures, applied in the field of ophthalmic compositions, can solve problems such as patient dissatisfaction, patient discomfort, and vision obstruction

Inactive Publication Date: 2015-05-06
BAUSCH & LOMB INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While hard gels may have extended residence time in the eye and help facilitate higher drug bioavailability, and perhaps enhance clinical outcomes per instillation, such gels, such as ointments, may disadvantageously Obstructing vision and causing patient dissatisfaction
In addition, these prior art compositions often have to be formulated at a significantly acidic pH, causing patient discomfort when instilled in the patient's eye

Method used

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  • Ophthalmic compositions with omega-3 fatty acids
  • Ophthalmic compositions with omega-3 fatty acids
  • Ophthalmic compositions with omega-3 fatty acids

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0070] A sterile aqueous solution of polyacrylic acid polymer is mixed with a sterile filtered solution of a mixture of omega-3 fatty acids, preservatives, isotonicity agents and chelating agents. After careful and thorough mixing of the starting materials, sterile filtered caustic soda solution was added to initiate gel formation, which was further stirred until it was homogenized. Alternatively, a mixture of omega-3 fatty acids can be first dissolved or suspended in a small amount of mineral oil and added to the polyacrylic acid polymer solution. The resulting suspension is then routinely decanted or drained under aseptic conditions.

[0071] Gel suspensions are well accepted by patients because they do not have the undesirable properties of known ointments when instilled, and are not oily. Furthermore, stability studies have demonstrated that the gel has a relatively long shelf life without any change in its physical properties. In particular, the mixture of omega-3 fatty...

Embodiment 2

[0084] The carrier formulations of the invention comprising a mixture of omega-3 fatty acids and jojoba wax esters are described in Table 3.

[0085] Table 3. Omega-3 / jojoba suspension formulations

[0086]

Embodiment 3

[0088] The carrier formulations of the invention comprising mixtures of omega-3 fatty acids and phospholipids are described in Table 4.

[0089] Table 4. Omega-3 / phospholipid suspension formulations

[0090]

[0091] To determine the tear thinning properties of Example 1, 30 mL of the composition was mixed with 10 mL of simulated tear fluid. As noted, it is believed that the thinning properties of the carrier formulation are primarily driven by the difference in ionic strength between the carrier formulation having a relatively low ionic strength and the tear fluid represented by the simulated tear fluid having a relatively high ionic strength. When the carrier formulation is administered to the eye in the form of eye drops, the percentage increase in the ionic strength of the carrier-tear mixture causes the carrier formulation to dilute. The concentration of lightly cross-linked carboxypolymer, the calculated ionic strength of the example (vehicle) formulations, and the p...

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Abstract

A suspension comprising a mixture of wax esters suspended in a formulation vehicle. The formulation vehicle comprises a lightly cross-linked carboxy-containing polymer and a concentration of ionic salt components to provide the suspension with a calculated ionic strength of less than 0.1. The suspension has the following rheological properties, (T > G" and a suspension yield value of greater than 1 Pa. Also, upon addition of 30 mL of the suspension to a volume of 6 mL to 12 mL of simulated tear fluid, the resulting tear mixture transitions to a liquid form wherein, G" > G' and the tear mixture has a yield value of less than 0. 1 Pa.

Description

Background of the invention [0001] The present invention relates to ophthalmic compositions comprising omega-3 fatty acids suspended in an aqueous gel formulation carrier and the medical use of said compositions for alleviating symptoms associated with dry eye or other ocular conditions mixture. [0002] From a statistical point of view, one in five patients who see an ophthalmologist has dry eye. In modern life, it is generally known that the eyes are under high stress, for example due to hours of staring at a computer screen, watching TV, wearing contact lenses, or due to dry air from heaters or air conditioners. This pressure can cause, inter alia, a burning sensation, itching or tearing of the eyes. The reason for this is a disorder of the tear film due to high evaporation or low tear production. As a result of taking certain medications (for example, antibiotics, antihypertensives, antihistamines, vasoconstrictors, birth control pills, diuretics, or antidepressants) or...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/10A61K31/202A61K47/02A61K47/32
CPCA61K9/0048A61K47/32A61K9/10A61K47/12A61K31/201A61K31/202A61P27/04A61K2300/00A61P27/02A61K47/44A61K47/10
Inventor M·J·科菲
Owner BAUSCH & LOMB INC