Contact lens and eye drop rewetter compositions and methods

• US 20050266089A1
• Filed: 07/29/2005
• Published: 12/01/2005
• Est. Priority Date: 01/08/2003
• Status: Abandoned Application

• Current Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Original Assignee: Advanced Medical Optics Incorporated (Johnson & Johnson)
• Inventors: Huth, Stanley W., Cook, James N.
• Application Number:
  US11/192,718
• Publication Number:
  US 20050266089A1
• Time in Patent Office: Days
• US Class Current: 424/488
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/728 Hyaluronic acid
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61P 27/00 Drugs for disorders of the senses
• CPC Class Codes: A61P 27/02 Ophthalmic agents

Abstract

Stable ophthalmic formulations comprising hyaluronic acid (sodium hyaluronate) as the primary active demulcent ingredient, stabilized oxy-chloro complex (available commercially as OcuPure™ from Advanced Medical Optics, Purite® from Allergan, and Purogene from Biocide) for preservative efficacy, balanced salts mimicking the tear film, and sodium borate as a buffer are disclosed. In one embodiment, preferred stable formulations may be used in the human eye with or without contact lenses. In another embodiment preferred formulations may also be used as a storage and conditioning solution for contact lenses following disinfection.

Claims

1-102. -102. (canceled)

103. A stable ophthalmic composition which is comfortable to the human eye comprising:

about 0.1% to about 0.6% w/v hyaluronic acid; and

about 0.0020% to about 0.02% w/v stabilized oxy-chloro complex;

wherein said composition increases tear film breakup time.

104. The stable ophthalmic composition of claim 103, wherein said hyaluronic acid has a molecular weight of about 800,000 to about 1,750,000 daltons.

105. The stable ophthalmic composition of claim 103, wherein the concentration of said hyaluronic acid is about 0.2% to about 0.4% w/v.

106. The stable ophthalmic composition of claim 103, wherein the concentration of said stabilized oxy-chloro complex is about 0.003% to about 0.01% w/v.

107. The stable ophthalmic composition of claim 103 further comprising a boric acid/borate buffer to maintain a pH of about 6.0 to about 9.0.

108. The stable ophthalmic composition of claim 107, wherein the pH of said composition is about 6.8 to about 8.0.

109. The stable ophthalmic composition of claim 108, wherein the pH of said composition is about 7.0 to about 7.4.

110. The stable ophthalmic composition of claim 103, further comprising balanced salts.

111. The stable ophthalmic composition of claim 110, wherein said balanced salts comprise NaCl, KCl, CaCl₂, and MgCl₂.

112. The stable ophthalmic composition of claim 110, wherein the balanced salts provide a composition osmolality of about 140 to about 400 mOsm/kg.

113. The stable ophthalmic composition of claim 112, wherein the balanced salts provide a composition osmolality of about 240 to about 330 mOsm/kg.

114. The stable ophthalmic composition of claim 103, further comprising about 0.05 to about 1% polyol demulcent.

115. The stable ophthalmic composition of claim 114, wherein the polyol demulcent is selected from the group consisting of glycerin, polyethylene glycol 300, polyethylene glycol 400, polysorbate 80 and propylene glycol.

116. The stable ophthalmic composition of claim 103 further comprising about 0.2 to about 2.5% cellulose derivative demulcent.

117. The stable ophthalmic composition of claim 116 wherein the cellulose derivative demulcent is selected from the group consisting of carboxymethylcellulose sodium, hydroxyethyl cellulose, hydroxypropyl methylcellulose, and methylcellulose.

118. A method of treating dry eye in a manner which is comfortable to the human eye comprising:

instilling a stable ophthalmic composition into the human eye;

wherein said stable ophthalmic composition comprises;

about 0.1% to about 0.6% w/v hyaluronic acid; and

about 0.0020% to about 0.02% w/v stabilized oxy-chloro complex.

119. The method of claim 118, wherein a contact lens is present in said human eye.

120. The method of claim 118, wherein said hyaluronic acid has a molecular weight of about 800,000 to about 1,750,000 daltons.

121. The method of claim 118, wherein the concentration of said hyaluronic acid is about 0.2% to about 0.4% w/v.

122. The method of claim 118, wherein the concentration of said stabilized oxy-chloro complex is about 0.003% to about 0.01% w/v.

123. The method of claim 118, wherein said composition further comprises a boric acid/borate buffer to maintain a pH of about 6.0 to about 9.0.

124. The method of claim 123, wherein the pH of said composition is about 6.8 to about 8.0.

125. The method of claim 124, wherein the pH of said composition is about 7.0 to about 7.4.

126. The method of claim 118, wherein said stable ophthalmic composition further comprises balanced salts.

127. The method of claim 126, wherein said balanced salts comprise NaCl, KCl, CaCl₂, and MgCl₂.

128. The method of claim 126, wherein the balanced salts provide a composition osmolality of about 140 to about 400 mOsm/kg.

129. The method of claim 128, wherein the balanced salts provide a composition osmolality of about 240 to about 330 mOsm/kg.

130. The method of claim 118, wherein said stable ophthalmic composition further comprises about 0.2 to about 1% polyol demulcent.

131. The method of claim 130, wherein the polyol demulcent is selected from the group consisting of glycerin, polyethylene glycol 300, polyethylene glycol 400, polysorbate 80 and propylene glycol.

132. The method of claim 118 wherein said stable ophthalmic composition further comprises about 0.2 to about 2.5% cellulose derivative demulcent.

133. The method of claim 132 wherein the cellulose derivative demulcent is selected from the group consisting of carboxymethylcellulose sodium, hydroxyethyl cellulose, hydroxypropyl methylcellulose, and methylcellulose.