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(12) Patent Application Publication (10) Pub. No.: US 2013/0324481 A1 Wong Et Al

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(12) Patent Application Publication (10) Pub. No.: US 2013/0324481 A1 Wong Et Al US 2013 0324481A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2013/0324481 A1 Wong et al. (43) Pub. Date: Dec. 5, 2013 (54) SUSTAINED RELEASE EYE DROP Publication Classification FORMULATIONS (51) Int. Cl. (71) Applicant: Ramscor, Inc., Menlo Park, CA (US) A647/22 (2006.01) A647/4 (2006.01) (72) Inventors: Vernon G. Wong, Menlo Park, CA (US); A647/12 (2006.01) Louis L. Wood, Potomac, MD (US) A638/3 (2006.01) A 6LX3/573 (2006.01) (73) Assignee: Ramscor, Inc., Menlo Park, CA (US) (52) U.S. Cl. CPC ................. A61K 4 7/22 (2013.01); A61K 38/13 (21) Appl. No.: 13/963,574 (2013.01); A61 K3I/573 (2013.01); A61 K 1-1. 47/12 (2013.01); A61 K47/14 (2013.01) (22) Filed: Aug. 9, 2013 USPC ....... 514/20.5: 514/180: 514/383: 514/263.4: O O 514/152514f628: 514/253.08: 514f198: Relatede U.S. Applicationpplication DatUata 514/450;s 514/317;s 514/217.05;s 514/648:s (63) Continuation of application No. 12/236,877, filed on 514/226.2: 514/259.41; 514/291; 514/456 Sep. 24, 2008, now Pat. No. 8,541,413, which is a continuation-in-part of application No. 1 1/826,833, filed on Jul. 18, 2007, now abandoned, which is a (57) ABSTRACT continuation-in-part of application No. 1 1/236,426, This invention provides for biocompatible, biodegradable eye filed on Sep. 27, 2005, now Pat. No. 7,906,136. drop pharmaceutical formulations useful for the treatment of (60) Provisional application No. 60/960,315, filed on Sep. ocular indications. In particular, tocopherols and their esters 25, 2007, provisional application No. 60/831,991, of low water solubility, notably C-tocopheryl acetate, are filed on Jul. 19, 2006, provisional application No. exceptional vehicles for biocompatible, nonirritating topical 60/709,665, filed on Aug. 19, 2005, provisional appli eye drop formulations that provide Sustained release of active cation No. 60/614,484, filed on Oct. 1, 2004. agents. Patent Application Publication Dec. 5, 2013 Sheet 1 of 7 US 2013/0324481 A1 08 09 % esteele, ?eo-xeO Patent Application Publication Dec. 5, 2013 Sheet 2 of 7 US 2013/0324481 A1 (6uu98°W)VSO?? (6uuy6:9)VE--o-- (fiul 16?Z)VSO___(6uu89:8)VE_…_ /9Gº9z Ápn?SI?ASTJeeLWE-VSO 000'O),È 000'000'|| |D 8 O O Patent Application Publication Dec. 5, 2013 Sheet 3 of 7 US 2013/0324481 A1 (6uu9'O)aseq?ojou?L–º– 6uu £7'O)aseq:ToTou?I---- (6uu18'2)VE--º-- (6uuy'G)VE–º– 000|| 000000|| (u/6u) uOlerueouOO Patent Application Publication Dec. 5, 2013 Sheet 4 of 7 US 2013/0324481 A1 0609 O O d O OO CO w v % 'eSeee (e.O-XeO Patent Application Publication Dec. 5, 2013 Sheet 5 of 7 US 2013/0324481 A1 vr r v wer v s Co N N c re y C O O O O 9 O(6H/uu)8 & dOl9 ° Er S (6H/uu)3 & dOl : o o so so r y N O CY) s r a O o o (6H/uu) Ol (6H/Luu) dO Patent Application Publication Dec. 5, 2013 Sheet 6 of 7 US 2013/0324481 A1 O OO g 2 Ed c v CD O O t KC CC w LL SS X X 9. 33 3 SS & 5 rf r w Y CN c s O H- O as o co D CD 5. S l H O X CO CD ? O cy) O 3 Q 3 o % 'eSeele (e.OXeO Patent Application Publication Dec. 5, 2013 Sheet 7 of 7 US 2013/0324481 A1 s O N O N % 'eSeeeeo L'XeO US 2013/0324481 A1 Dec. 5, 2013 SUSTAINED RELEASE EYE DROP invention disappear harmlessly after delivering active agent FORMULATIONS to the desired site. The formulations of the present invention provide for novel therapies that are easily used by qualified RELATED APPLICATIONS medical practitioners as well as by Subjects in need thereof. 0001. This application is a continuation of U.S. patent The formulations deliver therapeutic and non-toxic levels of application Ser. No. 12/236,877, filed on Sep. 24, 2008, active agents over the desired extended time frame, often which claims the benefit under 35 U.S.C. S 119(e) of U.S. primarily at the site of administration. Patent Ser. No. 60/960,315, filed Sep. 25, 2007, entitled Sus 0006. The embodiments of the present invention provide tained Release eye Drops and Conveniently Implantable Sus for formulations for topical administrations of active agents tained Release Drug Formulations, by Vernon G. Wong and to the eye. The present invention provides for eye drop for Louis L. Wood, and is a continuation-in-part of U.S. patent mulations comprising at least one active agent in a biocom application Ser. No. 1 1/826,833, filed Jul. 17, 2007, which patible, biodegradable excipient that sustains the release of claims the benefit under 35 U.S.C. S 119(e) of U.S. Patent the active agent, and which may be chosen from tocopherol Application Ser. No. 60/831,991, filed Jul. 19, 2006, and isomers and/or their esters; and tocotrienols and/or their which is a continuation-in-part and claims the benefit under esters, such as d. 1 and dl isomers of C, B, Ö, e, m tocopherols 35 U.S.C. S 120 of U.S. patent application Ser. No. 1 1/236, and similar isomers of the tocotrienols and the esters of these 426, filed Sep. 27, 2005, now U.S. Pat. No. 7,906,136, issued tocopherols and tocotrienols with straight and branched chain on Mar. 15, 2011, which is related to and claims the benefit C2 to C20 aliphatic acids, or their esters of C3 to C20 straight under 35 U.S.C. S119(e) of U.S. Patent Application Ser. Nos. chain dicarboxylic acids; the mono, di, and triesters of O-ace 60/709,665, filed Aug. 19, 2005, and 60/614,484, filed Oct. 1, tylcitric acid or O-propionylcitric acid or O-butyrylcitric acid 2004, each entitled Conveniently Implantable Sustained with C1 to C10 straight and branched chain aliphatic alco Release Drug Compositions, by Vernon G. Wong and Louis hols; the mono, di, and triesters of citric acid with C1 to C10 L. Wood. Each of the foregoing applications is incorporated straight and branched chain aliphatic alcohols. In another in its entirety herein. embodiment of the invention, the active agent or excipient may be an omega-3 fatty acid or an ester thereof. Another FIELD OF THE INVENTION embodiment of the present invention provides for a formula tion comprising a nonpolymeric, biodegradable, bioabsorb 0002 The present invention relates to the field of ophthal able excipient and the active agent is one or more antioxi mology involving biocompatible, biodegradable, Sustained dants, either alone or included with one or more steroids release formulations of beneficial, active agents for topical and/or quinolone anti-infectives. Typically, the formulations administration to the eye. of the present invention provide for the sustained release of BACKGROUND OF THE INVENTION the active agent for at least four days. 0007. The active agent envisioned in an embodiment of the 0003 Current topical eye drop formulations, in addition to present invention is at least one agent of the analgesics, anes often eliciting some degree of transient irritation, provide thetics, narcotics, angiostatic steroids, anti-inflammatory Ste only short term exposure of beneficial agents to the eye and roids, angiogenesis inhibitors, nonsteroidal anti-inflammato thus often require several administrations daily. Other modes ries, anti-infective agents, antibiotics, antifungals, antivirals, of drug delivery, such as oral delivery and injection, may alpha androgenergic agonists, beta adrenergic blocking result in high and low blood concentrations and/or shortened agents, carbonic anhydrase inhibitors, mast cell Stabilizers, half-life in the blood, in addition to systemic delivery of miotics, prostaglandins, antihistamines, antimicrotubule medicaments that are only required in the eye. In some cases, agents, antineoplastic agents, antipoptotics, aldose reductase achieving therapeutic efficacy with these standard adminis inhibitors, antihypertensives, antioxidants, growth factor trations requires large doses of medications that may result in agonists and antagonists, vitrectomy agents, adenosine recep toxic side effects. Additionally, Some eye drop formulations tor antagonists, adenosine deaminase inhibitors, glycosyla are unstable over the normal period of treatment, which may tion antagonists, anti-aging peptides, topoisemerase inhibi be exacerbated by patient mis-handling. The technologies tors, anti-metabolites, alkylating agents, oncogene activation relating to controlled drug release have been attempted in an inhibitors, telomerase inhibitors, antibodies or portions effort to circumvent some of the pitfalls of conventional thereof, fusion proteins, tyrosine kinase inhibitors, ribonucle therapy. Their aims are to deliver medications on a continuous otide reductase inhibitors, cytotoxins, IL2 therapeutics, neu and Sustained manner. rotensin antagonists, peripheral sigma ligands, endothelin 0004. There remains a need for a more economical, prac ETA/receptor antagonists, antihyperglycemics, anti-glau tical, and efficient way of producing and manufacturing drug coma agents, anti-chromatin modifying enzymes, insulins, delivery systems that may be used locally, in liquid, gel, or glucagon-like-peptides, immunosuppressive agents, tissue ointment formulations. In particular, there remains a need for repair agents, essential fatty acids, and nucleic acids such as Sustained-release formulations for topical administrations antisense oligonucleotides, siRNA or RNAi. (eye drops) of beneficial, active agents to the eye. 0008. In another aspect of the present invention, more than one biodegradable, biocompatible excipient may be used to SUMMARY OF THE INVENTION facilitate Sustained release of an active agent. For example, a 0005.
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