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Safety Evaluation of Ocular Drug Delivery Products: Techniques and Practical Concerns

 Essay regarding Safety Evaluation of Visual Drug Delivery Formulations: Approaches and Useful Considerations

Toxicologic Pathology

http://tpx.sagepub.com Basic safety Evaluation of Ocular Medication Delivery Formulations: Techniques and Practical Things to consider Brian G. Short Toxicol Pathol 08; 36; forty-nine DOI: 10. 1177/0192623307310955 The web version of the article can be found at: http://tpx.sagepub.com/cgi/content/abstract/36/1/49

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Toxicologic Pathology, 36: 49-62, 2008 Copyright laws В© 08 by World of Toxicologic Pathology ISSN: 0192-6233 print / 1533-1601 online DOI: 10. 1177/0192623307310955

Safety Evaluation of Visual Drug Delivery Formulations: Methods and Functional Considerations BRIAN G. SHORT From Allergan, Inc., Irvine, California, USA. ABSTRACT Advancement new drug candidates and novel delivery techniques for treatment of ocular illnesses has recently faster. Treatment of anteriorsegment diseases provides witnessed advances in prodrug formulations and permeability enhancers. Intravitreal, subconjunctival, and periocular routes of administration and sustained-release products of nanoparticles and microparticles, as well as nonbiodegradable and eco-friendly implants to supply drugs to the posterior portion of the eye, are becoming popular therapeutic methods. Without sufficient regulatory insight into ocular drugs, such routes of operations and new formulations can pose unique challenges to those involved with designing nonclinical programs, which include considering scientific and non-clinical factors and choosing species, strains, and ocular degree of toxicity parameters. Toxicologic pathologists likewise contribute working experience to considering morphological effects of these book formulations. Finally, understanding species' anatomical differences is useful pertaining to interpreting toxicological and pathological responses to the eye which is important for individual risk assessment of these significant new solutions for ocular diseases. Keywords: Ocular medicine delivery; intravitreal; subconjunctival; periocular; ocular implant.

INTRODUCTION Millions of people suffer from a wide variety of ocular diseases, many of which usually lead to visible impairment and ocular blindness and expense the federal government about $4 billion annually (Clark and Yorio, 2003). Certain ocular disorders are quite unusual, whereas others, such as cataracts, age-related macular degeneration (AMD), and glaucoma, are very common, especially in the ageing population (Table 1). A rapid expansion of recent technologies in ocular drug delivery and new medicine candidates, including biologics, to treat these difficult diseases inside the anterior and posterior sectors of the vision have recently emerged. These kinds of approaches are necessary because the eyesight has many one of a kind barriers to drug delivery (Figure 1). Current routes of government include tend to be not restricted to topical operations, systemic administration, intravitreal shots, and intraocular implants, each of which has its own set of issues and disadvantages (Figure 2). Visual bioavailability after topical visual eyedrop operations, the most common type of ocular medicine , is less than 5% and often below 1%, and for that reason, only the conditions of the anterior segment of the eye can usually be treated with eyedrops. Blood-ocular obstacles, Address correspondence to: Brian G. Short, Allergan, Inc., 2525 Dupont Dr . RD-2A, Irvine, CALIFORNIA 92612. Short-hand: AMD, age-related macular deterioration; CNTF, ciliary neurotrophic factor; DDS, medication delivery program; ECT, encapsulated cell technology; ERG, electroretinogram; EVA, ethylene vinyl acetate; FIHS,...

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