Ophthalmic products/drugs

The potential effects of packaging component/dosage form interactions are numerous. Hemolytic effects may result from a decrease in tonicity, and pyrogenic effects 

Performance of a syringe is usually addressed by establishing the force to initiate and maintain plunger movement down the barrel and the capability of the syringe to deliver the labeled amount of the drug product. 

These drug products are usually solutions marketed in a LDPE bottle with a dropper built into the neck (sometimes referred to as droptainer) or ointments marketed in a metal tube with an ophthalmic tip. A few solution products use a glass container because of stability concerns 

Although ophthalmic drug products can be considered topical products, they have been grouped here with inject-ables because they are required to be sterile (21 CFR 200.50(a)(2)) and the descriptive, suitability, and quality control information is typically the same as that for an injectable drug product. Because ophthalmic drug products are applied to the eye, compatibility and safety should also address the container closure system s potential to form substances which irritate the eye or introduce particulate matter into the product (see USP 771 Ophthalmic Ointments). 

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Patrick Faustino Division of Anti-Inflammatory, Analgesic and Ophthalmic Drug Products, FDA, R 310,9021 Corporate Boulevard, Rockville, Maryland 2085, USA... 

Bimatoprost, latanoprost, and travoprost may be used concomitantly with other topical ophthalmic drug products to lower lOP. If more than 1 topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart. 

Drug Products for Injection and Ophthalmic Drug Products... 

Although ophthalmic drug products can be considered topical products, they have been grouped here with injectables because they are required to be sterile and the descriptive, suitability, and quality control information is typically the same as that for an injectable drug product. 

Since ophthalmic drug products are applied to the eye, compatibility and safety concerns should also address the container closure system s potential to form substances which irritate the eye or introduce particulate matter into the product (USP (771), ophthalmic ointments). 

The primary disadvantages of metals relate to their cost and quality control. Metals are inherently more expensive to purchase and to fabricate into a useful container. Metals also are prone to the development of pinhole defects during manufacturing that can drastically compromise their barrier properties— especially in particularly thin sections. Not only can these defects be deleterious to the container, but they can also compromise the quality of the pharmaceutical itself. Drug product should be monitored to assure that no metallic packaging defects have been transferred to the preparation—especially in ophthalmic drug products. Much like copolymerization of plastics, metals can be alloyed to enhance their characteristics as The USP has no test requirements for... 

Although usually considered to be inactive ingredients in ophthalmic formulations added because they impart viscosity, many of these polymers function as ocular lubricants. They are marketed as the active ingredients in OTC ocular lubricants used to provide relief from dry eye conditions. The regulatory requirements for these OTC products are found in the FDA CFR (21 CFR 349 Ophthalmic Drug Products for Over-the-Counter Human Use), and their formulations are presented in the 15th edition of the APhA Handbook of Nonprescription Drugs. 

In conclusion, the fluid dynamics in the precorneal area of the eye have a huge effect on ocular drug absoiption and disposition. When the normal fluid dynamics are altered by e.g., tonicity, pH, or irritant drugs or vehicles, the situation becomes even more complex. The formulation of ophthalmic drug products must take into account not only the stability and compatibility of a drug in a given formulation, but also the influence of that formulation on precorneal fluid dynamics. 

Lewis, D.B. (2011) Current FDA perspective on teachable impurities in parenteral and ophthalmic drug products. Presentation at the AAPS Workshop on Pharmaceutical Stability, Washington, DC, 2011. 

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