Ophthalmic drug products packaging

The ophthalmic drug products are usually solutions marketed in a LDPE bottle with a dropper built into the neck. A few solution products use a glass container due to stability concerns regarding plastic packaging components. 

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... 

It is quite rare that the composition or the packaging of an ophthalmic pharmaceutical will lend itself to terminal sterilization, the simplest form of manufacture of sterile products. Only a few ophthalmic drugs formulated in simple aqueous vehicles are stable to normal autoclaving temperatures and times (121°C for 20-30 min). Such heat-resistant drugs may be packaged in glass or other heat-de-formation-resistant packaging and thus can be sterilized in this manner. The convenience of plastic... 

Topical dosage forms such as unpressurized sprays, lotions, ointments, solutions, and suspensions may be considered for marketing in glass bottles with appropriate dispenser. Some topical drug products, especially ophthalmic, are sterile or may be subject to microbial limits. In these cases, packaging material and handling should be done as those for injectables. 

One of the important requirements of any packaging material is that it should not release any component into the drug product. Preparation of containers free of any leachables such as monomeric component is especially important for the containers of ophthalmics, parenteral products, and any liquid products. It was shown that di(2-ethylhexyl) phthalate was released from the PVC bags and that caused haziness of the taxol solution (37), USP/NF offers the protocol of chemical, spectral, and water vapor permeation tests and tolerances for plastic containers (55). Among those, chemical test is designed to give a quantitative assessment of the extractable materials in both organic solvents and water. 

---