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Eye care moving toward multidose preservative free bottles for medications, tears
The bottles offer several advantages for patients, but there are technological challenges to producing them.
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There has been a trend over the past few years to move toward multidose preservative-free, or MDPF, bottles for prescription medications and artificial tears. The reasons for using an MDPF bottle are numerous:
- Preservatives often cause ocular toxicity, resulting in discomfort, blurred vision and noncompliance.
- Most patients prefer the convenience of a bottle over unit dose vials.
- Many patients will open and reuse their unit dose vials, keeping them at room temperature for days or weeks after they are opened, risking contamination.
- It is easier and less bulky to carry a bottle than several boxes of single unit dose vials.
- There is no product waste, ie, it can be used until the last drop.
- It is more environmentally sustainable. It uses around eight times less plastic and nine times less energy for transportation.
- It administers one drop at a time (no streaming).
- There is a calibrated drop size.
- Some MDPF designs have a colored tip, which helps patients direct the drop into the eye.
- Patients with arthritic hands generally prefer bottles over unit dose vials, which can be challenging to twist off the top and squeeze the “belly” of the vial.
- No sharp edges mean less risk of injury compared with unit dose vials.
The technological challenges in producing such a bottle, however, have been daunting. For years, designers have attempted to make MDPF bottles that are both contamination-proof and cost-effective to produce, but they have often met with failure. Some designs are indeed contamination-proof but cost a great deal to manufacture, even on a massive scale; these bottles have a high unit cost even before they are filled with medication or artificial tears. Others are much cheaper to mass produce but fail the contamination tests required by FDA, which include absence of tip contamination, no “suck-back” of airborne contaminants, and biocompatibility of the drug and materials.
Some of the MDPF bottle designs over the last few years have included 3K (Ursapharm), Ophthalmic Squeeze Dispenser (Aptar), Abak (Théa), Vismed (TRB Chemedica), Novelia (Nemera) and NDC MDPF.
In 2016, the FDA approved the Aptar Squeeze multidose bottle for Restasis (cyclosporine ophthalmic emulsion 0.05%, Allergan). It features a unidirectional valve and air filter that prevent contaminants from entering the bottle. The Novelia design is also in common usage; it is utilized in the production of Oasis Medical MDPF tears and Freshkote PF tears (Eyevance). These two bottles have the Novelia design in common but are made from different plastics. The Freshkote PF has more than 300 drops; the drop count in the Oasis Medical MDPF bottle is unknown. Eyevance and Oasis Medical are the only companies that are currently offering their artificial tears in the MDPF bottle while also distributing (either selling or sampling) that same tear in unit dose vials.
Retaine HPMC lubricant eye drops (hypromellose ophthalmic solution 0.3%) from Ocusoft are a MDPF artificial tear that is available in a 10 mL size; it features an original airless pump design and holds 300 drops.
There is another design, the NDC delivery system, that has been used successfully for years in the food and cosmeceutical industries; it is under serious consideration for use in MDPF ophthalmic drop bottles. The NDC system has a preservative-free main chamber, a one-way valve and an antimicrobial tip that has passed rigorous testing at New York Medical College for reservoir and tip sterility. The patient uses an easy-to-depress button to dispense a metered drop.
In summary, the availability of easy-to-produce, reasonably priced, contamination-proof MDPF bottles is a significant advancement in ophthalmology that will enhance comfort and compliance while decreasing ocular toxicity for our patients.
Editor’s note: This article has been updated to remove a paragraph that incorrectly described products and manufacturers.
- For more information:
- Marguerite B. McDonald, MD, FACS, can be reached at Ophthalmic Consultants of Long Island, 360 Merrick Road, Lynbrook, NY 11563; email: margueritemcdmd@aol.com.
Disclosure: McDonald reports she has a financial relationship with NDC, Eyevance and Allergan and is a consultant to Ocusoft.