Preservative-free multidose

Over the past decades, a trend has been emerging encouraging the use of multidose preservative-free bottles. Indeed, in order to avoid bacterial contamination, the vast majority of the ophthalmic packaging market has been used by multi dose eye droppers which requires preservatives.
The main issue lays in the observation that the use of preservatives can damage the patients’ eyes by causing ocular irritation or allergies. Patients need a convenient and affordable way to avoid drugs with preservatives.

According to the European Medicines Agency, preservatives should be avoided for patients undergoing a long-term treatment, or  forpatients who do not tolerate preserved eye drops. Switching to preservative-free topical ocular medications can decrease preservatives' harmful effects.

Innovations in glaucoma and dry eye syndrome management -  especially  the use ofpreservative-free medicines in multi dose bottles - allow an effective and convenient intraocular pressure control for glaucoma and dry eye patients (adults). Glaucoma is a  typeof eye conditions that damages the optic nerve, it is often caused by an abnormally high pressure in the eye. Glaucoma is one of the leading causes of blindness and dry eye. As an effective glaucoma treatment, your doctor may prescribe eye drops, oral medications, laser surgery or microsurgery in order to lower the pressure in your eye.

Eye drops allow to lower the creation of fluid in the eye or increase its flow out, lowering its pressure.

There are numerous reasons to opt for  multidose preservative-free bottles:

  • to avoid ocular toxicity
  • patients mostly prefer the convenience of a bottle (over unit dose vials) as they risk contamination by opening and reusing their unit dose vialsas they are being kept at room temperature for days
  • bottle is easier to carry than several single unit dose vials
  • to generate no product waste making the form more environment-friendly

In order to meet the demand of its customers and the preservative-free ophthalmology market, Unither Pharma has equipped itself with a multi dose aseptic filling capacity machine. Therefore, Unither Pharma is able to offer development services and subcontracting of ophthalmic formulas for both BFS and PFMD technologies

Specifities

  • Filling: 5 mL, 10 mL, 11 mL, 15 mL
  • Cases 1, 2 or 3 bottles
  • Aptar’s OSD® and Nemera’s standard Novelia® OSD® droppers
  • Other droppers under development

Advantages

  • no preservatives
  • prevention of microbial contamination throughout the treatment period
  • complement to the BFS ophthalmological range

Manufacturing
process:

It is worth noting that there are technological challenges to produce these multidose preservative-free bottles. In fact, designers have attempted to produce multidose preservative-free bottles both contamination-proof and cost-effective, but the processus didn’t go as smoothly as it should have as some designs were contamination-proof but cost a great deal to manufacture.

Indeed, even before being filled with medication, multidose preservative-free bottles have a high unit cost. Some are much cheaper to mass-produce but fail the Food and Drugs Administration’ high standards contamination tests.

Multidose preservative-free bottles (which are easy-to-produce, available at a reasonable price and contamination-proof) represent a significant advancement in ophthalmology. The innovation will enhance patients’ comfort and compliance while decreasing ocular toxicity.

The aseptic dispensing technology has been developed to achieve a very high level of sterility assurance.

As with the BFS technology, the process design strongly limits the risk of environmental contamination as the machine is:

  • cleanable in-situ,
  • sterilizable in-situ,
  • integrated in a continuously monitored isolator
  • supplied with sterile vials and droppers, contained in specific bags allowing aseptic connection of the double door sealed transfer type (DPTE/RTP)

Authorizations

The site is regularly inspected by various authorities including: EU GMP, FDA, Brazil, MFDS (Korea), Russia, Belarus, and other health authorities around the world.

Manufacturing plants and capacities

Coutances, France
> 25 million bottles/year


 

Blow-fill-seal

Liquid Stick-Packs

Bottles