Pharmaceutical companies are spirited about packaging advancements. The spiralling fervor is evident probably more with ophthalmic drug product manufacturers than in any other type.
Adverse Outcomes Raised Safety Concerns in Post-market Review
Pharmaceutical companies are spirited about packaging advancements. The spiralling fervor is evident probably more with ophthalmic drug product manufacturers than in any other type. Their packaging needs have evolved stridently fast, with patient’s safety risks and acceptability the guiding principle. The beacon has opened the ophthalmic packaging market to seek a bevy of design options that meet all criteria of the patient’s demand.
Both methods and materials use for packaging have advanced, supporting the array of ophthalmic products pharmaceutical companies market year-over-year in North America. Among several points that have attracted attention, safety, dispensing accuracy, and the choice of packaging materials have been reverberating concerns, especially among ophthalmic organizations. These concerns certainly are key determinants that shape the acceptability of products in the ophthalmic packaging market. Evidently, pharmaceutical companies are keenly looking to incorporate unique features in the packaging design to meet these criteria.
Pharma Companies Mindful of Drug-Packaging Interaction for Patients’ Acceptability
Branded as well as generic ophthalmic drug products haven’t found it easy to navigate the complexity of ophthalmic packaging market. Eliminating adverse drug-packaging and minimizing interactions and contamination from tampering have been at the at the top of agenda of pphthalmic drug products (ODP) developers in the ophthalmic packaging market. Another aspect that has befuddled patients is them ensuring measured volumes of the drug to be dispensed, which is likely more to do with how the tip is punctured. Incidences have come to the notice of regulators when tamper-evident ring fell off to the patient’s eye, leading to significant irritations and cornea abrasions. Tamper-evident seal is also essential for clinicians working with ophthalmic products.
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Regulatory Push for Patient’s Safety Spurs Packaging Design Innovation
The U.S. FDA, European Medicines Agency (EMEA), and various other regional regulators have taken these concerns in serious strides. Their constant guidance shapes the direction of product development in the ophthalmic packaging market. Pharma companies have thus come to adopt robust testing and extraction/toxicological evaluations for their ophthalmic solutions and suspensions (OSS).
Aside from the design advancement, materials used for packaging are no less crucial for the formulation efficacy and patients’ safety. Despite the fact that plastics are most commonly usedand are preferred over glass-dropper combination, poor barrier to chemical migration has been a longstanding concern with certain plastics. These include low- and high-density polyethylene, LDPE, and HDPE. For instance, shedding of foreign materials from plastics have been brought to the fore by patients in their complaints to the FDA.
Numerous advances have been made to overcome the concerns and manage the complexity with compliance. New norms have come to the fore for qualifying leachables and extractables of ODPs. Pharmaceutical companies catering to the demand for ODPs will likely benefit from a comprehensive and clear database of toxicity endpoints
Multi-Dose Ophthalmic Packaging Key Focus
Stridently, the intensifying need for regulatory compliance have nudged pharmaceutical companies to constantly strengthen their value chain. A notable development has been growing number of partnerships and collaborations between ophthalmic drug packaging and product manufacturers.
Collaborations to Set Tone for Frequent Innovations
Pharmaceutical companies in have come to engaging with contract packaging and filling experts in North America. The use of patented multi-layer technology has largely set the tone for product innovation in the ophthalmic packaging market.
Ophthalmic drug delivery research has made vast strides particularly ophthalmic delivery of antibiotics. These research studies have been spurred by epidemiological trends. There is a substantial demand for multi-dose drug forms for various patients with ocular diseases. The prevalence of Meibomian gland dysfunction, microbial keratitis, and dry eye in worldwide populations is a key trend. The growing use of OTC antibiotics have been used for eye infections. However, ocular drug delivery is ridden with numerous technical challenges, such as low bioavailability of the drug.
Thus, packaging companies are relentlessly looking to come out designs and materials that improve these drug delivery forms considerably over the next few years. Studies are ongoing for developing unit dose ophthalmic packaging for those who want to disrupt the marketplace in North America.
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