Enhancing ophthalmic care: the role of multidose with preservative (MDWP) In ophthalmology, multidose with preservative (MDWP) droppers remain a cost-effective and user-friendly pharmaceutical option. These containers maintain medication sterility and effectiveness over extended periods, thanks to preservatives that prevent microbial contamination. These containers maintain medication sterility and effectiveness over extended periods, thanks to preservatives that prevent microbial contamination. Erica Melo, Latam Business Development Manager at Unither Pharmaceuticals, brings nearly two decades of pharmaceutical industry experience, having held key roles at companies like Hypera, Dr. Reddy’s Laboratories, Allergan, and Blanver. Her expertise in sales, manufacturing, strategic partnerships, and commercial excellence offers valuable insights into the best pharmaceutical forms for patients. What is Multidose With Preservative (MDWP)? MDWP allow multiple doses from a single package, particularly important in ophthalmic products like eye drops. Preservatives prevent contamination, ensuring medication safety and efficacy throughout its use. What are the advantages of MDWP? The inclusion of preservatives extends the shelf life of the medication by preventing bacteria and fungi growth, maintaining its effectiveness until the last dose. They are cost-effective, reducing waste and offering significant savings compared to single-dose alternatives. They provide greater convenience for patients, improving adherence to medication regimens. Additionally, these containers are more environmentally friendly, resulting in less plastic waste and a smaller carbon footprint. Can you elaborate on the applications in ophthalmology? They are commonly used for treating chronic eye conditions such as glaucoma, dry eye syndrome, and allergic conjunctivitis by dispensing medications like beta-blockers, artificial tears, and antihistamines. These containers are also essential in post-surgical care, providing antibiotics, steroids, and NSAIDs to prevent infections and control inflammation. Additionally, they manage eye infections, offer diagnostic and therapeutic solutions like mydriatics and anesthetics, and support contact lens maintenance through cleaning and disinfecting solutions. What are the challenges linked to the use of preservatives in ophthalmology? The use of preservatives in ophthalmic products poses challenges such as preservative sensitivity and potential ocular surface damage with long-term use. To address these issues, preservative-free formulations and alternative delivery systems are being developed. While preservatives in multidose containers ensure safe, effective doses by preventing microbial contamination, some patients may be sensitive or allergic to certain compounds. A systematic review published in the British Journal of Ophthalmology demonstrated that benzalkonium chloride (BAK), remains prevalent in about 70% of available ophthalmic drops due to its broad-spectrum efficacy and long shelf life. The review found no significant differences in adverse effects between BAK-preserved and preservative-free eye drops. However, while preservatives like BAK are effective in preventing contamination, their use should be balanced against potential ocular surface issues, especially in long-term treatments (1). This highlights the need for careful consideration when selecting preservatives to ensure both efficacy and patient comfort particularly for those requiring long-term ophthalmic care. Can you tell us about the services provided by Unither Pharmaceuticals’ Butantã plant? Unither Pharmaceuticals provides comprehensive CDMO services, including the development and manufacturing of various pharmaceutical forms. We also offer out-licensing dossiers for ophthalmic products, facilitating regulatory approval and ensuring compliance with industry standards. Currently available dossiers include Carboxymethylcellulose Sodium (CMC) formulation for the MDWP form in multidose bottles of 10 or 15 ml. Our sterile and preserved solution, containing 0.5% and 1% CMC. Unither Pharmaceuticals has a significant presence in ophthalmology. Can you tell us more about Unither’s Butantã site manufacturing capabilities? To meet the demands of our customers and the multidose market, we have equipped ourselves with aseptic multidose filling capacity in São Paulo, Brazil. With more than 70 million vials manufactured each year, Unither’s Butantã site is a specialist in ophthalmology. Continuous investments are being made, including the acquisition of this plant in Latin America in 2022, which allows the company to manufacture ophthalmic healthcare products on four continents (Europe, Asia, North America, and South America). Our capabilities include the distribution, compounding, filling, and packaging of solutions and suspensions in multidose containers with preservatives, with a filling range of 1.5 to 15 mL. We are specialized in ophthalmic solutions and suspensions as well as otology products, adhering to standards and regulations set by ANVISA (Brazil), INVIMA (Colombia), DIGEMID (Peru), and DRAP (Pakistan). Conclusion Multidose containers with preservatives represent a significant advancement in medication delivery systems. They offer numerous benefits, including extended shelf life, cost-effectiveness, convenience, and reduced environmental impact. As the healthcare industry continues to evolve, these containers will play a vital role in ensuring that patients have access to safe, effective, and user-friendly medications. Unither Pharmaceuticals offers a synergistic approach to ophthalmic care by integrating multiple advanced technologies, including blow-fill-seal (BFS) technology, multidose containers with preservatives, and preservative-free multidose (PFMD) solutions. Each technology addresses different patient needs and regulatory requirements, ensuring comprehensive coverage for diverse markets. Reference: Hedengran, A., et al. (2019). Efficacy and safety evaluation of benzalkonium chloride preserved eye-drops compared with alternatively preserved and preservative-free eye-drops in the treatment of glaucoma: a systematic review and meta-analysis. British Journal of Ophthalmology. DOI: 10.1136/bjophthalmol-2019-315623.
