Ophthalmics Process by Merck – Keep a close eye on quality and safety

Reduce risk and overcome challenges

Ophthalmic drugs pose special formulation challenges to manufacturers. In general, choosing the right processes and materials is important to ensure the required quality, drug tolerability and patient adherence. Formulators must pay attention to tonicity, pH, stability and viscosity, as well as sterility and microbiological purity, which has to be assured throughout the time of use. The final ophthalmic formulation must remain sterile, microbially pure, and stable throughout shelf life. Finding the right excipient that supports these needs is key.

Merck´s large product portfolio covers all excipient groups required for ophthalmic formulation, such as viscosity enhancers, surfactants, buffers and pH regulation agents, isotonicity adjusting agents as well as antioxidants and preservatives – all in the right quality.

Mitigate risk during formulation development.

For an ophthalmic formulation to succeed, making sure all of its properties are in line with regulatory guidelines right from the start is essential.

We are aware that developing formulations to treat ocular diseases is challenging and that requirements for the final product are high. To support full supply chain transparency and risk mitigation, we not only provide excipients in the highest quality but also in-depth, consistent documentation in a centralized location, so you can access the information you need when you need it. And when it comes to regulatory expertise, our experts
are always here to support you.

Features

A vast portfolio of top-quality raw materials for all dosage forms in line with ophthalmic industry standards and needs
Seamless service to support your process from formulation to final fill
Special capabilities and services such as customized packaging available on request
Comprehensive ready-to-use Emprove® documentation

Our Emprove® Program, along with the Emprove® Expert portfolio range, combines comprehensive documentation with excellent service, to support risk assessment and qualification for your ophthalmic process.

Benefit from PVA that meets your needs.

Our portfolio offers a wide range of polyvinyl
alcohol (PVA) grades of different viscosities,
molecular weights, and degrees of hydrolysis.
This way, we can provide you with a high-quality product for your exact need and application.

Broad range of PVA types for multiple application needs
Multi-compendial material
Additional specifications surpassing compendial requirements to support patient safety and good tolerability
Emprove® Program and documentation

Make the most of our preservatives.

Preservatives are used in liquid and semi-solid formulations to prevent microbial growth in pharmaceutical products and to increase the products’ shelf life. The solubility and chemical properties of preservatives mean they can be used in different types of formulations.

We offer a broad portfolio of preservatives suitable for multiple administration routes and dosage forms. And to help you navigate regulatory challenges, manage risks, and improve your manufacturing processes, we offer comprehensive documentation as part of our Emprove® Program.

Comprehensive portfolio of products
Multi-compendial
Emprove® Program and documentation

Ophthalmics Process

When designing a manufacturing process for ophthalmic
products and selecting a supplier, it is important to
consider the full breadth of needs from API synthesis
to final filling:

An integrated portfolio and contract manufacturing capabilities in APIs, critical raw materials (Chemiflex™), intermediates, solvents, excipients and other reagents (incl. cleaning in place) to ensure the required performance, quality and regulatory compliance in every step of your process

Services to support development, compatibility and integrity testing
A comprehensive range of chromatography solutions, filters and hardware for your purification steps
Final filters to ensure bioburden and particulate control and sterility in aseptic processes
Regulatory expertise and comprehensive documentation to meet stringent regulatory requirements

See the full brochure on “Ophthalmics Process by Merck” here

(click the picture to download the brochure)

Source: Merck brochure “Ophthalmics Process by Merck”