Celanese Advances Controlled-Release Science for the Pharmaceutical Industry
Celanese has announced that its subsidiary, Celanese EVA Performance Polymers, has launched VitalDose, a polymer-based excipient that facilitates drug makers' efforts to develop and commercialize novel controlled-release solutions.
Based on ethylene vinyl acetate (EVA) polymers, VitalDose excipients offer a wide degree of flexibility in the design of transdermal, subcutaneous implant and mucosal insert dosage forms. Celanese has combined its proven excipient technology with product development and regulatory expertise to deliver customized solutions to the pharmaceutical industry.
Celanese's VitalDose EVA excipients are currently being used in the development of various controlled-release pharmaceutical applications, including:
• polymer matrices
• drug reservoirs
• release-controlling membranes
• combination devices
• medical implants and inserts
According to Mark Murray, general manager of Celanese's EVA Performance Polymers business unit, the company is investing in new resources to grow with the evolving pharmaceutical market.
"With patents expiring and competition from generic pharmaceuticals on the rise, developing novel dosage forms is now key to retaining a competitive edge in the industry," said Murray. "Developing new routes of administration for existing products, or enhancing the bioavailability of newly developed yet poorly soluble drugs, are important options that pharmaceutical companies consider as a strategy to maintain the success of their product franchises. By applying our VitalDose EVA excipient technology, we are helping our customers retain an edge in a competitive marketplace filled with complex challenges."
Customizing excipients
VitalDose EVA release properties primarily depend on the ratio of ethylene to vinyl acetate (VA) content which Celanese can adjust as part of its manufacturing process. The VA content can be adjusted from 0% to 40%, which alters the polarity and hydrophilicity of the copolymer, ultimately enabling a wide formulation window regarding the release parameters of the active pharmaceutical ingredient (API). Furthermore, the molecular weight of the copolymer can be adapted to achieve the desired rheological properties (i.e., melt index) required by the end processing technique. EVA excipients are low melting thermoplastics that are especially suitable for processing temperature-sensitive APIs via mixing or melting manufacturing processes.
Jamie Beggs, market development manager, Celanese EVA Performance Polymers, describes how VitalDose EVA excipients offer customizable release properties and the potential for new delivery routes to be used in the development of product line extensions and new concepts.
"Drug developers, formulators and manufacturers are working with Celanese by tailoring VitalDose excipients to provide the dosage forms needed to optimize their API release profiles. The wide processing flexibility and formulating latitude of our excipients provide a unique solution to a variety of pharmaceutical applications and provide a novel delivery system to an industry that is highly competitive," said Beggs.
EVA polymers have long been known for their biocompatibility and bioinertness, and have been clinically accepted around the world. Celanese EVA VitalDose excipients are produced in accordance with agreed upon Good Manufacturing Practices (GMP) to ensure the highest quality. They are compliant with various international regulations for medical applications, such as USP-Plastic Class VI.
Celanese is committed to helping companies realize their product objectives with VitalDose EVA excipients, from proof of concept to commercialization. Alternative delivery routes and novel formulations are increasingly becoming a viable way for pharmaceutical companies to not only differentiate their products, but also provide benefits to patients and medical professionals through improved patient compliance. Celanese is dedicating resources to provide valuable insights into the structure-process-property relationships of EVA polymers and APIs. VitalDose is one of many innovative products currently being launched or under development at Celanese.
