Colorcon's Excipient Qualification Program Supports Increasing Global Regulatory Requirements
Numerous and often complex regulations have been implemented around the world to ensure that excipients used in drug applications are safe. Colorcon can support our customer’s supplier qualification efforts through our comprehensive excipient control programs. As the leading global provider of film coating products, Colorcon critically assesses its raw material suppliers to verify they can meet Colorcon’s standards before using their excipients in our formulation processes.
Before any new product launch, Colorcon performs a thorough investigation of all the regulatory requirements for the intended application, and target markets, to determine the key criteria to be met by each excipient. Significant confirmatory testing is done to verify compliance of each excipient to the crucial requirements. Excipient GMP is a requisite qualification for our suppliers, and Colorcon also assesses the supplier’s ability to provide appropriate business continuity assurances. In some circumstances, third-party certifications may be used to supplement Colorcon’s supplier assessment process.
Colorcon’s regulatory and quality experts have built close relationships with international and local regulators and routinely meet with them to discuss issues related to excipient regulations. Colorcon is actively involved in global industry associations like the International Pharmaceutical Excipients Council (IPEC) Federation, a global organization that promotes quality in pharmaceutical excipients. The IPEC Federation represents the five existing member regions - IPEC Americas, IPEC Europe, IPEC India, IPEC Japan and IPEC China - and provides a unified voice to promote the best use of excipients in medicines as a means of improving patient treatment and safety.
Optimal use of excipients provides pharmaceutical manufacturers with drug development cost-savings, enhanced functionality capability and can also assist in formulation drug innovation.
Continuing in Pursuit of the Perfect Coating
At Colorcon, we are passionate about understanding all aspects of film coating; from the thermodynamics of coating application through to the mechanical movement of tablets as they progress through different types of coating equipment. Ensuring that a film coating is uniformly applied, while pushing for the lowest tablet transit times with the highest possible batch loads, and achieving color consistency is what drives our constant pursuit of perfection.
Recently we partnered with GEA and Kaiser Optical to examine the process robustness coupled with real-time and off-line measurements of tablet critical quality attributes (CQAs) using a non-contact Raman Spectroscopic Probe (Kaiser Optical) for our newest product, Opadry® QX, quick and fleXible film coating system. This was a follow-up to earlier studies with other continuous processing equipment. (1,2). The study published in European Pharmaceutical Manufacturer (EPM), discusses the work presented at the 30th International Forum and Exhibition on Process Analytical Technology, Washington DC (USA), 2016, which examines real-time measurements of critical quality attributes (CQA's); tablet coating weight gain, and off-line measurements of gloss, surface roughness and color uniformity when coating in the GEA ConsiGma™ Coater. Through the application of Opadry QX, to 3% weight gain (3 kg batch sizes), tablets were perfectly coated in just over three minutes, further validating the superior performance of Opadry QX for use in continuous processing equipment.(3)
(1) December 2015 Solid Dose: Keeping Pace with Continuous Coating »
(2) July 2015 Solid Dose: Continuous Process Update »
(3) Application of a Developmental, High Productivity Film Coating in the GEA ConsiGma™ Coater »
Capsule Formulation: Let it Flow with StarCap 1500®
While often used in capsule formulations as a disintegrant, native corn starch requires further excipients to make up for less than adequate flow and lack of compressibility. These additional ingredients add formulation complexity with the potential for drug interactions, extra raw material testing and inventory management.
StarCap 1500® , co-processed starch excipient replaces complex capsule filler combinations. Through co-processing of native starch with partially pregelatinized starch, StarCap 1500 provides an excipient that delivers improved flow and compressibility, and with rapid disintegration, it simultaneously simplifies the formulation. Capsule formulations using StarCap 1500 result in clean and efficient filling operations through superior flow and low adhesion. As a one-stop capsule excipient, it offers the best combination of performance and simplicity. To learn more about StarCap 1500, view the latest literature or contact your dedicated Colorcon representative to discuss how we can help with your current formulation challenge.
A Solvent-Free High Productivity Technology for Barrier Membrane Coatings: ETHOCEL™ HP
Through the Controlled Release Alliance, Dow recently launched ETHOCEL™ High Productivity (HP), an innovative new product designed for barrier membrane coating using powder layering, using rotor technology. By providing a solvent-free solution, Colorcon can offer our customers a more efficient coating process and extend the range of technical solutions we provide.
ETHOCEL™ HP complements Colorcon’s existing product portfolio for barrier membrane multiparticulate and taste-masking applications, which includes the aqueous-based system, SURELEASE®, ethylcellulose dispersion type B NF, as well as traditional ETHOCEL™ grades for organic coating.
Choosing the Right Size Sphere
It’s imperative to choose the right size Suglet®, sugar sphere, for a modified release multiparticulate dosage form, to ensure a robust formulation and achieve the most efficient processing time. Smaller size sugar spheres can present disadvantages as they are harder to coat, due to the higher incidence of agglomeration and the larger surface area requires higher weight gain of coatings to achieve similar film thickness.
In a recent study we have shown that using a Colorcon proprietary tool, My Dosage Design, film thickness and surface area to film thickness ratios, can be determined to predict drug release rates with various size sugar spheres as the starter core. Through My Dosage Design, variables relating to the multiparticulate dosage form can be calculated for different stages of the process; this includes particle size, surface area, film thickness, the volume of the final dose and the size capsule shell required to fill. The goal of My Dosage Design is two-fold, predicting drug release and minimizing processing issues related to smaller bead size.
Building Capacity to Meet Demand for Pharmaceutical Spheres
As growth continues for multiparticulate dosage forms, especially for geriatric and pediatric populations, there is an ongoing need in the industry for a consistent supplier who provides a high-quality multiparticulate product, with a robust business continuity plan. Colorcon is building capacity to meet demand and investing to support our growing customer base around the world.
At Colorcon, we have continued to improve and expand our sphere operations to offer the best quality product from our two Suglets manufacturing locations, Stoughton, Wisconsin, USA, and Bazainville, France. As the only manufacturer dedicated to the production of spheres for pharmaceutical use, we have the ability to produce equivalent products from both sites, providing much-desired business continuity.
New investments, which increase our annual capacity by 50%, are being made ahead of anticipated demand to manage product availability efficiently for our customers. This expansion complements Colorcon's existing investment in its people, capabilities, and organization, which have consistently delivered superior products and services to Colorcon's pharmaceutical and dietary supplement customers.
Local Production Coming Soon to Brazil
During this year’s FCE conference in Sao Paulo, Brazil, there was excitement around Colorcon's announcement of the investment in a new manufacturing facility in Brazil.
The facility, scheduled to open in January 2017, is the first production plant in the region, the eleventh around the world and the seventh dedicated exclusively to film coatings. This is another excellent opportunity to demonstrate the full support Colorcon provides to our customers, staying closer and supplying them with a much shorter lead-time for the full range of pigmented and clear/white film coatings.
The plant reinforces our business continuity plan, extends product shelf-life for locally manufactured pigmented formulations, and simplifies logistics management. Customers will benefit from supply chain security, locally manufactured coatings and a wider range of batch sizes. All these benefits will demonstrate, once again, our commitment to supporting our customers better than anyone else, earning the position of Your Supplier of Choice.
Colorcon Latin America is again the proud winner of the 2016 Sindusfarma Quality Award for Raw Materials Supplier (Excipients), in Brazil. The award, created by Sindusfarma, recognizes companies that help raise standards, ensure drugs meet sanitary specifications and provide products with the quality the market demands in the region.