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New, Fully Operational Containment Suite
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The new containment suite is a testament to Colorcon’s commitment to supporting pharmaceutical development, our customer focus and promise to excel.
Many development companies work with small quantities of active ingredients which can have unknown safety profiles with limited availability and be extremely costly. The containment suite provides the capability to develop early phase prototype tablet or capsule dosage forms for clients when active pharmaceutical ingredient (API) quantity is limited and/or the API potency requires a higher level of protection. The lab utilizes mobile isolation modules to offer maximum process flexibility.
Learn more about these new lab capabilities.
With Colorcon’s understanding of formulation development, along with excipients and coatings, we can support early phase screening activity, providing both big pharma and virtual or small companies complimentary access to our experts, equipment, and services as well as generating non-GMP prototypes of the dosage form for subsequent clinical supply. The expanded facility, with new capabilities and professional expertise, means developers can manage through challenges they face today and years ahead.
Tour our containment suite virtually.
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Improving Stability of a Moisture Sensitive Drug
Stability issues with moisture sensitive drugs are common. Ranitidine HCI, is a widely prescribed and OTC medicine for the treatment of GERD, erosive esophagitis, and stomach and intestinal ulcer. The stability of ranitidine HCI is significantly affected by elevated humidity and temperature. Recently, the FDA recommended to recall some ranitidine HCI formulations from the market over the concern of N-nitroso dimethylamine (NDMA) impurity. This recall presented an opportunity for affected pharma companies to reformulate their product using core excipients to help improve drug stability.
A recent study by Colorcon demonstrated improved stability of ranitidine HCl, with the inclusion of Starch 1500®, partially pregelatinized starch. Presented as a poster during the AAPS Annual Meeting in 2020, the work confirmed inclusion of Starch 1500® within the core formulation reduced the rate of degradation of ranitidine HCl and led to lower levels of total impurities. Inclusion of Starch 1500 enhanced stability due to its moisture scavenging property, reducing drug hydrolysis and degradation.
Multi-compartment compliance aids (MCA) or pill organizers are frequently used by patients to manage their treatment regimes. However, there are not many studies showing how the stability of drugs when stored in these aids is impacted. Find out more about how the selection of Starch 1500, can positively impact the formulation of moisture sensitive drugs when used in an MCA. Improving the Stability of a Moisture-Sensitive Drug - Ranitidine HCl (colorcon.com).
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The Power of Productivity
In continuous processing, focus has shifted from high throughput to process flexibility, quality improvements and manufacturing gains. Regulatory agencies, such as the FDA also recognize the benefits in advancing manufacturing processes to reduce production interruptions and product failures.
The continuous film coating process can shorten coating times and provides excellent color uniformity.
As interest grows, Colorcon has responded by not only developing high productivity coating systems but has also invested in a continuous coating machine, the Driaconti-T coater. Situated in the Global Technical Center in Harleysville, PA, USA, the equipment is now fully validated and ready for customer projects.
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Meeting Label Friendly Needs
Colorcon recently expanded the line of Nutrafinish® Film Coatings to include a Label Friendly option for the nutritional and dietary supplements market. These best-in-class coatings are designed to meet consumer needs for simple ingredients and clean label.
Nutrafinish®, Label Friendly Coatings, use “naturally-derived” pigments and exclude the use of titanium dioxide (TiO2) and talc. High opacity white, clear and pigmented coatings provide a high-quality tablet finish, with superior opacity.
Through the extensive Nutrafinish® portfolio, Colorcon reduces complexity and time-to-market by delivering high-quality products, with carefully selected ingredients or approved food additives that meet local regulatory requirements and support clean label claims.
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Colorcon's Virtual Color Selector
Select and streamline your color choices to support brand differentiation using the online Color Selector tool. Colorcon enables you to visualize a rainbow of colors online, then helps you to make the right choice for your film coatings.
It’s worth noting, as with any online color visualization, the colors displayed are subject to the settings and performance of the screen displayed on.
Specialists will work to confirm the right coating system to meet your needs and check the acceptability of pigments for your application and target market. They’ll work diligently to provide the right coating system containing the exact amount of pigments to match the shade and intensity you desire. If regulations may restrict your choices, Colorcon will work with you to obtain the closest match possible, helping you meet your brand goals.
Open up to a New World of Color® with the On-line Colorcon Color Selector.
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Specialty Markets LinkedIn Page
Colorcon’s Specialty Markets is pleased to share they have joined the LinkedIn community!
The Specialty Markets page gives the No-Tox and Food & Confectionery divisions of Colorcon a platform to share their expertise and educate across the food, pharmaceutical and medical markets.
No-Tox direct and indirect contact products offer the safest printing ink and coating options for consumers and the environment by using only FDA food additive components and EU food contact compliant materials.
The Food & Confectionery Division of Colorcon offers products to color, glaze, polish, coat and enhance the appearance of food. With best-in-class technologies and value-added services, including technical service, global regulatory information and product development support, the team are dedicated to assuring our customer's success from development through to final product.
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Continuing Education
Register for Colorcon’s Coating School!
Now available as virtual events with interactive sessions, the program is presented in a modular way, with understanding tablet preparation, the fundamentals of film coating, dispersion preparation and how to ensure an optimal coating process. Throughout the coming months these events will be supported by live demonstrations from around the world.
With 2-3-hour sessions, held across 2-3 days, the events cover theoretical and practical aspects of film coating, laboratory and production scale coating equipment, troubleshooting and the latest innovation in coating solutions, with live Q&A.
Learn more about film coating. Register for our next school now.
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