The Solid Dose - Colorcon News

Connect with Colorcon

Colorcon recently upgraded its website to mobile-enabled technology making access simpler and content easier to read across any device. With this update comes engaging new content to help you get the best in coating performance - our Connect with Colorcon® best practices series.

No one anticipates scale-up problems, product registration delays or downstream manufacturing issues, but they can happen. In this new series, we share tips and tricks from our technical experts around the world. Our goal is to share their collective knowledge to help you avoid coating problems, from bench to market, before they occur.

“Connect with Colorcon”, available to subscribers through the website will provide access to the latest best practices that only coating experts like ours can bring.

Start now by reading our first tips on avoiding adhesion problems. As the series promises, we’re confident we can help improve your process, delivering a superior finish for your product because better film coating starts with a conversation.


Approaches to Reduce the Weight of Extended Release Tablets: Metformin HCl

Extended Release (ER) matrix formulations of high dose drugs, like metformin, typically result in large tablets which often have a negative impact on patient acceptance, compliance, and ease of swallowing.

Recently, researchers at Colorcon studied how to reduce the weight of ER medications using a tablet containing 500 mg dose of metformin HCI as the model drug. Various approaches, such as polymer blends and barrier membrane coating, were evaluated.

Formulations were prepared on a small scale to understand primary drug release compliance to different USP criteria for dissolution test specifications.

Learn how Colorcon formulation methods help address dosage design with medication adherence and patient compliance concerns in mind.

Study of Dose-Weight Proportionality for Fixed Dose Combinations (FDCs)

Colorcon continues to study innovative ways for formulators to address patient acceptability in the development of their solid oral dosages.

Fixed dose combinations offer the advantage of reducing the complexity of medication management, especially in the elderly. However, a potential disadvantage does exist with FDC formulations, due to the resulting increase in tablet size.

To address this concern Colorcon recently conducted a study of FDC bilayer tablets, with immediate and sustained release combinations (IR/SR).

The findings, presented at the 2017 Controlled Release Annual Meeting, explored ways to achieve dose-weight proportionality in (FDC) bilayer tablets with constant IR dose, different SR doses and vice-versa.

Link to Poster »

Regulatory & Quality

Smaller Packaging and Reduction in Off-Color Particles

You asked. We responded

POLYOX Water-Soluble Resins
In the last edition, we reported on the result of improvements Dow has made to extend retest intervals for POLYOX; enabling wider use of this polymer for modified release applications. The grades, which still have a six month re-evaluation period, are now being offered in a smaller pack size (25 kg instead of 63 kg), to better support pilot and small scale manufacturing. For R&D trials an even smaller 4.5 kg pack is available, helping to reduce waste and inventory.

Off-Color Particles (OCP), also referred to as Technically Unavoidable Particles (TUP), continue to be an industry-wide concern, and steps have been taken to reduce these occurrences with POLYOX.

Click here to learn more »

Investments Complete to Match Demand for Pharmaceutical Spheres

Multiparticulate dosage forms have grown for pediatric and geriatric populations as they offer unique advantages and flexibility to formulators as well as patients and care providers; including the ability to mix with food for ease of swallowability. They also offer choices to formulators through different dosage forms such as capsules, sachets or compression into tablets; modulation of drug release by mixing beads with different coatings to achieve a range of drug release profiles and fixed-dose combination formulation.

As such, 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.

Recognizing that need, Colorcon has added capacity to meet demand, and we continue to invest to support our growing customer base around the world.

At Colorcon, our sphere operations offer the best quality product from both our Suglets® Sugar Spheres, manufacturing locations in Stoughton, Wisconsin, USA, and Bazainville, France. As the only manufacturer dedicated to the production of spheres for pharmaceutical use, we can produce equivalent products from both sites, providing much-desired business continuity.

In 2016, new investments increased our annual capacity by 50%. This latest expansion complements Colorcon's investment in its people, capabilities, and organization, which have consistently delivered superior products and services to Colorcon's pharmaceutical and dietary supplement customers.

Click here to learn more about Suglets, best-in-class drug layering substrates.

Driving Business Growth

There is a lot going on in the world of OTC and dietary supplement development. Worldwide, disposable incomes are on the rise, resulting in wellness and prevention programs that are creating opportunities for growth for supplement manufacturers. In many regions of the world, packaging claims such as “no artificial colors”, “improved taste”, “ingredients derived from natural sources”, “organic”, and “Non-GMO” are influencing consumers to choose one brand over another.

Nutra, Natural Advantage Coatings, introduced by Colorcon in April of 2017 across Europe and North America, are formulated to help manufacturers develop consumer health products with these challenges in mind.

Colorcon has designed a wide range of coating systems including colors derived from natural sources, as well as non-GMO excipients.

Nutra, Natural Advantage coatings are supported by Colorcon’s extensive network of tablet design, technical and regulatory professionals to assist in developing a finished consumer health product with the competitive edge needed to drive business growth. Our in-depth knowledge of colorant regulations, market data, design tools and technical support help speed products to market in this highly competitive environment.

Click here for more information »


Local Production Begins in Brazil

Colorcon is excited to begin shipping pigmented and clear film coating formulations from the new Indaiatuba, Brazil manufacturing plant on October 1, 2017.

Those customers who had previously approved the facility after the ANVISA license was granted in June, were already taking advantage of the shorter lead time this local Latin American production facility can now provide.

As the eleventh Colorcon production plant and the seventh dedicated exclusively to film coatings, our Latin American team is especially proud to mark this occasion as another part of Colorcon’s history of investment in response to market development needs and growth.

Supporting Pharmacy Education in China

Colorcon China announced the formation of a Five-Year Scholarship and Teaching Bonus Agreement with the School of Pharmacy, China Pharmaceutical University.

The program rewards both students with outstanding academic performance and young teachers who make an exceptional contribution to oral solid dosage formulation.

Expansion of Technical Service Network in Asia

It has been a busy summer for Colorcon Technical specialists as they marked the opening of two new Technical Services Laboratories (TSL) in Asia -- our 20th and 21st worldwide.

In June, our teams supported the opening the new TSL and Conference Facility in Nodia, New Delhi, India (left). The facility extends Colorcon’s direct support to customers and supplements the existing laboratory facilities established in Goa.

In August, a new laboratory in Vietnam was opened, located at the Ton Duc Thang University (right). As Prof. Dr. Minh Duc Nguyen, Dean of Faculty of Pharmacy at the University comments “The Colorcon laboratory is a good symbol of the collaboration in education and research between Ton Duc Thang University and the industry, which helps to provide students professional knowledge and skills during their study and contribute to the research on high quality pharmaceutical solid dosage forms for the health of people."

In addition to technical support, both facilities provide the opportunity for our teams to extend the educational events offered through the Colorcon Academy such as the Colorcon Coating Schools and Formulation Training Programs which will facilitate knowledge sharing and benefit individuals as well as their companies.

For more information on any products or services mentioned in this newsletter, please Contact Us!

North America

Latin America
+54-11- 5556-7700

Europe/Middle East/Africa



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