The US Center for Drug Evaluation and Research (CDER), part of the FDA, published its final version of a Guidance for Industry document: (2015) Size, Shape, and other Physical Attributes of Generic Tablets and Capsules applying to abbreviated new drug applications (ANDAs). The guidance conveys the FDA’s current thinking in relation to the design of generic tablets and capsules; and how manufacturers should ensure the design of a generic version does not hinder patient compliance.

At Colorcon, we maintain unique quality standards for our sugar spheres, SUGLETS®, going beyond the pharmaceutical monograph test requirements. To ensure a highly consistent product, we focus on three Critical Quality Attributes (CQAs): sphericity, particle size and friability.

Friability presents a specific user concern. During the drug layering process it can result in changes to particle size and loss of sphericity, potentially resulting in variability in drug release. Since there are no monograph limits for friability, we set out to raise standards, and through more relevant testing, deliver Suglets to our customers with lower friability.

Oscillating friability is shown to be an appropriate method to determine robustness; and with two years of historical data, Colorcon has implemented internal friability limits to ensure a robust, reliable substrate for our customers, especially when using Suglets with fluid bed processing. Today, all shipped batches meet our new lower friability specification, giving our customers consistent, high-quality product and peace of mind. Read more

Colorcon continues to support its customers interest in the rapidly evolving continuous coater technology area. The July 2015 Solid Dose Newsletter featured our work evaluating tablet movement, transit times and coating uniformity in a high throughput continuous coating process. Since then, we have completed an evaluation of our novel, developmental, film coating formulation capable of application at solids concentrations as high as 35%. The study was conducted in DRIACONTI-T® continuous-cycled coater that employs a unique, segmented drum configuration to convey the tablets through the coating process. Our trials resulted in excellent coated tablet appearance at low coating weight gain with color consistency. Details of this study are published in the October 2015 issue of Tablets and Capsules Evaluation of a Continuous-Cycled Film Coating in Applying a High-Solids Coating Formulation.

Dosage Form Design

Since 2007, when the EU Pediatric Regulation (191/2006) came into force, pharmaceutical companies have been obliged to complete a Pediatric Implementation Plan (PIP) for their molecules. The objective of the regulation is to ensure that medicines for use in children are high quality, ethically researched, authorized appropriately and improve the availability of information on the use of medicines for children.

The EuPFI (European Pediatric Formulation Initiative), a collaboration of academia, clinicians and industry, has been instrumental in promoting the development of pediatric medicines. The Geriatric Medicines Society is aiming to do the same thing for geriatric dosages.

FDA’s approval of Colorcon’s Color Additive Petition (CAP 4C0300) expands the use of Spirulina Extract in coating formulations applied to dietary supplements, drug tablets and capsules marketed in the United States. Colorcon developed its petition in response to requests from dietary supplement manufacturers for more naturally derived pigment options, specifically stable blue colors, which are difficult to achieve. The FDA, after their review of Colorcon’s updated safety assessment and additional product stability testing agreed to expand the range of product categories used in coating formulations in which Spirulina Extract can be used to include all types of pharmaceutical and dietary supplement tablets and capsules in the United States. Colorcon has confirmed with FDA that this approval also covers the use of Spirulina Extract in printing ink formulations applied to dietary supplement and drug tablets and capsules since the print films that result on the surface of a tablet or capsule are essentially discontinuous coatings.

Colorcon is extremely proud of Simon Tasker, Managing Director for his personal accomplishments and business achievements managing Colorcon operations in China. That’s why we were thrilled that the Shanghai Pharmaceutical Professional Association recently presented him with the February Flower Business Leadership Award. This prestigious award, given to business leaders of pharmaceutical and associated companies operating in Shanghai, recognizes Simon’s special commitment in leading and coaching his Colorcon team to success.