Colorcon is a world leader for the design and technical support of advanced coating systems, modified release technologies and functional excipients for solid oral dosage forms. Its long-term collaboration with PA Cuthbert aims to bring innovative products and technical support to the South African pharmaceutical industry.
Together, Colorcon and PA Cuthbert assist manufacturers in designing products for improved quality and patient compliance; supporting excipient quality by design (QbD) through knowledge, documentation and collaboration.
Colorcon constantly seeks new ways to enhance products and services for the pharmaceutical and nutritional supplement markets, and over many decades has played a vital role in the advancement of film coating technology and functional excipients to bring innovation to reduce manufacturing cost and improve finished product quality.
Film coatings for improved performance
In South Africa, the Opadry II high performance film coating system continues to be a first choice for immediate release (IR) coatings, bringing customers a superior finish and enhanced film adhesion along with process efficiency to ensure market competitiveness.
Colorcon’s portfolio of ready-to-use coatings is wide, and the availability of pigments is expanding. Recently new non-synthetic pigments have been approved for use, particularly for the Nutraficient food supplement coatings range, providing colourful and cost-effective solutions to the nutritional supplement market.
Superior moisture protection
Colorcon is launching a new innovative product: Opadry amb II, high performance moisture barrier film coating. An excellent choice for use in sub-Saharan Africa, this aqueous system is the first fully formulated PVA-based IR system without polyethylene glycol (PEG). It is available in a wide range of colour matched formulations and combines high productivity, superior appearance and reduced moisture uptake supporting final product stability.
Innovation in enteric film coating
In October 2014, Colorcon extended its product portfolio as a result of cooperation with Evonik. Acryl-eze II, an optimised aqueous acrylic enteric coating system recently launched by Colorcon, incorporates the Evonik methacrylic acid copolymer, Eudragit L100-55D. Acryl-eze II is a high performance coating that offers reliable enteric protection at lower weight gains compared to earlier Acryl-eze systems. This fully formulated system brings convenience and reduced risk through one-step raw material handling and simpler application during manufacture. The formulations are suitable for use on multiparticulates or tablets including proton pump inhibitor (PPI) applications.
Expanding portfolio for film coatings
Also in 2014, Colorcon added Kollicoat IR from BASF as an alternative polymer for use in targeted Opadry complete film coating systems. ‘Kollicoat IR provides Colorcon with the capability to bring more choice to our customers while providing customised solutions. We are pleased to cooperate with BASF to bring Kollicoat IR to a wider market, combining BASF’s polymer expertise with Colorcon’s knowledge of fully formulated film coating systems and our global reach,’ says Cornelis van den Muyzenberg, VP of sales and business development at Colorcon.
Proven and trusted excipients
In solid oral dose development, API compatibility will drive the selection of the excipient, and this choice will determine the necessary manufacturing process, which has the most significant impact upon long-term production costs and resulting profitability. Direct compression using starch 1500, partially pregelatinised maize starch, continues to offer economic advantages, including:
- fewer unit operations
- lower production time and energy consumption
- less equipment and space
- more cost-efficient production of tablets.
The physical structure of starch 1500 also imparts excellent disintegration, good compactability, and improved flow and lubrication properties.
Multiparticulate drug delivery systems are increasing as pharmaceutical companies seek to improve clinical effectiveness. Sugar spheres are an excellent starting substrate, providing a reliable platform for drug loading. Suglets from Colorcon are uniform drug layering pellets made of sucrose and starch, for immediate, delayed or extended release dosage forms.
Accelerating development and design
Driven by the draft FDA guidance’s issued December 2012 and 2013, reducing medication errors and improving patient compliance is a hot topic for the pharmaceutical industry. By accessing Colorcon’s specialist services, customers can shorten development time and design tablets that are easier for patients to recognise while improving ease of swallowing.
Best unique tablet design is a specialist service used throughout the pharmaceutical industry to differentiate products while improving decision making during product development. Customers can visualise and discuss shape and colour selection, eliminating the need for expensive tooling for trials.
By accessing Colorcon’s HyperStart formulation service, customers receive starting formulations for immediate and controlled release oral solid dosage forms. Its formulation experts are also on hand to provide direct support to customers to assist them in achieving their desired release profile. Ultimately Colorcon’s goal is to shorten development time, getting customers’ products to market faster.
Controlled release alliance
Colorcon with Dow Pharma & Food Solutions – Unique Together in the global Controlled Release Alliance continues to bring joint resources to accelerate pharmaceutical product development efforts and reaches markets throughout the world. Colorcon has exclusive global sales and distribution rights for Methocel premium cellulose ethers, Ethocel premium ethylcellulose polymers and Polyox polythene oxide water soluble resins.
Founded in 1961, Colorcon has 24 offices and 18 dedicated technical centres around the world and remains the market leader for the supply of film coating systems in South Africa. Colorcon prides itself on providing superior quality products, exceptional technical support and services, making it easy to see why they are the supplier of choice worldwide.