Introduction
There is more to maximizing productivity and profitability of capsule manufacturing than line speed alone. Though line speed is a useful measure of productivity, ultimately the unit yield and line speed are dependent on many other factors, many of which come back to the capsule itself. Lonza’s Capsugel® Vcaps® Plus capsules have been developed with multiple features that contribute to increased productivity and high performance in high-speed machine filling.
The aim for each new project at Lonza Capsugel is to create a high-quality product that meets consumer needs, as well as to provide a fast track to commercial success for the business partner. Lonza Capsugel proactively collaborates with partners to problem solve, maximize production efficacy, and produce consistently high-quality finished products. Behind the teams who directly support our customers is an organization aligned to consistently developing and delivering high-quality, ethically and sustainably manufactured capsules that enable the safe and effective delivery of the APIs developed by our customers.
The Quality by Design (QbD) culture encompasses the entire customer engagement process and continuing partnership. Scientists at our Innovaform® Accelerator center provide expert support on preclinical and formulation development, while scale-up and commercialization are supported by the manufacturing expertise of our global team of Technical Service Engineers.
An example of our focus on product innovation is the Capsugel® Vcaps® Plus range of gelling-agent-free HPMC capsules. Testing with acetaminophen, acetylsalicylic acid and caffeine found that Capsugel® Vcaps® Plus capsules offer a release profile equivalent to gelatin. Additionally, compared to gelatin capsules Capsugel® Vcaps® Plus capsules do not have the drawbacks of cross-linking, relatively high moisture content or unsuitability for those whose religious beliefs or dietary constraints prohibit them from consuming animal products.1,2 Importantly, Capsugel® Vcaps® Plus capsules are manufactured using a unique patented thermogelation process, which means they contain no gelling agent that can compromise dissolution and API bioavailability.2 They also exhibit excellent mechanical and machinability qualities.2,3
What does productivity mean for capsule manufacturing?
The simplest definition of “productivity” is the rate of usable output derived from the inputs. In capsule manufacturing, this measure reflects the speed that a filling and packaging line can consistently output product to the required quality and specification. Achieving optimized productivity and yield is a balancing act where the limiting factor will always be the “weakest link” in the chain. Many factors have to be considered in optimizing production yield, from excipient flow and formulation to maintenance regimes. At the center of the filling and closing processes is the capsule itself.
Capsule “machinability” encompasses a wide variety of factors that determine suitability for high-speed filling. These include aspects such as gliding proprieties, closure mechanisms, and performance under different conditions, such as temperature, humidity, and mechanical stresses. The quality, purity, and consistency of the capsule material and how it is manufactured all impart specific machining qualities.
Machinability and mechanical stability of Lonza Capsugel’s premium vegetarian capsule
Reliability of the closure mechanism and correct calibration of the vacuum forces required for opening are one of the commonest points of failure in the filling process. Capsugel® Vcaps® Plus capsules are designed for reliable closing. In solid fill applications, the innovative Coni-Snap® closure, with its unique locking mechanism, offers secure locking and containment. For liquid fill applications, Capsugel® Vcaps® Plus capsules use the Licaps® design, allowing traditional banding and cutting-edge sealing technologies like LEMS® to produce a reliable seal.
Once the optimal calibration of all the capsule handling steps has been determined, the key factor becomes capsule adherence to precisely defined tolerances to produce capsules that meet required specifications.
Capsugel® Vcaps® Plus capsules have lower weight variations than first-generation HPMC capsules and a weight-range profile that more closely mimics that of a gelatin capsule.2 Electron micrographs of Capsugel® Vcaps® Plus capsules show that they have a smooth, even gloss surface, giving excellent gliding qualities and higher performance in manufacturing processes, demonstrating excellent performance in a range of high-speed filling machines and typically yielding fewer than 0.01% rejects.2,4
In a recent review of more than 30 filling operations across a range of intermittent motion, continuous motion, and semi-automatic machines, the Capsugel® Vcaps® Plus capsules had an average yield rate of 99.86%, with a range from 99.782% to 100%.4
Batch manufacturing of encapsulated products requires frequent recalibration of lines. By providing easy access to extensive technical data online, certified training support for operators, and remote or onsite support from expert Technical Service Engineers, Lonza Capsugel give users of Capsugel® Vcaps® Plus and their other capsules access to “insider” knowledge when setting up and calibrating production lines for optimal performance.
Consistent compliance to specifications, and product availability, are critical to maintaining continuity of production. Lonza Capsugel apply QbD methodologies to all steps in their capsule manufacturing process, from auditing raw material suppliers to quality testing every batch of finished capsules produced. Every batch of Lonza Capsugel capsules is delivered with a Certificate of Analysis demonstrating our absolute commitment to product quality and consistency.
Conclusion
The ability to optimize capsule manufacturing begins and ends with quality of the capsule itself and its suitability for machinability. Capsugel® Vcaps® Plus capsules provide consistent dissolution performance, a high-gloss appearance for consumer appeal, as well as excellent machinability and quality-assured consistency. Lonza Capsugel works as a collaborative partner, sharing product knowledge and manufacturing expertise, to fast-track commercialization and profitability.
To learn more or discuss how Capsugel® Vcaps® Plus capsules can advance your next formulation, contact your Lonza Capsugel expert today Contact Us
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