In the competitive pharmaceutical industry, commitments to quality and continuous improvement are critical to achieving a competitive advantage. Forming partnerships with innovative suppliers with a deep understanding of the market, the capability to provide customized solutions and tailored technical support can help companies realize these commitments. The right capsule supplier can help clients overcome obstacles throughout the product life cycle, supporting development, commercialization and brand growth.
More than Capsules
Capsule manufacturers do not simply supply empty capsules to their customers. The capsules are a means to an end — the safe and effective delivery of the ingredients with which they are filled. As such, capsules serve to enhance the therapeutic value of the drugs they encapsulate. Capsule suppliers with this philosophy can provide optimal capsules for the production of oral solid dosage (OSD) forms.
The quality and physical design of hard-shell capsules impact their performance during filling and the performance of the final drug product upon storage and administration to patients. A commitment to quality and continuous improvement is essential to ensuring the production of consistent capsules with robust performance characteristics.
Capsule suppliers can also create custom capsule formulations to address the specific needs of their customers and act as true partners in the drug development process, providing complete solutions — rather than just capsules. Capsule manufacturers with experience in final drug manufacturing are also positioned to provide ongoing technical support during the capsule filling process, further facilitating commercialization of their customers’ OSD products.
Understanding the Marketplace
One of the leading trends in the OSD sector — particularly for dietary supplements and increasingly for OSD drug products — is the consumer preference for capsules of vegetable origin (vegetarian capsules). This preference is largely driven by a desire to be healthier, but religious requirements are also a factor. Traditionally, capsules for human consumption have been produced from gelatin derived largely from cow, pig and fish bones and other parts. Capsules derived from plant-based hydroxypropyl methylcellulose (HPMC) are increasingly seen as preferable.
CapsCanada’s founder developed the first HPMC vegetarian capsules, and the company remains a pioneer in the field. Our proprietary plant-based K-CAPS® HPMC capsules are formulated without gelling agents and are certified as GMO-free. To meet the growing demand for
K-CAPS®, we recently invested $28 million in a new 100,000-ft2, state-of-the-art, dedicated K-CAPS® facility, increasing our capacity for vegetarian capsules by 50%.
Exceeding Performance Expectations
A second key trend in the market is increasing expectations for capsule performance. The higher-value, lower-volume therapies being developed today are based on increasingly complex APIs with challenging properties. The most effective capsule suppliers are positioned to support the development of safe, effective and stable oral dosage forms, even for the most challenging actives.
Quality by Design
Manufacturing high-performance capsules requires commitments to both quality and continuous improvement. The adoption of a QbD approach to capsule production can ensure the consistent production of defect-free capsules with designs that will optimize their performance during filling and as part of the final drug product.
By designing quality into the capsule production process from the start, it is possible for CapsCanada to address all aspects of the development process from raw material sourcing to production and product release testing. Through this approach, we ensure appropriate documentation, follow standardized processes in compliance with GMP requirements and provide for clear traceability. The result is a reliable supply of robust, high-quality capsules.
Ongoing Tech Support
Access to high-quality empty capsules is not sufficient for ensuring the successful production of filled capsule products. To realize the comprehensive benefits of high-quality capsules, drug and dietary supplement manufacturers must have well-developed filling processes that are implemented on state-of-the-art filling machines using effective processes that are performed by highly trained operators.
Capsule manufacturers that provide support beyond capsule selection to the filling process — from training to optimization to problem-solving — are true partners with their customers, creating real value and helping accelerate commercialization.
Because we also produce hard-shell OSD drug products, we have extensive experience with the filling process using various APIs and formulation types, capsule materials and filling machines. Our team of technical experts collaborates with customers from capsule selection to regulatory submission, advising them on the most appropriate capsule compositions for their product formulations and the filling machines that will be used. They also visit customer facilities on a regular basis to ensure that filling processes are running smoothly. In many cases, they help improve the efficiency and productivity of customer processes.
Internal and External Collaboration
Our technical team is backed by strong production and quality teams that account for a large portion of our workforce. Everyone is committed to anticipating our customers’ needs and providing rapid responses to enquiries. Our internal systems ensure that enquiries quickly reach the right experts so that responses can be provided within 24 hours.
All of these experts are committed to producing the highest-quality capsules supported by appropriate regulatory documentation. They work closely with our customers to develop optimal capsule solutions that will lead to successful drug and dietary supplement products. As such, we are seen as a preferred partner that can facilitate new product development and commercialization.
Capsule suppliers can create custom capsule formulations, providing complete solutions — rather than just capsules
Capsule suppliers must constantly innovate and diversify their capabilities. Currently, standard size zero clear and white capsules are in greatest demand, with differentiation achieved through printing. There is growing interest, however, in using other sizes and colors to make products more distinctive. CapsCanada has established the capability to produce a range of capsule sizes and colors using different film materials and is positioned to support this trend going forward.
Our LQ-CAPS® Liquid Formulation Capsules for liquid-fill materials is another example of innovation at CapsCanada. While capsules have traditionally been used for powder filling, encapsulation offers several advantages for liquids, particularly those that have toxicity concerns or issues with abrasiveness, hygroscopicity or sensitivity to degradation from light and heat. Because both the drug formulation and the polymer composition of the capsule can be customized to accommodate APIs with many different properties and dissolution profiles, liquid-fill capsules can facilitate formulations not previously possible. We are excited to continue our work on next-generation versions of this liquid-fill capsule technology.