Author: Eduardo Molinares, Logistics Manager, CapsCanada
Consumers of dietary supplements are increasingly seeking products that present themselves as “all-natural.” This preference includes the active ingredients as well as the capsules that deliver them, with consumers valuing capsules sourced from vegetable materials over traditional gelatin capsules. In the pharmaceutical sector, demand for vegetarian capsules is also growing, largely owing to these same concerns (as well as dietary and/or religious restrictions in certain populations). Capsules of vegetable origin address these patient-centric concerns while providing similar formulation, filling, and storage benefits as gelatin capsules.
Ideal for Patient-Centric Solutions
Two-piece hard-shell capsules offer numerous benefits for dietary supplements and active pharmaceutical ingredients intended for oral solid dosage forms that cannot easily be formulated and manufactured as tablets.
Traditional capsules are formed from gelatin, which is derived from animal by-products — mainly the bones and skin of cows and pigs, but also fish. For decades, these capsules were the only option available to manufacturers looking to encapsulate ingredients intended for human consumption.
Today, capsules of vegetable origin provide an increasingly attractive alternative for consumers. These capsules are 100% natural and contain no preservatives, gelatin, wheat, gluten or animal by-products. They are produced from cellulose harvested from pine or poplar trees and meet the dietary and cultural needs of vegetarians.1 They also meet the requirements for religions that prohibit the consumption of ingredients derived from certain types of animals.
Furthermore, in some studies, vegetarian capsules have been shown to exhibit enhanced dissolution/ disintegration performance compared with gelatin capsules.1 They are also reported to provide improved performance on filling machines, directly translating into reduced raw material losses and downtime.2
Fast Growing Market
Unsurprisingly, the demand for vegetarian capsules is increasingly rapidly, with the value of the global market projected to reach $509.13 million by 2022.2 This estimate includes vegetarian capsules composed of pullulan (α-1,4-α-1,6-glucan, a polysaccharide polymer consisting of maltotriose units), starch and hydroxypropyl methylcellulose (HPMC) used in the manufacture of pharmaceutical, nutraceutical (including dietary supplements) and cosmeceutical products. The HPMC segment is expected to grow at the fastest rate.
Benefits for the Formulator
In order to be accepted in the marketplace, capsules of vegetable origin must behave the same or better than traditional gelatin capsules during filling, packaging and storage and upon administration to patients/consumers. Regardless of the polymer and other ingredients in the capsule formulation, capsules that are not designed to be acid-resistant must remain intact until they reach the stomach, at which point they must dissolve and release their contents in less than 15 minutes.
Vegetarian HPMC capsules meet this requirement and offer some advantages over gelatin capsules. Temperature and humidity must be carefully controlled over narrow ranges for traditional gelatin capsules during storage and handling. HPMC capsules are more tolerant, and thus the controls do not need to be as extensive during manufacture and distribution of final drug and supplement products.
In addition, no preservatives are required to prevent microbial growth in capsules of vegetable origin, owing to the nature of the polymers used for their production. This attribute allows simplification of both capsule formulation and the production process while providing a real benefit to consumers that are health conscious and/or cannot consume products containing certain preservatives.
HPMC capsules also have a lower moisture content than gelatin capsules, which is beneficial for filling, particularly for sensitive ingredients. In some cases, the use of HPMC capsules enables delivery in an encapsulated form of a formulation that is not suitable for filling in gelatin capsules.
Importantly, HPMC capsules and other capsules of vegetable origin have very similar dimensions, weights and overall physical properties to traditional gelatin capsules. As a result, there is no need for any special filling equipment when working with vegetarian capsules.
Positive Cost-Benefit Analysis
Vegetarian capsules typically carry a price premium over traditional gelatin capsules. This premium is not unreasonable given their recent entry in the marketplace and the benefits they provide. As demand for HPMC capsules continues to grow and manufacturing volume expand in response, the price differential is decreasing.
Even so, given that HPMC capsules allow drug, nutraceutical and cosmeceutical manufacturers to extend their reach into new market segments and create opportunities for significant expansion of sales, the price premium is not a hindrance. In addition, much of that premium can be recouped through the higher output and productivity achieved with HPMC capsules on high-speed automated filling machines and the reduction of temperature and humidity controls required during production and distribution.
Vegetarian Capsules from CapsCanada
CapsCanada was the first capsule manufacturer to develop vegetarian HPMC capsules for use in drug products and nutraceuticals. Our proprietary plant-based K-CAPS® HPMC capsules are formulated without preservatives. The entire K-CAPS portfolio is certified as being GMO-free. We have also received kosher and halal certifications for these capsules.
All of the raw materials used to produce K-CAPS HPMC capsules are purchased from strategic, long-term partners that have been selected after extensive review of their product characteristics and processing technologies, supply chains, quality management systems, registrations and certifications, regulatory histories, GMP compliance records and packaging and shipping capabilities. These suppliers have been able to demonstrate that their production processes are robust and yield materials of consistently high quality.
In addition, we have a system in place that enables the identification within just six hours of raw materials used for the manufacture of a specific lot number of capsules. Similarly, when given a specific lot number of raw material, we can rapidly identify which capsules were produced using an ingredient in question.
All K-CAPS (and gelatin) capsules manufactured by CapsCanada are produced according to current Good Manufacturing Practice guidelines for drugs or foods, respectively. In addition to our standard portfolio of K-CAPS HPMC capsules, we often work closely with customers to develop tailored capsule formulations designed to provide optimal performance for their specific products and desired delivery profiles.
As with our gelatin capsules, banding and printing options are available to differentiate products encapsulated in K-CAPS HPMC capsules. We are actively developing additional natural dyes that will extend the color options for these vegetarian capsules.
CapsCanada also recently invested $28 million in the construction of a new 100,000 square-foot K-CAPS® facility, increasing our production capacity for HPMC capsules by 50%. With this investment in additional state-of-the-art manufacturing capabilities, we have underscored our commitment to customers seeking the highest quality vegetarian capsules that will meet the growing demands of the marketplace.
References
- Global Vegetarian Capsules Market Set for Rapid Growth, to Reach Around USD 509.13 Million by 2022. Zion Market Research. 13 Sept. 2017. Web. https://www.zionmarketresearch.com/news/vegetarian-capsules-market.
- Private customer correspondence.
