Vegetarian Substitutes for Gelatin Soft Capsules

Vegetarian Substitutes for Gelatin Soft Capsules

As appeared in January 2020 Tablets & Capsules Copyright CSC Publishing www.tabletscapsules.com capsules Vegetarian substitutes for gelatin soft Claudia Silva capsules Procaps Kirti Vatsa Beroe This article provides an overview of the current state of materi- oft capsules, also called softgels, are one of the most als and technology used to produce vegetarian soft capsules widely used solid oral dosage forms, particularly in the and discusses applications, processing, and suitable products nutraceutical market. Traditional softgels are made from Sgelatin, but interest in vegetarian alternatives to gelatin for these alternatives to soft gelatin capsules. soft capsules (GSCs) is growing. The materials used to make vegetarian soft capsules (VSCs) have very different properties than gelatin. The first commercially viable VSCs appeared on the market around 2001 and were developed for encapsulating oils Copyright CSC Publishing and suspensions for dietary and cosmetic products [1]. derived from animals, is prone to price fluctuations, and The capsules were made from carrageenan-modified has a relatively large carbon footprint. starch (C-MS), and the encapsulation equipment sub- VSCs have faced some concerns from consumers jected the capsules to a curing step, in which the capsules interested in “clean label” products—defined as products passed through a band of hot air. Later machines included containing only unprocessed or unmodified ingredi- die rolls designed to increase the thickness of the seal and ents—since starches are chemically modified materials. prevent the capsule contents from leaking. Also, carrageenan suffered from a The industry has made continuous long period of concerns that it was car- improvements to the materials, equip- Vegetarian soft cinogenic, causing many food produc- ment, and processes involved in their ers, especially in the US, to stop using manufacture. As a result, vegetarian soft capsules can now be it in their products. However, the FDA capsules can now be produced using considers carrageenan a generally recog- the same type of mixing and encapsula- produced using the nized as safe (GRAS) material. tion equipment used for GSCs at similar encapsulation speeds. same type of mixing VSC materials The most common gelatin substitutes VSC market and encapsulation used to make VSCs are carrageenan, VSC products are currently avail- modified starch, and alginate. Table 1 able in the nutraceutical and cosmetics equipment used for summarizes the market and sourcing markets as well as a few products in the challenges for each. pharmaceutical market. VSCs currently gelatin soft capsules Carrageenan. The global market for constitute approximately 10 to 15 per- carrageenan is approximately 60 to 70 cent of the nutraceutical soft capsule at similar kilotonnes per year, with an expected market in terms of revenue, and their use compound annual growth rate (CAGR) is expected to continue to grow due to encapsulation speeds. of 4 to 5 percent [2]. Seventy to 80 per- increasingly competitive material prices cent of the carrageenan produced is used and optimized processing technology as in the food industry for its gelling, thick- well as expansion into the pharmaceutical market. ening, and stabilizing properties, while less than 10 per- The primary market for VSCs includes consumers cent is used by the pharmaceutical industry. Pharma- who demand vegetarian capsules for cultural, religious, ceutical applications, particularly soft capsules, are still or dietary reasons. VSCs can also be beneficial in appli- considered a niche segment. cations where gelatin is not a suitable capsule polymer, As previously mentioned, the first VSCs consisted of such as high-temperature encapsulation or products with a blend of carrageenan and modified starch (hydroxy- high-pH fill content. Manufacturers are also looking to propyl starch), and most nutraceutical VSCs currently VSC polymers as alternatives to gelatin because gelatin is on the market still use carrageenan-based formulations. Table 1 Market and supply for gelatin substitutes in soft capsules Material Global market Pharma Major pharma Average Raw material Sourcing challenges in 2018 usage suppliers* price (kilotonnes) ($/kg) Carrageenan 60-70 7% ~10-12 11-12 Red seaweeds Limited supply base and concerns VSC: 500 with feedstock availability may tonnes occur due to climate change. Currently, no supply issue with feedstock in major producing regions. Alginates 40 8-10% ~2-4 12-14 Brown seaweed Highly consolidated supply base and GSC: high entry cost for new suppliers. unknown Modified 9,000-10,000 10-15% ~5 4-5 Many, Important to track price movement. starch (as an including: excipient) potato, corn, cassava, etc. Source: Beroe analysis * Indicates the number of suppliers who cater to pharmaceutical applications but not necessarily soft capsule shells. Copyright CSC Publishing Manufacturers offering carrageenan-based soft capsules starch, which is derived from the cassava root [9]. Some include Procaps, Ayanda, Captek, Catalent, and Euro- other modified starches such as corn or pea are used in caps, among others. combination with carrageenan for softgel applications. Carrageenan is produced by two species of cultured Alginate. Europe and North America combined red seaweeds, kappaphycus alvarezii and eucheuma spp. account for more than 50 percent of the global algi- Production of these seaweeds was estimated at 8.3 mil- nate market, which is growing at a CAGR of 1 to 3 per- lion tonnes in 2012 [3]. Indonesia and the Philippines are cent. Growth in the Asia-Pacific market is higher due to the two major producers of this raw material, which sells increased demand from the processed food and pharma- for approximately $1,800 per tonne [4, 5]. ceutical industries. The pharmaceutical market for alginate Climate change has the potential to affect the red is consolidated, with two major suppliers that account for seaweed supply, but suppliers are taking actions to avoid more than 90 percent of global market share [10]. shortages. For example, the carrageenan manufacturer Currently, the pharmaceutical alginate supply is suf- Cargill has committed to sourcing 60 percent of its red ficient to meet demand, and if demand should increase seaweed sustainably by 2025 [6]. suddenly, suppliers focused on food-grade alginate could The number of suppliers manufacturing pharmaceu- switch production to pharmaceutical applications, since tical-grade carrageenan suitable for soft capsule pro- all regulatory approvals are in place. duction is limited, but it is expected that suppliers will The sole raw material for commercial-scale alginate expand and improve their product portfolios due to production is brown seaweed, which is time consuming increased demand from end-user industries. and labor intensive to cultivate. Currently, the brown Modified starch. Global production of modified starch seaweed supply is sufficient to meet the needs of the was between 9 and 10 million tonnes in 2017 [7], and the alginate market, and there are no issues with feedstock import price in the European Union was $922 per tonne, capacity. However, because there is a limited number of which represented a 3.9 percent increase over the previ- qualified suppliers and a high entry cost for new suppli- ous year [8]. Starch has good film-forming properties and ers, alginate buyers do not have much negotiating power good raw material availability, which, along with its price with suppliers. advantage, makes starch-based soft capsules a good low- price alternative to GSCs or other vegetarian capsules. The world’s first carrageenan-free vegan softgel, Plantgels, replaces carrageenan with modified tapioca Table 2 Comparison of processing steps for GSCs versus VSCs Gelatin Modified starch Carrageenan-modified starch Film casting Fast, easy Slow, difficult, sensitive to RH Slow, easy (equipment adaptations) Polymer mass preparation No No Yes specific mixing system High temperature heated- No Yes Yes (extrusion systems can be required) transfer system Conventional die rolls Yes No No Encapsulation Yes spreader boxes design No No (some cases) Required curing step No No Yes Tray-drying (days) + ++ + (oil-based capsules) Batch-to-batch variability No Yes No Process cost $ $$ $$$ Source: Procaps Copyright CSC Publishing VSC manufacturing Table 2 shows a summary of the technical require- As previously mentioned, the properties of the mate- ments for VSC production and compares the pros and rials used to make VSCs differ from gelatin. Raw mate- cons of VSCs and GSCs. Items in red show processing rial and equipment suppliers have had to learn how to differences compared to GSCs due to new equipment, work with these new materials to overcome challenges adaptations to existing equipment, or additional process- related to the resulting capsules’ physical, chemical, and ing steps, such as heated transfer and curing. functional properties, such as soft- In recent years, modified starch ness, leaking, poor dissolution, and suppliers have offered materials with increased dissolution times at stability Raw material and viscosities of about 40,000 to 50,000 conditions. Also, VSC polymers have centipoise that can be handled in higher viscosities and require higher equipment suppliers GSC equipment. In contrast, C-MS processing temperatures than gelatin, formulations can have viscosities as which makes mixing, deaeration, and have had to learn how high as 90,000 centipoise. As the transfer processes challenging. table shows, such polymer masses With

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    5 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us