RESURRECTING NUTRACEUTICALS WITH LIQUID ......Nutraceuticals Market - Global Industry Analysis,...

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62 nutraceuticals now 63 The current spotlight, therefore, is on nutraceuticals with a ‘clean label’—nutraceuticals containing natural ingredients that consumers recognize. In contrast to the well-defined chemical entities used in pharmaceuticals, the ingredients used in nutraceuticals are diverse, containing multiple components in a single product. Many of these natural ingredients have physicochemical properties, such as low solubility, that pose a challenge for formulation scientists. Thus, the successful development of nutraceuticals requires knowledge of the fundamental aspects of the physical and chemical properties of the ingredients and selection of the right delivery system. Liquid Encapsulation Technology (LET) is one of the most promising and cost-effective strategies to address the multiple physicochemical challenges associated with the use of nutraceutical ingredients. Recently, there has been a renewed interest in using liquid-filled hard capsules after having rediscovered its advantages. The most important advantage of these capsules is their ability to formulate compounds with poor solubility. Additionally, they can help accelerate the speed to market by providing the flexibility to rapidly develop and test formulations in-house at R&D and large scale. Most importantly, from a branding perspective, liquid-filled capsules can serve as a valuable tool to create a distinct brand differentiation in health and wellness, which is in line with the latest trends. This novel dosage form can be utilized for reintroducing existing formulations in a new attractive format that revitalizes the brand and extends its life. Liquid Encapsulation Technology (LET) Encapsulation of liquids has been prevalent for a long time, primarily in the form of one-piece soft gelatin capsule (softgels). While many nutraceutical companies continue to use softgels for liquid encapsulation, formulation scientists are relooking at two-piece hard gelatin capsules to effectively overcome the limitations of softgels. Liquid-filled hard capsules are particularly beneficial for nutraceuticals like vitamins (e.g. vitamins E and A), and pure oils or oil-based products (e.g. Safflower oil, Flaxseed oil, Garlic oil, Evening Primrose oil, Habbatus Sauda oil, Fish oil), which can be filled and sealed into a capsule dosage form. Why choose hard capsules for liquid filling over the conventional softgels? The key advantages of hard capsules vs. softgels at the process level can be summarized as follows: • Ease and convenience: Softgel capsules are tedious to manufacture in-house. The entire manufacturing process— from preparing the gelatin solution to encapsulation, and finally drying the capsules under a controlled operating environment by maintaining low relative humidity — must be performed in-house. This requires a high capital expenditure and a considerably large space. In contrast, manufacturing of empty hard capsule is easier, requiring minimal space, operator skills, and investment. The manufacturer just needs to invest in installing an automated, compact filling and sealing machine. • Scalability and flexibility: Even at an R&D stage, softgels must be manufactured in large batches. In contrast, liquid- filled hard capsules can be manufactured at an R&D scale and can be scaled up easily, making it convenient and economical for product development. Manufacturers can keep the entire product development process in-house to protect their intellectual property, while significantly reducing the ‘concept- to-counter’ time for their products. • Wastage: Due to the unified manufacturing process the quantitative and economic impact of wastage is higher in softgel, for example, excess gelatin that is cut off during formation of softgels. Further, the embossing or printing, if any, takes place after encapsulation. Therefore, if there is any error or quality problem after printing, the losses incurred would include costs associated with wastage of the active ingredient. However, hard capsules can be easily sourced as empty, pre- printed shells from the capsule manufacturer. As these empty capsules undergo rigorous quality checks, the end-product manufacturer is reassured of the quality of the capsules that are used for the encapsulation process. From the perspective of nutraceutical manufacturers, hard capsules offer an array of benefits which are shown in Table 1. Table 1: Benefits of hard capsules for nutraceutical manufacturers Liquid Fill Combinations in Hard Capsules Liquid-filled hard capsules offer several specific advantages apart from formulation benefits. These advantages include: • Consumer preference The nutraceutical industry uses various commercial approaches for providing innovations in the oral drug delivery system. To a certain extent, it was the nutraceutical sector, which led the early adoption of liquid-filled hard capsule products to market. Since the nutraceutical industry is in close RESURRECTING NUTRACEUTICALS WITH LIQUID ENCAPSULATION TECHNOLOGY (LET) The global nutraceutical industry, valued at US$182.6 billion in 2015, is one of the fastest growing industries today and is expected to expand at a CAGR of 7.3% from 2015 to 2021. 1,2 This rapid growth can be attributed to consumers’ inclination to use nutrition for their health and wellness. Recently, consumer preference has undergone a paradigm shift from choosing synthetic ingredients to natural and organic foods, beverages, and supplements. A recent survey found that about 70% of consumers are happy to pay a higher retail price for a product made with ingredients they recognize and trust. 3 By Fernando Diez, Scientific Business Development Manager at ACG Capsules Justin Kalafat, Scientific Business Development Manager at ACG Capsules Dr. Jnanadeva Bhat, General Manager – Product Development and New Product Offerings at ACG Capsules contact with the consumers, they understand consumer needs. Lately, consumers are seeking more benefits from delivery systems beyond those possible through traditional (tablet and capsule) technologies. As a result, the formulator needs to work far harder to cater to increasing consumer demands. As the nutraceutical industries look to carve a niche of their own and create a differentiated product, an important trend is the growth and diversity of new dosage forms that enjoy consumer preference. Consumers prefer liquid-filled capsules as they are easier to swallow. These capsules are also considered to work faster and better. Moreover, the capsules can also be made visually attractive to guarantee instant consumer appeal. • Commercial benefits Novel formulations combining two or more compounds are an excellent lifecycle management strategy to revitalize product pipelines. Combining existing compounds is less expensive, hastens the speed to market, and is less risky to develop. • Improved bioavailability Compounds with poor solubility may suffer from poor bioavailability. Liquid-filled capsules are ideal for compounds with poor solubility and can, therefore, improve bioavailability of such compounds. Multiple combinations of release profiles within a single hard capsule are also possible. Figure 1 shows different combination fills possible in hard capsules. Figure 1: Examples of combination fill hard capsules Liquid Filled Hard Capsules: The Road Ahead Liquid-filled hard capsule technology is becoming increasingly accepted by the nutraceutical industry. Table 2 provides examples of nutraceuticals delivered using LET. Active Brand Licence Holder Table 2: Examples of marketed nutraceuticals filled in hard capsules There are three primary areas where this technology is expected to grow strongly in the future. • Sports Nutrition: The flourishing sports nutrition market is expected to propel further to US$45 billion by 2022 from US$28.37 billion in 2016 with a CAGR of 8.1%. The recent trend in sports nutrition is expansion of the ingredients list to include those that are used to enhance metabolism, improve digestion or reduce fat (L-carnitine, CoQ10, amino acids). The increased use of creatine and Vitamin B complex are perfect examples of this trend. Creatine has been used as a bodybuilding supplement for many years. However, after receiving a positive European Food Safety Authority (EFSA) health claim, it is now moving into consumer markets for improvement of muscle strength in the elderly. Another example is the Vitamin B complex family (particularly, Vitamin B6 and B12). Apart from its use as a dietary supplement, these vitamins are now being increasingly used for benefits such as ‘reduction of fatigue’ and ‘support for normal energy metabolism’. Liquid formulations in hard shell capsules are a popular form of a delivery system for this emerging sports nutrition market. • Probiotics: Probiotics are sensitive to moisture. Exposure to moisture during manufacturing and packaging can reduce the product’s shelf-life. Liquid-filled vegetarian capsules made from HPMC can provide moisture protection as they are low in moisture content. • Herbal Formulations: Herbal formulations in capsule form are gaining importance because of several advantages like taste masking, encapsulating mucilaginous (sticky) ingredients, etc. Liquid-filled hard capsules are ideal to encapsulate single or combination of three to five herbs. Conclusion LET has been around for long. However, there is a resurgence in its use in recent times. Formulators are now rediscovering the myriad benefits of using this technology to meet emerging and eclectic market needs. Apart from solving the formulation challenges, LET provides a wide scope for unique, innovative products enabling distinct brand visibility. With such incredible opportunities, LET is definitely here to stay in nutra for a long time. http://www.acg-world.com/capsules References 1 Nutraceuticals Europe. Why Nutraceuticals [Internet]. 2016 [cited 2018 April 06]. Available from: http://www. nutraceuticalseurope.com/event/why-nutraceuticals/ 2 Nutraceuticals Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 – 2021. 3 Crane M. Majority of Consumers Willing to Pay More for Recognizable Ingredients, Survey Suggests [Internet] 2016 [cited 2018 April 06]. Available from: http://www. nutritionaloutlook.com/trends-business/majority-consumers- willing-pay-more-recognizable-ingredients-survey-suggests

Transcript of RESURRECTING NUTRACEUTICALS WITH LIQUID ......Nutraceuticals Market - Global Industry Analysis,...

62 nutraceuticals now 63

The current spotlight, therefore, is on nutraceuticals with a ‘clean label’—nutraceuticals containing natural ingredients that consumers recognize. In contrast to the well-defined chemical entities used in pharmaceuticals, the ingredients used in nutraceuticals are diverse, containing multiple components in a single product. Many of these natural ingredients have physicochemical properties, such as low solubility, that pose a challenge for formulation scientists. Thus, the successful development of nutraceuticals requires knowledge of the fundamental aspects of the physical and chemical properties of the ingredients and selection of the right delivery system.

Liquid Encapsulation Technology (LET) is one of the most promising and cost-effective strategies to address the multiple physicochemical challenges associated with the use of nutraceutical ingredients. Recently, there has been a renewed interest in using liquid-filled hard capsules after having rediscovered its advantages. The most important advantage of these capsules is their ability to formulate compounds with poor solubility. Additionally, they can help accelerate the speed to market by providing the flexibility to rapidly develop and test formulations in-house at R&D and large scale.

Most importantly, from a branding perspective, liquid-filled capsules can serve as a valuable tool to create a distinct brand differentiation in health and wellness, which is in line with the latest trends. This novel dosage form can be utilized for reintroducing existing formulations in a new attractive format that revitalizes the brand and extends its life.

Liquid Encapsulation Technology (LET)Encapsulation of liquids has been prevalent for a long time, primarily in the form of one-piece soft gelatin capsule (softgels). While many nutraceutical companies continue to use softgels for liquid encapsulation, formulation scientists are relooking at two-piece hard gelatin capsules to effectively overcome the limitations of softgels.

Liquid-filled hard capsules are particularly beneficial for nutraceuticals like vitamins (e.g. vitamins E and A), and pure oils or oil-based products (e.g. Safflower oil, Flaxseed oil, Garlic oil, Evening Primrose oil, Habbatus Sauda oil, Fish oil), which can be filled and sealed into a capsule dosage form.

Why choose hard capsules for liquid filling over the conventional softgels?

The key advantages of hard capsules vs. softgels at the process level can be summarized as follows:

• Ease and convenience: Softgel capsules are tedious to manufacture in-house. The entire manufacturing process—from preparing the gelatin solution to encapsulation, and finally drying the capsules under a controlled operating environment by maintaining low relative humidity — must be performed in-house. This requires a high capital expenditure and a considerably large space. In contrast, manufacturing of empty hard capsule is easier, requiring minimal space, operator skills, and investment. The manufacturer just needs to invest in installing an automated, compact filling and sealing machine.

• Scalability and flexibility: Even at an R&D stage, softgels must be manufactured in large batches. In contrast, liquid-

filled hard capsules can be manufactured at an R&D scale and can be scaled up easily, making it convenient and economical for product development. Manufacturers can keep the entire product development process in-house to protect their intellectual property, while significantly reducing the ‘concept-to-counter’ time for their products.

• Wastage: Due to the unified manufacturing process the quantitative and economic impact of wastage is higher in softgel, for example, excess gelatin that is cut off during formation of softgels. Further, the embossing or printing, if any, takes place after encapsulation. Therefore, if there is any error or quality problem after printing, the losses incurred would include costs associated with wastage of the active ingredient. However, hard capsules can be easily sourced as empty, pre-printed shells from the capsule manufacturer. As these empty capsules undergo rigorous quality checks, the end-product manufacturer is reassured of the quality of the capsules that are used for the encapsulation process.

From the perspective of nutraceutical manufacturers, hard capsules offer an array of benefits which are shown in Table 1.

Table 1: Benefits of hard capsules for nutraceutical manufacturers

Liquid Fill Combinations in Hard CapsulesLiquid-filled hard capsules offer several specific advantages apart from formulation benefits. These advantages include:

• Consumer preference The nutraceutical industry uses various commercial approaches for providing innovations in the oral drug delivery system. To a certain extent, it was the nutraceutical sector, which led the early adoption of liquid-filled hard capsule products to market. Since the nutraceutical industry is in close

RESURRECTING NUTRACEUTICALS WITH LIQUID ENCAPSULATION TECHNOLOGY (LET)The global nutraceutical industry, valued at US$182.6 billion in 2015, is one of the fastest growing industries today and is expected to expand at a CAGR of 7.3% from 2015 to 2021.1,2 This rapid growth can be attributed to consumers’ inclination to use nutrition for their health and wellness. Recently, consumer preference has undergone a paradigm shift from choosing synthetic ingredients to natural and organic foods, beverages, and supplements. A recent survey found that about 70% of consumers are happy to pay a higher retail price for a product made with ingredients they recognize and trust.3

By Fernando Diez, Scientific Business Development Manager at ACG CapsulesJustin Kalafat, Scientific Business Development Manager at ACG CapsulesDr. Jnanadeva Bhat, General Manager – Product Development and New Product Offerings at ACG Capsules

contact with the consumers, they understand consumer needs. Lately, consumers are seeking more benefits from delivery systems beyond those possible through traditional (tablet and capsule) technologies. As a result, the formulator needs to work far harder to cater to increasing consumer demands. As the nutraceutical industries look to carve a niche of their own and create a differentiated product, an important trend is the growth and diversity of new dosage forms that enjoy consumer preference. Consumers prefer liquid-filled capsules as they are easier to swallow. These capsules are also considered to work faster and better. Moreover, the capsules can also be made visually attractive to guarantee instant consumer appeal.

• Commercial benefitsNovel formulations combining two or more compounds are an excellent lifecycle management strategy to revitalize product pipelines. Combining existing compounds is less expensive, hastens the speed to market, and is less risky to develop.

• Improved bioavailability Compounds with poor solubility may suffer from poor bioavailability. Liquid-filled capsules are ideal for compounds with poor solubility and can, therefore, improve bioavailability of such compounds. Multiple combinations of release profiles within a single hard capsule are also possible. Figure 1 shows different combination fills possible in hard capsules.

Figure 1: Examples of combination fill hard capsules

Liquid Filled Hard Capsules: The Road AheadLiquid-filled hard capsule technology is becoming increasingly accepted by the nutraceutical industry. Table 2 provides examples of nutraceuticals delivered using LET. Active Brand Licence Holder

Table 2: Examples of marketed nutraceuticals filled in hard capsules

There are three primary areas where this technology is expected to grow strongly in the future.

• Sports Nutrition: The flourishing sports nutrition market is expected to propel further to US$45 billion by 2022 from US$28.37 billion in 2016 with a CAGR of 8.1%. The recent trend in sports nutrition is expansion of the ingredients list to include those that are used to enhance metabolism, improve digestion or reduce fat (L-carnitine, CoQ10, amino acids). The increased use of creatine and Vitamin B complex are perfect examples of this trend. Creatine has been used as a bodybuilding supplement for many years. However, after receiving a positive European Food Safety Authority (EFSA) health claim, it is now moving into consumer markets for improvement of muscle strength in the elderly. Another example is the Vitamin B complex family (particularly, Vitamin B6 and B12). Apart from its use as a dietary supplement, these vitamins are now being increasingly used for benefits such as ‘reduction of fatigue’ and ‘support for normal energy metabolism’. Liquid formulations in hard shell capsules are a popular form of a delivery system for this emerging sports nutrition market.

• Probiotics: Probiotics are sensitive to moisture. Exposure to moisture during manufacturing and packaging can reduce the product’s shelf-life. Liquid-filled vegetarian capsules made from HPMC can provide moisture protection as they are low in

moisture content.

• Herbal Formulations: Herbal formulations in capsule form are gaining importance because of several advantages like taste masking, encapsulating mucilaginous (sticky) ingredients, etc. Liquid-filled hard capsules are ideal to encapsulate single or combination of three to five herbs.

Conclusion LET has been around for long. However, there is a resurgence in its use in recent times. Formulators are now rediscovering the myriad benefits of using this technology to meet emerging and eclectic market needs. Apart from solving the formulation challenges, LET provides a wide scope for unique, innovative

products enabling distinct brand visibility. With such incredible opportunities, LET is definitely here to stay in nutra for a long time.

http://www.acg-world.com/capsules

References 1 Nutraceuticals Europe. Why Nutraceuticals [Internet]. 2016 [cited 2018 April 06]. Available from: http://www.nutraceuticalseurope.com/event/why-nutraceuticals/ 2 Nutraceuticals Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2015 – 2021. 3 Crane M. Majority of Consumers Willing to Pay More for Recognizable Ingredients, Survey Suggests [Internet] 2016 [cited 2018 April 06]. Available from: http://www.nutritionaloutlook.com/trends-business/majority-consumers-willing-pay-more-recognizable-ingredients-survey-suggests