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Nutra Manufacturing Innovation & Customization, from Product to Package

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With everything from botanicals to cannabis now being encapsulated, the combinations of innovative and customized options in liquid filling are infinite. But it’s also the advancements in customization of the manufacturing processes that is bringing liquid filling to the forefront in delivery options.

By customizing the manufacturing design and technology process from the earliest development stages, manufacturers can cut costs, provide formulators more flexibility, increase product viability and differentiate brands from competitors.

When evaluating if liquid filling is right for your product, it is imperative to partner with a supplier that provides pre-formulation and feasibility studies. Innovations in combination-filled capsules are bringing products to the market once deemed stubbornly incompatible or far too complex.

Benefits of Liquid Filling Hard-shell Capsules

R&D Customization & Innovation

The ability to formulate and manufacture at a research and development scale with easy scale-up capabilities makes encapsulating hard shell capsules not only customizable in small batches, but also enables innovation. When formulators are able to run studies on smaller batches, less money is spent in research and development allowing for more advancements. The rapid in-house transition from R&D to full-scale production also accelerates speed to market.

Liquid Filling Formulations Advantages

Market demands for more complex formulations and combinations is resulting in an increased demand for manufacturing technologies that address formulation challenges such as stability, solubility, absorption and permeability. Liquid fill hard capsules (LFHC) technology is not only addressing these formulation and manufacturing challenges, but also proving to be a simpler and more versatile process.

Product Marketing Advantages

The global nutraceuticals market is worth roughly $241 billion and is projected to reach $373 billion by 2025; numbers like this, while welcome, threaten market saturation, creating a landscape where failure can be quick and expensive. Standing apart from the competition with customized branding and increased recognition is just as important as knowing who your customer is. Do they have specific dietary needs? Do they have religious requirements? Are they environmentally conscious? The nutra manufacturer must know what customers want even before they do—a clairvoyance that allows them to stand out amidst a sea of same old, same old.

Polymer type, size, color and printing adds that custom touch that today’s nutra customer is seeking.

Improved 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.

Combination Fill: Liquid + Pellets

Two different particulate systems can be incorporated in one dosage from to obtain different profile.

• Drug dissolved in liquid gives immediate release
• Drug can be in the form of delayed release pellets and dispersed in liquid formulation

Examples: Vitamins A, D, E + B complex pellets

Combination Fill: Liquid + Tablet(s)

Two different active drugs can be incorporated in one dosage from to obtain different release profiles.

• Drug in solution form provide immediate release
• Drug can be in the retard tablet form and dispersed in oily li quid

Examples: B complex tablets + omega-3,6,9, omega/fish oil with iron, folic acid and vitamin B12

Combination Fill: Liquid + Capsule

Two different incompatible drugs can be incorporated in one dosage from to avoid stability concerns.

• One active dissolved or dispersed in solvent
• Other active can be encapsulated in smaller capsule and dispersed in liquid

Examples: Vitamin A, E + vitamin C capsule, prebiotic + probiotic

Gelatin Versus HPMC As Capsule Shell Material

Gelatin is the most widely used capsule shell material due to its non-toxicity, solubility in biological fluids at body temperature, and ability to undergo thermal gelation and form a strong, flexible and homogeneous film.

However, a few inherent characteristics of gelatin such as animal origin, cross linking reactions, temperature-dependent disintegration/dissolution, moisture content and stability problem and need for special manufacturing conditions create a market for the “veggie” alternative, hydroxypropyl methyl cellulose (HPMC).

HPMC capsules are known for their vegetable origin and are backed by a lengthy list of certifications such as non-GMO (genetically modified organism), kosher, halal, vegan, ‘clean’ and organic. They are free of preservatives, allergens, starch and gluten.

HPMC capsules provide a highly flexible and widely acceptable platform capable of solving numerous challenges currently facing the nutraceutical industries, expanding the selection possibilities relating to various types of fill materials.

Encapsulation Machine Customization

With advancements in liquid encapsulation equipment, filling and sealing formulations into two-piece hard gelatin capsules can be done easily in-house. At the level of experimental batches, capsules can be filled manually using a hypodermic syringe. This process is useful for preliminary investigations into capsule shell integrity and compatibility with excipients, as well as in-vitro and in-vivo dissolution and pharmacokinetic studies. Semi-automatic and automatic filling machines are available for all scales of output, from bench to production. Therefore, there are minimal problems during the scale-up process.

Liquid Filling Process Sealing and Banding

Once closed, the capsule must be sealed to prevent leakage and tampering. The purpose of banding or sealing is to create a leak-proof closure to contain liquids including oil, pastes and non-solids. This enables manufacturers to comply with the regulatory requirement for OTC (over-the-counter) capsule products sold in the USA (FDA’s Compliance Policy Guide 400.500). There are two main procedures in the industry to complete this process: Application of a gelatin or HPMC solution on the gap between the cap and body (adhesion of band to external shell surface), or micro spraying aqueous ethanol (fusion of inner cap and outer body surface).

Banding colors are also customizable and provide a tamper-proof seal.

Packaging

Increasing demand for non-toxic, cost effective and sustainable products has increased the need for customization and innovation in packaging solutions. In addition to determining the right barrier type to both protect the product and avoid costly wastage, to sustain the market competition, companies are focused on creating unique packaging, shapes, and materials to distinguish their products on cluttered shelves.

Customization in packaging goes beyond barrier type; the branding, like the logo printed on the back of a blister pack is also there for safety and anti-counterfeiting measure.

Customization and innovation is a fast-paced game in nutraceuticals, so maintaining a competitive advantage is critical for sustained growth. NIE

References:

Naresh Thamada*, D. Satyavathi, Sunil Gupta, Dinesh Kumar Challenges and opportunity in encapsulation of liquid filled in hard gelatin over soft gelatin capsules – an innovative technology. https://pdfs.semanticscholar.org/35aa/0379c867c4e732caae51ddac703a47e5d741.pdf.

Bhatt B, Agrawal SS. Pharmaceutical Technology. Capsules; 2008. www.niscair.res.in/jspui/bitsream/123456789/747/1/Revised%20CAPSULES.pdf. [Last accessed on 10 May 2017].

Majee, Sutapa. (2017). Hpmc As Capsule Shell Material: Physicochemical, Pharmaceutical and Biopharmaceutical Properties. International Journal of Pharmacy and Pharmaceutical Sciences. 9. 1-6. 10.22159/ijpps.2017v9i10.20707.

ACG Whitepaper. “Liquid Encapsulation Technology for Nutraceuticals.” June 2017.

Poorva Chaudhar. Top 4 Trends In Nutraceutical Packaging. Packaging Digest. www.packagingdigest.com/nutraceuticals/top-4-trends-nutraceutical-packaging. (August 20, 2018).

Evelyn Reinson is an international marketing manager at ACG, responsible for global marketing strategies of the company’s product range of capsules, films & foils, engineering, and inspection worldwide. www.ACG-world.com.

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