Issue link: http://www.e-digitaleditions.com/i/883179
Here are 10 key questions to ask a CDMO—and yourself—about product concept, ingredient characteris- tics, capsule choice, and contractor qualifications. 1. What kind of product are you developing? Does your product contain multiple ingredients? Combination supplements have become more popular as consumers seek products that meet multiple health needs in a single dose. However, because of the "less-is-more" movement (also known as the clean-label trend), these same consumers are asking for products with fewer excipi- ents. Your formulator should aim to balance these com- peting needs without sacrificing product effectiveness. Additionally, does the product require immediate, extended, delayed, or targeted release? Some ingredients like melatonin and caffeine can be formulated to release immediately and over an extended period. Probiotics and enzymes, however, work best when delivered in the intestines, and may require enteric protection. You and your CDMO should consider technologies that allow you to protect your ingredients and maximize bioavailability, while minimizing the use of coatings or other additives. 2. How can capsules improve brand identity? Consumers recognize and remember dosage forms pri- marily by color and less by shape, size, or brand name [3]. Ask your manufacturer about color options, including two-tone, opaque, translucent, and transparent capsules. Also ask your CDMO about imprints. Logos, icons, slo- gans, numbers, and other identifiers help differentiate your product. 3. Do your customers have lifestyle or cultural needs that affect your choice of capsules? Your customers' dietary restrictions and/or religious customs may impact the type of capsule you use. Ask your manufacturer if halal- or kosher-certified capsules are available. To appeal to the growing vegetarian market, a capsule made of hydroxypropyl methylcellulose (HPMC) might be needed. Your CDMO should be able to provide capsules with vegetarian and/or vegan certifications. The demand for clean-label products is on the rise, especially among consumers who value natural, vegetar- ian, and organic products. Fortunately, most capsule for- mulations require few excipients. Ask your CDMO about capsules certified as non-GMO and/or "made with organic" designation to further appeal to these consumers. 4. Do the key ingredients pose delivery challenges? Some ingredients are unstable when exposed to light, oxygen, moisture, or stomach acids and that can compro- mise their effectiveness before or after consumption. To protect your ingredients and maximize performance, ask your manufacturer about softgels and LFHCs that prevent premature activation, oxidation, and degradation. Naturally stinky or bitter ingredients are a turn off. Ask your CDMO about softgels and capsules with odor- and taste-masking properties. Are your ingredients hydrophilic or lipophilic? The solubility characteristics of your ingredients can influence a product's bioavailability and effectiveness. Whether you're using hard or soft capsules, it's important to deter- mine ingredient and capsule shell compatibility. Softgels use plasticizers like glycerol or sorbitol to maintain their elasticity. These plasticizers may migrate into the fill and affect ingredient solubility or compromise the dissolution of the finished product. The low oxygen permeability of hard capsule shells protects the active ingredients from oxidation. Vegetarian hard capsules contain little moisture and are suitable for hygroscopic and moisture-sensitive ingredients. Because hard capsules don't use plasticizers, they are neutral in taste and mask odors. They also tolerate fills as warm as 70°C, whereas softgels only accept fills as warm as 35°C. Hard capsules also accept fibrous materials in suspensions or pasty fills, which are difficult to encapsulate in softgels because they impair sealing. 5. Which technologies can help overcome delivery challenges? LFHCs protect unstable ingredients—such as resveratrol, astaxathin and other carotenoids, L-arginine, and L-carni- tine—from oxidation. The ingredients are stored, mixed, and filled under a nitrogen blanket to eliminate oxygen. The filled capsule is then hermetically sealed using proprietary fusion technology to prevent further oxygen penetration before consumption [4]. This seal provides six times the seal zone of a banded capsule and is more effective in preventing leaks [5]. In addition to protecting highly concentrated oils from oxidation, this technology masks the tastes and odors of fish oils, especially krill oils, while they're in the bottle and at consumption. Ask your CDMO what liquid delivery technologies best suit your product. For delivery of moisture- and acid-sensitive ingredi- ents, consider acid-resistant HPMC capsules. They have been shown to delay opening for an average of 52 min- utes without the use of enteric coatings [6]. They resist Tablets & Capsules October 2017 32C An opaque hard capsule inside a clear LFHC