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Tablets & Capsules January 2016 11 persible. In that state, even a poorly soluble API could be absorbed. The liquid form also provides a stable environment for labile actives and protects against oxidation. Liquids also promote fill weight uniformity, efficacy, stability, and safety, especially when the API is highly potent or toxic. Liquid fills can also reduce development time because they are typically a mixture of only one or two excipients. As a result, less time is spent on development and scale-up because fewer experimental replicates are required. On the business side, liquid fills can lengthen product lifecycles and patent protection because they enable you to reformulate old products and re-introduce them in a new form. That creates exclusivity and protects your market share. Advantages of two-piece capsules A major advantage of using two-piece capsules for liquid fills: They can be used at all stages of product development, from early bench testing to full-scale production. That sim- plifies the work and accelerates it, allowing you to get the product to market faster. And because most pharmaceutical companies manufacture their two-piece capsule products in-house, production efficiency is higher compared to soft- gels, which are typically made off-site. Two-piece capsules also offer many trade-dress options, including custom colors and imprints to establish and solid- ify brand identity. Furthermore, because the cap and body of liquid-filled capsules are typically band-sealed (photo) or fused, they ensure product integrity and tamper evidence. Band-sealing also helps prevent odors, reduces oxygen dif- fusion, and strengthens the capsule shell. That extra strength is especially important when the capsules are pack- aged in a blister. Two-piece capsules can be made from a number of sub- stances, but gelatin and hydroyxypropyl methylcellulose— also known as HPMC or hypromellose—are the primary materials. Hypromellose capsules are used when filling a liquid into gelatin capsules would lead to stability limita- tions or cross-linking. Hypromellose capsules are better suited to moisture-sensitive APIs and hygroscopic fills because they don't become brittle. They also accommodate a broader range of excipients suitable for liquid fills, thereby increasing the odds of identifying compatible excipients that can improve the bioavailability of poorly soluble drugs. Some hypromellose capsules have a moisture content of only 4 to 6 percent and can be exposed to low relative humidity without becoming brittle [1]. Advantages of softgels Softgels are formed, filled, and hermetically sealed in a single operation, and there is an elegance to the final dosage form, which helps differentiate them. Softgels are also well accepted by consumers and come in a variety of shapes, sizes, and colors, so they offer excellent branding opportunities (photo). There are also formulation advantages. Softgels are ideal for oils and fat-soluble fills, and because they fully encapsu- late the fill, sensitive ingredients are protected from conta- mination, oxidation, and photo-degradation. Softgels also withstand temperature fluctuations, making them conve- nient to store and transport. Furthermore, patients who have difficulty swallowing tablets find softgels easier to ingest. Softgels also mask some unpleasant flavors of fills and deter tampering. A gelatin band prevents liquid from leaking from filled two-piece capsules. It also strengthens the capsule and provides tamper evidence. The large variety of softgel shapes, sizes, and colors offer excellent branding opportunities.These are added to bathwater, not swallowed. Softgels are ideal for oils and fat-soluble fills, They also mask some unpleas- ant flavors and deter tampering.