Tablets & Capsules

TC0918

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Tablets & Capsules September 2018 33 H with an active pharmaceutical ingredient (API) to form a homogeneous suspension and then filled into hard cap- sules made of either gelatin or hydroxypropyl methylcel- lulose (HPMC). The mixture's viscosity at the filling tem- perature should be between 80 and 80,000 centipoise to ensure that the liquid adequately fills the capsules. If the liquid fill is flowable at ambient temperature, the capsules must be sealed after filling to prevent leakage. Liquid-filled hard capsules (LFHCs) allow companies to formulate drug products using many APIs that would be difficult or even impossible to formulate as other solid dosage forms. LFHCs can be a cost-effective alternative to some softgel products and can also improve product sta- bility and enhance an API's bioavailability. Liquid encap- Liquid-filled hard capsules are an important and versatile solid oral dosage form. This article provides a basic explanation of the form and explains how it can help to overcome common formulation challenges. ard capsules have traditionally been filled with pow- ders, but they can also be filled with non-aqueous liquids, suspensions, semisolids, thixotropic gels, self-emulsifying drug delivery systems (SEDDS), thermo-softened matrixes, and hot melts that flow at temperatures below 70°C (the temperature at which a hard capsule begins to soften). These flowable fill materials are typically mixed Solving formulation problems with liquid-filled hard capsules Milind K. Biyani Aspire Advisors capsule filling Courtesy of ACG

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