FORMULATION DEVELOPMENT – A QbD Approach to Develop Extended Release Softgels

Soft gelatin capsules (softgels) continue to be the oral solid dosage form preferred by consumers.1 Understandably, as they are easy to swallow and digest, effectively mask unpleasant tastes and smells, and have a pleasing appearance. Softgels also offer formulation and marketing benefits. They can accommodate a wide variety of compounds filled as liquids, solids, semi-solids, suspensions, or emulsions. They can also address a broad range of formulation challenges, such as improving the absorption and bioavailability of poorly water-soluble APIs. Softgels are particularly well suited for formulating low melting point APIs, which require additional processes for tablet forms. They also allow low- and ultra-low-dose precision for highly potent compounds. To extend product lifecycle with added patent protection, softgels can be developed in various dosage forms, such as chewables, controlled release, and softgels from non-animal materials.