ABSTRACT
Two-piece hard capsules are a well-established dosage form that provides solutions to many of today's drug delivery and nutraceutical formulation challenges. Two-piece hard capsules are an indispensable tool to support innovative drug development. The growing demand for all natural gelatin alternative capsules such as hydroxypropylmethyl cellulose (HPMC) is driving the usage of two-piece capsules. Capsules are one of the oldest known dosage forms dating back to the ancient Egyptians. One of the oldest and longest papyri is the Ebers Papyrus dating to approximately 1500 BC. While two-piece capsules may be composed of various materials, the vast majority are still made using high-quality gelatin prepared from collagen. Gelatin used in hard capsule manufacture must meet the requirements of all major pharmacopeias. Modern capsule manufacturing processes yield capsules with highly consistent critical quality attributes including weight, length, and shell wall thickness. Capsule printing is usually required by regulatory authorities for pharmaceutical products to comply with product identification requirements.
