Published Paper Details:

Capsules are one of the most versatile and widely accepted oral dosage forms used in pharmaceutical practice due to their ease of administration, rapid disintegration, and ability to accommodate a broad range of drug substances. Their manufacturing involves specialized processes that differ for hard gelatin capsules and soft gelatin capsules, each requiring precise control of materials and operating conditions to achieve consistent quality. Hard gelatin capsules are produced through sequential steps such as dipping, drying, trimming, and filling, while soft gelatin capsules are typically manufactured using techniques like the rotary die process, which enables simultaneous forming, filling, and sealing. To ensure the safety, efficacy, and uniformity of the final product, capsules must undergo rigorous quality control tests, including disintegration, weight variation, dissolution, assay, content uniformity, and moisture permeation testing. These evaluations verify the structural integrity of the shell, accuracy of the fill weight, and performance of the dosage form under physiological conditions. This review summarizes the manufacturing processes of both hard and soft gelatin capsules and highlights the essential quality control parameters required to comply with pharmacopeial standards, thereby ensuring reliable therapeutic outcomes.