Soft gelatin capsules, also known as softgels or soft elastic capsules, are hermetically sealed one-piece capsules containing a liquid or a semisolid fill without a bubble of air or gas. They are made from a more flexible, gelatin film plasticized by the addition of glycerine, sorbitol, or a similar polyol.

Soft gelatin capsules have grown in popularity in recent years because they enable administration of liquids in a solid dosage form with a bioavailability advantage over other commonly used solid dosage forms (e.g., tablets). They are available in a variety of sizes, shapes, and colours that may be specific to the manufacturer.

Presenting a drug substance to the gastrointestinal tract in a solubilized form overcomes the processes of disintegration and dissolution that are required from solid dosage forms (such as tablets and hard gelatin capsules) before the active pharmaceutical ingredient (API) is available for absorption. This has been utilized to improve the bioavailability of drugs with a range of solubilities.

Presentation of drug substances in a solution form can overcome the challenges of achieving dosage unit homogeneity compared to other solid oral dosage forms. Because soft gelatin capsules are filled with liquids or suspensions, excellent content uniformity can be achieved with even the most potent of drugs. The accuracy of the filling mechanism enables the dose to be filled to a tolerance of ± 1% for solutions and ± 3% for pastes.

Most of the unit operations involved in the manufacture of tablets and hard gelatin capsules can generate a significant quantity of airborne powders. This can be a cause of concern for the manufacture of highly potent or cytotoxic compounds because of safety considerations for the operator and environment.

In the case of soft gelatin capsules, the powder handling is restricted to drug dissolution or dispersion in a liquid medium. Therefore, soft gelatin capsules provide greater operator safety during manufacturing. In addition, as the drug formulation is hermetically sealed in a shell, the exposure to the medication is minimized during dispensing as well as use.

The contents of soft gelatin capsules vary from solids, solid in liquid, solution or suspension, a combination of miscible liquid, or a simple liquid formulation. Fill materials are limited to those that do not interact with the gelatin shell and/or other components of the shell.

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