Most capsules are made from gelatin. Gelatin is widely used in many food products such as puddings, desserts, marshmallows, chewable candies, glazes, whipped toppings, and dips. One popular consumer product is Jell-O® brand gelatin. In food applications, gelatin's ability to gel, thicken, stabilize, and aerate make it a highly desirable, nutritive, fat-free component. Gelatin also finds its way into many households in the form of cosmetics and toiletries, which utilize gelatin for its hypoallergenic and hydrating properties.
Gelatin itself is a mixture of water-soluble proteins derived primarily from collagen, which is the main naturally-occurring protein constituent of connective tissue. Gelatin is obtained from collagen by exposing animal skins and bones to a controlled extraction process. Gelatin comes in various types. Capsules are made from pharmaceutical-grade gelatin that has met the stringent requirements of the United States Pharmacopoeia and other international organizations that set standards for products that are used in medicines.
In addition to gelatin, capsules can also be created using non-animal sources suitable for addressing a variety of cultural and dietary requirements, including vegetarians, as well as patients with restricted diets. Two such non-animal capsule materials are pullulan and hypromellose. Pullulan, a water-soluble polysaccharide produced through a fermentation process, has achieved wide regulatory acceptance with its proven safety record. It has been in commercial production for more than 25 years, having numerous uses in the food and pharmaceutical industries. Hypromellose or HPMC is made from cellulosic raw materials and is also widely accepted globally.
In the production of capsules, a thin film of either gelatin, pullulan or hypromellose is formed on stainless steel pins. As the gel forming film dries on the pin, it hardens to form the capsule that is later removed from the pin. Typically, two different size pins are used; one size pin for the body, and another larger-diameter size pin for the cap of a two-piece capsule. The capsule is then transferred to a capsule filling machine, which fills the capsule with either a powder, liquid, or paste.
Jell-O® is a trademark of Kraft Foods, Inc.
How can I be assured the gelatin capsule is safe?
While there are studies of gelatin that can be obtained via a more intensive search of the Internet or other sources, the most significant assurance of the safety of gelatin relates to its long-term use, not only in capsules, but in many other food products that are routinely consumed.
The water-soluble gelatin shell dissolves in the stomach, releasing its contents within the first few minutes of swallowing.
Both tablets and capsules are well-proven and well-accepted dosage forms. The original rationale for developing the capsule as a dosage form was based on the capsule's ability to mask the taste and/or odor of specific medicinal compounds. It gained further popularity based on: ease-of-swallowing, attractive appearance, ability to hold a color, neutral taste, as well as its ability to be filled and processed easily.
Tablets are formed by direct compression of a powdered form of the active ingredient. Many "inactive" ingredients, primarily sugars, starches and other fillers, are often added to tablets to better enable efficient and stable tablet formation. Note that some tablets have chemical coatings that are added to make them easier to swallow, or less prone to distaste.
Gelcaps are basically tablets that are coated with a layer of gelatin.
Softgels are composed of a thick layer of gelatin, to which plasticizers have been added to maintain flexibility and stability. The inner section of the softgel usually contains a liquid form of the active ingredient.
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