Capsules are cylindrical-shaped oral dosage forms containing medicine and manufactured for ease of swallowing and masking the taste of the medicines. The pharmaceutical capsules are a preferred choice when, due to technical issues such as formulation and manufacturing limitations tablets can not be manufactured and physiological reasons to protect the medicament from the direct effect of the gastric juices. The capsule can be used to contain powders, granules, pellets, semi-solid substances or liquids that would otherwise not be palatable or be given in a tablet form. Capsules are to be swallowed whole with a glass of water and should not be chewed or broken into smaller pieces. Some of the common ingredients found in capsules are discussed below.
Pharmaceutical capsules are of 2 types: hard gelatin capsules and soft gelatin capsules. These are discussed in detail below:
- Hard gelatin capsules: They are made from animal-derived gelatin which is soluble in biological fluids at room temperature. They are used to deliver medicine either in dry powder form or pellet form. They are easy to formulate and produce, even in small batch sizes.
- Soft-gelatin capsules: The production procedure for soft gelatin capsules is virtually identical to that for hard gelatin capsules, differing only in moisture content. The addition of appropriate plasticizers during the production of soft gel capsules provides necessary elasticity and stability to the capsules. Softgel is a thick capsule; they are made soft by adding a lot of glycerin. These capsules typically contain essential nutrients like vitamins, minerals, and calcium. They may also hold liquid medications and other oil-based substances, and their supple texture makes them easier to swallow compared to hard capsules.
Pharmaceutical capsules are highly sophisticated products fabricated for the convenient and efficient delivery of medication in the human body. A capsule’s quality and efficacy depend on the skill of the pharmaceutical manufacturer. These manufacturers are accountable for the development, production, and substantiation of capsule safety, in strict accordance with various guidelines prescribed by regulatory authorities.
Pharmaceutical capsules fulfill a very important role in global clinical trials as they can be used as blinding for the test products. This is normally performed using hard gelatin capsules. In their double-blind local and global clinical trials, capsules are used to mask test and reference products in such a way that both treatments appear identical and neither the patient nor the investigator is aware of the intervention given. This approach helps in diminishing bias in the experiment.
There are a number of advantages that make capsules a popular choice among consumers. A recent study found that 52.9% of consumers prefer this dosage form. One of the most prominent benefits of the capsule is the lesser amount of excipients used in comparison to a tablet making it small and light so that it could be swallowed easily. Soft gel capsules are said to stand out for the facility with which they can be swallowed. Besides this, capsules can individually be packed, which adds to their convenience in transportation. They also allow information on crucial details in the printing on the capsule, which is a must for medication management since it will help prevent any inadvertent mix-ups; particularly in people who are on multiple medications.