What are hard capsules?
Hard capsules are an oral dosage form for the delivery of life-saving drugs, mineral, vitamins or other healthy ingredients via supplements. These convenient packages enable reliable dosing, portability and high consumer compliance. Alternatives include more cumbersome liquid, powder or paste formulations.
Specifically, hard capsules are made of two cylindrical shells – each closed off at one end. The upper part, called the cap, has a slightly larger diameter than the lower part, called the body. These two parts fit together perfectly to form a hermetically closed unit. Hardcaps are produced before filling with the active ingredient. In a secondary step, contract manufacturers or brand owners are filling the active ingredient or drug in the empty gelatin capsules. As the world's population ages and as we deal with COVID-19, health-minded consumers require dosage formats that are easy to use, easy to swallow and portable.
What are gelatin hard capsules?
Gelatin hard capsules are an elegant delivery format with gelatin as the primary gelling ingredient. Gelatin, a pure protein, is tasteless, gluten-free, GMO-free and offers a benign oral dosage form that creates a pleasant experience for the consumer. It enables producers to customize based on color, shape or size in order to meet the requirements of the active fills and of the targeted demographics. The filling of the capsules is independent of the empty capsule. In addition to gelatin, plasticizers like glycerin or polyethylene glycol are used to reduce capsule rigidity and increase pliability.
What are gelatin hard capsules used for?
Gelatin hard capsules are ideal for powdered or granulated ingredients. These ingredients can be easily filled in the two-piece hardcaps.
How long does it take hard gelatin capsules to dissolve?
A standard gelatin hard capsule dissolves in the stomach, under normal conditions, within twenty to thirty minutes after swallowing. Depending on the application, different gelatin types or additional process steps can influence the dissolution process. Some gelatin types dissolve faster than others when they are in contact with acidic fluids and higher temperatures (stomach conditions). For other applications, as for example pain relievers it is necessary to have an even faster dissolving shell. For applications where the drug is targeting the intestines a slower dissolving shell is required.
Is there a standard size of hard gelatin capsule?
While there is not one standard gelatin hard capsule size, empty capsules are available in various sizes. Capsules are numbered according to their capacity, with the most common sizes varying from about 0.13ml (size number 5) up to approximately 1.37ml (size number 000) in approximately eight incremental sizes.
What kind of gelatin is used in hard capsules?
The primary gelatin types used in capsules are typically from bovine or porcine raw materials. Depending on the fill, formulation and on the target market group, manufacturers have flexibility in the raw material type, with some opting for a combination of porcine and bovine options. Bovine bone gelatin, for example, contributes to capsule firmness. Porcine options, on the other hand, offer plasticity and clarity characteristics.
Why are gelatin hard capsules preferred over other formats?
Like their softgel counterparts, gelatin hard capsules offer value to consumers and producers alike. These advantages are due largely due to their main component, gelatin. Gelatin means "stiff" and is a colorless dry powder that has been used for centuries in a host of food and pharmaceutical uses. For consumers, gelatin dissolves in the human body at normal body temperature, making it the ideal ingredient in hardcaps. While protecting the precious actives inside the capsule against oxygen, light, moisture and dust, the gelatin of the hardcaps affords consumers easy swallowing. Consumers also appreciate that the capsule size and color can help them to more easily identify the respective pharmaceutical drug or nutrient inside. For producers, gelatin provides fast machinability and setting times, ideal dissolution properties and an optimal protection of fill ingredients. Producers can then market the empty hard gelatin capsules to brand owners who are filling with medications or nutrients. And, reputable gelatin suppliers offer Halal and Kosher certifications for different gelatin types to satisfy wide-ranging consumer requirements and preferences. Hard gelatin capsules also allow easy filling.
How are gelatin hard capsules produced?
Hard capsules are produced on a large machine that is comprised of polished stainless-steel pins that are dipped in a gelatin mass solution (gelatin, colorants, plasticizers). Within the drying tunnel the gelatin is dried in a gentle way where the airflow, the temperature and humidity are precisely controlled. In these conditions, the gel mass forms a film over the pins shaped like a cap. This half of the capsule is then stripped from the pin. The dry cap and body of the capsule are cut precisely and joined together with the counterpart of the hard capsule. Before the empty caps are packed for shipping, producers can print on the capsules for consumer identification purposes.
What is the difference between hard gelatin capsules and tablets or pills?
Different than tablets – that are essentially compressed powders - gelatin hard capsules are convenient delivery systems that beautifully encapsulate the active fills. Because of capsules‘ low friction properties – they are easy to swallow, which promotes higher compliance. Pills are often a generic term to encompass any solid oral delivery of drugs or minerals and vitamins.
Are gelatin hard capsules safe and non-allergenic?
Yes. Read answer here.
Can hard capsules be made from things other than gelatin?
Yes, but none of the alternatives compare to gelatin. Learn more here.
Are gelatin hard capsules vegan/vegetarian?
Gelatin hard capsules are not vegan nor vegetarian. Vegetarian capsules or vegan capsules, although a much smaller component of the global market, serve niche segments.