Hard gelatin capsules
The pharmaceutical industry cannot be imagined without hard gelatin capsules. These capsules are majorly used for filling the medicine in the form of dry powder or small pellets. If you wish to know hard gelatin capsule formulation and manufacturing process and the considerations you need to bear in mind, this article is certainly for you.
Hard gelatin capsules are also referred to as hard shell gelatin capsules or two piece capsules. A hard gelatin capsule comprises of two fabricated cylindrical shaped sections named as the body and the cap. Hard gelatin capsules are supplied by shell manufacturing companies and they are filled later on in a separate process or operation altogether. During the process, the body is filled with the necessary drug substances and the shell is closed by bringing together the body and the cap.
Hard gelatin capsules
Another crucial consideration is the shape and size while manufacturing hard gelatin capsules. Empty capsule size might vary between 000 to 5. Here 5 is the smallest and 000 is the largest size available. The size is determined by the formulation requirements. This includes dose of the active ingredients and drug’s compaction characteristics as well. If you wish to estimate the exact or necessary capsule size, you must determine the density of the formulation by utilizing tapped density for powders and bulk density for granules, minitablets and pellets. Target fill weight, capsule volume and measured density of the formulation are some of the key attributes to be taken into consideration. Know that some specific needs may require elongated sized capsules. These capsules typically have 10 percent extra fill volume as compared to regular hard gelatin capsules.
Hard Gelatin Capsules Filling Process
It goes without saying that the hard gelatin or hard shell gelatin capsule filling process is not possible without a machine. There is a wide array of equipment available ranging from small scale manual filling to intermediate level, semi-automatic and fully automatic large scale machines. They can also be hand-filled and compounding pharmacy is an example of that.
Steps of hard gelatin capsule filling
- Place empty gelatin capsules on the removable plate and make sure that bodies are facing downward.
- Separate the cap from bodies.
- Now, the body must be filled with the formulation utilizing a plastic spatula. Any excess powder should be removed.
- Now, the capsule shells are closed and filled capsules are ejected.