The basic principles of soft gel manufacturing involve a high level of homogeneity. There are several techniques to achieve this goal. This article will focus on the Equipment used in the manufacturing of soft gels and other industries. Despite the importance of homogeneity, soft gels are not necessarily better than hard gelatin capsules in every respect. Nevertheless, some important considerations must be kept in mind. Listed below are some of the key factors to consider when manufacturing soft gels.
Problems with hard gelatin capsules
Many problems with hard gelatin capsules in soft gel manufacture can be traced back to the mechanical properties of the material. Insufficient pre-lock position of the joining block, incorrectly setting cap hold-down pin, and foreign materials are common causes of loose caps. In addition, the gelatin may not be well-adjusted or contain sufficient plasticizer, causing the capsule shell to transfer water to the encapsulated components. In addition, hygroscopic components such as water may also absorb water from the capsule shell.
Gelatin is a nutrient-rich substance that improves oral bioavailability. It also ensures reduced variability in plasma levels, which makes it suitable for pharmaceutical applications. However, the development of gelatin-based capsules is highly complex and demanding, as gelatin is not a clean label substance. Soft gelatin capsules must be produced from high-quality gelatin and meet stringent industry regulations.
Techniques for achieving homogeneity in dosage units
Using liquid or paste filling techniques is a very effective way to produce solid oral dosage forms with excellent content uniformity. However, there are some challenges in the formulation process. One of the main challenges is the inability to dissolve pharmaceutically active ingredients in small volumes of solvent. Softgels must be formulated with a suitable solvent system to achieve homogeneity in content.
This invention describes techniques for improving the solubilization of pharmaceutically active ingredients. These methods permit the preparation of a smaller dosage unit while reducing overall fill volume. The invention also reduces undesirable interactions between fill ingredients and the gelatin casing. One embodiment of the invention involves increasing the concentration of the pharmaceutically active ingredient through incrementally adding it to the polyethylene glycol.
Another technique involves using enzymes as the fill. This allows for two-tier dissolution testing. In one tier, pepsin is added to water and an acidic solution to reach 750,000 units of activity per liter. The second tier adds pancreatin USP to a pH higher than 6.8 and a protease activity of 1750 units per milliliter.
Equipment used in soft gel manufacturing
Soft gel manufacturing begins with the preparation of the gelatin filling material. In a rotary-die machine, two plasticized gelatin ribbons are continuously fed with the fill. Fill material is either a paste, semi-liquid, or liquid, and the rotary-die mechanism forces the feed material to swell, forming a softgel shell. This swelling of the gelatin determines the softgel size and shape, and right-hand die pockets control the shape of the capsule. When the capsule is completed, matching die pockets seal the capsules hermetically.
The softgel manufacturing process requires clean room space. Encapsulation machines require some cleanroom space, so be sure to set aside enough space to accommodate the equipment. Once the machinery has been installed, the cleanroom space should be emptied and cleaned as necessary. Purchasing softgel manufacturing equipment can be challenging, but working with a professional softgel supplier can help you find the right equipment. Some equipment is essential for the process, including clean water, compressed air, vacuum, and power.
Equipment used in other industries
There are many factors to consider before you choose a soft gel manufacturing machine. You should consider the amount of production required and the speed of the machine. You should avoid compromising on either of these aspects as this can compromise on the working of the machine. Softgel manufacturing machines are not portable and require professional help to operate them. You should also check the quality and standard of these machines. Listed below are some tips on how to choose the best softgel machine for your needs.
The main objective of softgel encapsulation equipment is to convert syrup into thin layer of gelatin. Then, the gel mass is encased in a capsule by wrapping it around a fill material. The process is finished when the capsule is cooled. Softgel encapsulation equipment includes two spreader boxes on either side of the cooling drum. The size of these spreaders depends on the amount of material to be encapsulated.