When you work with capsules in the pharmaceutical industry, ensuring their quality is not just important, it’s essential. One of the most critical aspects of capsule quality is hardness, how well they withstand physical stress.
Whether you’re using a Gelatin Capsule Hardness Tester or soft gel capsule machine, understanding hardness testing helps you deliver reliable, high-quality products that meet both regulatory standards and consumer expectations.
This article covers everything from gelatin capsule, testing methods, to equipment tailored for your needs.
What is a Gelatin Capsule?
Gelatin capsules, commonly known as gel caps or soft gel capsules, are widely used in pharmaceuticals and nutraceuticals to encapsulate active ingredients. Made from gelatin derived from animal collagen, they are smooth, easy to swallow, and cost-effective compared to vegetarian capsules made from hydroxypropyl methyl cellulose (HPMC).
There are two main types:
- Hard Shell Capsules: Composed of two parts, they are used for dry powders or pellets.
- Soft Shell Capsules: A single-piece structure ideal for encapsulating oils or liquid formulations.
Their versatility and affordability make gelatin capsules the most popular choice for various applications.
What Is the Hardness Test for Capsules?
Hardness testing measures how resistant capsules are to breaking or deforming under force. For you, this means ensuring capsules can endure manufacturing, packaging, transportation, and handling without compromising their integrity.
Hardness testing also affects drug delivery because the capsule’s hardness impacts its dissolution rate, which determines how effectively the contents are released.
Using a soft gel hardness tester or a gelatin capsule hardness tester, you apply controlled force until the capsule deforms or breaks. The result, usually measured in newtons (N), tells you how strong your capsule is. This process is a cornerstone of pharmaceutical quality assurance, helping you produce capsules that are safe and effective.
What Is the Hardness of Gelatin Capsules?
The hardness of gelatin capsules depends on their type and formulation. Hard gelatin capsules are rigid and designed to withstand mechanical stress during production, packaging, and handling. Meanwhile, soft gelatin capsules or softgel capsules, are more flexible due to their higher moisture content and plasticizers like glycerin or sorbitol.
In the pharmaceutical industry, achieving optimal hardness requires precise control over ingredient ratios.
For example, the weight ratio of dry plasticizer to dry gelatin typically ranges from 0.4 to 0.6:1.0, with the hardest shells forming at a ratio of 0.3:1.0 and softer shells at 1.8:1.0. This balance ensures that capsules maintain their structural integrity while meeting dissolution and drug delivery requirements.
What Is the Difference Between Hard and Soft Gelatin Capsules?
Understanding the differences between hard and soft gelatin capsules helps you choose the best option for your pharmaceutical formulations. Each type serves distinct purposes and has unique characteristics tailored to specific applications.
1. Hard Gelatin Capsules
These capsules consist of two separate parts -a cylindrical body and a cap- designed to hold dry powders, compressed plugs, granules, or even small tablets. They are produced using two machines: one for making the shell and another for filling the contents.
Hard capsules contain less plasticizer, making them rigid and durable during handling and transportation. They dissolve quickly in the stomach, ensuring efficient drug delivery.
2. Soft Gelatin Capsules
These seamless, single-piece capsules are ideal for holding liquids or semi-solid formulations, such as oils or suspensions. Unlike hard capsules, softgels are manufactured in one step, using equipment that feeds, fills, and seals the capsule simultaneously.
Their flexible shell, rich in plasticizers, ensures leak-proof integrity. Soft gelatin capsules also come in a variety of shapes, including round, oval, and tubular, and they dissolve more rapidly in gastric juices, enabling faster action.
While hard capsules offer versatility for solid formulations, soft gelatin capsules provide a superior solution for liquid and semi-solid applications. Your choice depends on the specific requirements of your product, from formulation type to production efficiency.
When deciding between hard and soft gelatin capsules, it’s important to consider the nature of your formulation and application. Each type offers unique advantages and is designed for specific uses.
How Soft Gelatin Capsules Are Evaluated?
When you work with soft gelatin capsules, or softgel capsules, ensuring their quality is a top priority. These capsules, containing active pharmaceutical ingredients (APIs) within a flexible gelatin shell, require thorough testing to guarantee their performance.
You need to evaluate key attributes like shape, size, color, shell thickness, leakage resistance, disintegration, and content uniformity to meet industry standards.
To assess their hardness, you can rely on specific methods tailored for their flexible structure:
- Compression Testing: Measures how much force it takes to deform or break the capsule shell.
- Penetration Testing: Uses a probe to determine the force needed to pierce the capsule.
- Flexural Testing: Checks how much the capsule can bend before breaking.
A soft gel hardness tester is your go-to tool for simplifying these evaluations. With its precision and consistency, it helps you ensure that your capsules are robust enough to handle production and packaging while maintaining their intended quality and performance.
Gelatine Capsule Hardness Testers: A Must-Have Tool in the Pharmaceutical Industry
Gelatine Capsule and Soft Gel Hardness Tester – Auto PharmaCheck engineered to meet the stringent demands of the pharmaceutical industry, providing precise and automated testing for capsule hardness and compressive strength.
Unlike other testers, the Auto PharmaCheck boasts a motorized probe with an exceptional resolution of 0.0001 mm, ensuring unparalleled accuracy. The integrated load cell measures applied force with a resolution of 0.001 N and a full scale of 60 N.
Its automated probe plate rotation allows seamless testing of multiple capsules, significantly enhancing efficiency. Combined with its digital interface, the device provides real-time readings of force and displacement, ensuring reliable and user-friendly operations.
Why Gelatine Capsule Hardness Testers by Qualitest Stands Out
Auto PharmaCheck offers robust technical capabilities and flexibility. Our Gelatin Capsule Hardness Tester ensures:
- Comprehensive Testing Cycles: Customizable test cycles with precise control over force-time application and deformation levels.
- Enhanced Automation: Fully motorized rotation and interchangeable capsule holder plates to test various shapes, including oval, spherical, and oblong.
- High Precision: Its motor-controlled screw system achieves resolutions up to 0.0001 mm, far exceeding conventional standards.
- Robust Data Management: The integrated software stores results in SQL databases, enabling efficient access, analysis, and compliance with regulatory standards.
- Flexible Reporting: Customizable reports can be generated in multiple formats (PDF, Word, Excel) for streamlined documentation and sharing.
Final Thoughts
When you prioritize hardness testing for your capsules, you ensure that your products meet regulatory standards, perform as intended, and satisfy customer needs.
Whether you’re evaluating soft gelatin capsules or hard capsules, using tools like a soft gel hardness tester or a gelatine capsule hardness tester helps you deliver reliable results.
For pharmaceutical manufacturers, Qualitest’s Gelatine Capsule and Soft Gel Hardness Tester - Auto PharmaCheck offers a blend of precision, efficiency, and versatility, setting a new benchmark in capsule hardness testing. Whether you prioritize compliance, data integrity, or operational efficiency, this tool delivers unmatched value.
