Soft capsules can be filled with various oils or liquid drugs or suspensions that do not dissolve gelatin. It is widely used in the pharmaceutical, health care and cosmetics industries.
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The components contained in the soft capsule shell are substantially similar to the hard capsule shell. They mainly include gel compound, plasticizer, water and additive.
The elasticity of the soft capsule shell depends on the weight ratio of gelatin, plasticizer (typically glycerin, sorbitol or a mixture of the two) to water. Its hardness is determined by the weight ratio of gelatin to plasticizer.
In general, a suitable weight ratio is that dry plasticizer: dry gelatin = 0.4 - 0.6: 1.0, and the ratio of water to dry gelatin is 1:1. The capsule shell is the hardest when the weight ratio between the plasticizer and gelatin is 0.3:1.0, and the shell is soft if 1.8:1. During the drying of the soft capsule, the moisture is reduced. In contrast, the proportion of plasticizer and gelatin increased, while the weight ratio of plasticizer to gelatin did not change.
The ratio of various materials in the plastic shell prescription needs to be determined according to the nature and requirements of the drug. The nature of the filled drug and the interaction between the capsule and the drug should be considered when selecting the hardness of the soft capsule. The nature of the drug should also be considered when selecting a plasticizer.
The soft capsule shell is thick and non-breathable, so it is very good at preventing oxidation of the drug. Most of the drugs that are sensitive to light, unstable to heat, or oxidizable can be made into soft capsules. In order to prevent decomposition of the drug by light, a light-shielding material such as titanium oxide or iron oxide may be added to the capsule material for preparing the capsule to obtain good light stability. To prevent the drug from coming into contact with the air, an inert gas can be introduced during the preparation process.
Gelatin capsules or gel caps or softgel capsules, are composed of gelatin manufactured from the collagen of animal skin and bone.
There are Vegetable capsules as well made up of cellulose. The main ingredient of vegetarian capsules is hydroxypropyl methyl cellulose (HPMC).
However, in the current market, gelatin capsules are more extensively used than vegetarian capsules because the cost of production is lower.
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Types of Gelatin Capsules:
Finished capsules are subjected to a number of tests in accordance with compendial standards and regulatory requirements for unit dose capsule products. These tests help identify whether the batch is acceptable for marketing or its intended usage.
Leaking gelatin capsules destroy consumer confidence in the product and the manufacturer. To prevent defective capsules from reaching the market, a manufacturer must develop tests to identify them.
Gelatin Capsule Hardness tester is a device that indicates the hardness of a capsule by measuring the effect on its surface of a localized penetration by a standardized flat shaped indenter made of hard steel. Qualitest offers suitable solution and a precise instrument to test the hardness of Gelatin capsules.
Our Gelatin Capsule Hardness Tester is a plug and play hardness tester and non-destructive method developed for determination of the hardness and resistance on gelatin, gelatin capsules, play dough, paintballs, agars, etc.
The unique design and digital measuring systems ensures that a very high measuring precision and most reliable measurement is obtained. An automatic measurement for hardness test on gelatin capsules is required to obtain optimum accuracy and repeatability.
The user can choose a measuring head from either 0 - 2 N or 0 - 20 N and has an option to attach an Automatic positioning device called Rotofix or a manually operated sample fixture known as Centrofix. With the help of our software, user can analysis the results, store data, see histograms, create batch folders, etc.
Based on the clients requirements, Qualitest designs and develops customized automated optical inspection systems that could be integrated with a Gelatin Capsule hardness tester or as a stand alone. This system will allow the quality specialists to check the size and defects of the finished product, achieving close to 100% perfection in quality for each batch that is manufactured. This efficient technology will maximize your business values and embrace cost optimization for your company.
Our products are highly customizable and our team of experts can help you navigate the standards requirements alongside helping you choose the right machine for your unique requirement. For more information, write to us at
Qualitest is well aware of the various testing requirements that may arise in different industries. We guarantee efficient logistics and a high level of standards. Our products are built to last and various government agencies, educational institutions, and private businesses have benefitted from our advanced state-of-the-art testing products.
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