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Research, Development, and Manufacture of Investigational Drugs
Manual for Soft Capsule Development
 Description of Our Technology
Technology of Insolubility Prevention (Amber-Colored Gelatin Capsule)
Issues with gelatin
A delay in dissolution or insolubility had occurred in the past with the capsule shell, which is mainly made of gelatin, due to reactivity with certain inner fill material.
Insolubility mechanism
Aldehyde functional groups that exist in inner fill material form bonds with amino acid residue of the gelatin, and the resulted cross linkages cause insolubility of the capsule shell.
Succinated gelatin capsules
Tokai Capsule has been dedicated throughout the years to the research and development of succinated gelatin capsules that readily dissolve without causing delayed solubility. Succinated gelatin is derived from a reaction between gelatin and an organic acid, succinic anhydride, and amino acid residue in gelatin is substituted with acidic chloride.
Theoretically, any organic acid can be used for this particular reaction. However, succinated gelatin derived from using succinic anhydride is the most suitable for production of soft capsules. This succinated gelatin that readily dissolves and does not delay its dissolution is equivalent to regular gelatin in terms of elasticity, adhesiveness, and viscosity as a gelatin solution. The succinated gelatin soft capsule developed by Tokai Capsule has been widely used from formulation of unsaturated fatty acids to herbal extracts.
Chewable Soft Capsule
Development concept
Softness of the outer capsule shell and significantly increased solubility make the capsule chewable, allowing for easy and ready-to-take oral administration without water.
Characteristics
Easily-chewable capsule with a soft capsule shell
Can be taken without water
Easy-to-take formulation achieved by flavoring the inner fill material
NC-CAP technology prevents capsules from sticking to each other
Maintains characteristics of regular capsules
Oily complex can be processed into capsules at room temperature
Ideal bioavailability can be achieved
Content uniformity with high accuracy and precision
Provides stability for compounds susceptible to oxidation
Provides stability for compounds that are light sensitive
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Capsule hardness testing
CSC
CSC
Gly 30
Gly 30
graf graf
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