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Questions and Answers
Soft gelatin capsules are filled exclusively with powder.
Soft gelatin capsules are filled exclusively with powder.
False
In the reciprocating die process, the thickness of the gel ribbon is one of the in-process tests.
In the reciprocating die process, the thickness of the gel ribbon is one of the in-process tests.
True
Both soft and hard gelatin capsules are cylindrical in shape.
Both soft and hard gelatin capsules are cylindrical in shape.
False
High levels of impurities in polyethylene glycols can lead to the insolubilization of gelatin through polymerization.
High levels of impurities in polyethylene glycols can lead to the insolubilization of gelatin through polymerization.
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Soft gelatin capsules consist of sugar, gelatin, and plasticizer.
Soft gelatin capsules consist of sugar, gelatin, and plasticizer.
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Content uniformity testing is a part of finished product testing for soft gelatin capsules.
Content uniformity testing is a part of finished product testing for soft gelatin capsules.
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All ingredients used in soft gelatin capsule production must pass microbiological testing.
All ingredients used in soft gelatin capsule production must pass microbiological testing.
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The sealing of hard gelatin capsules results in a single piece structure.
The sealing of hard gelatin capsules results in a single piece structure.
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Moisture content testing is crucial in the finished product evaluation of soft gelatin capsules.
Moisture content testing is crucial in the finished product evaluation of soft gelatin capsules.
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Soft gelatin capsules typically have a greater variety of shapes than hard gelatin capsules.
Soft gelatin capsules typically have a greater variety of shapes than hard gelatin capsules.
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Study Notes
Industrial Pharmacy: Soft Gelatin Capsules
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Production Methods:
- Plate Press Process: Oldest commercial method, semi-automatic, equipment less common, used for small-scale production of capsules with one flat side. Drawbacks include uneven dosage and high manufacturing losses. Labor intensive—typically 2-3 operators.
- Rotary Die Press: Modern process, developed in 1933, creates uniform and accurate capsules, continuous production. Material fed between rollers, swelled into molds, and the die rolls seal and cut the filled capsules. Production capacity depends on die size, machine speed and material properties. Product cost is directly proportional to shell thickness. Most soft gelatin capsules are made this way.
- Reciprocating Die Process: Continuous process, similar to the rotary die press. Gelatin ribbons are fed between vertical dies, pockets are created, filled and sealed, and cut from ribbon in a cooled solvent bath. Developed by Norton Company in 1949.
- Accogel Process: Continuous process designed for powders and granules, overcomes the limitation of rotary and reciprocating processes. Involves measuring roll, die roll and sealing roll. Measuring roll holds fill material and transfers it to the capsule. Gelatin ribbons are fed and the measuring, die and sealing rolls work together to shape, seal, and cut the capsules.
- Seamless/Bubble Method: One-piece soft gelatin capsules, creating seamless, spherical capsules without dies. Molten gelatin stream flows through a nozzle, medicated liquid is dispensed, and capsules are ejected from the system.
Quality Control
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Ingredient Specifications: Strict control and testing of all ingredients to ensure pharmaceutical standards are met. Impurities like aldehydes and peroxides in polyethylene glycols must be managed to prevent cross-linking (insolubilization) of the gelatin polymer.
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In-Process Testing: Essential control measures during capsule production, includes:
- Gel ribbon thickness
- Soft gel seal thickness
- Fill matrix weight and capsule shell weight
- Soft gel shell moisture content
- Sof gel hardness
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Finished Product Testing: Crucial final checks on the produced capsules:
- Capsule appearance
- Active ingredient assay and related substance assay
- Weight variation test
- Content uniformity test
- Microbiological testing
- Moisture content test
- Disintegration test
- Dissolution test
Gelatin Capsule types
- Hard Gelatin Capsules: Two-part capsules (body and cap) made of gelatin, typically for dry powders and liquids.
- Soft Gelatin Capsules: One-piece capsules made of gelatin, water and plasticizer, suitable for liquid, pastes, oils, suspensions or powdered materials that are encapsulated for ease of swallowing.
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Description
Explore the production methods of soft gelatin capsules in industrial pharmacy. This quiz covers the plate press process, rotary die press, and reciprocating die process, highlighting their features, advantages, and drawbacks. Perfect for students interested in pharmaceutical manufacturing practices.
