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Questions and Answers
Which impurity in polyethylene glycols can lead to cross-linking of the gelatin polymer in soft gelatin capsules?
Which impurity in polyethylene glycols can lead to cross-linking of the gelatin polymer in soft gelatin capsules?
Which of the following is NOT one of the four most important in-process tests during the encapsulation of soft gelatin capsules?
Which of the following is NOT one of the four most important in-process tests during the encapsulation of soft gelatin capsules?
What type of testing evaluates the appearance, active ingredient assay, and weight variation in soft gelatin capsules?
What type of testing evaluates the appearance, active ingredient assay, and weight variation in soft gelatin capsules?
Which of the following characteristics distinguishes soft gelatin capsules from hard gelatin capsules?
Which of the following characteristics distinguishes soft gelatin capsules from hard gelatin capsules?
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What is primarily evaluated in the moisture content test of soft gelatin capsules?
What is primarily evaluated in the moisture content test of soft gelatin capsules?
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What formulation can be filled into soft gelatin capsules that is not typically used in hard gelatin capsules?
What formulation can be filled into soft gelatin capsules that is not typically used in hard gelatin capsules?
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Which of the following statements about the shell composition of soft gelatin capsules is true?
Which of the following statements about the shell composition of soft gelatin capsules is true?
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Which test measures the time it takes for soft gelatin capsules to break down in a specified environment?
Which test measures the time it takes for soft gelatin capsules to break down in a specified environment?
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Which testing aspect is NOT considered during the finished product testing of soft gelatin capsules?
Which testing aspect is NOT considered during the finished product testing of soft gelatin capsules?
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What is the primary purpose of conducting microbiological testing on soft gelatin capsules?
What is the primary purpose of conducting microbiological testing on soft gelatin capsules?
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Study Notes
Industrial Pharmacy: Soft Gelatin Capsules
- Production Methods: Soft gelatin capsules are produced using various methods, including plate press, rotary die, reciprocating die, accogel, and seamless (bubble) methods.
Plate Press Process
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Description: The oldest commercial process, but equipment is now largely obsolete. Semi-automatic.
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Procedure: A plasticized gelatin sheet is placed over a die plate with pockets, vacuum draws the sheet into the pockets, pockets are filled with liquid or paste, the lower half of the gelatin sheet is folded over the filled pockets, and the sandwich is pressed to form and cut out capsules.
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Use: Primarily used for small-scale production of soft gelatin capsules, often with a flat side.
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Drawbacks: Lack of dosage uniformity, high manufacturing losses, and labour-intensive (requiring 2-3 operators).
Rotary Die Process
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Description: The most common method, developed in 1933 by Robert P. Scherer. Continuous process, high accuracy, and improved uniformity.
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Procedure: Two plasticized gelatin ribbons are fed continuously into the rotary die machine. The fill material is injected between the ribbons. The gelatin swells into the pockets, the dies converge, sealing and cutting out the capsules.
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Advantages: High production capacity, determined by die size, machine speed, and physical characteristics of the material to be encapsulated; high accuracy, and negligible material loss (variation to ±3%).
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Gelatin Thickness: Typically between 0.25–0.32 inches, thickness of the shell influences the cost.
Reciprocating Die Process
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Description: Developed by Norton Company in 1949. A continuous process like the rotary die process, differing in the encapsulating process.
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Procedure: Gelatin ribbons are fed between vertically moving dies. Pockets are continuously formed in the ribbons. The pockets are filled with medication, sealed, shaped, and cut into capsules. Capsules fall into a cooled solvent bath, preventing sticking.
Accogel Process
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Description: Developed in 1949 by Lederle Laboratories to address the need for soft gelatin capsules capable of handling powders and granules, an improvement over other earlier processes. Continuous process.
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Procedure: A measuring roll holds the fill material (powders or granules) under vacuum while the gelatin ribbon is drawn into the cavity by the vacuum. The die roll meets the sealing roll, creating pressure to seal and cut the capsules.
Seamless (Bubble) Process
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Description: Produces one-piece soft gelatin capsules without dies, referred to as a bubble method.
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Procedure: Molten gelatin flows through a nozzle. A medicated liquid is dispensed through another orifice, creating droplets enveloped in the gelatin which are then cooled to harden.
Product Quality Considerations
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Ingredient Specifications: All ingredients are carefully controlled and tested to ensure compliance with pharmacopoeial specifications, including checking for impurities (e.g., aldehydes, peroxides in polyethylene glycols).
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In-Process Testing: Key tests include gel ribbon thickness, soft gel seal thickness, fill matrix/capsule shell weight, soft gel shell moisture level, and hardness at the end of drying.
Finished Product Testing
- Testing Included: Capsule appearance, active ingredient assay, related substances assay, weight variation, content uniformity, microbiological testing, moisture content, disintegration, and dissolution tests.
Gelatin Capsules vs. Vegetarian Capsules
- Differences: Hard gelatin capsules are made of two parts (body + cap); soft gelatin capsules are a single piece; hard gelatin shells are cylindrical; soft gelatin shells are oval or tube-shaped; hard gelatin capsules use gelatin, sugar, and water; soft gelatin uses gelatin, water, and plasticizer; hard capsules are filled with powders or oily liquids; soft gelatin capsules are filled with powders, suspensions, pastes, liquids, or tablets.
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Description
Explore the production methods of soft gelatin capsules in industrial pharmacy, focusing on techniques like plate press and rotary die processes. This quiz delves into the advantages and drawbacks of each method, helping you understand the intricacies of capsule manufacturing.
