Experiments and Results
Experiment Overview
This experiment consists of two major phases. The first phase involves the creation of a specialized capsule designed to effectively deliver E. coli to the human colon. The second phase focuses on evaluating the performance of the capsule through a series of tests to verify its functionality. Both the capsule manufacturing and the subsequent tests are crucial to ensure the accurate delivery of E. coli to the colon and to guarantee its effectiveness at the target site. The following sections provide a detailed explanation of each phase.
Ⅰ . Capsule Creation
The first step is to create spherical gelatin capsules with cavities, which will serve as the structural base of the capsule. This spherical gelatin is crucial for protecting E. coli and safely delivering it to the human colon. To form the spherical capsule, two hollow gelatin hemispheres are combined, and inside the capsule, a liquid culture medium containing cultured E. coli is enclosed. The surface of the gelatin sphere is first coated with HPMCP (Hydroxypropyl Methylcellulose Phthalate), followed by an additional shellac coating.
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Diameter and Volume Measurement Results
Ⅱ . Testing
Next, a series of tests will be conducted to evaluate the functionality of the capsules.
Dissolution Test
In this test, we measure how long it takes for the spherical gelatin to fully dissolve when exposed to body temperature (approximately 37°C). This data is crucial for determining at what point after oral administration the gelatin dissolves, allowing the release of E. coli. This ensures that the bacteria are released at the optimal time within the digestive tract.
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Second Melting Test Experiment
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Viable Bacteria Count Test
This test evaluates the following two points:
- Whether the PMC (Phase Master Coat) can maintain the viable bacteria count.
- Whether the CDC (Colon Disintegrating Coat) and EC (Enteric Coat) can protect the internal E. coli from acid.
This test is important to verify the significance of using a liquid medium within the PMC, rather than freeze-drying, and to confirm the protective functions of the CDC and EC.
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Viable Bacteria Count Test Protocol
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First Viable Bacteria Count Test_Result
Second Viable Bacterial Count Test Experiments
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Disintegration Test (According to the Japanese Pharmacopoeia Standards)
Passing this test confirms that the capsule is properly designed.
The disintegration test, based on the Japanese Pharmacopoeia 18, evaluates the durability of the capsule as a drug delivery system and assesses whether it disintegrates at the appropriate timing. This ensures that the capsule performs as intended during its journey through the digestive system.