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Formulation and Filling of Hard Gelatin Capsules

hard gelatin capsules
hard gelatin capsules

1. Aim

To study the Year 3 practical formulation and filling of hard gelatin capsules using the assigned verified method and document its outcome. Actual product or compound must be entered in the student record.

2. Requirements

Instructor-approved master formula or monograph, authenticated sample or teaching data, calibrated apparatus, control and quality records, observation sheet, protective equipment, and local waste instructions. Use the approved master formula for substances, quantities, process settings, and software. Acceptance limits and any unconfirmed drug identity are to be recorded from the assigned current monograph or approved college method in the student record.

3. Theory

Capsule filling requires an approved shell size, fill material, target weight, blend uniformity, and product-specific tests. Fill weight alone does not prove content uniformity or dissolution. Moisture and shell integrity can affect quality. The practical should connect the master formula to in-process records and release testing.

4. Procedure

  1. Confirm the exact syllabus entry and the instructor-selected compound, formulation, or test.
  2. Read the current approved method, risk controls, material identities, and equipment status before work.
  3. Review the approved capsule formula and shell record. Observe supervised blend preparation and filling, then record shell condition, filled mass, and relevant quality checks.
  4. Record raw observations, controls, sample identifiers, and any deviation without replacing missing values with assumptions.
  5. Calculate only where the validated method, units, and actual inputs support it.
  6. State the supported result and all missing details marked Record here.

5. Observation and calculation

Student record field Entry
Case or product Record here
Method Record here
Observation Record here
Inference Record here
Supervisor check Record here
Outcome Record here

Assumed values or observations for practice only: Assumed empty shell mass is 80 mg and assumed filled mass is 300 mg. Assumed net fill is 220 mg. These invented numbers are not an actual capsule specification. Every invented input and output is assumed and is not an actual manufacturing instruction or release result.

6. Output or final result

Submit a labelled shell and fill mass diagram and a conditional result. Record the supervised outcome here.

Teaching-lab safety: Any synthesis, manufacture, or testing requires teaching-lab supervision, approved hazards review, and local disposal. Sterile or injectable products are not for human use. Software-dependent work requires the approved lab system.

This page is a supervised-activity guide; it does not report a completed case.

7. Sources

← Manufacture of Tablets: Wet Granulation, Direct Compression, Soluble and ChewableManufacture of Parenterals: Ascorbic Acid, Calcium Gluconate, Sodium Chloride, and Dextrose Combinations →

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Theory notes: Pharm D Year 3, Pharmaceutical Formulations