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How We Overcame API Shortages and Tight Development Timelines in Early Clinical Stages － Xcelodose® Utilization Case Studies

These case studies showcase how, through the combination of the Xcelodose® system and SPERA PHARMA’s expertise, we were able to meet project requirements even with limited API quantities and tight timelines.

Case Study 1: Projects Requiring High Yield with Only a Limited Amount of API Available

Request

• Only a very small amount of API is available, but the required number of capsules must be secured.

Key Challenges

• The amount of API available is already limited, making additional supply difficult.
• A yield of approximately 80% had been assumed for the project.
• Based on the available API quantity, achieving the required number of capsules would require a yield of 90%.

SPERA PHARMA’s Approach

• Evaluation of powder characteristics: Observed the API’s powder characteristics during in-bottle vibration tests and scooping operations.
• Dispensing head selection: Chose the most suitable dispensing head from dozens of hopper types based on the API’s powder characteristics.
• Adjustment of vibration frequency: Tuned operating speed to achieve the target fill weight.
• Troubleshooting: Monitored for early signs of issues such as API clogging and capsule ejection abnormalities.

Outcome

• Through various adjustments, we successfully secured the required number of capsules.
• By avoiding API re-synthesis or re-procurement, we were able to mitigate the risk of delays to the early clinical schedule.

Case Study 2: Capsule Filling of an API with Low Flowability and a Strong Tendency to Accumulate Static Electricity

Request

• The client requested that mass-produce capsule fills using an API that is prone to static electricity.

Key Challenges

• Because the API is highly prone to static electricity, it agglomerates inside the hopper, resulting in poor flowability and making machine filling difficult.
• Manual filling was estimated to require approximately nine months, which would not meet the clinical study timeline.

SPERA PHARMA’s Approach

• Static Electricity countermeasures: Use of an ionizer
• Fundamental solution: Implementing a formulation adjustment that prevents the generation of static electricity.

Outcome

• Improved the powder’s flowability and achieved stable filling using the Xcelodose®.
• Completed manufacturing and delivery within one month.

When to Consult SPERA PHARMA

If you face challenges like these, please feel free to consult us:

• You want to minimize development cost and timelines.
• The dosage (administered amount)  is difficult to finalize.
• The clinical team is requesting a shorten formulation development timelines
• You aim to accelerate development －　and proceed more quickly with clinical studies and evaluations －by reducing the number of tests required.

Contact
https://heuristic-ardinghelli.153-122-123-210.plesk.page/en/inquiry/
By sharing an overview of your API and target schedule, we can assess feasibility and provide an estimated lead time.

Reference: Operational Capabilities at SPERA PHARMA

• Supported capsules: HPMC size 0 to 4 (extensive experience with sizes 0 and 3)
• Fill weight range: 1 mg to 100 mg
• Throughput: Up to 1,500 capsules/day (depending on API properties)
• Weight control: Individual capsule weight recorded for all capsules (GMP-compliant)
• Number of systems: 2 units

For further details, please visit
API Direct Capsule Filling Using Xcelodose®
https://heuristic-ardinghelli.153-122-123-210.plesk.page/en/technology/formulation/xcelodose/