API Direct Capsule Filling Using Xcelodose®
Overview
SPERA PHARMA, Inc. operates two Xcelodose® systems that enable direct filling of APIs (active pharmaceutical ingredients) into capsules.
These systems offer precise filling from 1 mg to 100 mg, along with automatic recording of capsule weights that complies with GMP traceability requirements.
Because APIs can be filled directly into capsules without any excipients, this approach simultaneously enables:
- Minimization of API loss
- Reduction of time required for formulation and process development
- Support for early-stage clinical planning
What Is Xcelodose®?
Xcelodose® is characterized by its ability to fill APIs directly into capsules without any excipients. By eliminating the need for compatibility testing between APIs and excipients, as well as formulation studies, it enables a significant acceleration of development during the early clinical stages.
Although only a limited number of companies in Japan possess this equipment, SPERA PHARMA operates two Xcelodose® units, leveraging their capabilities in projects where the speed of formulation development is a priority.
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
SPERA PHARMA’s Strengths — Practical Expertise and Experience
Dosing is fundamentally influenced by the powder characteristics of the API. Even with a high-performance system like the Xcelodose®, identifying the optimal filling conditions requires experience. Since introducing this equipment, we have accumulated the following expertise:
- 1. Expertise in hopper selection
We visually inspect the condition of API and select the optimal hopper that satisfies flowability, target fill weight, and required quantity. Based on our past performance and accumulated experience, we can identify several suitable candidates as soon as we visually assess the API, enabling a rapid response.
- 2. Troubleshooting during filling
In addition to issues caused by the API itself－such as electrostatic adhesion－we have extensive troubleshooting experience with capsule locking, ejection, and other process steps. This allows us to avoid wasting valuable API.
- 3. Operation in a GMP environment
By controlling room temperature and humidity, we maintain conditions that enable stable capsule filling.
- 4. Dual-system setup
In addition to offering flexibility in manufacturing －such as accelerating timelines and doubling production capacity－ we also maintain a robust backup system to ensure continuity in the event of equipment failure.
These solutions are a perfect fit for challenges such as：
- Limited API quantities: We help you secure the required number of capsules using the API on hand, avoiding the risks or re-manufacturing or additional synthesis.
- APIs that are difficult to handle manually: We quickly determine optimal conditions tailored to the powder characteristics of the API.
- Limited cost or for formulation studies: We reduce the workload associated with formulation development and shorten the early stage of dosage－form evaluation.
Contact Us if
- You have only a limited amounts of API available
- You need to minimize time and cost
- You are facing a tight development schedule
Share with us the API details, required quantities, you’re your timelines.
We will support you in finding the right solution.
Contact us here
View Case Studies here