API IN CAPSULE AND BOTTLE

From API to receipt to CTM release in as little as 12 weeks!

Fast. Flexible. Efficient.

Micro-Dosing for API in Capsule and Bottle

AustinPx's API in Capsule and Bottle technology helps get your product to clinic FASTER!

Combined with our strong project management and streamlined processes, AustinPx's micro-dosing capabilities offer unmatched flexibility, accuracy, and speed - moving your NCE quickly from API receipt to CTM release in as little as 12 weeks.

Jump start feasibility and first-in-human studies
Gain valuable data to help with the drug substance’s life cycle
Asses your drug substances’ physical characteristics in parallel to formulation development without losing valuable time.
Reduce upfront formulation development, without losing material in the earliest phases.

Advanced Precision Micro-Dosing

With the growth of precision medicines and highly-potent APIs, lower fill weights are becoming increasingly important. AustinPx utilizes precision dosing technology from 3P Innovations to dispense small amounts of drug substance directly into capsules or vials. This advanced precision dosing equipment can tackle various challenges, including poor flow properties, variable particle sizes, hygroscopicity, and a range of particle morphology.

We can directly fill API into capsules, bottles or vials using our micro-dosing technology. The system can weigh powder aliquots of less than 1 mg with a 1% tolerance during producti to comply with USP <41> guidelines.

When Speed is the Driver

While this approach is not always suitable, using APIs in capsule or vial form can eliminate the need for initial formulation development, thereby reducing costs and timelines for First-in-Human studies.

Additionally, for our clients aiming to expedite their path to clinical trials while simultaneously advancing formulation development, AustinPx offers parallel development. This approach allows for comprehensive drug substance characterization early on, minimizing time and material wastage.

Typical Scope of Work

Capsule Selection

Choose between bottles, vials or HPMC or gelatin capsules. At this phase you may choose to perform a compatibility study with your API and capsule choice.

Feasability Evaluation

With as little as 3mg of API, our team evaluates the capsule filling process and optimizes it for your specific API characteristics. This step will inform the processing parameters and expected yield for CTM Manufacturing.

Analytical Stability

Leveraging insights from the feasibility stage, we produce high-quality CTM with thorough documentation and compliance checks

CTM Manufacturing

Feasibility materials can be utilized for drug product method development and validation as well as prototype accelerated stability for regulatory filings

Regulatory Support

Receive comprehensive support with COAs and stability protocols.

When Formulation is Required

Not all APIs are compatible with an API in Capsule or Bottle strategy. When enhancing bioavailability becomes necessary, AustinPx leverages its extensive expertise in developing and manufacturing enhanced dosage forms.

Bioavailability Enhancement

Tell Us About Your API in Capsule & Bottle Needs

Speak to one of AustinPx's experts on how we can accelerate your path to the clinic with our micro-dosing capabilities.

Our Pharmaceutics team is comprised of seasoned formulation scientists that will provide phase-appropriate guidance and development expertise.

Contact Us

Let our experts deliver the results you need to help advance your drug candidate to the next phase. Contact us about our Formulation Development services.