With over 30 years of formulation development experience, Scantox has the expertise and infrastructure to transform your drug candidate into a viable and effective therapeutic product. From early-stage pre-formulation to clinical manufacturing for Phase I and II trials, we support your project across all critical stages of drug development.
Key Service Lines
Whether your drug requires oral, topical, or injectable delivery, we specialize in tailoring formulations that ensure optimal efficacy, stability, and patient compliance.
Our expertise covers the following dosage forms:
- Oral Dosage Forms: Solutions, capsules, and tablets – including immediate-release, and more specialized formulations like controlled-release formulations and combination products, – optimized for efficacy and patient convenience.
- Topical and Dermal Products: Gels, creams, and ointments designed for optimal skin absorption and targeted therapeutic effects.
- Injectable Products: Sterile injectable formulations with precise dosing and stability for parenteral administration
Formulation Development Capabilities
Our formulation scientists specialize in optimizing solubility and bioavailability, addressing the common challenge of poorly soluble drugs. We work primarily with small-molecule APIs across various therapeutic areas, but we do not handle highly toxic substances classified as Category 4.
We also develop formulations that offer a unique product profile, allowing for new Intellectual Property Rights (IPR). By creating innovative compositions and delivery systems that differentiate your product from existing treatments, we help you secure IPR.
Early-Stage Development and Prototyping
Understanding your API’s behavior early is crucial. Our formulation studies lay a strong foundation and help prevent later-stage issues like crystallization, which can compromise solubility and bioavailability. In addition, compatibility testing plays a key role in ensuring that your API interacts safely and effectively with excipients, packaging materials, and containers. This proactive approach saves time, reduces costs, and minimizes risks as you progress toward clinical trials.
Key areas include:
- API/Excipient Compatibility Testing: Identifying the best carriers and matrices to maintain your API in a non-crystalline, stable form
- pH-Solubility Profiling: Evaluating how solubility varies across pH levels to predict absorption and bioavailability
- Log P Determination: Understanding the lipophilicity of your compound and its impact on drug absorption and distribution
- Stress and Stability Studies: Assessing the stability of your API under various stress conditions to predict and address potential challenges early
- Rapid Prototyping: Conducting flexible prototyping on early-stage formulations to identify potential upscaling issues, saving time and money
GMP Manufacturing for Clinical Trials
After developing and optimizing your formulation, we transition your project to clinical batch manufacturing. Utilizing our Good Manufacturing Practice (GMP)-compliant facilities, we supply products for clinical studies. Authorized by the Medicines Agency, we are equipped to produce medicines for Phase I and II clinical trials.
Our services include:
- GMP manufacture of bulk products for Phase I and Phase II trial
- Primary and secondary packaging tailored for clinical settings
- Efficient logistics management to deliver clinical trial materials to study sites on time
- Reconciliation and destruction of returned study medication including a destruction certificate
Integrated Analytical Services
To ensure the success of your formulation, we integrate robust analytical services throughout the process. Using advanced techniques like High-Performance Liquid Chromatography (UPLC/HPLC with UV/VIS detection), we develop and validate precise methods to measure drug concentration and purity. This comprehensive analysis guarantees product quality and provides the data needed to make informed decisions at every stage – from initial prototyping to final clinical batch manufacturing.
We perform in process control as well as QC release testing of products.
In addition, we perform stability testing at all ICH conditions and regulatory guidelines to establish Shelf Life of product
Quality by Design Implementation
Quality by Design (QbD) is central to our formulation development strategy. By applying QbD principles from the earliest stages, we gain a deep understanding of how formulation variables impact product performance.
This scientific, risk-based approach allows us to create robust, reproducible processes, reducing trial-and-error experiments and streamlining development timelines.
Embedding QbD into every step not only optimizes your formulation but also generates detailed documentation to expedite regulatory approvals.
Why Choose Us
- Experienced and Dedicated Team: With over three decades of experience, our highly trained scientists and technical staff bring deep expertise in handling complex formulation challenges, particularly for poorly soluble drugs.
- Flexibility and Rapid Response: As a small, agile organization, we quickly adapt to your specific needs, meeting the demands of tight schedules or funding constraints.
- Cost-Effective Solutions: We offer competitive pricing without compromising on quality, making us an ideal partner for small and medium-sized companies.
Learn how we can accelerate your project and ensure a successful formulation process. Our experts are ready to advise you on the best solutions to optimize drug delivery for patients’ benefit.