Bringing a new drug candidate from the lab to preclinical testing is a critical milestone. At Scantox, we focus on small molecules, specializing in transforming your active pharmaceutical ingredients (APIs) into effective preclinical formulations. Our formulations are optimized for safety and bioavailability in animal models, ensuring successful study progression.
Core Services Solutions
Formulating drugs for preclinical studies presents distinct challenges: i) Early-stage compounds often exist in small quantities and are typically poorly soluble, requiring efficient use of materials; ii) Different animal models have varying physiological and metabolic profiles that affect drug absorption and efficacy; and iii) Accelerated timelines are crucial to keep development on track.
Our team addresses these challenges by providing:
- Flexible Dosing Solutions: Formulations allowing precise dosing adjustments based on species and study requirements.
- Customized Formulations: Tailored to the specific needs of your API and chosen animal models, maximizing bioavailability
- Efficient Development Processes: Streamlined workflows that save time without compromising quality.
Specialized Dosage Forms for Animals
Oral administration is the most common route for preclinical testing due to its relevance to patient treatments. These tests typically use liquid formulations, which are easily adjustable based on the selected animal model. We offer a range of dosage forms to suit various preclinical study needs:
- Aqueous Solutions and Suspensions: Ideal for APIs soluble in water, these formulations allow for precise dosing and easy adjustments across different animal models.
- Lipid Formulations: Enhance the solubility of lipophilic APIs, ensuring better absorption and bioavailability.
- Hard shell capsules: Ideal for dosing of animals like dogs and mini-pigs in a convenient manner. Often more stable formulations for bigger studies.
- Mini-Tablets: Our unique two-millimeter tablets are suitable for small animals like rats, enabling accurate dosing and mimicking human administration methods.
Tailored Formulation Development for Optimal Drug Delivery
Every API has unique characteristics that influence its behavior in biological systems. A crucial challenge is preventing the API from passing through the body without achieving the intended bioavailability. Our scientists collaborate closely with you to develop formulations that address these specifics:
- Species-Specific Excipient Selection: We evaluate excipients for compatibility and safety in different animal species.
- Solubility Optimization: Techniques to enhance the solubility of poorly soluble compounds, crucial for reliable efficacy and toxicity studies.
- Stability Testing: Formulations are developed to maintain stability throughout the study, accounting for factors like temperature and light sensitivity.
- Absorption Enhancement: Strategies to improve gastrointestinal absorption in various species, ensuring your API reaches its target effectively.
Robust Analytical Support Ensuring Regulatory Compliance
For regulatory toxicology studies and IND approval, animal dose formulations must be analyzed for test item concentration and homogeneity. Scantox performs these analyses using robust analytical methods such as UPLC/HPLC with UV/VIS detection and other relevant techniques, including LC-MS/MS, to ensure compliance with regulatory standards.
We offer full support in dose formulation analysis, including method development and validation when clients lack the capabilities or resources. Our validation process ensures accurate and reliable results and includes critical parameters such as specificity, sensitivity, linearity, range, precision, accuracy, homogeneity, and stability.
All validations are performed according to established industry guidelines, including those outlined in the white paper on non-clinical dose formulation analysis (Whitmire et al., AAPS J. 2010 Aug 14;12(4):628–634).
Why Choose Us?
- Internal Expertise and Guidelines: Our internal “cookbook” – how you can develop a preclinical formulation – is a culmination of years of expertise. This guidebook enables us to effectively design optimized formulations based on your API’s physicochemical properties and study requirements.
- Unique Capabilities with Mini-Tablets: Mini-tablets enable accurate dosing in small animal models and facilitate a seamless transition to human formulations. This unique Scantox capability mirrors human administration methods even in preclinical studies.
- Flexible and Client-Focused Approach: We understand the pressures of preclinical timelines and resource constraints. Whether you have limited API material or tight timelines, our reactive team works with you to find the best and most cost-effective formulation strategy.
Scantox Can Help
At Scantox, we’re committed to being your trusted partner in preclinical formulation. Our extensive experience and structured approaches ensure your API is formulated for optimal performance in preclinical studies. We help you mitigate risks, save time, and move confidently toward First-In-Human studies.
Ready to optimize your preclinical formulations?