Your Molecule
Your Molecule

Small Molecule Sterile Injectables

Small Molecule Sterile Injectables

Robust formulations tailored for parenteral delivery — with a focus on solubility and long-term stability.

Early risk identification to design stable, patient-ready drug products

Laboratory staff
Laboratory staff

Small molecule therapeutics remain a cornerstone of modern medicine, providing a wide range of treatment options across oncology, cardiology, neurology, and infectious diseases. However, when these compounds are developed as sterile injectables, they face unique challenges that differ significantly from oral or topical dosage forms. Leukocare specializes in the stabilization and formulation of small molecules as sterile injectables—ensuring solubility, safety, chemical stability, and manufacturability from early development through global distribution.


Why small molecule injectables require special attention

Why small molecule injectables require special attention

Many small molecules present solubility limitations, chemical instability, or incompatibility with excipients. Without careful design, these molecules may precipitate, degrade under stress, or lose efficacy over time.



Furthermore, sterile injectables must withstand heat, light, pH variation, and mechanical stress during manufacturing, shipping, and storage. By systematically addressing these risks early, we help ensure that injectable small molecule formulations remain safe, stable, and effective across their lifecycle.





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Many small molecules present solubility limitations, chemical instability, or incompatibility with excipients. Without careful design, these molecules may precipitate, degrade under stress, or lose efficacy over time.



Furthermore, sterile injectables must withstand heat, light, pH variation, and mechanical stress during manufacturing, shipping, and storage. By systematically addressing these risks early, we help ensure that injectable small molecule formulations remain safe, stable, and effective across their lifecycle.





Explore our full modalities hub


Our expertise

Our expertise

Leukocare provides tailored formulation development to overcome solubility and stability hurdles. Our scientists combine excipient optimization with advanced analytical methods to design sterile injectable products that meet stringent regulatory and clinical requirements. Whether the challenge is low solubility, chemical degradation, or manufacturing scalability, our integrated development approach delivers solutions built for clinical and commercial success.

Leukocare provides tailored formulation development to overcome solubility and stability hurdles. Our scientists combine excipient optimization with advanced analytical methods to design sterile injectable products that meet stringent regulatory and clinical requirements. Whether the challenge is low solubility, chemical degradation, or manufacturing scalability, our integrated development approach delivers solutions built for clinical and commercial success.

Ready to talk about your bispecific formulation strategy?

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Laboratory assistant

Ready to talk about your bispecific formulation strategy?

Book an appointment

Laboratory assistant

Turning complex molecules into robust drug products

Key Focus Areas

Formulation development for sterile injectables

Excipient selection for solubility and stability, pH adjustment, isotonicity control, and prevention of precipitation/crystallization.

Formulation development for sterile injectables

Excipient selection for solubility and stability, pH adjustment, isotonicity control, and prevention of precipitation/crystallization.

Formulation development for sterile injectables

Excipient selection for solubility and stability, pH adjustment, isotonicity control, and prevention of precipitation/crystallization.

DoE-driven optimization

Efficient, statistically validated experiments that streamline formulation, conserve API, and enable reproducibility at scale.

DoE-driven optimization

Efficient, statistically validated experiments that streamline formulation, conserve API, and enable reproducibility at scale.

DoE-driven optimization

Efficient, statistically validated experiments that streamline formulation, conserve API, and enable reproducibility at scale.

Stability-focused development

ICH-compliant programs with accelerated and long-term testing, degradation pathway mapping, and stress testing under heat, light, and mechanical conditions.

Stability-focused development

ICH-compliant programs with accelerated and long-term testing, degradation pathway mapping, and stress testing under heat, light, and mechanical conditions.

Stability-focused development

ICH-compliant programs with accelerated and long-term testing, degradation pathway mapping, and stress testing under heat, light, and mechanical conditions.

Integration with process development

Ensuring compatibility with sterilization methods, fill-finish processes, and primary packaging systems.

Integration with process development

Ensuring compatibility with sterilization methods, fill-finish processes, and primary packaging systems.

Integration with process development

Ensuring compatibility with sterilization methods, fill-finish processes, and primary packaging systems.

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Let’s Build the Right Formulation — Together

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

Talk to our experts



Let’s Build the Right Formulation — Together

Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.

Talk to our experts

How we support you

1. Feasibility assessment to identify solubility and stability risks early.

2. Optimization strategies guided by DoE and biostatistics for faster development.

3. Stability programs aligned with ICH requirements to support clinical trials and beyond.

4. Long-term partnership from early development through late-stage support, ensuring readiness for commercialization.




Explore related services & insights

Formulation Development (overview)
Formulation Development & Optimization
Pre-Formulation Studies
Stability Studies
Forced Degradation Studies

Explore related services & insights

Formulation Development (overview)
Formulation Development & Optimization
Pre-Formulation Studies
Stability Studies
Forced Degradation Studies