Formulation Studies

Formulation Development Services

Our formulation development services support pharmaceutical and biotech companies from early-stage preformulation through final drug product optimization. We focus on stability, scalability, and performance to ensure reliable results for both small molecules and biologics.

We design robust formulations that improve drug stability, enhance bioavailability, and support successful clinical outcomes. Our team works closely with you to optimize every stage of development using proven scientific methods and efficient workflows.

Preformulation and Stability Studies

Our formulation development services begin with detailed preformulation studies. We evaluate physicochemical properties, degradation pathways, and excipient compatibility to identify the best formulation strategy.

We conduct stability studies under real-time and accelerated conditions to predict shelf life and ensure long-term product performance.

Lyophilization and Drug Product Optimization

We provide advanced lyophilization (freeze-drying) support to improve stability for sensitive compounds. Our team develops optimized cycles that protect product integrity and ensure reproducibility at scale.

Our formulation development services also include dissolution testing and drug release profiling to confirm performance and consistency.

Scalable Formulation Development

We build scalable processes that transition smoothly from lab development to manufacturing. Our approach reduces risk and ensures consistency across batches.

Our formulation development services support:

  • Small molecule formulations
  • Biologic and protein-based products
  • Stability-indicating methods
  • Process optimization for scale-up

Key Formulation Studies

Stress Degradation Studies

We expose products to stress conditions such as oxidation, temperature, pH, and agitation to evaluate stability and identify degradation pathways.

Preformulation Studies

We screen excipients and formulation conditions to determine the most stable and effective composition.

Formulation Selection

We compare multiple candidate formulations under accelerated and real-time conditions to identify the optimal final product.

In-Use Stability

We test stability under real-world conditions such as clinical dosing and handling environments.

Material Compatibility

We evaluate compatibility with container closure systems and manufacturing materials to ensure product integrity.

Why Choose Synergy Bioscience

Our formulation development services combine scientific expertise with efficient execution. We deliver reliable, high-quality data that supports regulatory submissions and accelerates development timelines.

We focus on precision, speed, and scalability so your product moves forward with confidence.

Learn More

Explore our full pharmaceutical development services:
https://synergybioscience.com/pharmaceutical-development-services/ 

At Synergy Bioscience, we can support your product development activities by offering the following studies:

Stress-degradation

Protein is subjected to stress conditions (e.g. oxidation, extreme pH, elevated temperature, freeze-thaw cycling, agitation) in order to identify product sensitivity to various stress conditions and to confirm that the selected assays are stability-indicating.

Preformulation

A variety of excipients and parameters are examined under accelerated conditions to identify those providing the greatest product stability

Formulation Selection

Several candidate formulations are examined under real-time and accelerated conditions, typically over a period of three months, to provide an optimized final formulation together with preliminary stability data

In-use Stability

Product stability is assessed in configurations to be used in a toxicology dose-ranging study or in the clinic

Material Compatibility

Product compatibility is assessed with materials used in candidate container closure systems or with materials used during manufacturing.