i2 Pharma Solutions
Discriminatory Dissolution Method development and validation
In vitro dissolution is a critical quality attribute of a drug product. Regulatory guidance expects the dissolution method to be discriminatory that can detect any unexpected changes in critical material attributes and process parameters that may affect in vivo drug performance. i2 Pharma Solutions has extensive experience developing and validating discriminatory dissolution methods through a systematic understanding of drug substance physicochemical properties, formulation excipients, and manufacturing parameters.
i2 Pharma Solutions
HPLC Method development and validation
i2 Pharma Solutions has extensive experience developing and validating HPLC methods for assay and impurity testing of drug substances and drug products. Using a phase-appropriate approach, our team supports drug development efficiently in terms of time and cost without compromising quality or compliance.
i2 Pharma Solutions
Solubility and Bioavailability enhancements
Aqueous solubility across biorelevant pH conditions is a key biopharmaceutical property of an API that influences the bioavailability of oral dosage forms. However, many APIs have poor aqueous solubility. i2 Pharma Solutions specializes in addressing this challenge through advanced technologies such as spray drying and hot melt extrusion, converting poorly soluble APIs into higher-performing amorphous dispersions.
i2 Pharma Solutions
Solid Orals formulation development
Solid oral dosage forms are the most widely used delivery format, and most drugs are developed and commercialized in this form. i2 Pharma Solutions specializes in developing high-quality solid oral formulations that are robust, scalable, and aligned with regulatory expectations. Drawing on our expertise in preformulation, excipient selection, and process optimization, we design formulations that deliver consistent performance, manufacturability, and bioavailability.
Our team consists of scientific experts with decades of experience in drug development and successful track record of supporting multiple investigational and commercial products.
Our commitment to scientific excellence, regulatory compliance, and data integrity ensures dependable results at every stage of development
Precision Testing You Can Trust
We provide accurate and reliable testing and research, using advanced techniques to support scientific discovery and healthcare solutions.
Accurate & Reliable
Our accredited ensures precise test results you can count on.
State-of-the-Art Equipment
Utilizing advanced instruments for cutting-edge scientific analysis.
Experienced Scientists
A team of experts dedicated to quality research and testing.
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Our Facility 17 Briden Street, Suite #220, Worcester, MA-01605
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Connect With Us 508 -752-5559