Preformulation Studies

Excipient Compatibility

We assess the stability of an API with individual and groups of commonly used pharmaceutical excipients in various accelerated stability conditions. Obtain an in-depth understanding of physical or chemical API-excipient interactions. Support the selection of the most appropriate excipients in dosage form design.

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Physical & Chemical Stability

With a molecular understanding of the degradation pathways, whether chemical or physical, we can rationally design a strategy to stabilize the compound. These studies are tailored to meet customer requirements. Obtain a detailed knowledge of the stability of different crystal forms and their inter-relationship. Identification of the best physical form by evaluating physical and chemical changes in accelerated storage tests. Accelerated stressing stability studies in accordance to the ICH guidelines.

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Solubility Enhancement

The bioavailability issue can be due to insufficient solubility of permeability. Most compounds face the solubility problems. We have developed various methods of solubility enhancement. Physical Modifications: Particle size reduction, modification of the crystal habit like polymorphs, amorphous form and co-crystallization. Chemical Modifications: Derivatization, complexation, and salt formation.

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Improvement of API Stability

We have invested in state of the art equipment, and people who have passion for developing solutions for clients with complex challenges in drug substance and product development. We can help when an unexpected solid form appears. We have the experience to find solutions when drug product fails to meet specifications. Improve API stability and properties. Find novel forms with targeted characteristics.

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In Vitro Bioequivalence

A statistical test is proposed for in vitro bioequivalence testing between drug products. We developed dedicated programs to meet all requirements necessary for in vitro bioequivalence and stability. Test generic drug products for which there is an approved Reference Listed Drug (RLD). Test new drug products for which adequate clinical studies have already been conducted. Test reformulated drug products.

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