As an integrated part of our formulation services, the preformulation studies cover the assessment of a wide range of physical, chemical, and biopharmaceutical properties, which are critical to establishing the ideal formulation and delivery method for your lead candidates. The knowledge of various parameters based on regulatory and client-specific requirements is essential to formulate a high-quality drug product to satisfy scientific requirements.
Why choose Aurigene Preformulation Studies and Services?
Extensive expertise in advanced characterization techniques
State-of-the-art, US FDA-inspected laboratories ensuring data integrity
Comprehensive knowledge of regulatory and pharmacopeial standards
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Learning Resources
JULY 03, 2026
The journey from Scientific Insight to Patient Impact
Home › Company › Aurigene 360°: The Journey from Scientific Insight to Patient ImpactPublish on : January 25, 2026 Shares:Every medicine begins with a question.Sometimes with a scientist studying a protein structure late at night.Sometimes with a disease that still has no effective treatment.Sometimes with a simple thought:"What if we could design something ...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Physiochemical Characterization Services
Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...
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Delivering 3 g dose of emetic and poorly bioavailable compound for 90 days repeated dose toxicity studies in dog
Background: Develop oral liquid dosage form of an IND candidate (small molecule) suitable for chronic toxicology studies in dogs. Must meet required systemic exposure and shall be dose proportional. Developed vehicle or used excipients shall be safe for chronic preclinical toxicology studies in dog. Challenges: Conventional suspension in dog resulted in low oral ...
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August 28, 2020
A metal catalyst-free and one-pot synthesis of (3,4- dihydro-2H-benzo[b][1,4]oxazin-2-yl)methanol derivatives in water
A robust and metal catalyst-free method has been developed for the general and green synthesis of racemic (3,4-dihydro-2H-benzo[b][1,4] oxazin-2-yl)methanol derivatives. This simple, mild and practical method involves the reaction of 2-aminophenols with ()-epichlorohydrin in the presence of NaOH in water at room temperature. The reaction features high regioselec...
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April 21, 2026
H2SO4-SiO2 catalyzed synthesis, in silico and in vitro evaluation of quinazoline-based fused tetracyclic derivatives as new inhibitors of PDE4B
The 6,6a-dihydro-5H-isoquinolino[2,3-a]quinazoline-5,7,12-trione (DIQT) derivatives (that belong to the quinazoline-based fused tetracyclic class of compounds) though known in the literature, their biological properties have not been explored previously. In the current study, we have explored the phosphodiesterase 4B (PDE4B, an important target for the identifica...
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January 31, 2025
Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
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January 31, 2025
Development of novel paullone-based PROTACs as anticancer agents
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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Frequently asked questions
How is chemical and physical stability evaluated in preformulation?
Stability is assessed under stress conditions such as heat, light, humidity, and oxidation. Aurigene integrates systematic stability studies to identify degradation pathways early and guide formulation design.
What are the challenges in scaling preformulation findings to formulation development?
Scaling preformulation findings can be challenging due to differences in processing conditions, material behavior, and formulation complexity at larger scales. Aurigene integrates preformulation insights with formulation and process expertise to ensure seamless transition and maintain consistency across development stages.
How are pH–solubility profiles used to inform formulation strategies?
pH–solubility profiling identifies solubility behavior across physiological pH ranges, guiding salt selection and formulation design. Sharp solubility shifts can complicate oral delivery strategies.
How are early compatibility risks identified during API-excipient screening?
Stress testing combined with analytical techniques helps detect interaction risks. Aurigene applies systematic compatibility screening to support robust formulation development.
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