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 Aurigene Preformulation Studies and Services?
Experience with various characterization techniques
US FDA -inspected labs with advanced instrumentation
Understanding of various regulatory and Pharmacopeial requirements
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Drug Formulation Services
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Learning Resources
“Bathtub Chemistry” - Necessity and Aspects of Process Research
Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they lose. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.Drug discovery is a vast and ...
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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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A metal catalyst-free and one-pot synthesis of (3,4- dihydro-2H-benzo[b][1,4]oxazin-2-yl)methanol derivatives in water
2015
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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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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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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Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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Frequently asked questions
What is formulation research and development?
Formulation development is a part of the drug product development process where the drug substance is combined with suitable excipients and processed to produce stable drug products such as tablets, capsules, injectables, topical cream/gel.
What is the role of formulations in pharmaceutics?
The formulation in pharmaceuticals is a process where the drug substance/API is mixed with an excipient to form a final drug product by considering the particle size, pH, stability, polymorphism, and solubility. It helps to decide the most optimal delivery mode such as oral, parenteral, pulmonary, nasal, topical, ophthalmic or rectal.
What does drug formulation mean?
Drug formulation is the process where a drug substance/ Active Pharmaceutical Ingredient (API) is converted into a final human consumable oral, parenteral, pulmonary, nasal, topical, ophthalmic, or rectal formulation to treat diseases.
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