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.
Experience with various characterization techniques
US FDA -inspected labs with advanced instrumentation
Understanding of various regulatory and Pharmacopeial requirements
MAY 19, 2023
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 ...Read More
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....Read More
Backed by our strong chemistry, we enable “Finger-print” protein structure and functional characterization for proteins from naked proteins to hyperglycosylated or derivatized proteins. ...Read More
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 ...Read More
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...Read More
Scalable alternate end-game strategies for the synthesis of the anti-COVID drug molecule Nirmatrelvir (1,PF-07321332) have been described. The first involves a direct synthesis of 1 via amidation of the carboxylic acid 7 (suitably activated as a mixed anhydride with either pivaloyl chloride or T3P) with the ...Read More
Mutations in MEK1/2 have been described as a resistance mechanism to BRAF/MEK inhibitor treatment. We report the discovery of a novel ATP-competitive MEK1/2 inhibitor with efficacy in wildtype (WT) and mutant MEK12 models. Starting from a HTS hit, we obtained selective, cellularly active ...Read More
Synthesis of the anti-covid therapeutic Nirmatrelvir by using flow chemistry to enhance efficiency of amide to nitrile conversion in a functionally and Stereochemically Embellished environment. ...Read More
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.
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.
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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