Our early-phase formulation development services help solve oral bioavailability challenges encountered at both preclinical and clinical stages. We are able to address issues such as incomplete dissolution, low solubility, low oral bioavailability and food effects, through in-depth molecular characterization and various solubilization/enabling technologies.
Our services for discovery phase formulation development are tailored to address specific challenges which arise due to higher systemic exposure requirements for toxicology studies, non-feasibility of high doses/strengths, studies in varied animal species, emesis, compound limitation, liquid dosage form requirement, precipitation of compound at absorption site and more.
Many hits and lead NCEs get shelved from pharmacological and toxicity screening despite high potency because of poor bioavailability or suboptimal formulation. We have more than a decade of experience in overcoming these challenges and enabling GLP toxicology studies. Our preclinical formulations development approach considers but is not limited to:
NCE properties are assessed from pre-formulation studies suited to the discovery phase to obtain maximum information from minimum compound amounts.
Our formulation team is expertise in troubleshooting complex problems by banking various oral bioavailability strategies to accelerate your drug discovery program to the next phase.
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Our data-driven approach enables our partners to advance candidates and to select the most optimal formulation for a specific drug development phase.
Aurigene Pharmaceutical Services is
provides the best contract research manufacturing
Pre-formulation is the foundation of formulation development. Physicochemical, biopharmaceutical, physico-technical, solid-state, and stability parameters are essential to guide the selection of formulation technologies.
By identifying potential limiting steps for oral absorption of a compound (including dissolution, solubility, permeability, and limited metabolism process), understanding the physicochemical properties of a compound, recognizing physiological processes affecting drug absorption, along with awareness of a drug's BCS and DCS characteristics, pharmaceutical scientist can better predict formulation approaches that can maximize the drug’s bioavailability.
Diversity in the physiology between various animal species, routes of administration, limited compound amount, and limitations posed by specific pharmacological models make formulation development much more challenging. Consistency in the exposure is also a key aspect as significant variations are observed in early NCE batches.
Additionally, preclinical tox (GLP) studies at early development, require NCE formulations that are simple, robust, provide ease of preparation, convenient to deliver to animals with minimal ancillary effects of vehicle and provide provision of high and dose-related systemic exposures in animals relative to anticipated human exposures to facilitate determination of tox profiles.
The selection and development of effective formulation and drug delivery strategies are essential to achieve this
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