Our early-phase formulation development services help solve oral bioavailability challenges encountered at both preclinical formulation development and clinical formulation development 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.
Aurigene Pharmaceutical Services is
that provides contract research and manufacturing services
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
You are about to leave Aurigene Pharmaceutical Services and affiliates website. Aurigene Pharmaceutical Services assumes no responsibility for the information presented on the external website or any further links from such sites. These links are presented to you only as a convenience, and the inclusion of any link does not imply endorsement by Aurigene Pharmaceutical Services.
If you wish to continue to this external website, click Proceed.