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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.

Our services for preclinical formulation development include:

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:

  • Administration route (Oral, parenteral & topical)
  • Animal species
  • Study duration
  • Excipient tolerability
  • Target exposures
  • Compound properties

NCE properties are assessed from pre-formulation studies suited to the discovery phase to obtain maximum information from minimum compound amounts.

Our oral bioavailability enhancement services include:

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 formulation development strategies are:

  • Solubilization strategies
    • Micellar solubilization
    • Complexation
    • pH adjustment/buffering
    • Cosolvents
  • Enabling technologies
    • Solid dispersions
    • Particle size reduction
    • Lipid-based drug delivery systems

Our data-driven approach enables our partners to advance candidates and to select the most optimal formulation for a specific drug development phase.

Early Phase Formulation Development

 

Aurigene Pharmaceutical Services is

a leading CDMO/CRO

that provides contract research and manufacturing services

FAQ

Pharmaceutical development identifies and evaluates processes required to convert an NCE/drug substance into a drug product to deliver for its intended performance/purpose consistently. The pharmaceutical development process begins by measuring drug substance properties, identifying critical attributes of the drug product, checking absorption and stability profile of the drug, and the most appropriate route of administration (e.g. oral, parenteral, or topical).

Pharmaceutical development evaluation already at the early drug development stage is essential for selecting the right NCE and formulation to reduce the attrition rate in the late-stage development. These activities streamline efficacy/toxicology evaluations, allowing pharmacologically effective and developable molecules to reach the clinic and eventually patients.

The integration and close collaboration of preclinical and clinical development teams accelerate the FIH product development process by utilizing already available pre-formulation and bioavailability information and experience gained during preclinical formulation development. It also helps identify obstacles and apply the right formulation strategies early in the drug development process to avoid costly late-stage failures, significantly saving time and costs.

Pre-formulation identifies characteristics of NCEs, which are decisive parameters for the in vitro or in vivo performance of a drug. Pre-formulation assists scientists in screening/prioritizing lead candidates based on their physicochemical and biopharmaceutical properties.

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.

The rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the biological system site.

The movement of the drug in the biological system is influenced by many factors such as routes of administration, physicochemical drug properties, physiological factors (e.g. gastrointestinal pH, gastric emptying, small intestinal transit time, bile salt, absorption mechanism, food, metabolism), manufacturing technique, dosage form, and excipients. Understanding the interrelationship of these factors leads to biopharmaceutical and science-based drug product developments.

Incomplete oral absorption could be due to poor solubility, poor intestinal permeability, or presystemic metabolism. Incomplete oral bioavailability can often be surmounted through formulation efforts.

We can enhance the oral bioavailability through formulation efforts using solubilizers, pH adjustment, cosolvents, complexing agents, permeation enhancers, and enabling technologies (solid dispersion, particle size reduction and lipid-based drug delivery systems).

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.

Formulations play a crucial role in assessing the biological properties of a molecule during drug discovery. Maximizing exposure is the primary objective of early animal experimentation to avoid discarding developable compounds with the desired pharmacologic properties.

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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