Investigating ADME/DMPK properties for drug development
Syngene offers in vivo pharmacokinetics (PK) services to study the absorption, distribution, metabolism, and excretion (ADME) of drugs and new chemical entities (NCEs) in animals. Our team of scientists conducts comprehensive analyses to identify various parameters that aid in the discovery, selection, efficacy, and development of drugs.
Capabilities
Our experts conduct various PK studies to understand the plasma exposure responsible for the efficacy or toxicity of drugs in animals and determine the fraction bioavailable in the systemic circulation after dose administration. Our analysis helps in deciding the dosing frequency of the drug or test compound to achieve drug efficacy. We also develop pharmacokinetic profiles of new chemical entities, which help in rank ordering and selection during the early stages of drug discovery.
Methodologies
Syngene utilizes comprehensive routes of drug administration for conducting PK studies, which include intravenous bolus, intravenous infusion, oral, intramuscular, intraperitoneal, intraocular, intraduodenal, subcutaneous, topical, and inhalation. We conduct varied time-duration intravenous infusion studies on mice and rats and also offer PK studies in transgenic animals.
Our scientists utilize mice, rats, and rabbits for various pharmacokinetics studies. We procure all our animals from authorized vendors across the globe, such as Envigo Netherlands/US, Taconic, Jackson Laboratories, and Charles River. For the in-life phase of pharmacokinetics studies on species such as dogs, monkeys, and mini pigs, we collaborate with other contract research organizations (CROs) in India, Europe, Japan, and the US. We monitor the in-life phase of these CRO partner studies and perform all bioanalysis and PK data reporting at Syngene’s facilities while ensuring quality standards.
Services
Our assay services include the screening of NCEs for PK evaluation, bioequivalence PK studies for generic compounds or different formulations in rodents, cassette dosing pharmacokinetics, mass balance pharmacokinetics, and tissue distribution studies. Other services include dose proportionality pharmacokinetics, mechanistic PK models, in vivo drug-drug interaction (DDI) studies in rodents, serial blood sampling in mice, intravenous infusion in jugular vein cannulated mice and rats, and crossover pharmacokinetics in dual vein cannulated rats. We also offer pharmacokinetics services with jugular vein and femoral vein cannulated rats and design need-based PK studies to address various pharmacokinetic-related issues of the new chemical entities and drugs.
Pre-formulation services
Syngene’s dedicated formulation development center plays a crucial role in early drug discovery pharmacokinetic studies. The facility helps us quickly prepare formulations for single-dose intravenous pharmacokinetic studies based on various intended routes of administration, and within acceptable limits of excipients.
As part of pre-formulation, we develop drugs in different formulations, such as solutions, suspensions, creams, emulsions, ointments, and gels and conduct their stability analysis and microscopic evaluations. After studying the physico-chemical properties of NCEs, we develop multiple oral formulations in our micronization facility, to enhance their palatability and oral bioavailability.
