Phase 1 Clinical Supply and Support Services

Phase 1 Clinical Supply

With the help of our strength in formulation design and characterization of new drug candidates, our expertise covers the aspects of early drug product development including the preformulation studies and formulation, and process development of novel dosage forms. Our goal is in line with our client’s goal to make rapid deliverable drug product supplies in support of preclinical to Phase I clinical studies.

Preformulation Study Service

Preformulation studies characterize physical and chemical properties of a drug molecule alone or combined with excipients at early stage of drug product development to ensure formulation and process development can be carried out leading to a safe, effective, stable, and manufacturable dosage form. Sometimes, the property characterization of functional excipients (e.g. rate-controlling component) is also important to successfully develop a novel dosage form with a desirable release profile. Preformulation studies can be conducted in vitro throughout the drug product development from pre-clinical studies, clinical studies, to final scaling up for commercial launch. Established data from preformulation studies are required by the regulatory agencies to compose the CMC sections.

Services Provided in Pre-Formulation Studies

Characterization of the Physicochemical Properties of NCE/API

Identification of the Bulk Properties of NCE/API and/or Drug Preparations

Investigation of the Stability of NCE/API and/or Drug Preparations

Reverse Engineering

Properties

Physiochemical

Melting Point

pKa

Water Content

Hygroscopicity

Solubility/pH-Solubility Profile

Polymorphism/Pseudopolymorphism

Salt and Crystallinity

Bulk

Particle Size Distribution

Bulk and Tapped Density

Flowability

Compressibility, Compactability and Tabletability

Thermodynamic

Stability (API & Drug Product)

Drug Excipient Compatibility

Pre-Formulation Instruments

Pre-Clinical and Clinical Supply Service

Pre-clinical study in drug development is a stage of research before clinical trials which tests a new chemical entity (NCE) in animals to collect information about drug safety and potential administration route, etc. The aim of a pre-clinical study is to determine the safe dose for first-in–human and assess a product’s safety profile. We can help to select the best dosage forms for the NCE based on our strengths in preformulation studies and formulation and process development, and produce the supplies of drug product from pre-clinical to Phase I clinical studies.

The Goals of Pre-Clinical and Clinical Trials

Basic Dosage Forms for Pre-Clinical Studies

Solutions

Suspensions

Dispersions

Semi-solids

Lipid-based forms

Solids (Salt or amorphous)

Complex formulations

Service to Support Phase 1 Clinical Studies

Formulation development

Phase 1 clinical supplies

Collaborate with Phase 1 Clinical CRO by supplying GMP API and formulation design for on-site compounding

Phase 1 Supply Equipment

Characterization Instruments