Drug Product Platform Technology - Technology Platform

APIs Technology Platform
Drug Product Platform Technology

Physicochemical and Biopharmaceutical Characterization of Medicinal Compounds/Drug Substances Salt and Polymorph Screening Preclinical Animal Formulation Development and Their In Vitro and In Vivo Evaluation Poorly Soluble Drug Solubilization Technology Platform Liquid Dosage Form Platform Topical Dosage Forms Oral Dosage Forms Pediatric Dosage Forms

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Physicochemical and Biopharmaceutical Characterization of Medicinal Compounds/Drug Substances

In the early stages of drug development, characterizing and understanding the physicochemical and biopharmaceutical properties of compounds are crucial. These evaluations help determine the compounds' potential as lead candidates and identify areas for improvement. Additionally, they play a significant role in aiding the formulation development later on.

Scope of Services

Solubility Study: Determining the solubility of compounds in various media, including different pH levels, simulated fast-state and fed-state intestinal fluid, simulated gastric fluid, and various lipids, oils, surfactants, cyclodextrin solutions, and co-solvents
Stability Study: Conducting stability studies of compounds, including but not limited to forced degradation studies, pH stability studies, stability in simulated gastrointestinal fluids, and stability studies under ICH guideline conditions
Measuring the Log P, pKa, and Caco-2 permeability of the compounds
Conducting solid-state studies of compounds using techniques such as XRPD, DSC/TGA, PLM, DVS, NMR and IC-HPLC
Evaluating the intrinsic dissolutions of compounds
Measuring the particle size and size distribution of powdered compounds
Powder Characterization: Characterizing the powder form of compounds for repose angle, bulk density, tap density, specific surface area, flowability, compressibility, wettability, and mechanical stability
Assessing the excipient compatibility of compounds

The Key Advantages of the Platform

The primary strength of our platform lies in Langhua Pharmaceutical’s in-depth knowledge in physical chemistry, solid-state chemistry, material mechanics, and life sciences. This expertise ensures science-based experimental design and reliable results, effectively guiding the dosage form development for compounds later on.