R&D
Abon’s scientists and chemists identify, scrutinize, and effectively use the physicochemical attributes of API, excipients, and the finished product to connect a drug and dosage form’s pharmacokinetic parameters. We integrate quality and regulatory requirements into the development program, giving a higher guarantee of a rapid product review, approval, and launch.
Pre-formulation
We are devoted to utilizing our state of the art equipment to properly characterize the API and the formulation before and during product development cycles to deliver a bioavailable, manufacturable, and stable final product.
Abon offers a full suite of characterization studies to support the formulation and process design:
- Solid State Characterization
- Thermal Behavior
- Visco-elastic Behavior
- Powder Characteristics
- Compatibility and Interaction Analysis
- Micro-structure Elucidation
- Solubility and Solution Characteristics
- Osmolarity
- Hydration and Swelling
- Texture Analysis
- Particle Size Analysis
We are continually improving and investing in our pre-formulation capability. Our current instrumentation includes:
- Scanning Electron Microscope (SEM)
- Powder X-Ray Diffraction (PXRD)
- Differential Scanning Calorimetry (DSC)
- Thermogravimetric Analysis (TGA)
- Thermal Activity Monitoring (TAM)
- Hybrid Rheometer (DHR)
- Dynamic Vapor Sorption/Desorption (DVS)
- Digital Microscope
- Powder Flow Analyzer
- Texture Analysis
- Malvern Mastersizer
Formulation & Process
Abon has capabilities in major and niche dosage forms across a wide range of pharmaceutical production technologies. We evaluate formulations using bench-top equipment up to pilot scale machines and support all tech transfer activities empowered by Abon’s robust and scalable formulation & process design.
Parenteral
- Oil-based Preparations (solution and suspension)
- Aqueous Micro-Particle Suspension
- Lyophilized Powder for Injection
- Biodegradable Microspheres
- Nanotube Depot
- High-pressure Homogenization
- Micro-fluidization
- Suspension Micronization
- Platform Technology Development
- Biodegradable Microsphere Drying
Oral
- Readily Available Dosage Forms (IR, ODT)
- Sustained and Modified Release Tablets
- Sustained and Modified Release Capsules
- Multi-Layered Tablets
- Osmotic and Pseudo-osmotic Tablets
- Micro Tablets
- Gastroretentive Dosage Forms
- Pulsatile Drug Delivery Systems
- Transmucosal Drug Delivery Systems
- Liquid Sustained Release Suspensions
Analytical Services
- Physical and chemical characterization of API, Finished Products and Excipients
- HPLC methods for assay, impurities, and other analysis
- GC for residual solvents
- Bio-indicative dissolutions
- Polymer Characterization (Mn, Mw, DS, Functional Group Analysis)
- Impurity characterization, including mechanism of formation studies
- Peptide characterization using 1D and 2D NMR, IR, Mass spec, and other analytical techniques
- Development of unique dissolution methods for complex drug products
- Particle size analysis
- BSA binding studies
- Pepsis inhibitory studies
- Bile salts binding studies
Pharmacokinetics
The use of statistical design and mathematical modeling with consideration of pharmacokinetic principles in formulation development enables Abon’s scientists to develop a product with a predictable outcome that offers higher assurance in bio/clinical studies’ success.
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