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

      Long-Acting Injectable Products
  •    Oil-based Preparations (solution and suspension)
  •    Aqueous Micro-Particle Suspension
  •     Lyophilized Powder for Injection
  •     Biodegradable Microspheres
  •     Nanotube Depot
      Micro and Nanotechnology
  •    High-pressure Homogenization
  •    Micro-fluidization
  •    Suspension Micronization
     Injectable Microparticles
  •    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
  •  Analytical method development, optimization, and validation
  •    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
  •  In-vitro bioequivalence studies
  •    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.

© 2021 Abon Pharmaceuticals, LLC