Service Details

Product Development Services

 

At ADEPT, we understand the critical needs of our national and internationally valued customers. ADEPT  is a niche of highly skilled and qualified formulators and developers, who will develop stable, robust and compliant formulations. We offer the following specific studies and propose to formulation and Development.

Pre-formulation studies

Bulk drug characterization:

  • Hygroscopicity
  • Fine particle characterization
  • Powder flow properties
  • Bulk Density
  • Tap Density
  • Strength of agglomeration
  • Degradation product analysis and characterization
  • Acid, Base and oxygen stability
  • Impurity Profiling in the bulk drug
  • Crystallinity and polymorphisim (X-ray diffraction)

Solubility Studies
Ionization Constant
Common ion effect
Thermal effects
Solubilization
Partition co-efficient
Dissolution
Stability Analysis

Solution stability
     pH stability Profile

Solid state stability
     Bulk stability
     Compatibility

Container and closure Interactions

Container content compatibility study is indispensible as a part of new product market authorization file submission to regulators in US, Europe and Japan .We at ADEPT follow cGMP, CPSC and USP Requirements on Containers and Closures. Following are quality control tests for containers and closures, performed at ADEPT to ensure quality, safety and efficacy of the formulations.

  • Stiffness
  • Moisture-vapor transmission
  • Stress Cracking
  • Clarity or translucency
  • Gas permeability
  • Leaching
  • Sorption
  • Chemical reaction
  • Alteration in the physical property of the container or the product.

Drug and excipients compatibility

Complete characterization and physicochemical interaction of active pharmaceutical ingredient with that of the excipients are carried out at ADEPT to ensure consistent efficacy, stability and safety. Drug excipients compatibility (DEC) studies data is mandatory for investigational new drug (IND) application for USFDA. We here at ADEPT perform the following testes to address the complex DEC related issues leading to physical and chemical instability of the formulations.

Thermal Methods of Analysis

  • Differential Scanning Calorimetry (DSC)
  • Thermo gravimetric analysis
  • Differential thermal analysis
  • Isothermal micro calorimetry
  • Hot stage microscopy (HSM)

Spectroscopic Techniques

  • Vibrational spectroscopy
  • Powder X-ray diffraction (PXRD)
  • Solid state nuclear magnetic resonance spectroscopy (ss NMR)
  • Near Infrared spectroscopy
  • Fourier transforminfrared spectroscopy (FTIR)
  • High performance liquid chromatography (HPLC)

Microscopic Techniques

  • Scanning Electron Microscopy (SEM)
  • Transmission Electron Microscopy (TEM)
  • Log P and Log D

Formulation and Development
We are integrated formulations and development service provider for our clients ensuring End to End clarification. We provide solutions to all types challenges occurs in drug development and formulation/ method development etc. to unstable drug candidates (Majorly ester and amide linked molecules). We are proficient in:

  • New drug delivery system (NDDS)
  • Liposomes and Na