We provide following pre-formulation support services needed at various stages of drug product development.
· HPLC’s equipped with UV-Vis., PDA, Refractive Index (RI) and Fluorescence Detection Capabilities
and Fraction collectors.
· Thin Layer Chromatography.
· USP Dissolution Apparatus (USP Apparatus
1 and 2) and Modified In-Vitro Release Apparatus for Different New Dosage forms and Devices containing pharmaceutically active substances.
· Disintegration Tester
· UV-Visible Spectrophotometer (Single Beam and Double Beam)
· Stability Chambers
at 2°C to 8°C, -20°C, 25°C/60%RH, 30°C/65%RH, 40°C/75%RH and chambers to meet Custom conditions needed by clients.
· Differential Scanning Calorimeter (DSC)
· Scanning Electron Microscope (
· Malvern Particle
Size Analyzer.
· Osmometer
Ø Solubility Screening and Enhancement:
v Solubility screening of drugs, effect of pH, ionic strength, and formulation composition on solubility.
v Solubility enhancement by use of cosolvents, solubilizing agents, inclusion complexing agents, hydrophilic agents, and lipid vehicles.
v Solubility enhancement by solid dispersions, and spray drying.
v Dissolution rate enhancement by nanomilling.
Ø Permeation Studies:
v Permeation of drugs across synthetic membranes, biologic tissues (porcine buccal, sublingual, intestinal, and cadaver skin), and cell lines (CaCo2 - human colon cancer cell line).
v Enhancement of permeation by manupulation of vehicle pH, and surfactants.
Ø Moisture Uptake / Hygroscopicity:
v Moisture content by Karl-Fisher titration, and screening of powders and granules for moisture uptake.
Ø Thermal Analysis:
v Evaluation of drug-drug or drug-excipient interactions based on changes in polymorphs and/or melting point.
Ø Surface Morphology and Particle Size Analysis:
v Analysis of surface morphology of micronized particles by scanning electron micrography. Size and zeta potential of micron and submicron particles or emulsion globules by light scattering technique.
Ø Granules Characterization:
v Physical characterization of granules for bulk density, tapped density, compressibility, flow nature, moisture content, moisture uptake / hygroscopicity, sieve analysis, and compaction.
Ø Compatibility Studies:
v Evaluation of drug-drug or drug-excipient interactions based on thermal and chromatographic analysis.
Ø Physical Stability of Disperse Systems:
v Evaluation of physical stability of emulsions and suspensions by microscopic and sedimentation methods.
Ø Bioadhesion Testing:
v Screening of bioadhesive properties of polymers with synthetic or biologic tissues; Enhancement of bioadhesion and wetting properties of high molecular weight polymers; In vitro screening of gastroretention time.
Ø Nano-Sizing:
v Size reduction of particles by milling and evaluation of physical stability of dispersions.