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Pre-Formulation Services

We provide following pre-formulation support services needed at various stages of drug product development.

Pre-Formulation Services

Formulation Services

Analytical and Stability Services

Clinical Manufacturing Services

Key Capabilities:
 

·    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 (SEM)

·    Malvern Particle Size Analyzer.

·    Osmometer

Services:
 

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.