Our dedicated team of scientists have their core training in the area of preformulation and have expertise in the complete pharmaceutical profiling of molecules.

Preformulation Services:

• Polymorph screening and selection
• Salt form selection
• Crystalline properties
• pH solubility and stability
• Solid-state and solution-state stability
• Photostability
• pKa and partition coefficient determination
• Hygroscopicity
• Morphology assessment
• Solubility studies
• Intrinsic dissolution
• Excipient compatibility
• Leachables and Extractables studies
• Flowability
• Particle size determination by laser lights
• Container – active pharmaceutical ingredient (API)  interactions

Capabilities:

• Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
• Dynamic Vapor sorption/desorption
• NMR (Nuclear Magnetic Resonance)
• pXRD (X-Ray Diffraction)
• FT-IR (A Fourier Transform Infrared) spectrometer Capillary Electrophoresis
• SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
• Potentiometer
• Hot-stage Microscopy
• Laser light diffraction Particle size analyzer
• Intrinsic dissolution
• Head Space GC analyzer

Our scientists use Quality-By-Design (QbD) tools at all stages of formulation development. Design of experiments (DOE) along with risk assessment strategies allows us to design our experimental plan. Our development approach allows us to meet our delivery timelines and helps us in providing our clients with cost-effective drug delivery solutions.

Dosage forms:

• Tablets : Immediate-release, Sustained-release, Delayed-release, Film-coated
• Capsules : Powder, Granule filling
• Pellets : Into tablets or Capsule filled
• Powders : Powder in a bottle
• Liquids : Solutions, Suspensions, Emulsions
• Semi-solids : Creams, Ointments, Gels, Lotions

New offering:

• Nanotechnology
• Hot melt extrusion
• Parenterals

Our extensive formulation development services and capabilities include

• Formulation development for early safety studies
• Prototype formulations for clinical trials
• Prototype formulation screening studies
• Formulation / process optimization
• Preliminary process identification
• Commercial formulation development for NME’s, ANDA’s and OTC’s
• Process development optimization
• Scale up / technology transfer

Equipment and process capabilities:

• Direct tablet compression
• Fluid bed processing (granulation, drying, coating)
• High shear wet granulation
• Dry granulation (roller compaction, slugging)
• Extrusion spheronization
• Perforated pan tablet coating
• Automated capsule filling (powder, granules, pellets)
• Spray drying
• Microencapsulation
• Low humidity / moisture requirements
• Taste-masking
• High potency compound handling
• Instrumented tablet press

Analytical research and development (AR&D) offers standalone services and supports our formulation development activities. The AR&D teams are integrated with preformulation, product development and quality assurance teams to ensure effective and accelerated product development. Our experience in developing methods for highly complex and unstable drug products compliments our formulation capabilities.

Equipment and Capabilities :

• HPLCs with photodiode array detectors
• Head space GC analyzer
• FT-IR (A Fourier Transform Infrared) spectrometer
• NMR (Nuclear Magnetic Resonance)
• pXRD (X-Ray Diffraction)
• Thermal analysis: DSC (Differential Scanning Calorimetry), TGA (Thermogravimetric Analyzer)
• Dynamic vapor sorption/desorption
• Capillary electrophoresis
• SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscope)
• Potentiometer
• Laser light diffraction particle size analyzer
• Intrinsic dissolution

Microbiology
We offer a wide range of compendial and non-compendial testing services. Our microbiology laboratories are designed to facilitate in-house studies as well standalone testing services for our clients.

Our core strengths include:

• Microbial Limit test
• Antimicrobial Efficacy test
• Environmental Monitoring
• Water chemical and microbial analysis
• Bacterial endotoxin test
• Antibiotics and vitamins assays
• Raw materials/excipients analysis as per BAM (Bacteriological Analytical Manual)
• Disinfectants analysis

Stability Testing
Aizant offers GLP compliant ICH stability testing services. We have dedicated stability chambers for informal (R&D) and registration (cGMP) stability. All our walk-in stability chambers are continuously monitored. We use 21 CFR Part 11 compliant software. An alert system, back up chamber and electricity back-up assures sample integrity. The following climatic zones are available:

• 5°C
• 25°C/60% RH
• 30°C/65% RH
• 30°C/35% RH
• 40°C/75% RH
• Photo stability chamber
• Customer specific conditions

Our extensive analytical development services and capabilities include

• API Characterization
• Method development, validation and transfer
• Stability studies
• Photo stability studies
• Analytical methods for cleaning verification and validation
• Dissolution and drug release profiling
• Forced degradation studies and stability indicating method development
• Specifications development
• Leachables and extractables studies
• Regulatory support