Our Services & Capabilities
MERGING CLASSICAL PHARMACEUTICS WITH CUTTING-EDGE
INNOVATION AND TECHNOLOGY
Preformulation Services
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API Physical and Chemical Characterization
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Excipient Compatibility Studies conducted with multiple API’s if necessary and excipient functionality categories
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Particle Size Distribution
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Polymorph screen studies
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Partition coefficient studies
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Thermal analysis interpretation
Formulation Development
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High Shear wet granulation
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Hobart “medium” shear wet granulation
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Fluid Bed top spray wet granulation
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Fluid Bed bottom spray wet granulation
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Fluid Bed drying multiple units
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Dry Granulation/Roller compaction
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V-shell dry blending
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Octagonal Bin tumbler dry blending
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Encapsulation via various techniques
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Coating via conventional pan & bottom spray wurster techniques
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Bi-layer fully instrumented tableting with micro-tablet capabilities
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Lyophilization capability
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Lightnin type impeller mixers, homogenizers and various mixing vessels for liquid and semi-solid dosage forms
Formulation Support
& Analytical Development
• Analytical method development for stability-indicating methods via HPLC
• Stability storage at ICH condition via various analytical techniques testing developed products both physically and chemically
• Stability studies conducted under protocol with stability calendars
• Stability chambers 25°C/60% RH, 30°C/65% RH, 40°C/75% RH.
Custom conditions can be utilized at client’s request.
Pilot Scale
& Clinical Manufacturing
• Solid oral (tablet, capsule). Tablets in multiple platforms including multi-layer and micro. Capsules in both solid fill and multi-particulate. Micro-tablets in capsules
• Liquid oral (solution, suspension and emulsions)
• Topical (lotions, ointments, creams and gels)
Packaging
• Universal Packaging Systems, Inc. unit dose blister pack machine.
• Solids, liquids and semi-solids manual operation for small studies with automated units to be acquired as needed.