MERGING CLASSICAL PHARMACEUTICS WITH CUTTING EDGE INNOVATION AND TECHNOLOGY

AM-IMG_9402-scaled

PREFORMULATION SERVICES

• API Physical and Chemical Characterization
• Excipient Compatibility Studies conducted with multiple API’s if necessary and excipient functionality categories
• Particle Size Distribution
• Polymorph screen studies
• Partition coefficient studies
• Thermal analysis interpretation

DEA License #RB0589537

FDA Reg # 3015234532 and DBPR # 20380

LG-IMG_9404-scaled

FORMULATION DEVELOPMENT STUDIES

• High Shear wet granulation
• Hobart “medium” shear wet granulation
• Fluid Bed top spray wet granulation
• Fluid Bed bottom spray wet granulation
• Fluid Bed drying multiple units
• Dry Granulation/Roller compaction
• V-shell dry blending
• Octagonal Bin tumbler dry blending
• Encapsulation via various techniques
• Coating via conventional pan & bottom spray wurster techniques
• Bi-layer fully instrumented tableting with micro-tablet capabilities
• Lyophilization capability
• Lightnin type impeller mixers, homogenizers and various mixing vessels for liquid and semi-solid dosage forms

CoVer bottle IMG_0965

FORMULATION SUPPORT AND 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 AND 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)

boxes

pills

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.