Formulation Development

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Featured Publication
Recent Options for Phase 1 Formulation Development and Clinical Trial Material Supply. By: Balaji V. Kadri - Featured in the August 2008 Issue of Pharmaceutical Technology







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Formulation


Services/Capabilities
Excipient compatibility
Formulation development of both NDA and ANDA dosage forms
Formulation troubleshooting and Process Development of existing dosage forms
Optimization of existing formulations
Quantitative and Qualitative evaluation of proprietary dosage forms


Formulation Dosage Forms


Liquid Dosage Forms
Development of dosage forms and preservative systems
Development and optimization, lyophilization


Semi-Solid Dosage Forms (oral, mucosal, topical)
Emulsions and micro-emulsions
Gels (aqueous, nonaqueous)
Gels (aqueous, nonaqueous)
Lipid solutions and suspensions


Solid Dosage Forms
Capsules (hard gelatin), (granulated or dilution blend)
Direct compression, dry and wet granulation, bead coating, lyophilization
Tablets (immediate release, modified release, sustained release, chewable, lozenge)


Topical Formulations
Creams, ointments
Gels, solutions
Lotions

Parenterals

Test


Physical Testing of Powders
Bulk and tap density
Particle size analysis
a. Laser diffraction
b. Sonic sifter


Physical Testing of Solids
Weight variation
Thickness
Hardness
Friability
Disintegration


Solutions, semi-solids
Osmolality
pH viscibility
Sedimentation
Viscosity
Brookefield RVOVIII
Rheometer


Equipment View PDF


Processing


Particle Sizing
Fitzpatrick Model J Mill
Quadro Comil, Model 197


Mixing
4L pressure vessel
4qt. and 16qt. Patterson-Kelly (P-K) V-blenders
Fisher lab high shear mixer
KitchenAid planetary mixer
Lightnin L1 U10 Mixer
Turbula T10B Mixer
Omni Lab Top Homogenizer


Tableting and Coating
Two (2) Stokes Rotary Tablet Presses, 16 station, type Bb tooling
Vector LDCS tablet coater with 11.5” and 15” perforated pan inserts
Carver single station press


Wet Granulation/Drying
Diosna Minilab fluid bed granulator/dryer w/ top spray insert and wurster column
Diosna P1/6 verticle high shear granulator w/ jacketed vessels, 1L and 6L


Encapsulation
Feton manual fill encapsulators sizes AA and 0-4
PAM Model MF-30
Schaefer Capsule Sealing Machine
CFS 1200 ™
IN-CAP® Capsule Filling Machine


In Process/Physical Testing
ATM Sonic Sifter
Flodex Flowability Index Test Instrument
Brookfield dial viscometer
Brookfield Digital Rheometer
Mettler Toledo Moisture Analyzer
Mitutoyo Thickness Gauge Tester
Ro-Tap Sieve Shaker
Vanderkamp and Optimal Hardness Testers
VanKel Disintegration Tester
VanKel Friabilator
VanKel Tap Density Tester


Transfer/Packaging
Baxa Repeater Pump
Lepel Lepak Jr Induction Sealer
MasterFlex Peristaltic Pump
Spring Torque tester


Miscellaneous
Consolidated Automatic Steam Sterilizer (Autoclave)
Flow Sciences HEPA Filter Hoods
Microfluidics Model 110 Microfluidizer
Advanced Instruments Model 3320 Osmometer




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