The University of Iowa Pharmaceuticals offers a full range of contract pharmaceutical services including solid dose pharmaceutical manufacturing.

 

Solid Dosage Forms

Lyophilization Cycle Development

 

Clinical Supply Manufacturing

 

Small Scale Commercial Manufacturing

 

Analytical Method Development and Validation

 

Routine Quality Control Analysis

 

Stability Assessment

 

Formulation Development

 

Comparator Products

 

Powder in a Bottle

 

Preformulation Studies

 

Active Pharmaceutical Ingredient (API) and Excipient Release Testing

 

QP Release Services

 

EncapsulatingSolid Dosage Form products

The University of Iowa Pharmaceuticals’ (UIP) Solid Dosage Formulation Products area has four suites: one suite is dedicated to tablet and capsule coating, two suites are dedicated to the handling of potent/cytotoxic compounds, and one suite is divided into four separate manufacturing rooms and is designed for handling less potent/toxic materials.

 

 

 

 

  • Each solid dose pharmaceutical manufacturing room has its own gowning/entry way that opens from a central staging area.
  • Differential air pressures and single pass air, along with other measures including cleaning verification, are used to prevent cross-contamination. 
  • Special protective suites, wireless intercoms, and supplied air respirators are used to protect employees from exposure to potent/toxic materials.  
  • The Solid Dosage Forms area is supported with a clean, dry compressed air system and a hot loop USP Purified Water system. 
  • All incoming air is HEPA filtered and humidity controlled and exhausted air is double HEPA filtered.

 

Tablet PressThe Solid Dosage Formulation Products Group has the capability to produce tablet and capsule dosage forms using a variety of processes. Batch sizes can range from a few hundred to the hundreds of thousands of dosages units, depending on the dosage form unit weight and formulation blend density.

Processing techniques available to prepare products include:

  • Screening, Milling or Micronizing
  • Roller Compaction
  • Low or High Shear Wet Granulation
  • Fluid Bed Granulation or Coating
  • Fluid Bed or Conventional Drying
  • Holt Melt Capsule Filling
  • Tablet or Capsule Pan Coating
  • Low or High Shear Blending
  • Capsule Banding

 

V-BlendingOnce dosage forms are produced, UIP can sort them by weight to ensure the weight of every dosage unit is within the specified weight range. UIP has the ability to package finished products into bottles or bulk containers and apply labeling as desired. Clinical kits can be assembled and materials shipped directly to clinical sites.  UIP is fully capable of preparing comparator products via a variety of means.   

 

 

 

For more information about our solid dose pharmaceutical manufacturing and packaging capabilities please, Contact Us or view our Full Equipment List here.