GRAM Laboratories, Inc.
One
of our major strengths is in the efficient development of a clinically relevant
and more stable formulation. This is
made possible because of the knowledge gained from preformulation evaluation.
Formulation studies are customized to achieve the most appropriate formulation
in a timely and cost efficient manner. Based on the desired dosage form, key elements of formulation development studies are selected from the following list of studies.
- Compatibility
with Manufacturing Components
- Compatibility
with Primary Packaging Components
- Mixing
Studies
- Order
of Addition
- D-value
and Z-value Determination
- Autoclave
Feasibility at various Fo
- Lyophilization
Cycle Development Studies
- Filter
Qualification and Validation Studies
- Extractables
and Leachables Study
- Admixture
Compatibility Studies
- Photostability
Studies
- pH
Range Studies
- Headspace
Oxygen Study
- Residual
Moisture Stability Studies
- Zeta
Potential Determination
- Particle
Size Distribution Studies
- Suspension
and Emulsion Stability Studies
- Dissolution
Studies
- Manufacture
of Prototype Batches
- Short
Term Accelerated Stability Evaluation
- Statistical
Analysis of Stability Data
- Establish
Draft Component Specification
- Establish
Draft Manufacturing Process Specification
- Establish
Draft Product Release Specification
- Establish
Draft Product Stability Specification
SERVICES: Formulation Development
