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Process optimization means the optimization of a process with considering all of the possible critical parameters. It is also a documented verification that the process and/or total process related system performs as intended throughout all anticipated operating ranges.
In this article we try to briefly mention the critical parameters of solid products to be optimized during a new product and process development.
Before going to conduct an optimization batch in pharmaceutical industry following steps should be taken:
- Defining a quality target product profile (QTPP) as it relates to quality, safety and efficacy (for example: the route of administration, dosage form, bioavailability, dosage, and stability).
- Identifying critical quality attributes (CQAs) of the drug product, so that these characteristics can be studied and controlled.
- Identifying the critical process parameters (CPPs) to assess and identify the control strategy.
- Determining the quality attributes of the drug substance and excipients, and selecting the right excipients to deliver drug product of the desired quality and efficacy.
- Selecting an feasible and appropriate manufacturing process with necessary precautions.
Process Optimization in Pharmaceutical Manufacturing
Granulation Stage Optimization
- Granulation time
- Speed of choppers (I & II) or mixer blades
- Solvent addition rate and overall amount
- Ratio of intra-granulate Disintegrant and binders agents
- Milling Configuration, Screen size and speed
- Evaluation of optimized granules (BD, TD & PSD)
- Drying temperature versus target LOD and range limits and the effect on granulate and tablet properties (flow, capping, sticking)
Blending Stage Optimization
- Effect of level of lubricant: Lubricant Split into two parts (pre-blending and final blending).
- Effect of Blending Time and Speed
Compression Stage Optimization
- Evaluation of Content Uniformity and Dissolution Profile
- Evaluation of unit dose sampling vs. Content Uniformity
- Effect of hardness on tablet properties (Aging, dissolution, friability)
- Evaluation of Hardness Range Limits
- Evaluation of stability results of optimized mfg. process
Coating Stage Optimization
- Evaluation of spray rate, pan speed, weight gain and physical appearance
- Evaluation of %LOD before spraying and after drying
Process Optimization Report
- Prepare a process optimization report covering all critical parameters challenge study data
- This report is a part of the Product Development Report
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