Pharmacy Courses

Process Optimization of Pharmaceutical Products


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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